Actively Recruiting
A Study of Buntanetap in Participants With PD
Led by Annovis Bio Inc. · Updated on 2026-04-30
500
Participants Needed
27
Research Sites
198 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
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.
CONDITIONS
Official 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
- Cohort 1: Prior participation in a PD clinical trial with buntanetap
- Cohort 2: Receiving deep brain stimulation treatment in the subthalamic nucleus or globus pallidus internus for at least 12 months after successful surgery
- Hoehn & Yahr stage 1-3 in ON state
- MMSE score between 21 and 30 at screening and baseline
- Have a support person to accompany participant during study visits
- Female participants of childbearing potential must have a negative pregnancy test, be non-lactating, and agree to use highly effective contraception during the trial and for one month after last dose
- Male participants must be sterile, sexually inactive, or agree to use barrier contraception, and their female partners must use highly effective contraception
- No current suicidal ideation or suicide attempt in past month
- Stable permitted medications for at least 4 weeks prior to screening
- Adequate visual and hearing ability to perform study assessments
- Good general health without disease expected to interfere with the study
You will not qualify if you...
- For Cohort 1: Currently receiving deep brain stimulation treatment
- History of schizophrenia, bipolar disorder, or major depression unless mild and stable on or off treatment
- History of seizure disorder unless stable on medication
- History or evidence of long QT syndrome or abnormal QTcF interval
- Bradycardia (<50 bpm) or tachycardia (>100 bpm) deemed medically significant
- Uncontrolled Type-1 or Type-2 diabetes (HbA1c >7.5%)
- Significant kidney or liver impairment
- Clinically significant abnormal laboratory values (e.g., liver enzymes >2x upper limit)
- Imminent risk of self-harm or harm to others, recent suicidal ideation or behavior
- Cancer or malignant tumor within past year unless cured with no recurrence
- Moderate to severe alcohol or substance use disorder in last 5 years
- Participation in another investigational drug trial within 4 weeks prior to screening
- Learning disability or developmental delay
- Known allergy to the investigational drug or its ingredients
- Currently pregnant, breastfeeding, or lactating
- Uncontrolled hypertension or hypotension deemed medically significant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 27 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
Not Yet 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
Active, Not 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
Not Yet Recruiting
Research Team
S
Sarah MacCallum, BSN RN
CONTACT
A
Alexander Morin, PhD
CONTACT
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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