Clinical Trial

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

Active, Not Recruiting Phase 3
View on ClinicalTrials.gov →
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
Protocol Amendment History 2 changes
critical Trial status changed: Recruiting → Active, Not Recruiting 2026-05-19
notable Trial sites reduced: 81 -> 78 locations 2026-05-19
Trial Details
NCT Number NCT06709014
Lead Sponsor Annovis Bio Inc.
Collaborators: Prevail Infoworks, ProPharma Group
Conditions Early Alzheimers Disease
Enrollment 760 participants
Start Date 2025-02-04
Primary Completion 2027-12 (estimated)
Study Completion 2028-06 (estimated)
Updated on ClinicalTrials.gov 2026-05-18