buntanetap/posiphen for Parkinson's (NCT07284784)
Safety of new Parkinson medication
- 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
- Safety of new Parkinson medication
- 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
Goal: to learn about the long-term safety of buntanetap when taken by people with Parkinson's disease over 36 months. Approach: participants will take 30 mg of buntanetap once a day in an open-label study, with regular checks by the same trained clinician using memory and thinking tests, a suicide-risk screen, and standardized movement exams; at clinic visits participants will pause their usual Parkinson's medicines for about 12 hours, and those with deep brain stimulation will return their device settings to baseline before key visits. Eligibility: adults 40 to 85 years old with diagnosed idiopathic Parkinson's in early to mid stages (on-state stage 1 to 3) and screening thinking scores in the range 21 to 30; Cohort 1 is by invitation for people who were in earlier buntanetap trials, Cohort 2 is for people who have had deep brain stimulation for at least 12 months, and all participants need a support person to attend visits.
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. Goal: to learn about the long-term safety of buntanetap when taken by people with Parkinson's disease over 36 months. Approach: participants will take 30 mg of buntanetap once a day in an open-label study, with regular checks by the same trained clinician using memory and thinking tests, a suicide-risk screen, and standardized movement exams; at clinic visits participants will pause their usual Parkinson's medicines for about 12 hours, and those with deep brain stimulation will return their device settings to baseline before key visits. Eligibility: adults 40 to 85 years old with diagnosed idiopathic Parkinson's in early to mid stages (on-state stage 1 to 3) and screening thinking scores in the range 21 to 30; Cohort 1 is by invitation for people who were in earlier buntanetap trials, Cohort 2 is for people who have had deep brain stimulation for at least 12 months, and all participants need a support person to attend visits.
- 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?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This Phase 2/Phase 3 trial is estimated to last approximately 3 years and 8 months.
- 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.
- 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.
- Will I get a placebo in this trial?
- Everyone in this trial receives the experimental treatment. There is no placebo group.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Brain surgery / implanted device (invasive). Confirm the full schedule with the study coordinator.