A Study of Buntanetap in Participants With PD

June 2, 2026 updated by: Annovis Bio Inc.

An Open-label Clinical Trial Investigating the Long-term Safety of Buntanetap in Treating Participants With Parkinson's Disease

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

500

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Recruiting
        • University of Alabama at Birmingham
        • Contact:
        • Principal Investigator:
          • Natividad Stover, M.D.
    • Arizona
      • Sun City, Arizona, United States, 85351
        • Recruiting
        • Banner Sun Health Research Institute - Cleo Roberts Center for Clinical Research
        • Principal Investigator:
          • Sara Dhanani, M.D.
        • Contact:
    • California
      • Fountain Valley, California, United States, 92708
        • Recruiting
        • Parkinson's & Movement Disorder Institute (PMDI) - Orange County Office
        • Principal Investigator:
          • Daniel Truong, M.D.
        • Contact:
          • Evan Moreno-Davis
          • Phone Number: 714-378-5074
          • Email: evan@pmdi.org
    • Colorado
      • Englewood, Colorado, United States, 80113
        • Recruiting
        • CenExel Rocky Mountain Clinical Research
        • Contact:
        • Principal Investigator:
          • Meagen Salinas, M.D.
    • Connecticut
      • Stamford, Connecticut, United States, 06824
        • Recruiting
        • New England Institute for Clinical Research (Ki Health Partners)
        • Contact:
        • Principal Investigator:
          • Peter McAllister, M.D.
    • Florida
      • Aventura, Florida, United States, 33180
        • Recruiting
        • First Choice Neurology - Aventura Neurologic Associates
        • Principal Investigator:
          • Jonathan Cross, M.D.
        • Contact:
      • Daytona Beach, Florida, United States, 32117
        • Recruiting
        • Arrow Clinical Trials
        • Contact:
        • Principal Investigator:
          • David Billmeier, M.D.
      • DeLand, Florida, United States, 32720
        • Recruiting
        • Accel Clinical Sites-Georgia LLC dba Accel Research Sites-Lake Oconee CRU
        • Principal Investigator:
          • Bruce Rankin, D.O.
        • Contact:
      • Ocala, Florida, United States, 34470
        • Recruiting
        • Renstar Medical Research
        • Principal Investigator:
          • Annette Nieves, M.D.
        • Contact:
      • Tampa, Florida, United States, 33613
        • Recruiting
        • University of South Florida (USF) - University of South Florida College of Medicine - Parkinson's Di
        • Principal Investigator:
          • Robert Hauser, M.D., MBA
        • Contact:
      • Winter Park, Florida, United States, 32789
    • Georgia
      • Decatur, Georgia, United States, 30030
        • Recruiting
        • iResearch Atlanta
        • Contact:
        • Principal Investigator:
          • Kimball Johnson, M.D.
    • Indiana
      • Indianapolis, Indiana, United States, 46256
        • Recruiting
        • Josephson Wallack Munshower Neurology, P.C.
        • Principal Investigator:
          • Kristi George, M.D.
        • Contact:
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Recruiting
        • University of Kansas Medical Center (KUMC) - School of Medicine - Parkinson's Disease and Movement D
        • Contact:
        • Principal Investigator:
          • Rajesh Pahwa, M.D.
    • Michigan
      • Farmington Hills, Michigan, United States, 48334
        • Recruiting
        • Quest Research Institute
        • Principal Investigator:
          • Aaron Ellenbogen, D.O.
        • Contact:
    • New York
      • New York, New York, United States, 10019
        • Not yet recruiting
        • Mount Sinai Hospital
        • Principal Investigator:
          • Joohi Jimenez-Shahed, M.D.
        • Contact:
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke Department of Neurosurgery
        • Principal Investigator:
          • Kyle Mitchell, M.D.
        • Contact:
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • The Ohio State University Wexner Medical Center
        • Principal Investigator:
          • Zachary Jordan, M.D.
        • Contact:
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74136
        • Recruiting
        • The Movement Disorder Clinic of Oklahoma
        • Contact:
        • Principal Investigator:
          • Kevin Klos, M.D.
    • Pennsylvania
      • Willow Grove, Pennsylvania, United States, 19090
        • Recruiting
        • Abington Neurology
        • Principal Investigator:
          • David Weisman, M.D.
        • Contact:
    • South Carolina
      • Charleston, South Carolina, United States, 29401
        • Not yet recruiting
        • Medical University of South Carolina (MUSC) - The Murray Center for Research on Parkinson's Disease
        • Contact:
        • Principal Investigator:
          • Vanessa Hinson, M.D., PhD
    • Tennessee
      • Cordova, Tennessee, United States, 38018
        • Recruiting
        • Neurology Clinic, P.C.
        • Contact:
        • Principal Investigator:
          • Kendrick Henderson, M.D.
      • Memphis, Tennessee, United States, 38157
        • Recruiting
        • Veracity Neuroscience LLC
        • Contact:
        • Principal Investigator:
          • Mark LeDoux, M.D., PhD
    • Texas
      • Round Rock, Texas, United States, 78681
        • Recruiting
        • Central Texas Neurology
        • Contact:
        • Principal Investigator:
          • Elizabeth Peckham, M.D.
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • Recruiting
        • University of Virginia Health System (UVAHS) - Adult Neurology Clinic
        • Contact:
        • Principal Investigator:
          • Binit Shah, M.D.
    • Washington
      • Spokane, Washington, United States, 99202
        • Recruiting
        • Inland Northwest Research
        • Principal Investigator:
          • Jason Aldred, M.D.
        • Contact:
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Medical College of Wisconsin
        • Contact:
        • Principal Investigator:
          • Karen Blindauer, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 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,
    3. Intrauterine device (IUD),
    4. Intrauterine hormone-releasing system (IUS),
    5. Bilateral tubal occlusion,
    6. Vasectomized partner (a vasectomized partner is a highly effective contraception method provided that the partner is the sole male sexual partner of the participant, and the absence of sperm has been confirmed. If not, an additional highly effective method of contraception should be used),

    7. Sexual abstinence (sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatment. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the study and the preferred and usual lifestyle of the participant).

      • Non-childbearing potential includes surgically sterilized or postmenopausal with no menstrual bleeding for at least one year prior to study start.

    Protocol ANVS-25002 Ver. 2.1; 09-23-2025 Confidential Page 30 of 54

  4. Male participants must be sterile or sexually inactive or agree not to father a child during the study and one month after the last dose of study medication and must agree to use a barrier method for contraception. Female partners of male participants must adopt a highly effective method of contraception with a failure rate of less than 1% per year when used consistently and correctly 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,
    3. IUD,
    4. IUS,
    5. Bilateral tubal occlusion.
  5. No evidence of current suicidal ideation or previous suicide attempt in the past month as evaluated in the C-SSRS.

  6. Stability of permitted medications for at least 4 weeks prior to screening. Refer to Concomitant Medications section above for details on prohibited and permitted medications.

    1. Standard of care anti-parkinsonian medication,
    2. Cholinesterase inhibitors and/or memantine medication,
    3. Anticonvulsant medications used for epilepsy or mood stabilization, or neuropathic pain indications, and have not had a breakthrough seizure 3 years prior to screening,
    4. Mood-stabilizing psychotropic agents including, but not limited to, lithium,
  7. Adequate visual and hearing ability (physical ability to perform all the study assessments).
  8. Good general health with no disease expected to interfere with the study.

Exclusion Criteria:

  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).
  8. Any clinically significant abnormal laboratory values. Participants with liver function tests (aspartate aminotransferase [AST] or alanine aminotransferase [ALT]) greater than twice ULN will be excluded.
  9. Is at imminent risk of self-harm, based on clinical interview and responses on the C-SSRS, or of harm to others in the opinion of the investigators. Participants must be excluded if they report suicidal ideation with intent, with or without a plan or method (e.g., positive response to Items 4 or 5 in assessment of suicidal ideation on C-SSRS) in the past 2 months, or suicidal behavior in the past 6 months.
  10. Cancer or has had a malignant tumor within the past year, except participants who underwent potentially curative therapy with no evidence of recurrence (participants with stable untreated cancer are not excluded).
  11. Alcohol / Substance use disorder, moderate to severe, in the last 5 years according to the most current version of the DSM.
  12. Participation in another clinical trial with an investigational agent and have taken at least one dose of study medication, unless unblinded on placebo, within 4 weeks prior to the start of screening, or five half-lives of the investigational drug, whichever is greater. The end of a previous investigational trial is the date the last dose of an investigational agent was taken.
  13. A learning disability or developmental delay.
  14. Participants whom the site PI deems to be otherwise ineligible.

  15. A known allergy to the investigational drug or any of its components.

    Inactive ingredients of the investigational medicinal product:

    • Silicified microcrystalline cellulose
    • Dibasic calcium phosphate dihydrate
    • Mannitol
    • Stearic acid
    • Hypromellose (capsule shells structure)
    • Titanium dioxide (opacifier of the capsule shells)
  16. Is currently pregnant, breast-feeding, and/or lactating.
  17. Uncontrolled hypertension (systolic >160mmHg and/or diastolic >95mmHg) or hypotension (systolic <90mmHg and/or diastolic <60 mmHg) and deemed medically significant by the PI.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1 - buntanetap
Cohort 1 will enroll via invitation only for PD participants who have previously participated in bun
Drug: buntanetap/posiphen
buntanetap capsules 30 mg by mouth daily
Experimental: Cohort 2 - buntanetap
Cohort 2 will be for PD participants who are receiving deep brain stimulation (DBS) treatment.
Drug: buntanetap/posiphen
buntanetap capsules 30 mg by mouth daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety of buntanetap
Time Frame: 36-months of treatment
Safety assessments of participants with PD receiving treatment with buntanetap
36-months of treatment
Adverse Events (AE)
Time Frame: 36-months of treatment
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention
36-months of treatment
Treatment Emergent Adverse Events (TEAE)
Time Frame: 36-months of treatment
TEAE is an event that emerges during treatment, having been absent pretreatment, or worsens relative to the pretreatment state
36-months of treatment
Serious Adverse Events (SAE)
Time Frame: 36-months of treatment
SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization, or prolongation of an existing hospitalization, results in persistent or significant disability or incapacity, is a birth defect or congenital anomaly
36-months of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Annovis Bio Inc.

Collaborators

Duke Clinical Research Institute

Investigators

  • Principal Investigator: Laurie Sanders, Ph.D., Duke Clinical Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 9, 2026

Primary Completion (Estimated)

September 1, 2029

Study Completion (Estimated)

November 1, 2029

Study Registration Dates

First Submitted

November 26, 2025

First Submitted That Met QC Criteria

December 9, 2025

First Posted (Actual)

December 16, 2025

Study Record Updates

Last Update Posted (Actual)

June 3, 2026

Last Update Submitted That Met QC Criteria

June 2, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANVS-25002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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