Actively Recruiting
An Open-label Clinical Trial Investigating the Long-term Safety of Buntanetap in Treating Participants With Parkinson's Disease
Led by Annovis Bio Inc. · Updated on 2026-06-03
500
Participants Needed
27
Research Sites
8 weeks
Total Duration
On this page
Sponsors
A
Annovis Bio Inc.
Lead Sponsor
D
Duke Clinical Research Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the long-term safety of buntanetap in people with Parkinson's Disease (PD) through a 36-month open-label safety study. The trial includes two groups: one with participants previously involved in buntanetap trials and another with participants receiving deep brain stimulation (DBS) treatment. This study focuses on safety, monitoring side effects and adverse events during the treatment period. Participants will receive a daily oral dose of buntanetap 30 mg after a screening period of up to 42 days. Cohort 1 participants stop their usual Parkinson's medications 12 hours before baseline and annual visits to ensure an OFF state during assessments. Cohort 2 participants, who have had DBS surgery, will also stop standard medications 12 hours before visits and reset their DBS settings to baseline the night before key visits. Throughout the study, participants will undergo assessments including cognitive and motor function tests such as MMSE, MoCA, C-SSRS, and MDS-UPDRS by trained clinicians. They will be monitored for adverse events, treatment safety, and treatment-emergent side effects over the 36 months. Participants must have a support person for visits, and safety will be closely observed to ensure well-being during the trial.
CONDITIONS
Brief Title
A Study of Buntanetap in Participants With PD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 40 to 85 years
- Diagnosis of idiopathic Parkinson's Disease according to MDS Clinical Diagnostic Criteria
- For Cohort 1: Prior participation in a buntanetap clinical trial
- For Cohort 2: Receiving deep brain stimulation (DBS) for at least 12 months after successful surgery
- Hoehn and Yahr stage 1 to 3 in ON state
- Mini-Mental State Examination (MMSE) score 21 to 30 at screening and baseline
- Have a support person to accompany to study visits
- Female participants of childbearing potential must have a negative pregnancy test, be non-lactating, and agree to use highly effective contraception during and one month after treatment
- Male participants must be sterile, sexually inactive, or agree to use barrier contraception during and one month after treatment
- No evidence of current suicidal ideation or suicide attempt in the past month
- Stable use of permitted medications for at least 4 weeks before screening
- Adequate vision and hearing to complete study assessments
- Good general health without diseases expected to interfere with the study
You will not qualify if you...
- For Cohort 1: Currently receiving DBS treatment
- History of psychiatric disorders such as schizophrenia, bipolar disorder, or major depression unless stable or mild and well-managed
- History of seizure disorder unless stable on medication
- History or evidence of long QT syndrome or prolonged QT intervals on ECG
- Bradycardia (heart rate <50 bpm) or tachycardia (heart rate >100 bpm) deemed medically significant
- Uncontrolled diabetes (HbA1c >7.5% unless controlled)
- Significant kidney or liver impairment
- Abnormal lab values including liver enzymes greater than twice the upper limit of normal
- Risk of self-harm or harm to others based on clinical assessment
- Cancer or malignant tumor within the past year unless treated with no recurrence
- Moderate to severe alcohol or substance use disorder within last 5 years
- Recent participation in another investigational drug trial within 4 weeks prior to screening
- Learning disability or developmental delay
- Known allergy to buntanetap or its components
- Pregnant, breastfeeding, or lactating
- Uncontrolled high or low blood pressure deemed medically significant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 6 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 36 months
Participants receive buntanetap capsules 30 mg by mouth daily to assess long-term safety in Parkinson's Disease.
Baseline and annual clinic visits with medication adjustments; DBS cohort participants have additional preparation the night before visits
Trial Site Locations
Total: 27 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
Banner Sun Health Research Institute - Cleo Roberts Center for Clinical Research
Sun City, Arizona, United States, 85351
Actively Recruiting
3
Parkinson's & Movement Disorder Institute (PMDI) - Orange County Office
Fountain Valley, California, United States, 92708
Actively Recruiting
4
Cenexel Rocky Mountain Clinical Research
Englewood, Colorado, United States, 80113
Actively Recruiting
5
New England Institute for Clinical Research (Ki Health Partners)
Stamford, Connecticut, United States, 06824
Actively Recruiting
6
First Choice Neurology - Aventura Neurologic Associates
Aventura, Florida, United States, 33180
Actively Recruiting
7
Arrow Clinical Trials
Daytona Beach, Florida, United States, 32117
Actively Recruiting
8
Accel Clinical Sites-Georgia LLC dba Accel Research Sites-Lake Oconee CRU
DeLand, Florida, United States, 32720
Actively Recruiting
9
Renstar Medical Research
Ocala, Florida, United States, 34470
Actively Recruiting
10
University of South Florida (USF) - University of South Florida College of Medicine - Parkinson's Di
Tampa, Florida, United States, 33613
Actively Recruiting
11
Conquest Research
Winter Park, Florida, United States, 32789
Actively Recruiting
12
iResearch Atlanta
Decatur, Georgia, United States, 30030
Actively Recruiting
13
Josephson Wallack Munshower Neurology, P.C.
Indianapolis, Indiana, United States, 46256
Actively Recruiting
14
University of Kansas Medical Center (KUMC) - School of Medicine - Parkinson's Disease and Movement D
Kansas City, Kansas, United States, 66160
Actively Recruiting
15
Quest Research Institute
Farmington Hills, Michigan, United States, 48334
Actively Recruiting
16
Mount Sinai Hospital
New York, New York, United States, 10019
Not Yet Recruiting
17
Duke Department of Neurosurgery
Durham, North Carolina, United States, 27710
Actively Recruiting
18
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210
Actively Recruiting
19
The Movement Disorder Clinic of Oklahoma
Tulsa, Oklahoma, United States, 74136
Actively Recruiting
20
Abington Neurology
Willow Grove, Pennsylvania, United States, 19090
Actively Recruiting
21
Medical University of South Carolina (MUSC) - The Murray Center for Research on Parkinson's Disease
Charleston, South Carolina, United States, 29401
Not Yet Recruiting
22
Neurology Clinic, P.C.
Cordova, Tennessee, United States, 38018
Actively Recruiting
23
Veracity Neuroscience LLC
Memphis, Tennessee, United States, 38157
Actively Recruiting
24
Central Texas Neurology
Round Rock, Texas, United States, 78681
Actively Recruiting
25
University of Virginia Health System (UVAHS) - Adult Neurology Clinic
Charlottesville, Virginia, United States, 22903
Actively Recruiting
26
Inland Northwest Research
Spokane, Washington, United States, 99202
Actively Recruiting
27
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
Research Team
S
Sarah MacCallum, BSN RN
A
Alexander Morin, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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