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The study is conducted by:

This is the first blood test ever to receive FDA breakthrough device approval for detecting amyloid plaques. It represents a major shift: from decades of research use to a regulated clinical tool that can now support earlier and more accessible clinical decision-making. Important to note, this test does not provide a diagnosis on its own, its results must be integrated with the results of a clinical assessment to reach a diagnosis.


FDA regulatory approval rested on a multi-centre study involving 499 people with cognitive impairment. Participants received both the blood test and either an amyloid PET scan or CSF test, the two validated and clinically used tests for amyloid pathology. The test showed strong alignment with those gold standard methods: 91.7% of positive blood tests matched with amyloid-positive results, and 97.3% of negative tests matched with amyloid-negative findings. Simply put, when the test said “yes” or “no,” it was right most of the time. Only around 1 in 5 participants fell into an indeterminate or so-called grey zone, where the results are inconclusive, however, newer studies suggest this number can be reduced further by using a method known as dual cut-offs approach. 

What does it mean for clinical practice? 

This test is not a replacement for existing diagnostics. Rather, it serves as a triage tool to guide decisions on whether more invasive and costly procedures like PET and CSF are necessary. It could be especially useful in primary care and in areas with limited access to PET imaging or where lumbar puncture is not possible. 

Additionally, it may also support the timely identification of candidates for anti-amyloid treatments like the recently approved Leqembi (lecanemab), which are only suitable for people in the early stages of the disease. 

That said, the test is not approved for use in people without symptoms and is not suitable for general population screening, because false positives or negatives, although infrequent, can still mislead.  

The test is currently cleared only in the U.S., with use limited to individuals aged 55 or older who already show signs of cognitive decline. It is not yet available in Europe, as the European Medicines Agency (EMA) will need to conduct its own assessment of the evidence. 

For the REAL AD study, these developments are pivotal. This new FDA decision directly supports the scientific and clinical premise of REAL AD: that Alzheimer’s pathology markers can reliably be measured with a simple blood draw. 

It marks a turning point in the field, reinforcing that blood-based tests have crossed from research tools to validated clinical aids. As these tests become available in more healthcare settings, it becomes essential to understand how they perform outside of specialist clinics and how they can be combined with other tools to support early diagnosis at scale. 

That is precisely the ambition of REAL AD. We are generating evidence on how these technologies work in real-world settings. As health systems prepare to roll out disease-modifying therapies, our work will help show whether accessible blood testing and digital assessments can be used to reach the right people at the right time. 

Read the FDA statement: https://www.fda.gov/news-events/press-announcements/fda-clears-first-blood-test-used-diagnosing-alzheimers-disease 

Read the Alzheimer’s Association statement: https://www.alz.org/news/2025/fda-clears-blood-test-alzheimers-diagnosis 

FDA clears the first blood test for Alzheimer's pathology detection 

When we think of Alzheimer’s disease, we often picture forgetfulness - lost keys, repeated stories, or missed appointments. But what is less talked about is the emotional and psychological weight carried by those living with Alzheimer’s, and those who love and care for them. That is why now during Mental Health Awareness month, we want to shed extra light on this.

Alzheimer's Association. (n.d.). Depression and Alzheimer's. Retrieved from https://www.alz.org/help-support/caregiving/stages-behaviors/depression

Richmond-Rakerd, L. S., D’Souza, S., Milne, B. J., Caspi, A., & Moffitt, T. E. (2022). Longitudinal Associations of Mental Disorders With Dementia: 30-Year Analysis of 1.7 Million New Zealand Citizens. JAMA Psychiatry, 79(4), 333-340. https://jamanetwork.com/journals/jamapsychiatry/fullarticle/2789298

National Institute on Aging. (2022). Mental Disorders Linked to Increased Risk of Dementia in Earlier Life. Retrieved from https://www.nia.nih.gov/news/mental-disorders-linked-increased-risk-dementia-earlier-life

A diagnosis can trigger depression and anxiety, particularly as people become aware of the changes happening to their brain and life. These emotional symptoms are common, especially in the early and middle stages of the disease. Some may experience:

Loss of interest in previously enjoyed activities

Worries about the future, or fear of being a burden

These are not just reactions - they are real mental health conditions that deserve care and attention. Read more here.

The brain-mood connection: What the science says

It is not just the emotional toll of a diagnosis. Emerging research suggests that Alzheimer’s pathology may itself contribute to psychiatric symptoms like anxiety, apathy, and depression.

A 2024 study from Lund University found that Alzheimer's related biological changes in the brain - such as amyloid plaques and tau tangles - appear to be directly linked to mood and behavioral symptoms, even before memory loss becomes severe. This reinforces what many families already know: the disease affects more than cognition - it touches the whole person. Read the study here.

The other side of the mirror: Caregiver mental health

While the person with Alzheimer’s faces one kind of battle, caregivers face another. Many are spouses, children, or close friends - people who watch someone they love change before their eyes.

Caregiving can be emotionally draining. It often leads to:

This is a mental health issue too. According to studies, caregivers of people with Alzheimer’s are significantly more likely to experience anxiety and depression. But too often, they put their own well-being last. This Mental Health Awareness Month, we want to remind caregivers: your health matters too.

Mental health earlier in Life - and the risk for Alzheimer’s

The relationship between mental health and Alzheimer’s is not only reactive. Research now suggests it may be bidirectional.

A study from the National Institute on Aging (UK) showed that people with mental health conditions earlier in life - such as depression, anxiety, and PTSD - are at higher risk of developing dementia, including Alzheimer’s, later on. These findings highlight how closely brain and mental health are intertwined across the lifespan. Read more here.

Breaking the silence, building Compassion

As we shine a light on mental health this month, let us not forget Alzheimer’s. Let us talk openly about the depression that can follow a diagnosis, the apathy and anxiety that may be part of the disease itself, and the silent suffering of caregivers.

Listen without judgment to those living with Alzheimer’s or caring for someone who is.

Encourage counseling or support groups for both patients and caregivers.

Advocate for dementia-inclusive mental health care.

Check in on friends or neighbors going through this journey.

Beyond memory: Alzheimer’s and mental health

On 15th of April, the European Commission granted EU‑wide marketing authorisation for Leqembi (lecanemab), the first medicine in Europe that targets the disease process underlying Alzheimer’s rather than simply easing its symptoms. The decision follows the European Medicines Agency’s positive opinion last November and takes immediate effect across all EU and EEA countries. 

What does this mean? 
This is big news as Leqembi becomes the first approved so-called disease-modifying treatment for early-stage Alzheimer's disease in Europe – a significant step forward for the more than 160 000 people in Sweden and the millions more across Europe who live with the condition. 

What is Leqembi? 
Lecanemab (Leqembi®) is an antibody given by intravenous infusion every two weeks. It binds to amyloid‑beta protein – a toxic protein that forms sticky plaques in the brains of people with Alzheimer’s, helping the body clear the plaques that gradually cause brain cell damage. By removing these plaques early in the disease progression, this treatment aims to preserve memory and thinking abilities for longer. In the clinical trial, individuals that were receiving this drug declined less in their memory functions than those who received placebo. 

As a side note, the science behind Leqembi began with research by Swedish professor Lars Lannfelt and colleagues at Uppsala University. 

Who can receive it – and why the restrictions? 
It is important to highlight that the treatment will only be provided for adults who are: 

In the very early stages of the disease (mild cognitive impairment and mild Alzheimer’s) 

Harbour amyloid-beta in the brain which is confirmed by a positive Positron Emission Tomography (PET) scan 

Carry one or no copies of ApoE4 gene.  

People with two copies of ApoE4 are excluded because they face a higher risk of amyloid‑related imaging abnormalities (ARIA) such as brain swelling or tiny bleeds on MRI scans. 

If you want to learn more about Leqembi, please read our previous article to gain more insights about the clinical evidence on the benefits and potential adverse effects.  

What happens next? 
From this moment on, each member state will make decisions regarding the funding and national reimbursement strategies of Leqembi. Health‑technology assessments and price negotiations will take time, so access is likely to differ across countries. Hospitals will also require additional resources for the infrastructure and training of staff, before the treatment can be rolled out. 

Read the Commission statement: https://ec.europa.eu/newsroom/sante/items/879055 European Commission 

Read Alzheimer Fonden : https://www.alzheimerfonden.se/nyheter/eu-godkaenner-nu-foersta-bromsmedicinet-leqembi-foer-behandling-av-tidig-alzheimers-sjukdom/ 

Read the press release from BioArctic https://www.bioarctic.com/sv/eu-godkanner-leqembi-lecanemab-for-behandling-av-tidig-alzheimers-sjukdom/

First disease-modifying drug Leqembi now approved for the treatment of early Alzheimer's disease in Europe

This year’s AD/PD conference (International Conference of Alzheimer's and Parkinson's Disease and Related Neurological Disorders) was marked by an impressive breadth of clinical research and a clear focus on the real-world implications of diagnostics and emerging treatments. With a program rich in translational science and practical takeaways, the meeting underscored how far the field has come—and how much opportunity still lies ahead in bridging discovery and care.

A highlight was the annual Alzheimer’s drug pipeline review by Jeffrey Cummings, which offered a comprehensive and forward-looking snapshot of where the field is headed. This year, there was notable attention on repurposed anti-inflammatory compounds, further strengthening the case for immune modulation as a viable therapeutic avenue in Alzheimer’s disease.

The conference also put a spotlight on therapies already approved in the United States but not yet adopted in Europe, sparking important conversations about access, regulatory divergence, and the pace of implementation across regions. These discussions emphasized the need for global alignment in translating innovation into clinical practice.

Important differences in sex-based biology—and how they relate to increased vulnerability to AD among females—were also discussed, reinforcing the urgent need to tailor prevention and treatment strategies based on sex and gender differences in disease risk and progression.

In the biomarker space, we saw exciting progress across proteomics (a field dedicated to measuring all the proteins in a sample simultaneously) and fluid markers, including novel MTBR-243, with promising candidates for early detection and stratification being shared.

Digital biomarkers were also front and center. In a particularly impactful talk, Rhoda Au described digital biomarkers as “the new blood,” pointing to their scalability and potential to enable continuous, real-time monitoring of brain health—a paradigm shift in how we think about early detection and long-term disease management.

Other highlight sessions included a forum on integrating fluid and imaging biomarkers with digital tools and AI, as well as a session on incorporating biomarkers into routine patient care to support timely diagnosis. There was a strong overarching focus on how diagnostics can be effectively integrated and implemented to realize their full potential in real-world clinical settings.

REAL AD was proud to contribute to this growing momentum. Project Manager Iris Bosch presented a poster on the REAL AD study, highlighting the challenges and achievements of conducting a fully remote preclinical Alzheimer’s disease screening study. The presentation focused on three key themes:

Multi-stakeholder collaboration across research, healthcare, public, and private sectors

Operational insights into running a fully remote study—from setup to data collection

Strategies to maintain participant engagement and minimize dropout over time

David Berron shared early findings from analyses using neotiv cognitive performance data.

In the session Fluid Biomarkers and Imaging, Dr. Sebastian Palmqvist (Lund University) and Dr. Michael Schöll (University of Gothenburg, study leader, REAL AD) shared new insights into the application of fluid biomarkers alongside neuroimaging. Dr. Palmqvist presented findings from a study evaluating a fully automated blood test in both primary and secondary care settings. Dr. Schöll presented preliminary baseline results from the REAL AD study. These initial findings underscore the potential of combining fluid biomarkers with digital tools to enhance early detection and monitoring of Alzheimer’s disease. Looking ahead, Dr. Schöll emphasized the importance of longitudinal data to assess the predictive value of these biomarkers over time and their role in guiding therapeutic interventions.

Both speakers stressed the critical need to translate biomarker discoveries into clinical practice. Their presentations underscored the potential of combining fluid biomarkers with imaging and digital tools to create a comprehensive, accessible, and effective diagnostic framework for Alzheimer’s disease.

The session Biomarkers in Clinical Use Across Dementias further illustrated the growing acceptance and clinical relevance of biomarkers across a broader range of neurodegenerative conditions. Kaj Blennow’s talk on the integration of blood and CSF biomarkers in the diagnostic workflow of patients with early cognitive symptoms emphasized the real-world utility of these tools and how they are reshaping early diagnostic pathways.

These presentations from the REAL AD team provided exciting initial insights, and we look forward to sharing more results once analyses are complete.

Overall, AD/PD 2025 served as a powerful reminder that innovation in Alzheimer’s research is accelerating—and that the challenge now lies in translating these advances into equitable, effective primary care. At REAL AD, we remain committed to driving that translation forward through collaboration and a patient-focused mission.

AD/PD 2025 Reflections: Translating Discovery into Clinical Impact

We spend about a third of our lives asleep, so it is no surprise that sleep is essential for both physical health and cognitive wellbeing. But it is not just about getting enough hours—sleep quality, timing, regularity, and depth all play vital roles, especially as we grow older.  

Sleep plays a fundamental role in supporting nearly every system in the body. It contributes to energy conservation, allowing the body to restore and recharge, and plays a key role in regulating the immune system, maintaining resilience against infections and inflammation. Sleep also supports physical development, tissue repair, and the balance of key metabolic and hormonal processes. It is a critical regulator of emotional wellbeing, helping us manage stress, stabilise mood, and process emotional experiences. 

Beyond these functions, sleep is also an essential pillar of cognitive health, orchestrating learning and memory consolidation—integrating new information and stabilising it into long-term memory—and contributing to overall brain maintenance. 

Although our bodies rest during sleep, the brain remains remarkably active. One of the most fascinating discoveries in neuroscience in recent years was the identification of the glymphatic system—a specialised waste clearance network unique to the brain. Similar to the lymphatic system in the rest of the body, the glymphatic system is made up of an intricate network of channels, uniquely supported by the brain’s support cells, the glial cells—hence the name “glia” + “lymphatic.” This system becomes particularly active during deep slow-wave sleep, functioning like a dishwasher for the brain, helping to rinse away waste products that accumulate during waking hours—including amyloid-beta and tau proteins, which are hallmark features of Alzheimer’s disease. When sleep is disrupted or insufficient, this vital cleaning process becomes less efficient, allowing these toxic substances to build up over time and potentially increasing the risk of neurodegeneration. 

Understanding the Architecture of Sleep 

Sleep is composed of a highly organised sequence of events/stages that repeat in cycles lasting approximately 90 minutes. These cycles alternate between two main types of sleep: Non-Rapid Eye Movement (NREM) sleep and Rapid Eye Movement (REM) sleep. 

NREM sleep consists of three stages, progressing from light sleep (Stage N1 and N2) to deep sleep (Stage N3)—also known as slow-wave sleep. This deepest stage is important for physical restoration, immune regulation, and memory consolidation, particularly for strengthening declarative memory—that is, factual information, events, and knowledge. It is also associated with synaptic downscaling, helping the brain filter out less relevant information and reset for new learning. Additionally, research has shown that the glymphatic (brain washing system) is predominantly active during this stage. 

During REM sleep, the brain becomes highly active—nearly as active as during wakefulness—while the body enters a state of temporary muscle paralysis, known as muscle atonia, which prevents us from physically acting out dreams. The only muscles that remain active are those involved in breathing and eye movement, resulting in the rapid eye movements that give this stage its name. REM sleep plays a critical role in emotional memory processing, creativity, procedural and motor skill learning, and brain plasticity—the brain’s unique ability to reorganise, form new connections, and integrate new experiences. 

Like many biological processes, sleep also changes with age—independent of health conditions or medications. 

Common age-related sleep changes include: 

More frequent awakenings during the night 

Decreased time spent in deep (slow-wave) sleep 

These changes can make it more difficult to feel well-rested and may also influence brain health over time. 

In the later stages of Alzheimer’s disease, sleep disturbances are common which is thought to result from damage to the brain systems that regulate the sleep–wake cycle. 

However, emerging research now suggests that poor sleep may not only be a consequence of Alzheimer’s disease—it may also contribute to its development. 

As we now understand that changes in the brain linked to Alzheimer’s disease can begin decades before any memory symptoms appear—a period known as the preclinical phase—studying this early stage is crucial. It can help us uncover which factors may contribute to increased risk and enable earlier identification of individuals who may be more vulnerable to disease progression. 

Emerging research suggests that people with poor or irregular sleep tend to have higher levels of beta-amyloid and tau proteins in the brain—key markers of Alzheimer’s pathology. In addition, disrupted sleep, particularly a reduction in deep (slow-wave) sleep, has been associated with reduced brain structural integrity and increased neuroinflammation, which may accelerate neurodegenerative processes over time. 

What Is the REAL AD Study Investigating? 

In the REAL AD study, we are exploring how sleep patterns relate to key Alzheimer’s disease biomarkers, brain structure and function, memory performance, and overall brain health. 

With your support and participation, we aim to answer important questions such as: 

Can disrupted sleep indicate early biological changes in the brain? 

Could better sleep help slow down the accumulation of Alzheimer’s-related proteins? 

How does sleep interact with other factors like genetics, hormones, lifestyle, and brain ageing trajectories? 

While scientists continue to investigate the precise mechanisms, there is already strong evidence that healthy sleep habits support brain health at every age. Here are some practical steps you can take: 

Aim for seven to nine hours of sleep per night 

Keep a regular sleep schedule, even on weekends 

Create a dark, quiet, and cool sleep environment 

Get exposure to natural daylight, especially in the morning 

Reduce screen time and caffeine and alcohol intake in the evening 

Seek medical advice if you experience snoring, insomnia, or persistent daytime tiredness 


Sleep is more than just rest—it is a powerful tool for protecting your brain. Consistently good sleep supports brain function, promotes healthy ageing, and may help lower the risk of Alzheimer’s disease—even before any symptoms appear. 

Thank you for your continued contribution to the REAL AD study—you’re helping us unlock new pathways to early detection, prevention, and healthy brain aging. 

Why Sleep Matters for Brain Health — and Alzheimer’s Disease Prevention

Introduction to Alzheimer's disease
Alzheimer's disease (AD) is a progressive neurodegenerative disorder that affects the brain and leads to problems in memory, thinking skills, and changes in behaviour. It is the most common form of dementia, affecting over 55 million people worldwide—a number expected to nearly triple by 2050. In Sweden alone, AD accounts for 36.6% of dementia cases diagnosed in specialist units, while the overall dementia estimates range between 130,000 and 150,000 (Seyed-Mohammad Fereshtehnejad et al., 2015; Lingren et al., 2021). While exact prevalence rates for AD alone are not always specified, these figures suggest that a substantial proportion of dementia cases in Sweden are likely due to Alzheimer’s disease.

As the population continues to age, the number of people affected is expected to rise, making early detection and better treatment options increasingly important.

Alzheimer's disease develops slowly over time, beginning with a preclinical stage, during which harmful proteins start to accumulate in the brain, yet in the absence of any symptoms. This silent phase can last for up to a few decades. Over time, mild cognitive impairment (MCI) emerges, marked by subtle memory and thinking difficulties that do not yet interfere with daily life. In the final Alzheimer’s dementia stage, severe memory loss, confusion, and difficulty with daily tasks take hold, often accompanied by mood and personality changes.

At the core of the disease are two key pathological hallmarks / proteins:

Amyloid beta (Aβ) which forms sticky plaques outside the brain cells (called neurons) which leads to the disruption of proper neuron communication.

Tau that builds inside neurons forming tangles which also results to brain cell death and cognitive decline.

Several risk factors have been identified that influence the risk of developing AD. These risk factors can be grouped into two main categories based on whether they can be changed or not (Livingston et al., 2024).

Non-modifiable risk factors – those that cannot be changed, such as increasing age, female sex, familial history of AD, and genetic predisposition (carriership of APOE e4 gene).

Modifiable risk factors – These are aspects of health and lifestyle that can be adjusted to help lower the risk of AD. They include heart health factors like high blood pressure and diabetes, exercise, healthy diet, as well as mental and social well-being, such as staying mentally active and maintaining strong social connections.

Current Diagnostics
Currently, diagnosing AD involves a set of procedures that vary depending on the level of care. In Sweden, the diagnostic process typically begins in primary care, where 50–80% of cases are identified using basic cognitive tests and computed tomography (CT) scans. These tests assess thinking abilities such as memory, attention, reasoning, and more complex tasks like mental flexibility. However, while widely used, they are not specific to AD and may miss early signs of the disease.

More advanced diagnostic tools are available in specialist units, including brain imaging techniques like magnetic resonance imaging (MRI) and positron emission tomography (PET) scans, as well as cerebrospinal fluid (CSF) analysis obtained via lumbar puncture. These methods allow for the direct measurement of toxic AD proteins in the brain, providing a more accurate diagnosis. However, they are invasive, time-consuming, costly, and often associated with long waiting times due to limited specialist resources. As a result, many patients face delays in receiving a definitive diagnosis.

To improve early detection and patient access to care, there is a growing need for simple, cost-effective, and disease-specific diagnostic methods that can be integrated into primary care settings. This would help ensure that more individuals receive timely and accurate diagnoses, allowing for earlier intervention and better disease management.

What are the Blood-based Biomarkers (BBMs)? 
Blood-based biomarkers are the indicators in the blood which inform about the presence of toxic proteins (molecules). They offer a new, highly sensitive way to detect proteins in the blood that are linked to Alzheimer’s disease, even in its early stages. With a simple blood test, scientists can measure key proteins associated with the disease, making early detection more accessible and less invasive than traditional methods.

Alzheimer’s disease-specific markers in the blood include proteins closely linked to the disease, such as the amyloid beta 42/40 ratio (Aβ42/40) and phosphorylated tau (p-tau). The Aβ42/40 ratio reflects changes in amyloid beta levels, which are associated with plaque buildup in the brain, while p-tau has emerged as a highly reliable indicator of Alzheimer’s-related brain changes.

A major part of the research and development of blood-based biomarkers for Alzheimer’s disease has taken place in western Sweden, specifically at the Neurochemistry lab of the University of Gothenburg, led by Professors Kaj Blennow and Henrik Zetterberg. Their work has been instrumental in advancing the field, helping to refine and validate these biomarkers for potential use in clinical settings. As research continues, blood tests could become a game-changing tool for earlier and more accessible Alzheimer’s diagnosis.

The advantages of blood-based biomarkers over traditional diagnostic methods
Currently, diagnostic methods specific to Alzheimer's disease are primarily available within specialised healthcare settings, which are limited in resources and geographically restricted. Additionally, existing techniques such as MRI, PET, and cerebrospinal fluid (CSF) analysis are costly, invasive, and burdensome. In contrast, blood-based biomarkers offer a non-invasive, cost-effective, and accessible alternative with high disease specificity. Their ease of implementation in primary care settings makes them a promising tool for improving early detection and diagnosis of Alzheimer's disease on a broader scale.

While blood tests are advancing Alzheimer’s diagnostics, their potential extends beyond early detection in clinical practice. They could also be useful in:

Clinical Trials: Helping to identify and enroll patients in the early stages of AD, improving the efficiency and accuracy of drug testing.

Monitoring Treatment Response: Assessing whether new therapies, such as lecanemab, are effectively targeting the key proteins—amyloid and tau—that contribute to brain changes in Alzheimer’s disease.

Status quo – Landscape and where REAL AD is in it
Research shows that blood-based biomarkers are highly accurate in identifying Alzheimer’s disease and can even predict cognitive decline before symptoms become severe. However, most studies so far have been conducted in research settings and memory clinics, yet it is still unclear how well these tests will work in the general population, as well as in healthcare settings.

The REAL AD study is helping to bridge this gap by testing whether blood based biomarkers can be used effectively in regular healthcare settings. The study takes place in Western Sweden region and aims to assess how well these blood tests, combined with remote cognitive assessments, can help detect early signs of AD in a general population. Unlike past studies that focused on small, carefully selected research groups, REAL AD works within existing healthcare systems, using established reference methods like CSF analysis and PET scans to confirm its findings. By doing so, it will help determine whether blood based biomarkers can be reliably used in primary care. As part of larger European projects like AD-RIDDLE and PROMINENT, REAL AD is an important step toward making early Alzheimer’s detection more accessible, ultimately improving diagnosis and treatment options for the future.

The Future of Blood Tests in Primary Care
In the near future, primary care physicians may incorporate simple blood tests into routine check-ups to aid in the early detection of Alzheimer’s disease. This advancement could lead to earlier interventions to slow disease progression, better patient stratification for personalised treatment, and increased accessibility of diagnostics, especially in underserved areas.

However, while these tests hold significant promise, they are not yet perfect. Challenges remain in ensuring that they are accurate, work well for everyone, and give reliable results. Different blood tests can produce slightly different results, as well as other health conditions may affect the readings, and more studies are needed to confirm how well they work in real-world settings outside of research contexts (Schöll et al., 2024).

As highlighted in recent work by the leader of the REAL AD study, Michael Schöll, and colleagues, more research is needed to refine these biomarkers before integrating them effectively into clinical practice. Michael Schöll emphasised that while blood tests offer hope for transforming Alzheimer's diagnostics, they should currently be viewed as a valuable addition to existing methods, complementing tools like cognitive assessments and imaging, rather than serving as a standalone solution.

Women account for nearly two-thirds of Alzheimer’s cases, yet their disproportionate risk is not just due to longer life expectancy. Sex-specific biology plays a crucial role in how the female brain ages, influencing everything from metabolism to disease susceptibility. 

Growing research reveals key sex differences in Alzheimer’s pathology and cognitive decline, with the menopause transition emerging as a critical inflection point in brain ageing, altering cognitive trajectories and potentially increasing Alzheimer’s risk. 

Female Brain Ageing: The Role of Menopause 

Menopause is not just a reproductive milestone— it is a neuroendocrine transition, driven by a decline in ovarian hormones like oestrogen. Oestrogen is a master regulator of the female brain, supporting glucose metabolism, mitochondrial efficiency, synaptic plasticity, and neuroinflammation control—all essential for brain health. 

As ovarian function declines, Alzheimer’s-vulnerable brain regions, such as the hippocampus and default mode network, undergo metabolic and structural changes, including reduced glucose metabolism, increased oxidative stress, and neuroinflammation—all linked to early Alzheimer’s pathology. 

Menopause Symptoms and Cognitive Ageing 

Beyond its biological effects on the brain, menopause brings a myriad of symptoms, including vasomotor symptoms (hot flushes and night sweats), feelings of anxiety and depression, disrupted sleep, brain fog, and memory lapses, to name a few—all neurological in nature. These further reinforce menopause’s role in brain ageing and may serve as early indicators of cognitive vulnerability. 

Midlife, overlapping with perimenopause, represents a critical window for Alzheimer’s prevention and intervention. Identifying high-risk individuals and developing targeted interventions is essential. 

Why This Matters and the Need for More Research 

Women make up half the population, and every woman will experience menopause. Yet, research into how menopause shapes cognitive ageing—and how we can intervene—remains severely underfunded. While progress is being made, there is an urgent need for greater government support, increased funding, and broader awareness. 

Understanding these sex differences is not just a matter of equity—it is essential for developing better diagnostics, earlier interventions, and more effective, targeted treatments. 

In REAL AD, the role of sex differences in Alzheimer’s disease is an important focus of our research. We look forward to sharing our insights with you soon! 

This International Women’s Day, let’s advocate for more awareness, more research, and better solutions for women’s brain health. 

International Women’s Day: Women and Alzheimer’s Risk 

The first drug to slow Alzheimer's disease has now been recommended for use in Europe. The drug has been shown to reduce disease progression by about 30 percent in the early stages of the disease. In a report on TV4, researchers and a study participant share their experiences of being part of the study. We encourage those who want to learn more to watch the TV4 clip (Swedish):  TV4-clip.

For more information and context regarding the recommendation of the drug (Leqembi) for treatment, we refer to the article we have published below, where we discuss the decision from the European Medicines Agency.

Swedish comment: Leqembi recommended for early Alzheimer's disease in Europe

The European Medicines Agency (EMA) has recommended approving the drug Leqembi (lecanemab) for the treatment of early Alzheimer’s disease in specific patients. This decision comes after a detailed re-examination by EMA’s Committee for Medicinal Products for Human Use (CHMP). Initially, the committee did not support the drug for all early Alzheimer’s patients but after new analysis, it now supports its use in patients with one or no copy of a genetic variation linked to a higher risk of Alzheimer’s disease, called the ApoE4 gene.

Leqembi is a treatment given as an intravenous infusion every two weeks. It works by targeting amyloid-beta, a protein that forms harmful plaques in the brain of Alzheimer’s patients. The treatment helps to remove these plaques and slow the disease’s progression.

The recommendation applies to patients with one or no copy of the genetic variant linked to a high risk of Alzheimer’s disease (ApoE4 gene).  Patients with two copies of this gene face a higher risk of amyloid-related imaging abnormalities (ARIA)—brain swelling or small bleeds. In the re-examined data, 8.9% of patients with one or no copy of ApoE4 experienced swelling (ARIA-edema), compared to 12.6% in the broader patient group. Similarly, small bleeds (ARIA-hemorrhage) occurred in 12.9% of this targeted group, compared to 16.9% in the full group. It is important to note that most ARIA events were asymptomatic, meaning patients did not experience noticeable symptoms. However, the use of anticoagulants (medications to prevent blood clots) significantly increases the risk of hemorrhage. Because of this, patients requiring anticoagulants should not be treated with Leqembi until further research clarifies the safety of this combination.

Leqembi was shown to slow down cognitive decline. In a re-examination study of 1,521 patients with one or no copy of ApoE4, those treated with Leqembi experienced a reduction in the severity of cognitive problems by 30.3% after 18 months compared with those receiving placebo. This means patients were able to preserve their memory and thinking abilities for longer.

Due to the risk of ARIA, patients must undergo brain scanning (MRI) before starting Leqembi and at specific points during treatment to monitor for side effects. The company will also provide training for doctors and guidance for patients, ensuring that symptoms like headache, confusion, or dizziness are quickly addressed. Additionally, a safety study will be conducted to track side effects and the long-term impact of Leqembi.

The European Commission will now review this recommendation. If approved, individual EU countries will decide on pricing and reimbursement based on their respective healthcare systems. Leqembi offers hope for people with early Alzheimer's disease, but requires careful monitoring to ensure patient safety and a number of steps are needed before it becomes available to patients in Sweden.

Implications for the REAL AD study
This approval emphasizes the importance of early detection and intervention in Alzheimer's disease, which is in line with the objective of the REAL AD study. Using remote cognitive tests and blood samples, the study aims to assess the feasibility of methods for early detection and screening of Alzheimer's disease. This may in the future facilitate the diagnosis and treatment of Alzheimer's disease, supported by treatments such as Leqembi. By participating in REAL AD, study participants will help prepare healthcare professionals to identify patients with Alzheimer's disease early and reliably, which will be a prerequisite for effective treatment.

Read the official statement here: https://www.ema.europa.eu/en/news/leqembi-recommended-treatment-early-alzheimers-disease 

The European Medicines Agency recommends treatment of early Alzheimer’s disease with Leqembi  

The scientific article discusses the study's design and has been published in 'Alzheimer's and Dementia'. The article is available to read here, but requires (paid) access.

It is important for large scientific studies to publish a "design paper" to explain the study's design as it provides transparency and clarity regarding the methodology. By describing how the study is structured, what data will be collected, and how the analysis will be conducted, other researchers can better understand and replicate the study. This helps ensure that the results are reliable and that any limitations or biases are identified early, which in turn strengthens the credibility and robustness of the research.

Leuzy A, Heeman F, Bosch I, et al. REAL AD—Validation of a realistic screening approach for early Alzheimer's disease. Alzheimer's Dement. 2024; 1-11. https://doi.org/10.1002/alz.14219

The first scientific article about the REAL AD study has now been published

An international expert commission has recently published an overview of the factors that can influence one's risk of developing dementia. 

Here you can read the scientific article in English (paywall).

According to the expert commission, 45% of all dementia cases can be prevented by addressing these 14 risk factors:

Controlling and treating cholesterol levels

Higher education or continuous cognitive activity

New findings on how dementia can be prevented

The American Food and Drug Administration (FDA) has now approved the treatment Donanemab for individuals with early symptomatic Alzheimers disease. Donanemab, marketed as Kisunla, has been developed by Eli Lilly and Company. The treatment will be available to patients in the U.S. with mild cognitive impairment (MCI) as well as those with the mild dementia stage of Alzheimer's disease, with confirmed amyloid pathology. The approval of Donanemab follows the two previously approved treatments, Aducanumab and Lecanemab. 

In Europe, the European Medicine Agency (EMA) is currently reviewing the treatments Donanemab and Lecanemab. 

For the news release by Lilly about the FDA approval of Donanemab, please click here. For a press release by NeurologyLive, please click here.

The American Food and Drug Administration (FDA) has approved a new treatment for individuals with early symptomatic Alzheimer's disease

Read about the latest developments in the REAL AD study and other breakthroughs in Alzheimer's disease research.

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