At a glance
ClinicalIndex Comparison Record- ✓Diagnosis of probable Alzheimer's disease per NIA-AA criteria
- ✓Age 55–85 years
- ✓MMSE score 14–24 (mild to moderate cognitive impairment)
- ✓Designated study partner in frequent contact (≥10 hours/week) willing to participate and attend visits
- ✕Significant psychiatric history (schizophrenia, bipolar, major depression), except stable depression on SSRI/SNRI
- ✕Non-AD dementia (vascular, Lewy body, frontotemporal, Parkinson disease dementia, B12/thyroid deficiency dementia)
- ✕QTc prolongation (≥450 ms men, ≥460 ms women) or history of long QT syndrome or torsades de pointes
- ✕Bradycardia (<50 bpm) or tachycardia (>100 bpm) on ECG at screening
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Multicenter Study of Buntanetap in Participants With Mild to Moderate Alzheimer's Disease
In Brief
A Phase 3 clinical trial evaluating Buntanetap/Posiphen and Placebo for Alzheimer Disease. Completed, enrolled 351 participants across 54 sites.
Detailed Summary
The purpose of this study is to measure efficacy and safety of three different doses of buntanetap/Posiphen compared with placebo in participants with mild to moderate Alzheimer's disease. Study details include: The double-blind treatment duration will include a screening period of up to 42 days followed by 12 weeks of treatment at home. The study duration will be 4-5 months. There will be 4 in-clinic visits and 1 phone call.
Study Details
Timeline
Interventions
HPMC (vegetarian source) capsule shells
HPMC (vegetarian source) capsule shells