Buntanetap for Parkinson's Disease

Not yet recruiting at 24 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Annovis Bio Inc.

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Laurie Sanders, Ph.D.

Principal Investigator

Duke Clinical Research Institute

Are You a Good Fit for This Trial?

This trial is for people with Parkinson's Disease (PD). Cohort 1 is by invitation only for those who've been in past buntanetap trials. Cohort 2 includes PD patients undergoing deep brain stimulation. Participants must pass a screening to take buntanetap daily.

Inclusion Criteria

I have been diagnosed with Parkinson's disease based on specific criteria.

I was in a PD trial with buntanetap and may need a legal representative if my mental test score is low.

I have someone who can come with me to my study visits.

Exclusion Criteria

Bradycardia (<50 bpm) or tachycardia (>100 bpm) on the ECG at screening and deemed medically significant by the PI.

Imminent risk of self-harm or harm to others.

I have been diagnosed with cancer or a malignant tumor in the last year.

What Are the Treatments Tested in This Trial?

Interventions

• Buntanetap

Trial Overview

The study tests the long-term safety of a drug called buntanetap, given as a daily dose over three years to two groups: previous trial participants and those receiving deep brain stimulation therapy.

How Is the Trial Designed?

Group I: Cohort 2 - buntanetap Experimental Treatment 1 Intervention

Cohort 2 will be for PD participants who are receiving deep brain stimulation (DBS) treatment.

Group II: Cohort 1 - buntanetap Experimental Treatment 1 Intervention

Cohort 1 will enroll via invitation only for PD participants who have previously participated in bun

Who Is Running the Clinical Trial?

Annovis Bio Inc.

Lead Sponsor

Trials

6

Recruited

1,700+

Duke Clinical Research Institute

Collaborator

Trials

69

Recruited

242,000+