drugset / Trial / NCT02925650
Safety, Tolerability, PK and PD of Posiphen® in Subjects With Early Alzheimer's Disease
Phase 1/2
Completed
18 enrolled
Annovis Bio Inc.
Alzheimer's Disease Cooperative Study (ADCS) · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This study evaluates the safety and pharmacological effects of 3 different doses of Posiphen® when compared to a placebo, in adult male and female patients with early Alzheimer's disease (AD).
Timeline
- Start
- 2017-03-02
- Primary completion
- 2021-12-10
- Completion
- 2021-12-31
Publications
- Galasko D, Farlow MR, Lucey BP, Honig LS, Elbert D, Bateman R, Momper J, Thomas RG, Rissman RA, Pa J, Aslanyan V, Balasubramanian A, West T, Maccecchini M, Feldman HH. A multicenter, randomized, double-blind, placebo-controlled ascending dose study to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamic (PD) effects of Posiphen in subjects with early Alzheimer's Disease. Alzheimers Res Ther. 2024 Jul 5;16(1):151. doi: 10.1186/s13195-024-01490-z.
- Galasko D, Farlow MR, Lucey BP, Honig LS, Elbert D, Bateman R, Momper J, Thomas R, Rissman RA, Pa J, Aslanyan V, Balasubramanian A, West T, Maccecchini M, Feldman HH. A multicenter, randomized, double-blind, placebo-controlled ascending dose study to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamic (PD) effects of Posiphen in subjects with Early Alzheimer's Disease. medRxiv [Preprint]. 2024 Mar 22:2024.03.20.24304638. doi: 10.1101/2024.03.20.24304638.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | buntanetap | Small molecule | 60 mg | Oral |
| Subject | buntanetap | Small molecule | 120 mg | Oral |
| Subject | buntanetap | Small molecule | 180 mg | Oral |