Brain Safe: Consumer Intervention to Reduce Exposure to Drugs Linked to Alzheimer's Disease (NCT04121858) | Clinical Trial Compass
CompletedNot Applicable
Brain Safe: Consumer Intervention to Reduce Exposure to Drugs Linked to Alzheimer's Disease
United States706 participantsStarted 2019-10-16
Plain-language 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.
Who can participate
Age range
60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 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)
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Total Standardized Daily Dose (TSDD) - From Medical Records
Timeframe: Baseline, 6 months, 12 Months
2
Log Transformed Total Standardized Daily Dose (TSDD) - From Medical Records