Brain Safe: Consumer Intervention to Reduce Exposure to Drugs Linked to Alzheimer's Disease
N/A
Completed
NCT04121858
| Condition | Alzheimer Disease, Dementia |
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| Phase | N/A |
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| Sponsor | Indiana University |
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| Status | Completed |
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| Enrollment | 706 participants |
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| Interventions | Brain Safe App, Attention Control App |
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| Start date | Oct 16, 2019 |
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| Completion date | Feb 27, 2025 |
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| Results posted | Jul 20, 2026 |
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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.
Total Standardized Daily Dose (TSDD) - From Medical Records
Baseline, 6 months, 12 Months · Standardized Doses Per Day
| Brain Safe App | 1.59 ± 3.04 Standardized Doses Per Day |
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| Attention Control App | 1.68 ± 3.57 Standardized Doses Per Day |
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| Brain Safe App | 0.86 ± 1.61 Standardized Doses Per Day |
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| Attention Control App | 1.19 ± 3.53 Standardized Doses Per Day |
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| Brain Safe App | 1.27 ± 2.51 Standardized Doses Per Day |
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| Attention Control App | 1.29 ± 3.18 Standardized Doses Per Day |
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Log Transformed Total Standardized Daily Dose (TSDD) - From Medical Records
Baseline, 6, and 12 Months · ln(doses per day)
| Brain Safe App | -0.93 ± 2.45 ln(doses per day) |
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| Attention Control App | -1.12 ± 2.70 ln(doses per day) |
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| Brain Safe App | -3.32 ± 3.50 ln(doses per day) |
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| Attention Control App | -3.01 ± 3.52 ln(doses per day) |
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| Brain Safe App | -3.04 ± 3.68 ln(doses per day) |
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| Attention Control App | -2.69 ± 3.59 ln(doses per day) |
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| p-value | 0.0156 |
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| Esttimated marginal means (EMMs) | -0.61 (95% CI -1.10–-0.12) |
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Open in BENITIONS
View on ClinicalTrials.gov
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