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

NCT04121858 | Completed Results DMC

• 2 other identifiers: 1811254189R01AG056926
• Study Type: interventional
• Target: 706
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

anticholinergic; cognitive function; brain; aging

Outcome Measures

Primary Outcomes (2)

• Total Standardized Daily Dose (TSDD) - From Medical Records

  To calculate the Total Standardized Daily Dose (TSDD), we first calculated the Standardized Daily Dose (SDD) for each anticholinergic medication with an ACB Score of 2 or 3. SDD was calculated by multiplying the strength by the units per dose and frequency per day and number of refills. The product was divided by the minimum effective daily dose (where available) or the minimum effective geriatric dose to standardize the quantity across multiple classes of medications. The SDD for all anticholinergics with an ACB score 2 or 3 was then summed for each participant for each 6-month period, and divided by the number of days in the relevant six month period to arrive at a TSDD. Range: The minimum possible value is 0 (optimal outcome; indicating zero exposure to ACB 2 or 3 medications). There is no fixed theoretical maximum score(higher value more exposure), as the upper limit is mathematically determined by the total volume and combination of medications a participant is prescribed.

  Baseline, 6 months, 12 Months

• Log Transformed Total Standardized Daily Dose (TSDD) - From Medical Records

  Construct: Measures natural log-transformed average daily exposure to medications with an Anticholinergic Cognitive Burden (ACB) score of 2 or 3 to normalize data distribution.How Computed: Medication Standardized Daily Dose (SDD) = (strength × units/dose × frequency/day × refills) / minimum effective daily or geriatric dose. The SDD for all eligible drugs is summed over 6 months, divided by the number of days in that period to find raw TSDD, and natural log-transformed ($\\ln(x+1)$ or similar) for the final score.Scale Range: Minimum value is 0 (representing 0 raw TSDD, or zero exposure). There is no fixed theoretical maximum, as it is mathematically determined by the volume of medications prescribed.Interpretation: A value of 0 is the optimal outcome (no exposure). Higher values represent greater exposure (worse outcome).

  Baseline, 6, and 12 Months

Secondary Outcomes (8)

• Overall Cognitive Score

  Baseline, 6 months, and 12 months

• Choice Reaction Time (CRT)

  Baseline

• Health Utilities Index (HUI) Mark 3

  Baseline, 6 months, and 12 months

• Hopkins Verbal Learning Test (HVLT) Total Recall

  Baseline, 6 months, and 12 months

• Hopkins Verbal Learning Test (HVLT) Delayed Recall

  Baseline, 6 months, 12 months

Other Outcomes (3)

• Medication Perceptions

  12 months

• Self-reported Deprescribing Behavior

  12 months

• Technology Use-

  12 months

Study Arms (2)

Brain Safe App

EXPERIMENTAL

1)Brain Safe App provides conversation starters for older adult patients on target anticholinergics. The conversation starters assist the patient to have discussions with their physicians regarding reduction in exposure to prescription anticholinergics. 2) Provides anticholinergic risk assessment.

Other: Brain Safe App

Attention Control App

SHAM COMPARATOR

1\) Attention Control App provides a medication list for older patients to use but lacks the conversation starters for patient to use with there physicians aimed at reduction in exposure to prescription anticholinergics.2) No anticholinergic risk assessment.

Other: Attention Control App

Interventions

Brain Safe App OTHER

The Brain Safe app includes the medication list, a personalized risk calculator, multimedia educational content, and a conversation starter/doctor's report.

Brain Safe App

Attention Control App OTHER

The attention control app, called Med Safe, includes only the medication list feature.

Attention Control App

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (2)

Indiana University

Indianapolis, Indiana, 46202, United States

Location

IU Health

Indianapolis, Indiana, 46202, United States

Location

Related Publications (2)

• Abebe E, Campbell NL, Clark DO, Tu W, Hill JR, Harrington AB, O'Neal G, Trowbridge KS, Vallejo C, Yang Z, Bo N, Knight A, Alamer KA, Carter A, Valenzuela R, Adeoye P, Boustani MA, Holden RJ. Reducing anticholinergic medication exposure among older adults using consumer technology: Protocol for a randomized clinical trial. Res Social Adm Pharm. 2021 May;17(5):986-992. doi: 10.1016/j.sapharm.2020.10.010. Epub 2020 Oct 22.

  PMID: 33773639 DERIVED

• Hill JR, Harrington AB, Adeoye P, Campbell NL, Holden RJ. Going Remote-Demonstration and Evaluation of Remote Technology Delivery and Usability Assessment With Older Adults: Survey Study. JMIR Mhealth Uhealth. 2021 Mar 4;9(3):e26702. doi: 10.2196/26702.

  PMID: 33606655 DERIVED

MeSH Terms

Conditions

Alzheimer Disease; Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Limitations and Caveats

Reliance on participant-driven app engagement, sample characteristics restrictions, limited follow-up duration, and sample size constraints. The study design precluded the evaluation of specific intervention characteristics associated with deprescribing, and did not allow for the identification of participant subgroups most likely to initiate, achieve, or sustain deprescribing. Additionally, after 6 months, the trial protocol shifted from in-person to remote data collection.

Results Point of Contact

• Title: Richard Holden
• Organization: Indiana University

rjholden@iu.edu

812-856-6265

Study Officials

• Richard J Holden, PhD

  Indiana University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The primary investigator and outcome assessor will be masked to the App assignment (Brain Safe vs Attention Control Medication list App)
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Indiana University School of Medicine Chief Healthcare Engineer, Center for Health Innovation and Implementation Science

Model Details: 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.

Study Record Dates

• First Submitted: October 2, 2019
• First Posted: October 10, 2019
• Study Start: October 16, 2019
• Primary Completion: February 27, 2025
• Study Completion: February 27, 2025
• Last Updated: July 20, 2026
• Results First Posted: July 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)