100,000 volunteers join digital brain health study to catch dementia early
NCT ID NCT04701177
First seen Jun 26, 2026 · Last updated Sep 11, 2026 · Updated 3 times
Summary
This observational study will enroll 100,000 people over age 45 to track early signs of Alzheimer's and Parkinson's using smartphone-based tests, genetic data, and brain scans. Researchers aim to develop better ways to identify who is at risk before symptoms worsen. Participants will be followed remotely, making it easier to join from home.
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 could lead to better early detection methods for Alzheimer's and Parkinson's, enabling earlier intervention in future trials.
- What could go wrong
- This is an observational study, not a treatment trial. It will not directly benefit participants and may not produce immediately actionable results.
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 100,000 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2021
- Expected to finish
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Nov 2031
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
The study is a decentralized, observational, digital assessment cohort study in healthy volunteers with negative AD biomarkers as control, subjects with MBI, preclinical AD and MCI due to AD dementia.
- Ages
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45 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
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 for Cohort participants: * Male or female over 45 years of age. * Subject is seen at a memory clinic or is part of an observational study. * An informant (caregiver/family member) is available to collaborate. * Diagnosis of individuals in the AD biological continuum with evidence of amyloid-beta accumulation based on the presence of Aβ load AD biomarkers (either in CSF or PET scan), MMSE, CDR score and cognitive tests as defined by the Guidance document of EMA (2016) or FDA (2018): * preclinical AD: MMSE≥27 and CDR=0, either none or borderline cognitive deficits (compatible with FDA stages 1 and 2, with positive AD biomarkers). Patients reporting subjective cognitive decline who meet the criteria above are eligible for assignment to the preclinical AD group. * prodromal AD/MCI due to AD: MMSE \>23, CDR=0.5, impairment on cognitive testing with RBANS (compatible with stage 3 FDA, with positive AD biomarkers). * Prodromal PD: Male or female age 60 years or older (except age 30 years or older for SNCA, or rate genetic mutations (such as Parkin or Pink1) participants). * Individuals taking any of the following drugs: alpha methyldopa, methylphenidate, amphetamine derivatives or modafinil, must be willing and medically able to hold the medication for at least 5 half-lives before DaTscan imaging. * Informed consent signed by the subject and informant. * Informant should be able to read and communicate in the language of the recruitment centre and available to actively engage in tests and questionnaires. * Subject and the informant own a smartphone. Inclusion Criteria for Healthy volunteers: * Male or female over 45 years of age. * Individuals with no evidence of amyloid-beta accumulation based on the presence of Aβ load AD biomarkers (either in CSF or PET scan). * Approximately age and gender matched to AD subjects on a group level. * An informant is available to collaborate. * MMSE \>27, CDR=0. * In otherwise good health conditions, or with diagnosis mild chronic disorders (of metabolic, respiratory, immunological, cardiologic, and metabolic origin) or any other affections that are controlled by the therapy and do not importantly limit ADLs or social interactions. * Able to read and to communicate in the language of the recruitment centre. * nformed consent signed by the subject and caregiver. * Subject and informant own a smartphone. Exclusion Criteria for Cohort participants: * Presence of an additional neurological or psychiatric disease that may affect ADL, cognitive function or social interactions. * Clinical diagnosis of PD, other parkinsonism, or dementia. * Received any of the following drugs: dopamine receptor blockers (neuroleptics), metoclopramide and reserpine within 6 months of Screening visit. * Current treatment with anticoagulants (e.g. coumadin, heparin) that might preclude safe completion of the lumbar puncture. * Abnormal VB12 value. * Any other kind of disorders that relevantly affect mobility and/or ADL, cognitive function or social interactions (e.g., immune-mediated inflammatory disorders, recovery from recent trauma, stroke, etc.). * TSH above normal range * T3 or T4 outside normal range with clinically significant. Exclusion Criteria for Healthy volunteers: * Presence of an additional neurological or psychiatric disease that may affect ADL, cognitive function or social interactions. * Diagnosis of any disorders or post traumatic conditions that are not fully controlled by the therapy and produce relevant limitations of ADL, cognitive function or social interactions.
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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
4 sites in 2 countries. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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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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Greek Alzheimer's Association and Related Disorders
Thessaloniki, 55250, Greece
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Hospital Clinic Barcelona
Barcelona, Spain
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Ionian University
Corfu, Corfu, 49100, Greece
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Panhellenic Federation Of Alzheimer's Disease And Related Disorders
Thessaloniki, 54643, Greece
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Other studies related to the condition(s) this trial covers.
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