Brain Safe: Consumer Intervention to Reduce Exposure to Drugs Linked to Alzheimer's Disease
NCT04121858 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 706
Last updated 2025-03-13
Summary
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.
Conditions
- Alzheimer Disease
- Dementia
Interventions
- OTHER
-
Brain Safe App
The Brain Safe app includes the medication list, a personalized risk calculator, multimedia educational content, and a conversation starter/doctor's report.
- OTHER
-
Attention Control App
The attention control app, called Med Safe, includes only the medication list feature.
Sponsors & Collaborators
-
National Institute on Aging (NIA)
collaborator NIH -
Indiana University
lead OTHER
Principal Investigators
-
Richard J Holden, PhD · Indiana University School of Medicine
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-10-16
- Primary Completion
- 2025-02-27
- Completion
- 2025-02-27
Countries
- United States
Study Locations
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