An Open-label Clinical Trial Investigating the Long-term Safety of Buntanetap in Treating Participants With Parkinson's Disease
Annovis Bio Inc.
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.
Description
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. MMSE, MoCA, C-SSRS, and MDS-UPDRS will be assessed by clinicians who have successfully completed the r…
Eligibility
- Age range
- 40–85 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Diagnosis of idiopathic PD according to MDS Clinical Diagnostic Criteria for Parkinson's Disease (Postuma et al., 2015) and a. Cohort 1: Participated in a prior PD clinical trial with buntanetap. i. A legally authorized representative is required for any participant whose MMSE \<21 at screening. b. Cohort 2: Has been receiving DBS treatment in either 1) the subthalamic nucleus or 2) the globus pallidus internus for at least 12 months after a successful DBS surgery that achieved the goal. i. Female or male adults aged 40 to 85 years. ii. H\&Y stage 1-3 in ON…
Interventions
- Drugbuntanetap/posiphen
buntanetap capsules 30 mg by mouth daily
Locations (27)
- University of Alabama at BirminghamBirmingham, Alabama
- Banner Sun Health Research Institute - Cleo Roberts Center for Clinical ResearchSun City, Arizona
- Parkinson's & Movement Disorder Institute (PMDI) - Orange County OfficeFountain Valley, California
- Cenexel Rocky Mountain Clinical ResearchEnglewood, Colorado
- New England Institute for Clinical Research (Ki Health Partners)Stamford, Connecticut
- First Choice Neurology - Aventura Neurologic AssociatesAventura, Florida