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Brain-Health app and coaching trial aims to prevent dementia in At-Risk seniors

NCT ID NCT07376135

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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Updated 1 time

Summary

This pilot study tests whether a personalized lifestyle program combining workshops, remote coaching, and a smartphone app can help adults aged 55-75 at risk for dementia adopt healthier habits. 300 participants will either receive tailored guidance or standard advice. The main goal is to see if the program is practical and engaging, not yet to prove it prevents cognitive decline.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
hybrid multidomain lifestyle intervention (personalized coaching, workshops, app, smartwatch)
What this could lead to
If successful, this could point toward an effective, scalable way to reduce dementia risk in older adults through lifestyle changes.
What could go wrong
This is a small pilot trial focused on feasibility, not proof of effectiveness. The results may not generalize, and long-term adherence to lifestyle changes is challenging.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 300 people

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

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Nov 2027

An estimate. End dates often move.

Lead sponsor

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.

Ages

55 to 75 years

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: * Age between 55 and 75 years at the time of screening. * Fluency in German. * All participants must be able and willing to provide written informed consent form (ICF) prior to any study-related procedures. * Ownership of a compatible Android smartphone, or willingness and capability to use a study-provided Android smartphone for the duration of the study. * Subjective cognitive decline and/or a positive first-degree family history of dementia. * Willingness to make meaningful changes in at least three of six lifestyle domains: dietary counselling, physical activity, cognitive training, vascular risk management, social interaction, and sleep and relaxation. * Cognitive performance at or slightly below age expectations, defined as an m-TICS (modified Telephone Interview for Cognitive Status) score ≥ 37/50, and a Montreal Cognitive Assessment (MoCA) ≥ 26/30. Exclusion Criteria: * Diagnosed or suspected dementia or substantial cognitive impairment, defined as an m-TICS score ≤ 36 or MoCA \< 26, or current or previous use of Alzheimer´s disease or other dementia medication. * Significant neurological disease, including but not limited to Parkinson´s disease, Huntington´s disease, normal pressure hydrocephalus, brain tumour, progressive supranuclear palsy, seizure disorder, subdural haematoma, multiple sclerosis, or a history of significant head trauma with persistent neurological sequelae or known structural brain abnormalities. * Diminished decision-making capacity, inability to provide informed consent, inability to complete study assessments, or any condition preventing effective cooperation, as determined by clinical judgement. * Severe impairment of vision, hearing, or communication abilities that would preclude participation in study procedure. * Any medical or psychiatric condition affecting safe engagement, including but not limited to active malignancy, major depressive disorder, symptomatic cardiovascular disease, or revascularisation procedures within the past year. * Current participation in another interventional trial, unless the study team determines this does not interfere with participation in the LETHE-AT.

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Conditions

The condition(s) this trial relates to.

Alzheimer disease Cognition Disorders Cognitive Dysfunction Motor Activity Risk Reduction Behavior subjective cognitive decline dementia prevention target

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

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    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

  • Medical University of Innsbruck

    Graz, Styria, 8010, Austria

  • Medical University of Innsbruck

    Innsbruck, Tyrol, 6020, Austria

  • Medical University of Vienna

    Vienna, Austria

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