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
Summary For Families
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.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.