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Your phone could detect Alzheimer's before you know it

NCT ID NCT05153941

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing whether smartphones and wearable devices can detect early signs of Alzheimer's disease better than traditional questionnaires. Researchers will follow 3,500 people with and without memory problems to see if digital tools can spot subtle changes in daily activities. The goal is to make diagnosis easier and earlier, potentially before symptoms are obvious.

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 earlier and more accurate detection of Alzheimer's disease using everyday devices like smartphones.
What could go wrong
This is an observational study, not a treatment trial. It may not directly benefit participants, and the technology might not prove reliable enough for widespread use.

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 3,500 people

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

Started

Jan 2022

Expected to finish

Jan 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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 main study comprises 3,510 subjects matched by age and gender. In the sub-study of amyloid PET, FDG PET, tau PET and fMRI scans: 400 subjects comprised of (1) \>100 of cognitively unimpaired with (A-, T-, (N)-) group, (2) \>100 of cognitively unimpaired with (A+, T+, (N)- or A+, T+, (N)+) groups, (3) \>100 of mild cognitive impairment with (A+, T+, (N)- or A+, T+, (N)+) groups and (4) \>100 of mild cognitive impairment with (A-, T-, (N)-).

Ages

50 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 Subjects enrolled in this study are diagnosed based on the established criteria as described below by physicians/medical doctors with expertise in Alzheimer's disease and other neurodegenerative disorders. To be eligible to participate in this study, a subject must meet the following criteria: 1a. For subjects in the Alzheimer's continuum and those with non-AD pathologic changes, (n=3,110): * Male or female over 50 years of age. * Approximately age and gender matched among groups as classified below. * A study partner (caregiver/family member) is available to collaborate to visit the site together with the subject and give necessary information on the subject. * Physician's clinical judgement of individuals by classifying into three syndromal stages of cognitive continuum: cognitively unimpaired, mild cognitive impairment, and dementia as described in 2018 NIA-AA research framework \[39\], \[40\] while taking into account of clinical assessment performance such as MMSE and CDR scores. This syndromic staging is applicable to all members of a research cohort independent from biomarker profiles. * Numeric clinical staging in 2018 NIA-AA research framework may also be applied to cognitive staging in the Alzheimer's continuum \[40\] . * cognitively unimpaired * mild cognitive impairment * mild dementia * moderate dementia * severe dementia * AT(N) biomarker profile as evidenced by CSF test results is combined with the clinical staging for the classification of each subject. * Aβ biomarker positive subjects without cognitive impairment, those with MCI, and those with dementia are considered as preclinical AD, MCI due to AD, and dementia due to AD, respectively. In case otherwise stated, these nomenclatures are used throughout this study. * Informed consent signed by the subject and/or study partner. * Study partners should be able to read and communicate in the language of the Hospital site and available to actively engage in tests and questionnaires. * Subject or the study partner owns a smart phone. * Their house should allow appropriate Wi-Fi and/or phone line connectivity. * For those participating in the sub-study from each intended respective subject grouping described in Sub-study section, signature on an additional Informed Consent 1b. Healthy volunteer subjects (n=400): * Male or female over 50 years of age. * Individuals with all AT(N) biomarkers at normal levels (i.e., A-,T-, (N)-) as confirmed by negative status of respective AD biomarker test utilized in this study. * Approximately age and gender matched to subjects in the Alzheimer's continuum and those with non-AD pathologic changes on a group level. * A study partner is available to collaborate. * Cognitively unimpaired as defined by syndrome staging of cognitive continuum in 2018 NIA-AA research framework \[40\], \[41\] supported by each of the following test scores: MMSE ≥27, and 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 center. * Informed consent signed by the subject and study partner. * Subject or study partner owns a smart phone. * Their house should allow appropriate Wi-Fi and/or phone line connectivity. * For those participating in the sub-study from each intended respective subject grouping described in Sub-study section, signature on an additional Informed Consent Exclusion criteria A potential subject who meets any of the following criteria will be excluded from participation in this study. Those criteria would be applied at the subject screening: 2a. For subjects in the Alzheimer's continuum and those with non-AD pathologic changes: * Presence of an additional neurological, psychiatric, or chronic disease that may affect ADL, cognitive function or social interactions. * 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.). MRI assessment should be utilized for verifying those disorders. * TSH above normal range * T3 or T4 outside normal range with clinically significant. * Positive test for SARS-CoV-2 on a nasopharyngeal swab * Failure to show negative PCR results for Covid19 or proof of vaccination 2b. Healthy volunteer subjects: * Presence of an additional neurological, psychiatric, or chronic 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. * Positive test for SARS-CoV-2 on a nasopharyngeal swab * Failure to show negative PCR results for Covid19 or proof of vaccination

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Conditions

The condition(s) this trial relates to.

Alzheimer disease Cognitive Dysfunction

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Nikaia Ag Panteleimon Hospital

    Athens, Greece

More trials for these conditions

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