Brain Safe: Consumer Intervention to Reduce Exposure to Drugs Linked to Alzheimer's Disease

Last updated: March 11, 2025
Sponsor: Indiana University
Overall Status: Completed

Phase

N/A

Condition

Dementia

Treatment

Attention Control App

Brain Safe App

Clinical Study ID

NCT04121858
1811254189
R01AG056926
  • Ages > 60
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 healthinformation.

  • English-speaking

  • At least one prescription for a strong anticholinergic medication withAnticholinergic Cognitive Burden (ACB) score 2 or 3 in prior 12 months, andcurrently using it

  • Community-dwelling in Central Indiana

  • Not cognitively impaired

  • Not terminally ill

  • Not sensory impaired (after correction)

Exclusion

Exclusion Criteria:

  • Permanent resident of an extended care facility (nursing home); independent orassisted senior care living is allowed if managing own medications.

  • Diagnosis of Alzheimer's disease or related dementia (ADRD), determined byInternational Classification of Diseases (ICD)-9/ICD-10 codes or current use of amedication for ADRD

  • Diagnosis of schizophrenia, bipolar disorder, or schizoaffective disorder defined byICD-9/ICD-10 codes

  • Involvement in another clinical trial that would prevent or interfere with studyobjectives

  • Sensory or other impairment prohibiting the use of a mobile touchscreen device orother study activity (after correction)

  • Not currently using anticholinergic medication

Study Design

Total Participants: 706
Treatment Group(s): 2
Primary Treatment: Attention Control App
Phase:
Study Start date:
October 16, 2019
Estimated Completion Date:
February 27, 2025

Study Description

This study is a randomized clinical trial (RCT) of the efficacy of a direct-to-consumer intervention called Brain Safe to primarily reduce older adults' exposure to prescription anticholinergics and secondarily improve cognitive function and health-related quality of life. 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.

The primary objective is to test the effect of Brain Safe on anticholinergic exposure at 12 months. We hypothesize that anticholinergic exposure will be lower among those randomized to the Brain Safe intervention compared to those randomized to the attention control app at 12 months. Our primary, powered outcome is the total standard daily dose (TSDD) measure of anticholinergic exposure at 12 months, which is calculated over the preceding 6 months of prescription data. We will electronically capture prescription data monthly and compute TSDD at baseline, 6, and 12 months.

The secondary objective is to test the effect of Brain Safe on: (a) cognitive function and (b) health-related quality of life at 12 months. We hypothesize older adults randomized to Brain Safe will have higher (a) cognitive function, measured by using an objective, performance-based composite, and (b) health-related quality of life (HRQOL), compared to those randomized to the attention control app, at 12 months.

Exploratory objectives are to test the effect of Brain Safe on anticholinergic exposure, cognitive function, and HRQOL at 6 months. This aim will explore the presence of early effects of Brain Safe at 6 months.

Connect with a study center

  • IU Health

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • Indiana University

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • Richard John Holden

    Indianapolis, Indiana 46202
    United States

    Site Not Available

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