NCT04121858Completed
Brain Safe: Consumer Intervention to Reduce Exposure to Drugs Linked to Alzheimer's Disease
Source: ClinicalTrials.gov · Last updated 20 Jul 2026
Brief summary (registry, in English)
This study is an RCT to evaluate the effectiveness of Brain Safe on reducing anticholinergic exposure. Over 42 months, the trial will enroll 700 community-dwelling older adults who were prescribed one or more strong anticholinergics. Participants will be randomized to use the Brain Safe app or an attention control medication list app for 12 months, with monthly usage reminders.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 706 (actual)
- First submitted
- 2 Oct 2019
- Start date
- 16 Oct 2019
- Primary completion date
- 27 Feb 2025
- Lead sponsor
- Indiana University
- Diseases
- Alzheimer disease
- NCT number
- NCT04121858
What you commit to
- Study type: Interventional
- Participants enrolled: 706
- From 16 Oct 2019 to the primary completion date, 27 Feb 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Permanent resident of an extended care facility (nursing home); independent or assisted senior care living is allowed if managing own medications.
- Not currently using anticholinergic medication
Other illness
- 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
- Sensory or other impairment prohibiting the use of a mobile touchscreen device or other study activity (after correction)
Other
- Involvement in another clinical trial that would prevent or interfere with study objectives
Who the study is looking for
- ≥ 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)
Age in the registry: 60 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Indiana University Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
| IU Health Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.