RecruitingParkinson's Disease (PD)Deep Brain Stimulation

A Study of Buntanetap in Participants With PD

Eligible age

40–85 yrs

Accepts

All genders

Locations

21 states

Healthy volunteers

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About this study

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.

Sponsor: Annovis Bio Inc.

You may qualify if…

✓ 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 state. iii. MMSE 21-30 at screening and baseline.
✓ 2. Have a support person who will accompany the participant on study visits at designated times.
✓ 3. Female participants of childbearing potential\* must have a negative urine pregnancy test at screening, must be non-lactating, and must agree to use a highly effective method of contraception (i.e., a method resulting in a failure rate of less than 1% per year when used consistently and correctly) during the trial and for one month after the last dose of trial treatment, such as:
✓ 1. Oral, intravaginal, or transdermal combined (estrogen plus progestogen) hormonal contraception associated with inhibition of ovulation,
✓ 2. Oral, injectable, or implantable progestogen-only hormonal contraception associated with inhibition of ovulation,

You may not qualify if…

✕ 1. Cohort 1 only: Is currently receiving DBS treatment. (Participant may enroll in Cohort 2 if they meet the corresponding inclusion/exclusion criteria).
✕ 2. A history of psychiatric disorder such as schizophrenia, bipolar disorder, or major depression according to the criteria of the most current version of the Diagnostic and Statistical Manual of Mental Disorders (DSM), unless their symptoms have been mild, and they are stable on treatment or no longer need treatment. Mild depression or history of depression that is stable on treatment with selective serotonin reuptake inhibitors (SSRI) or serotonin and norepinephrine reuptake inhibitors (SNRI) medication at a stable dose is acceptable. Refer to Concomitant Medications section above for details on prohibited and permitted medications.
✕ 3. A history of seizure disorder. If stable on medication, it is acceptable. Refer to Concomitant Medications section above for details on prohibited and permitted medications.
✕ 4. A history or current evidence of long QT syndrome, Fridericia's formula corrected QT (QTcF) interval ≥ 450 ms for men and ≥ 460 ms for women, or torsades de pointes.
✕ 5. Bradycardia (\<50 bpm) or tachycardia (\>100 bpm) on the ECG at screening and deemed medically significant by the PI.
✕ Protocol ANVS-25002 Ver. 2.1; 09-23-2025 Confidential Page 31 of 54
✕ 6. Uncontrolled Type-1 or Type-2 diabetes. A participant with hemoglobin subunit alpha 1c (HbA1c) levels up to 7.5% can be enrolled if the investigator believes the participant's diabetes is under control.
✕ 7. Clinically significant renal (Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\] \<50 mL/min/BSA \[body surface area\]) or hepatic impairment (Alkaline phosphatase \[ALP\] \> 2.0X the upper limit of normal \[ULN\] and/or total bilirubin \> 2.0X ULN).