Could an app help shield your brain from Alzheimer's-Linked drugs?
NCT ID NCT04121858
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
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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
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706 people
The number who actually took part.
- Started
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Oct 2019
- Finished
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Feb 2025
- Lead sponsor
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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
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60 years and older
- Sex
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Anyone
- Healthy volunteers
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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 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: * ≥ 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
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IU Health
Indianapolis, Indiana, 46202, United States
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Indiana University
Indianapolis, Indiana, 46202, United States
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