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NCT04121858 · ClinicalTrials.gov registry record · NA
Brain Safe: Consumer Intervention to Reduce Exposure to Drugs Linked to Alzheimer's Disease
A NA study, sponsored by Indiana University.
- Completed
- Registry status
- NA
- Development phase
- 706
- Enrollment target
NCT04121858: Completed NA study, sponsored by Indiana University.
NCT04121858 is a NA study that has completed, run by Indiana University. The registered enrollment target is 706 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04121858, a NA study, has completed, sponsored by Indiana University.
- COMPLETED
- Registry status
- NA
- Development phase
- 706 participants
- Enrollment target
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.
Primary Outcome
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 anticholin
Interventions
- OTHER Brain Safe App
- OTHER Attention Control App
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 706 participants |
| Start Date | 2019-10-16 |
| Est. Completion | 2025-02-27 |
| Phase | NA |
What the finished NCT04121858 record still lists
NCT04121858 is an interventional study that assigns participants to a tested intervention. The registered 706 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 2 interventions - of which Brain Safe App is the first listed.
NCT04121858 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04121858 about?
NCT04121858 is a clinical study titled "Brain Safe: Consumer Intervention to Reduce Exposure to Drugs Linked to Alzheimer's Disease". 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 at...
What is the current status of trial NCT04121858?
This trial is currently completed. It is a NA study. The enrollment target is 706 participants. The study started on 2019-10-16. Estimated completion is 2025-02-27.
What interventions are being tested in trial NCT04121858?
The interventions under investigation include: Brain Safe App (OTHER), Attention Control App (OTHER).
Who is sponsoring clinical trial NCT04121858?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04121858's enrollment target sits among peer trials
706 148th of 2000 higher than 1,853 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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