Could an app help shield your brain from Alzheimer's-Linked drugs?

NCT ID NCT04121858

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 20, 2026 · Last updated Jul 21, 2026 · Updated 1 time

Summary

This study tests whether a smartphone app called Brain Safe can help older adults reduce their use of strong anticholinergic medications, which are linked to a higher risk of Alzheimer's disease. The trial enrolls 700 adults aged 60 and older who currently take such medications. Participants use either the Brain Safe app or a basic medication list app for 12 months, and researchers track changes in medication use and cognitive function.

What this could mean

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

Active substance
a smartphone app called Brain Safe that provides a medication list, personalized risk calculator, educational content, and a doctor's report
What this could lead to
If effective, this app could help older adults lower their exposure to certain medications that are linked to a higher risk of Alzheimer's disease.
What could go wrong
This is a behavioral intervention, not a drug, so its impact may be modest. The trial is relatively small and results may not apply to all populations.

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

706 people

The number who actually took part.

Started

Oct 2019

Finished

Feb 2025

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

60 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * ≥ 1 primary care visit at Eskenazi Health or IU Health in past 12 months * Age ≥ 60 years * Written informed consent and HIPAA authorization for the release of personal health information. * English-speaking * At least one prescription for a strong anticholinergic medication with Anticholinergic Cognitive Burden (ACB) score 2 or 3 in prior 12 months, and currently using it * Community-dwelling in Central Indiana * Not cognitively impaired * Not terminally ill * Not sensory impaired (after correction) Exclusion Criteria: * Permanent resident of an extended care facility (nursing home); independent or assisted senior care living is allowed if managing own medications. * Diagnosis of Alzheimer's disease or related dementia (ADRD), determined by International Classification of Diseases (ICD)-9/ICD-10 codes or current use of a medication for ADRD * Diagnosis of schizophrenia, bipolar disorder, or schizoaffective disorder defined by ICD-9/ICD-10 codes * Involvement in another clinical trial that would prevent or interfere with study objectives * Sensory or other impairment prohibiting the use of a mobile touchscreen device or other study activity (after correction) * Not currently using anticholinergic medication

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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.

Contacts and locations

Locations

  • IU Health

    Indianapolis, Indiana, 46202, United States

  • Indiana University

    Indianapolis, Indiana, 46202, United States

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