RecruitingPhase 2Phase 3NCT07284784

A Study of Buntanetap in Participants With PD

An Open-label Clinical Trial Investigating the Long-term Safety of Buntanetap in Treating Participants With Parkinson's Disease

Sponsor

Annovis Bio Inc.

Enrollment

500 participants

Start Date

Jan 9, 2026

Study Type

INTERVENTIONAL

Conditions

Deep Brain Stimulation Parkinson's Disease (PD)

Summary

This study will examine the long-term safety of buntanetap in participants with PD. This will be a 36-month open-label safety study. This study will be conducted with two cohorts. Cohort 1 will enroll via invitation only for PD participants who have previously participated in buntanetap clinical trials. Cohort 2 will be for PD participants who are receiving deep brain stimulation (DBS) treatment. Qualified participants will receive buntanetap 30mg QD after a screening period of up to 42 days.

Eligibility

Min Age: 40 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying a drug called buntanetap in people with Parkinson's disease. It includes two groups: people who have already taken buntanetap in a previous study, and people who have a brain stimulator device (deep brain stimulation, or DBS) implanted. **You may be eligible if...** - You have a confirmed Parkinson's disease diagnosis - You previously participated in a buntanetap Parkinson's trial (Group 1), OR you have had a DBS device in place for at least 12 months (Group 2) - You are between 40 and 85 years old (Group 2) - Your Parkinson's is mild to moderate (H&Y stage 1–3) and your memory/thinking is reasonably intact - You have someone who can attend study visits with you **You may NOT be eligible if...** - You have not previously taken buntanetap or do not have a DBS device - You have severe cognitive impairment (MMSE below 21, unless in Group 1 with a legal representative) - You are outside the 40–85 age range (for Group 2) - You are pregnant or of childbearing potential without using contraception Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGbuntanetap/posiphen

buntanetap capsules 30 mg by mouth daily

Locations(27)

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

Medical University of South Carolina (MUSC) - The Murray Center for Research on Parkinson's Disease

Charleston, South Carolina, United States

Neurology Clinic, P.C.

Cordova, Tennessee, United States

Veracity Neuroscience LLC

Memphis, Tennessee, United States

Central Texas Neurology

Round Rock, Texas, United States

University of Virginia Health System (UVAHS) - Adult Neurology Clinic

Charlottesville, Virginia, United States

Inland Northwest Research

Spokane, Washington, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

View Full Details on ClinicalTrials.gov

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NCT07284784

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