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100,000 volunteers join digital brain health study to catch dementia early

NCT ID NCT04701177

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

About 100,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2021

Expected to finish

Nov 2031

An estimate. End dates often move.

Lead sponsor

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

45 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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.

  1. The places running it

    4 sites in 2 countries. The list below names each one and where it is.

  2. 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.

    Open the record ↗

  3. 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

  • Greek Alzheimer's Association and Related Disorders

    Thessaloniki, 55250, Greece

  • Hospital Clinic Barcelona

    Barcelona, Spain

  • Ionian University

    Corfu, Corfu, 49100, Greece

  • Panhellenic Federation Of Alzheimer's Disease And Related Disorders

    Thessaloniki, 54643, Greece

More trials for these conditions

Other studies related to the condition(s) this trial covers.