A Study of Buntanetap in Participants With PD

NCT07284784 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: ANVS-25002
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 27

Brief 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.

Conditions

Parkinson's Disease (PD); Deep Brain Stimulation

Keywords

Parkinson's Disease; PD; Deep Brain Stimulation; DBS; buntanetap; Open-Label; posiphen

Outcome Measures

Primary Outcomes (4)

• Safety of buntanetap

  Safety assessments of participants with PD receiving treatment with buntanetap

  36-months of treatment

• Adverse Events (AE)

  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)

  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)

  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

Study Arms (2)

Cohort 1 - buntanetap

EXPERIMENTAL

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

Drug: buntanetap/posiphen

Cohort 2 - buntanetap

EXPERIMENTAL

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

Drug: buntanetap/posiphen

Interventions

buntanetap/posiphen DRUG

buntanetap capsules 30 mg by mouth daily

Cohort 1 - buntanetap; Cohort 2 - buntanetap

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Have a support person who will accompany the participant on study visits at designated times.
• 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:
• Oral, intravaginal, or transdermal combined (estrogen plus progestogen) hormonal contraception associated with inhibition of ovulation,
• Oral, injectable, or implantable progestogen-only hormonal contraception associated with inhibition of ovulation,
• Intrauterine device (IUD),
• Intrauterine hormone-releasing system (IUS),
• Bilateral tubal occlusion,
• 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),
• 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

You may not qualify if:

• 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.
• 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.
• 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.
• 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
• 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.
• 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).
• 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.
• 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.
• 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).
• Alcohol / Substance use disorder, moderate to severe, in the last 5 years according to the most current version of the DSM.
• 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.
• A learning disability or developmental delay.
• Participants whom the site PI deems to be otherwise ineligible.
• A known allergy to the investigational drug or any of its components.

Sponsors & Collaborators

• Annovis Bio Inc.: lead
• Duke Clinical Research Institute: collaborator

Study Sites (27)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

NOT YET RECRUITING

Banner Sun Health Research Institute - Cleo Roberts Center for Clinical Research

Sun City, Arizona, 85351, United States

RECRUITING

Parkinson's & Movement Disorder Institute (PMDI) - Orange County Office

Fountain Valley, California, 92708, United States

RECRUITING

Cenexel Rocky Mountain Clinical Research

Englewood, Colorado, 80113, United States

RECRUITING

New England Institute for Clinical Research (Ki Health Partners)

Stamford, Connecticut, 06824, United States

RECRUITING

First Choice Neurology - Aventura Neurologic Associates

Aventura, Florida, 33180, United States

RECRUITING

Arrow Clinical Trials

Daytona Beach, Florida, 32117, United States

RECRUITING

Accel Clinical Sites-Georgia LLC dba Accel Research Sites-Lake Oconee CRU

DeLand, Florida, 32720, United States

RECRUITING

Renstar Medical Research

Ocala, Florida, 34470, United States

RECRUITING

University of South Florida (USF) - University of South Florida College of Medicine - Parkinson's Di

Tampa, Florida, 33613, United States

RECRUITING

Conquest Research

Winter Park, Florida, 32789, United States

RECRUITING

iResearch Atlanta

Decatur, Georgia, 30030, United States

RECRUITING

Josephson Wallack Munshower Neurology, P.C.

Indianapolis, Indiana, 46256, United States

RECRUITING

University of Kansas Medical Center (KUMC) - School of Medicine - Parkinson's Disease and Movement D

Kansas City, Kansas, 66160, United States

RECRUITING

Quest Research Institute

Farmington Hills, Michigan, 48334, United States

RECRUITING

Mount Sinai Hospital

New York, New York, 10019, United States

NOT YET RECRUITING

Duke Department of Neurosurgery

Durham, North Carolina, 27710, United States

RECRUITING

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

RECRUITING

The Movement Disorder Clinic of Oklahoma

Tulsa, Oklahoma, 74136, United States

RECRUITING

Abington Neurology

Willow Grove, Pennsylvania, 19090, United States

ACTIVE NOT RECRUITING

Medical University of South Carolina (MUSC) - The Murray Center for Research on Parkinson's Disease

Charleston, South Carolina, 29401, United States

NOT YET RECRUITING

Neurology Clinic, P.C.

Cordova, Tennessee, 38018, United States

RECRUITING

Veracity Neuroscience LLC

Memphis, Tennessee, 38157, United States

RECRUITING

Central Texas Neurology

Round Rock, Texas, 78681, United States

RECRUITING

University of Virginia Health System (UVAHS) - Adult Neurology Clinic

Charlottesville, Virginia, 22903, United States

RECRUITING

Inland Northwest Research

Spokane, Washington, 99202, United States

RECRUITING

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Interventions

phenserine

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Laurie Sanders, Ph.D.

  Duke Clinical Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah MacCallum, BSN RN

CONTACT

484-875-3192; maccallum@annovisbio.com

Alexander Morin, PhD

CONTACT

morin@annovisbio.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All participants will receive treatment with buntanetap 30 mg daily

Study Record Dates

• First Submitted: November 26, 2025
• First Posted: December 16, 2025
• Study Start: January 9, 2026
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): November 1, 2029
• Last Updated: April 30, 2026

Record last verified: 2025-11

Locations

US (27)