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NCT06709014 · ClinicalTrials.gov registry record · Phase 3
A Double-blind Dual Study Assessing Safety and Efficacy of Buntanetap in Participants With Early AD
A Phase 3 study of Early Alzheimer's Disease, sponsored by Annovis Bio.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 760
- Enrollment target
- 20
- Study locations
NCT06709014: Recruiting Phase 3 study of Early Alzheimer's Disease, sponsored by Annovis Bio.
NCT06709014 is a Phase 3 study of Early Alzheimer's Disease that is actively recruiting participants, run by Annovis Bio. The registered enrollment target is 760 participants, below the 993-participant average among 7 other Early Alzheimer's Disease trials with a reported enrollment target (23% lower). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06709014, a Phase 3 study of Early Alzheimer's Disease, is actively recruiting participants, sponsored by Annovis Bio.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 760 participants
- Enrollment target
- 20
- Study locations
Study 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
Primary Outcome
ADAS-Cog13 includes the original ADAS-Cog11 items that assess cognitive function across the memory, language, praxis, and orientation domains and adds a number cancellation task and a delayed free recall task. Total scores range from 0-85, with higher scores indicating greater cognitive impairment.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG buntanetap/posiphen
Study Locations (20)
California
- Advanced Research Center - Anaheim
- Hope Clinical Research - Canoga Park
- Eximia Clinical Research - Encino
- Sun Valley Research - Imperial
- Mary S. Easton Center for Alzheimer's Research and Care, UCLA - Los Angeles
- UC Davis Alzheimer's Disease Research Center - Sacramento
- The Neuron Clinic - San Marcos
Florida
- Visionary Investigators Network - Aventura
- SFM Clinical Research - Boca Raton
- K2 Medical Research - Clermont
- K2 Medical Research Daytona - Daytona Beach
- Neuropsychiatric Research Center - Fort Myers
- Velocity Clinical - Hallandale
- Jacksonville Center for Clinical Research - Jacksonville
Arizona
- MD First Research - Chandler
- Xenoscience - Phoenix
- Clinical Endpoints - Scottsdale
Colorado
- Mountain Neurological Center - Basalt
- CenExel Rocky Mountain - Englewood
Connecticut
- Research Center for Clinical Trials - Norwalk
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 760 participants |
| Start Date | 2025-02-04 |
| Est. Completion | 2028-06 |
| Phase | Phase 3 |
What NCT06709014 shows while recruiting
NCT06709014 is an interventional study that assigns participants to a tested intervention. The registered 760 participants enrollment target is mid-sized for trials with a published cap, below the 993-participant average among 7 other Early Alzheimer's Disease trials with a reported enrollment target (23% lower).
The record links to 1 condition, with Early Alzheimer's Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06709014 names 20 study sites across 5 states, led by California, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT06709014 about?
NCT06709014 is a clinical study titled "A Double-blind Dual Study Assessing Safety and Efficacy of Buntanetap in Participants With Early AD". 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-Co...
What is the current status of trial NCT06709014?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 760 participants. The study started on 2025-02-04. Estimated completion is 2028-06.
What conditions does trial NCT06709014 study?
This clinical trial studies the following conditions: Early Alzheimer's Disease.
What interventions are being tested in trial NCT06709014?
The interventions under investigation include: Placebo (DRUG), buntanetap/posiphen (DRUG).
Who is sponsoring clinical trial NCT06709014?
This trial is sponsored by Annovis Bio, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06709014 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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