Parkinson's Disease (PD)Phase 2/3NCT07284784
A Study of Buntanetap in Participants With PD
A Phase 2/3 study testing buntanetap/posiphen in people with Parkinson's Disease (PD) and Deep Brain Stimulation, run by Annovis Bio Inc. at 29 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Parkinson's Disease (PD), Deep Brain Stimulation
- What is being tested?
- buntanetap/posiphen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 29 sitesUnited States
- Study dates
- 9 Jan 2026to Nov 2029
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of idiopathic PD according to MDS Clinical Diagnostic Criteria for Parkinson's Disease (Postuma et al., 2015) and
- 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.
- 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.
- 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:
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- 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
- 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:
- 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,
- IUD,
- IUS,
- Bilateral tubal occlusion.
- No evidence of current suicidal ideation or previous suicide attempt in the past month as evaluated in the C-SSRS.
- 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.
- Standard of care anti-parkinsonian medication,
- Cholinesterase inhibitors and/or memantine medication,
- Anticonvulsant medications used for epilepsy or mood stabilization, or neuropathic pain indications, and have not had a breakthrough seizure 3 years prior to screening,
- Mood-stabilizing psychotropic agents including, but not limited to, lithium,
- Adequate visual and hearing ability (physical ability to perform all the study assessments).
- Good general health with no disease expected to interfere with the study.
Who cannot join
- Cohort 1 only: Is currently receiving DBS treatment. (Participant may enroll in Cohort 2 if they meet the corresponding inclusion/exclusion criteria).
- 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
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- 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.
- 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)
- Is currently pregnant, breast-feeding, and/or lactating.
- Uncontrolled hypertension (systolic >160mmHg and/or diastolic >95mmHg) or hypotension (systolic <90mmHg and/or diastolic <60 mmHg) and deemed medically significant by the PI.
Trial locations and contacts
29 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Alexander Morin, PhD contact
29 sites in 1 country
United States29 sites, 29 recruiting
- Recruiting
First Choice Neurology - Aventura Neurologic Associates
Aventura, Florida, 33180
Jonathan Palmquist, 786-744-5596, jpalmquist@vintrials.com
Jonathan Cross, M.D.
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Candace Cromer, 205-996-4034, candacecromer@uabmc.edu
Natividad Stover, M.D.
- Recruiting
Medical University of South Carolina (MUSC) - The Murray Center for Research on Parkinson's Disease
Charleston, South Carolina, 29401
Sandra Wilson, 843-792-3223, wilsosan@musc.edu
Vanessa Hinson, M.D., PhD
- Recruiting
University of Virginia Health System (UVAHS) - Adult Neurology Clinic
Charlottesville, Virginia, 22903
Lauren Miller, 434-982-6599, fdk5dn@uvahealth.org
Binit Shah, M.D.
- Recruiting
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Victoria Miller, 614-688-8672, victoria.miller@osumc.edu
Zachary Jordan, M.D.
- Recruiting
Neurology Clinic, P.C.
Cordova, Tennessee, 38018
Ye Liu, 901-747-1111, yliu@neuroclinic.org
Kendrick Henderson, M.D.
- Recruiting
Arrow Clinical Trials
Daytona Beach, Florida, 32117
Vinoothna Moluguri, 386-316-6152, vmoluguri@arrowtrials.com
David Billmeier, M.D.
- Recruiting
iResearch Atlanta
Decatur, Georgia, 30030
Elizabeth Davis, 404-537-1281, e.davis@cenexel.com
Kimball Johnson, M.D.
- Recruiting
Accel Clinical Sites-Georgia LLC dba Accel Research Sites-Lake Oconee CRU
DeLand, Florida, 32720
Erica Santoni, 1-386-785-2400 ext. 4608, erica.santoni@accelclinical.com
Bruce Rankin, D.O.
- Recruiting
Duke Department of Neurosurgery
Durham, North Carolina, 27710
Vera George, 919-668-3885, vera.george@duke.edu
Kyle Mitchell, M.D.
- Recruiting
Cenexel Rocky Mountain Clinical Research
Englewood, Colorado, 80113
Sally Modzelewski, 720-776-0092, s.modzelewski@cenexel.com
Meagen Salinas, M.D.
- Recruiting
Quest Research Institute
Farmington Hills, Michigan, 48334
Savannah Carra, 248-957-8940, savannah.carra@questri.com
Aaron Ellenbogen, D.O.
- Recruiting
Parkinson's & Movement Disorder Institute (PMDI) - Orange County Office
Fountain Valley, California, 92708
Evan Moreno-Davis, 714-378-5074, evan@pmdi.org
Daniel Truong, M.D.
- Recruiting
Josephson Wallack Munshower Neurology, P.C.
Indianapolis, Indiana, 46256
Tammy Root, 1-317-573-6061, troot@jwmneuro.com
Kristi George, M.D.
- Recruiting
University of Kansas Medical Center (KUMC) - School of Medicine - Parkinson's Disease and Movement D
Kansas City, Kansas, 66160
Kelly Lyons, 913-588-7159, klyons@kumc.edu
Rajesh Pahwa, M.D.
- Recruiting
Veracity Neuroscience LLC
Memphis, Tennessee, 38157
Hannah Touliatos, 901-604-0345, hannah@veracityneuroscience.com
Mark LeDoux, M.D., PhD
- Not yet recruiting
Ezy Medical Research Co.
Miami, Florida, 33015
Priscilla Hernandez, 786-483-8162, phernandez@ezytrials.com
- Recruiting
Professional Research Center
Miami, Florida, 33172
Saylet Corbera, 786-359-4091, RamirezMD@professionalresearchcenter.com
- Recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Shelby Schold, 414-955-0698, sschold@mcw.edu
Karen Blindauer, M.D.
- Recruiting
Mount Sinai Hospital
New York, New York, 10019
Sofya Glazman, 646-493-1862, sofya.glazman@mountsinai.org
Joohi Jimenez-Shahed, M.D.
- Recruiting
Renstar Medical Research
Ocala, Florida, 34470
Sebastian Mesa, 352-629-5800, sebastian.mesa@renstar.net
Annette Nieves, M.D.
- Recruiting
Central Texas Neurology
Round Rock, Texas, 78681
Koni Lopez, 512-218-1222, k.lopez@ctncpa.org
Elizabeth Peckham, M.D.
- Recruiting
Inland Northwest Research
Spokane, Washington, 99202
Aaron Dahl, 509-960-2818, adahl@inwresearch.com
Jason Aldred, M.D.
- Recruiting
New England Institute for Clinical Research (Ki Health Partners)
Stamford, Connecticut, 06824
Valerija Misev, 203-914-1903 ext. 125, Valerija@neinh.com
Peter McAllister, M.D.
- Recruiting
Banner Sun Health Research Institute - Cleo Roberts Center for Clinical Research
Sun City, Arizona, 85351
Serena Lowery, 623-832-6500, serena.lowery@bannerhealth.com
Sara Dhanani, M.D.
- Recruiting
University of South Florida (USF) - University of South Florida College of Medicine - Parkinson's Di
Tampa, Florida, 33613
Erica Botting, 813-974-8026, ericabotting@usf.edu
Robert Hauser, M.D., MBA
- Recruiting
The Movement Disorder Clinic of Oklahoma
Tulsa, Oklahoma, 74136
Elise Gibson, 918-392-4530, mdcclinicaltrials@gmail.com
Kevin Klos, M.D.
- Recruiting
Abington Neurology
Willow Grove, Pennsylvania, 19090
Brian Weingartner, 215-957-9250 ext. 130, brian.weingartner.ana@gmail.com
David Weisman, M.D.
- Recruiting
Conquest Research
Winter Park, Florida, 32789
Fabiola Perez, 407-916-0060, fabiola.perez@conquestresearch.com
Rekha Gandhi, M.D.
About this study
Official title: 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.
Read the 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.
- Conditions
- Parkinson's Disease (PD), Deep Brain Stimulation
- Being tested
- buntanetap/posiphen
- Keywords
- Parkinson's Disease, PD, Deep Brain Stimulation, DBS, buntanetap, Open-Label, posiphen
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
buntanetap/posiphenDrug
buntanetap capsules 30 mg by mouth daily
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 - buntanetap | Experimental | Cohort 1 will enroll via invitation only for PD participants who have previously participated in bun Receives: Drug: buntanetap/posiphen |
| Cohort 2 - buntanetap | Experimental | Cohort 2 will be for PD participants who are receiving deep brain stimulation (DBS) treatment. Receives: Drug: buntanetap/posiphen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of buntanetap
Safety assessments of participants with PD receiving treatment with buntanetap
Measured: 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
Measured: 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
Measured: 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
Measured: 36-months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start9 Jan 2026
- Primary completionSep 2029 (estimated)
- Study completionNov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's Disease (PD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- All participants will receive treatment with buntanetap 30 mg daily
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Annovis Bio Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Duke Clinical Research Institute
- Responsible party
- Sponsor
- Investigators
- Laurie Sanders, Ph.D., Principal investigator, Duke Clinical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07284784
- Sponsor's protocol ID
- ANVS-25002
- Status last verified
- Oct 2026
- First submitted
- 26 Nov 2025
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Clinical Trial Investigating the Long-term Safety of Buntanetap in Treating Participants With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT07284784
- Acronym / sponsor ID
- ANVS-25002
- Conditions
- Parkinson's Disease (PD), Deep Brain Stimulation
- Keywords
- Parkinson's Disease, PD, Deep Brain Stimulation, DBS, buntanetap, Open-Label, posiphen
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Annovis Bio Inc.Industry (pharma, biotech, devices)
- Collaborators
- Duke Clinical Research Institute
- Study start
- 9 Jan 2026 (actual)
- Primary completion
- Sep 2029 (estimated)
- Study completion
- Nov 2029 (estimated)
- First posted
- 16 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- All participants will receive treatment with buntanetap 30 mg daily
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 - buntanetap | Experimental | Drug: buntanetap/posiphenCohort 1 will enroll via invitation only for PD participants who have previously participated in bun |
| Cohort 2 - buntanetap | Experimental | Drug: buntanetap/posiphenCohort 2 will be for PD participants who are receiving deep brain stimulation (DBS) treatment. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (29 listed)
- Diagnosis of idiopathic PD according to MDS Clinical Diagnostic Criteria for Parkinson's Disease (Postuma et al., 2015) and
- 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:
- Protocol ANVS-25002 Ver. 2.1; 09-23-2025 Confidential Page 30 of 54
- 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:
Key exclusion criteria (25 listed)
- Cohort 1 only: Is currently receiving DBS treatment. (Participant may enroll in Cohort 2 if they meet the corresponding inclusion/exclusion criteria).
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| buntanetap/posiphenbuntanetap capsules 30 mg by mouth daily | Drug | Cohort 1 - buntanetap, Cohort 2 - buntanetap |
Primary outcome
Safety of buntanetap
Time frame: 36-months of treatment
Safety assessments of participants with PD receiving treatment with buntanetap
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alexander Morin, PhD contact
Laurie Sanders, Ph.D. principal investigator
Duke Clinical Research Institute
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing buntanetap/posiphen in people with Parkinson's Disease (PD) and Deep Brain Stimulation, run by Annovis Bio Inc. at 29 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 29 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah MacCallum, BSN RN (484-875-3192, maccallum@annovisbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of buntanetap (time frame: 36-months of treatment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.