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Brain Safe: Reducing Exposure to Drugs Linked to Alzheimer's

Recruiting

This study will test the efficacy of an application called Brain Safe in reducing older adults' exposure to prescription anticholinergics. Anticholinergics are a class of drugs used to treat many medical problems and have been associated with a higher risk of dementia.

Minimum Age Maximum Age Gender Healthy Volunteers
60 Years N/A All Yes
October 11, 2019
October 1, 2023
700

  • Primary care visit at Eskenazi Health or Indiana University Health in past year
  • English-speaking
  • At least one prescription for a strong anticholinergic medication in past year and currently using it
  • Community-dwelling in Central Indiana
  • Not cognitively impaired
  • Not terminally ill
  • Not sensory impaired (after correction)

  • Permanent resident of an extended care facility (nursing home); independent or assisted living is allowed if managing own medication
  • Diagnosis of Alzheimer's disease or related dementia or taking dementia medications
  • Diagnosis of schizophrenia, bipolar disorder, or schizoaffective disorder
  • 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

Participants will be randomly assigned to use either the Brain Safe application or a medication list application for 1 year, with monthly usage reminders. The applications will be loaded on a smartphone provided by the study or the participant. 

Brain Safe provides conversation starters for older adults to discuss use of anticholinergics and deprescribing with their doctor. It also includes a medication list, risk calculator, and educational content. The comparison application provides a medication list and information on medications. Investigators will explore the effects of the intervention on reducing use of anticholinergics and improving cognitive function and quality of life.

Name City State Zip Status Primary Contact
Eskenazi Health
Indianapolis Indiana 46202 Recruiting Dana L Musapatika, MS
317-260-1860
dalmcdon@iu.edu
Indiana University Health
Indianapolis Indiana 46202 Recruiting Dana L Musapatika, MS
317-260-1860
dalmcdon@iu.edu

Indiana University

  • National Institute on Aging (NIA)

Name Role Affiliation
Richard J Holden, PhD Principal Investigator Indiana University School of Medicine

Name Phone Email
Dana L Musapatika, MS (317) 260-1860 dalmcdon@iu.edu
Robin Valenzuela, MA (317) 260-1860 Brainsaf@regenstrief.org

NCT04121858

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