Brain Safe: Consumer Intervention to Reduce Exposure to Drugs Linked to Alzheimer's Disease
不适用
已完成
NCT04121858
| 适应症 | Alzheimer Disease, Dementia |
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| 分期 | 不适用 |
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| 申办方 | Indiana University |
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| 状态 | 已完成 |
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| 受试者人数 | 706 人 |
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| 干预（药物） | Brain Safe App, Attention Control App |
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| 开始日期 | 2019年10月16日 |
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| 完成日期 | 2025年2月27日 |
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| 结果公布日 | 2026年7月20日 |
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摘要
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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本页整理自 ClinicalTrials.gov 的公开数据，不构成医疗建议，也不构成投资建议。请务必咨询专业医师。