Can a simple blood test catch Alzheimer's before symptoms start?
NCT ID NCT06121544
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study is looking for early warning signs of Alzheimer's disease in 800 cognitively healthy adults aged 50 to 80. Researchers will use blood tests, brain scans, and memory assessments over about 4 years to see how Alzheimer's-related changes develop. The goal is to find a way to screen the general population for Alzheimer's risk long before memory loss begins.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this study could help develop a screening tool to detect Alzheimer's years before symptoms appear, enabling earlier intervention.
- What could go wrong
- This is an observational study, not a treatment trial, so it won't directly benefit participants. Results may not lead to a practical screening test for the general population.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 800 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2022
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Cognitively unimpaired individuals (50-80 years old) Step 1. Cognitively normal individuals will be screened using plasma p-tau217 (Eli Lilly-developed Meso Scale Discovery method). Step 2. Cerebrospinal fluid Alzheimer's disease biomarkers analysis will be done in a subpopulation including all plasma p-tau217 positive individuals and randomly selected individuals with normal p-tau217 (matching 9:1). Step 3. Amyloid PET imaging. 450 individuals with positive Alzheimer's disease biomarkers and 150 with normal Alzheimer's disease biomarkers will be enrolled into longitudinal study. FOLLOW-UP FOR 4 YEARS: Cognitive testing and blood draws will be conducted at baseline and 12, 24, 36 and 48 months. cerebrospinal fluid collection, MRI, amyloid PET and tau PET will be conducted at baseline, and 24 and 48 months.
- Ages
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50 to 80 years
- Sex
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Anyone
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age 50-80 2. Individuals aged 50-60 require at least one of the following risk factors for AD: 1. Known apolipoprotein E (APOE) -ε4 carrier 2. Known 1st degree family history of dementia or severe memory loss with onset prior to 75. 3. Known amyloid brain pathology by either CSF or PET scan. 3. Mini-Mental State Examination (MMSE) ≥26 (aged \>65); MMSE ≥27 (aged 50-65). 4. Score of 12 or above on the Montreal Cognitive Assessment (MoCA) telephone version. 5. Speaks and understands Swedish to the extent that an interpreter is not necessary to fully understand the study information and cognitive tests. 6a. Preclinical Alzheimer's disease subgroup (n=450): Amyloid pathology according to cerebrospinal fluid Alzheimer's disease and amyloid PET scans. 6b. Non-Preclinical Alzheimer's disease subgroup (n=150): No sign of preclinical Alzheimer's disease using cerebrospinal fluid Alzheimer's disease biomarkers or Aβ-PET scans. Exclusion Criteria: 1. Fulfils the criteria for minor or major neurocognitive disorder according to The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). 2. History of significant brain injury or other known neurologic disease or insult, resulting in lasting cognitive sequelae that would confound the assessment and staging of potential neurodegenerative disease. 3. Major depression, bipolar disorder, or recurrent psychotic disorders within the past year. 4. History of alcohol and/or substance abuse or dependence within the past year. 5. Significant unstable systemic illness or organ failure, such as terminal cancer, that makes it difficult to participate in the study. 6. Refusing or unable to complete baseline cognitive and biomarker assessments (i.e., cognitive testing, blood draw, MRI and PET).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Skåne University Hospital
RECRUITINGMalmö, Sweden
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