NCT06709014

A Double-blind Dual Study Assessing Safety and Efficacy of Buntanetap in Participants With Early AD

A 6-month & 18-month Prospective, Randomized, Placebo-controlled, Double-blind Dual Clinical Trial Investigating Efficacy and Safety of Buntanetap in Treating Participants of Early Alzheimer's Disease

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 760 (estimated)
• Sponsor: Annovis Bio Inc. · Industry
• Sex: All
• Age: 55 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn if buntanetap/Posiphen works to treat early Alzheimer's disease in adults aged 55-85. It will also learn about the safety of buntanetap/Posiphen. The main questions it aims to answer are: * Does buntanetap/Posiphen improve cognition as measured by ADAS-Cog13? * Does buntanetap/Posiphen improve function as measured by ADCS-iADL? * What medical issues do participants have, if any, when taking buntanetap/Posiphen? Researchers will compare buntanetap/Posiphen to a placebo (a look-alike substance that contains no drug) to see if buntanetap/Posiphen works to treat early Alzheimer's disease. Participants will: * Take buntanetap/Posiphen or a placebo every day for 18 months * Visit the clinic periodically for checkups, tests, and questionnaires (screening visits, enrollment, month 1, month 3, month 6, month 9, month 12, month 15, month 18), including a volumetric MRI at month 6 and month 18 * Complete pre- and post-clinic visit phone calls

Conditions

• Early Alzheimers Disease

Interventions

Type	Name	Description
DRUG	buntanetap/posiphen	30mg capsule by mouth once daily for 18 months
DRUG	Placebo	Placebo capsule by mouth once daily for 18 months

Timeline

• Start date: 2025-02-04
• Primary completion: 2027-12-01
• Completion: 2028-06-01
• First posted: 2024-11-29
• Last updated: 2026-04-17

Locations

81 sites across 1 country: United States

Regulatory

• FDA-regulated drug study