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Following the longer-term safety of buntanetap

Researchers are studying long-term use of buntanetap in selected people with Parkinson’s, including previous trial participants and people receiving implanted brain stimulation.

Testing a treatment or activity · Study reference: NCT07284784

Plain-language introduction written with AI from the registry; not independently checked by a clinician. Read the original details below ↓

Open the official registry record ↗

Who can join?

Ages 40 years to 85 years · Does not accept healthy volunteers

These are starting points, not the full rules. The research team can tell you whether the study is right for your situation.

Read all the rules for taking part

Sex eligibility reported by registry: all

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.
Full study name & original research details

Official study title

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

Short title used by the registry

A Study of Buntanetap in Participants With PD

Original 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.

Further description from the registry

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 reported: Parkinson's Disease (PD); Deep Brain Stimulation

Study type
Interventional
Interventions
buntanetap/posiphen
Phases
PHASE2; PHASE3
Sponsor
Annovis Bio Inc.
Start date reported by registry
2026-01-09 (actual)

Registry updated: 2026-09-21 · Status last verified by the registry submitter: 2026-09

Registry records retrieved 2026-10-11 (UTC). Individual records may have older updates. Recruitment and eligibility must be confirmed with the study team.

Contact the research team

Public study contacts supplied to the registry. Ask whether recruitment is still open and what participation involves.

Sarah MacCallum, BSN RN · 484-875-3192 · maccallum@annovisbio.com

Alexander Morin, PhD · morin@annovisbio.com

Study locations

Site status can differ from overall study status. “Status not reported” means local availability needs confirmation. Remote participation and travel arrangements must be checked with the team.

University of Alabama at Birmingham

Birmingham, Alabama, United States

Recruiting

Candace Cromer · 205-996-4034 · candacecromer@uabmc.edu

Natividad Stover, M.D.

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

Sun City, Arizona, United States

Recruiting

Serena Lowery · 623-832-6500 · serena.lowery@bannerhealth.com

Sara Dhanani, M.D.

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

Fountain Valley, California, United States

Recruiting

Evan Moreno-Davis · 714-378-5074 · evan@pmdi.org

Daniel Truong, M.D.

Cenexel Rocky Mountain Clinical Research

Englewood, Colorado, United States

Recruiting

Sally Modzelewski · 720-776-0092 · s.modzelewski@cenexel.com

Meagen Salinas, M.D.

New England Institute for Clinical Research (Ki Health Partners)

Stamford, Connecticut, United States

Recruiting

Valerija Misev · 203-914-1903 · Valerija@neinh.com

Peter McAllister, M.D.

First Choice Neurology - Aventura Neurologic Associates

Aventura, Florida, United States

Recruiting

Jonathan Palmquist · 786-744-5596 · jpalmquist@vintrials.com

Jonathan Cross, M.D.

Arrow Clinical Trials

Daytona Beach, Florida, United States

Recruiting

Vinoothna Moluguri · 386-316-6152 · vmoluguri@arrowtrials.com

David Billmeier, M.D.

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

DeLand, Florida, United States

Recruiting

Erica Santoni · 386-785-2400 · erica.santoni@accelclinical.com

Bruce Rankin, D.O.

Renstar Medical Research

Ocala, Florida, United States

Recruiting

Sebastian Mesa · 352-629-5800 · sebastian.mesa@renstar.net

Annette Nieves, M.D.

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

Tampa, Florida, United States

Recruiting

Erica Botting · 813-974-8026 · ericabotting@usf.edu

Robert Hauser, M.D., MBA

Conquest Research

Winter Park, Florida, United States

Recruiting

Fabiola Perez · 407-916-0060 · fabiola.perez@conquestresearch.com

Rekha Gandhi, M.D.

iResearch Atlanta

Decatur, Georgia, United States

Recruiting

Elizabeth Davis · 404-537-1281 · e.davis@cenexel.com

Kimball Johnson, M.D.

Josephson Wallack Munshower Neurology, P.C.

Indianapolis, Indiana, United States

Recruiting

Tammy Root · 317-573-6061 · troot@jwmneuro.com

Kristi George, M.D.

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

Kansas City, Kansas, United States

Recruiting

Kelly Lyons · 913-588-7159 · klyons@kumc.edu

Rajesh Pahwa, M.D.

Quest Research Institute

Farmington Hills, Michigan, United States

Recruiting

Savannah Carra · 248-957-8940 · savannah.carra@questri.com

Aaron Ellenbogen, D.O.

Mount Sinai Hospital

New York, New York, United States

Recruiting

Sofya Glazman · 646-493-1862 · sofya.glazman@mountsinai.org

Joohi Jimenez-Shahed, M.D.

Duke Department of Neurosurgery

Durham, North Carolina, United States

Recruiting

Vera George · 919-668-3885 · vera.george@duke.edu

Kyle Mitchell, M.D.

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States

Recruiting

Victoria Miller · 614-688-8672 · victoria.miller@osumc.edu

Zachary Jordan, M.D.

The Movement Disorder Clinic of Oklahoma

Tulsa, Oklahoma, United States

Recruiting

Elise Gibson · 918-392-4530 · mdcclinicaltrials@gmail.com

Kevin Klos, M.D.

Abington Neurology

Willow Grove, Pennsylvania, United States

Recruiting

Brian Weingartner · 215-957-9250 · brian.weingartner.ana@gmail.com

David Weisman, M.D.

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

Charleston, South Carolina, United States

Recruiting

Sandra Wilson · 843-792-3223 · wilsosan@musc.edu

Vanessa Hinson, M.D., PhD

Neurology Clinic, P.C.

Cordova, Tennessee, United States

Recruiting

Ye Liu · 901-747-1111 · yliu@neuroclinic.org

Kendrick Henderson, M.D.

Veracity Neuroscience LLC

Memphis, Tennessee, United States

Recruiting

Hannah Touliatos · 901-604-0345 · hannah@veracityneuroscience.com

Mark LeDoux, M.D., PhD

Central Texas Neurology

Round Rock, Texas, United States

Recruiting

Koni Lopez · 512-218-1222 · k.lopez@ctncpa.org

Elizabeth Peckham, M.D.

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

Charlottesville, Virginia, United States

Recruiting

Lauren Miller · 434-982-6599 · fdk5dn@uvahealth.org

Binit Shah, M.D.

Inland Northwest Research

Spokane, Washington, United States

Recruiting

Aaron Dahl · 509-960-2818 · adahl@inwresearch.com

Jason Aldred, M.D.

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Recruiting

Shelby Schold · 414-955-0698 · sschold@mcw.edu

Karen Blindauer, M.D.

The original descriptions and participation rules come from the registry. Participation is voluntary and does not guarantee benefit.