Assess long term buntanetap safety
- Trial ID
- NCT07284784
- Official Title
- An Open-label Clinical Trial Investigating the Long-term Safety of Buntanetap in Treating Participants With Parkinson's Disease
- Goal
- Assess long term buntanetap safety
- Phase
- PHASE2, PHASE3
- Status
- RECRUITING
- Sponsor
- Annovis Bio Inc.
- Study Type
- INTERVENTIONAL
- Enrollment
- 500 participants
- Conditions
- Parkinson's Disease (PD), Deep Brain Stimulation
- Interventions
- buntanetap/posiphen
Plain-Language Summary
The goal is to evaluate long-term safety of buntanetap as a way to lower brain levels of alpha-synuclein and other abnormal proteins that may drive Parkinson's progression. Buntanetap is an oral small molecule that works by reducing the production of those proteins at the mRNA translation step, it is not a dopamine replacement so people can generally continue levodopa and other standard Parkinson medicines while the trial watches for tolerability and side effects. The trial is looking for adults 40 to 85 with idiopathic Parkinson's at Hoehn and Yahr stages 1 to 3 in the ON state and an MMSE of 21 to 30, who either were in a prior buntanetap trial or have had successful deep brain stimulation for at least 12 months, and who can attend visits with a support person and meet the study safety and contraception requirements.
Locations
- University of Alabama at Birmingham, Birmingham, Alabama, United States
- Banner Sun Health Research Institute - Cleo Roberts Center for Clinical Research, Sun City, Arizona, United States
- Parkinson's & Movement Disorder Institute (PMDI) - Orange County Office, Fountain Valley, California, United States
- Cenexel Rocky Mountain Clinical Research, Englewood, Colorado, United States
- New England Institute for Clinical Research (Ki Health Partners), Stamford, Connecticut, United States
- First Choice Neurology - Aventura Neurologic Associates, Aventura, Florida, United States
- Arrow Clinical Trials, Daytona Beach, Florida, United States
- Accel Clinical Sites-Georgia LLC dba Accel Research Sites-Lake Oconee CRU, DeLand, Florida, United States
- Renstar Medical Research, Ocala, Florida, United States
- University of South Florida (USF) - University of South Florida College of Medicine - Parkinson's Di, Tampa, Florida, United States
- Conquest Research, Winter Park, Florida, United States
- iResearch Atlanta, Decatur, Georgia, United States
- Josephson Wallack Munshower Neurology, P.C., Indianapolis, Indiana, United States
- University of Kansas Medical Center (KUMC) - School of Medicine - Parkinson's Disease and Movement D, Kansas City, Kansas, United States
- Quest Research Institute, Farmington Hills, Michigan, United States
- Mount Sinai Hospital, New York, New York, United States
- Duke Department of Neurosurgery, Durham, North Carolina, United States
- The Ohio State University Wexner Medical Center, Columbus, Ohio, United States
- The Movement Disorder Clinic of Oklahoma, Tulsa, Oklahoma, United States
- Abington Neurology, Willow Grove, Pennsylvania, United States
And 7 more locations.
Frequently Asked Questions
- What is this trial testing?
- This trial is studying buntanetap/posiphen. The goal is to evaluate long-term safety of buntanetap as a way to lower brain levels of alpha-synuclein and other abnormal proteins that may drive Parkinson's progression. Buntanetap is an oral small molecule that works by reducing the production of those proteins at the mRNA translation step, it is not a dopamine replacement so people can generally continue levodopa and other standard Parkinson medicines while the trial watches for tolerability and side effects. The trial is looking for adults 40 to 85 with idiopathic Parkinson's at Hoehn and Yahr stages 1 to 3 in the ON state and an MMSE of 21 to 30, who either were in a prior buntanetap trial or have had successful deep brain stimulation for at least 12 months, and who can attend visits with a support person and meet the study safety and contraception requirements.
- Who can participate?
- Participants must be between 40 Years and 85 Years.
- Where is this trial located?
- This trial is recruiting at 27 locations.
- Does it cost anything to join?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This Phase 2/Phase 3 trial is estimated to last approximately 3 years and 8 months.