Actively Recruiting
An Open-label Clinical Trial Investigating the Long-term Safety of Buntanetap in Treating Participants With Parkinsons 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 Parkinsons 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 Parkinsons 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
Research Team
S
Sarah MacCallum, BSN RN
A
Alexander Morin, PhD
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here