NCT07284784

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

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: Annovis Bio Inc. · Industry
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 requisite certifications/trainings for each assessment. Each participant shall be assessed by the same clinician throughout the study. Cohort 1 participants will stop standard of care Parkinson's medications 12h before baseline and annual clinical visits to ensure clinical OFF-state during visit. Cohort 2 participants will stop standard of care Parkinson's medications 12h before all clinic visits. The night before the baseline and annual clinic visits (or early termination visit), Cohort 2 participants will return DBS settings to their initial baseline settings.

Conditions

• Parkinson's Disease (PD)
• Deep Brain Stimulation

Interventions

Type	Name	Description
DRUG	buntanetap/posiphen	buntanetap capsules 30 mg by mouth daily

Timeline

• Start date: 2026-01-09
• Primary completion: 2029-09-01
• Completion: 2029-11-01
• First posted: 2025-12-16
• Last updated: 2026-04-07

Locations

27 sites across 1 country: United States

Regulatory

• FDA-regulated drug study