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Parkinson's Disease, IdiopathicPhase 3NCT05357989

A Double-blind Study to Investigate Efficacy and Safety of Buntanetap Compared With Placebo in Participants With Early PD

A Phase 3 study testing buntanetap/posiphen in people with Parkinson's Disease, Idiopathic, run by Annovis Bio Inc. at 69 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to measure safety and efficacy of buntanetap/posiphen capsules compared with placebo capsules in participants with early PD. Study details include: The study duration will be up to 7-8 months. The double-blind treatment duration will be up to 6 months. Read more about this study

Who is it for?
Ages 40 to 85 years
Conditions the study is for
Parkinson's Disease, Idiopathic
What is being tested?
buntanetap/posiphen
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
523 participants
Where
69 sitesin 6 countries
Study dates
3 Aug 2022to 4 Dec 2023
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 Parkinson Disease according to MDS Clinical Diagnostic Criteria for Parkinson's Disease.
  • H\&Y score =1, 2 or 3 during ON-state \& OFF-state <2hrs per day.
  • Male or female aged 40 - 85 years.
  • MMSE score between the range of 22-30 during screening visit (ON-state) and subjects can live independently without a caregiver.
  • Female subjects of childbearing potential* must have a negative serum or 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 4 weeks after the last dose of trial treatment, such as:
  • Oral, intravaginal, or transdermal combined (estrogen plus progestogen) hormonal contraception associated with inhibition of ovulation
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  • 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.
  • Male subjects 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 subject 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
  • Intrauterine device (IUD)
  • Intrauterine hormone-releasing system (IUS)
  • Bilateral tubal occlusion 6. Female participants will be given a urine pregnancy test at the screening visit for which they should test negative.
  • General cognition and functional performance sufficiently preserved that the subject can provide written informed consent.
  • No evidence of current suicidal ideation or previous suicide attempt in the past month as evaluated in the Columbia Suicide Severity Rating Scale.
  • Stability of permitted medications prior to screening for at least 4 weeks.
  • At screening subjects do not need to but may be on the following medication:
  • Standard of Care anti-parkinsonian medication
  • Anticonvulsant medications used for epilepsy or mood stabilization, neuropathic pain indications
  • 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.
  • Subjects previously exposed to buntanetap can still be included in the study after a 28- day wash out period.

Who cannot join

  • Has a history of a 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). Mild depression or history of depression that is stable on treatment with a selective serotonin reuptake inhibitor (SSRI) or selective norepinephrine reuptake inhibitor (SNRI) medication at a stable dose is acceptable.
  • History of a seizure disorder, if stable on medication is acceptable.
  • Has a history or current evidence of long QT syndrome, Fridericia's formula corrected QT (QTcF) interval ≥ 475ms, or torsades de pointes.
  • Has bradycardia (<50 bpm) or tachycardia (>100 bpm) on the ECG at screening.
  • Has uncontrolled Type-1 or Type-2 diabetes. A subject with HbA1c levels up to 7.5% can be enrolled if the investigator believes the subject's diabetes is under control.
  • Has clinically significant renal or hepatic impairment.
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  • Has any clinically significant abnormal laboratory values. Subjects with liver function tests (aspartate aminotransferase [AST] or alanine aminotransferase [ALT]) greater than twice the upper limit of normal 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. Subjects 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 the C SSRS) in the past 2 months, or suicidal behavior in the past 6 months.
  • Has cancer or has had a malignant tumor within the past year, except subjects who underwent potentially curative therapy with no evidence of recurrence. (Subjects with stable untreated prostate cancer or skin cancers are not excluded).
  • Alcohol / Substance use disorder, moderate to severe, in the last 5 years according to the most current version 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 60 days prior to the start of screening. The end of a previous investigational trial is the date the last dose of an investigational agent was taken, or five half-lives of the investigational drug, whichever is greater.
  • Subjects with learning disability or developmental delay.
  • Subjects whom the site PI deems to be otherwise ineligible.
  • Subjects with a known allergy to the investigational drug or any of its components.
  • Subject is currently pregnant, breast-feeding and/or lactating.
  • Subject is currently taking CYP3A4 inhibitors and/or inducers.

Trial locations and contacts

69 sites in 6 countries.

69 sites in 6 countries

United States43 sites

  • Abington Neurology

    Abington, Pennsylvania, 19001

  • Visionary Investigators Network

    Aventura, Florida, 33180

  • University of Alabama at Birmingham (UAB)- The Kirklin Clinic

    Birmingham, Alabama, 35233-2110

  • Parkinson's Disease and Movement Disorders Center of Boca Raton

    Boca Raton, Florida, 33486-2359

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

    Charleston, South Carolina, 29401-1189

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

    Charlottesville, Virginia, 22903

  • Ohio State University Wexner Medical Center (OSUWMC) - CarePoint Gahanna

    Columbus, Ohio, 43211

  • Parkinson's Disease and Movement Disorders Center of Long Island

    Commack, New York, 11725-3400

  • The Neurology Institute - Coral Springs

    Coral Springs, Florida, 33067-4640

  • Arrow Clinical trial

    Daytona Beach, Florida, 32114

  • CenExel iResearch, LLC

    Decatur, Georgia, 30030

  • Accel Research Sites - DeLand Clinical Research Unit

    DeLand, Florida, 32720

  • Michigan State University (MSU)- Health Team- Neurology and Ophthalmology Clinic

    East Lansing, Michigan, 48824-7037

  • Rocky Mountain Movement Disorder Center

    Englewood, Colorado, 80113

  • Quest Research Institue

    Farmington Hills, Michigan, 48334

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

    Fountain Valley, California, 92708

  • Coral Clinic Reserach LLC

    Homestead, Florida, 33032

  • Hawaii Pacific Neuroscience, LLC

    Honolulu, Hawaii, 96817

  • Josephson Wallack Munshower Neurology, P.C.

    Indianapolis, Indiana, 46256

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • Veracity Neuroscience, LLC

    Memphis, Tennessee, 38157

  • Homestead Associates in Research, Inc

    Miami, Florida, 33032

  • Visionary Investigators Networks

    Miami, Florida, 33133

  • Medical Professional Clinical Research Center, INC

    Miami, Florida, 33165

  • Reliant Medical Research

    Miami, Florida, 33165

  • Ezy Medical Research Co.

    Miami, Florida, 33175

  • Visionary Investigators Network

    Miami, Florida, 33176

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Mount Sinai West (Mount Sinai Roosevelt)

    New York, New York, 10019-1147

  • Renstar Medical Research

    Ocala, Florida, 34470

  • Visionary Investigators Network

    Pembroke Pines, Florida, 33026

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19107

  • Parkinsons Disease Treatment Center

    Port Charlotte, Florida, 33952-6705

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Central Texas Neurology Consultants

    Round Rock, Texas, 78681

  • UCSF Medical Center - Parkinson's Disease and Movement Disorders Clinic

    San Francisco, California, 94143-2202

  • Inland Northwest Research

    Spokane, Washington, 99202-1342

  • Ki Health Partners LLC D/B/A New England Institute for Clinical Research

    Stamford, Connecticut, 06824

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

    Sun City, Arizona, 85351-3020

  • University of South Florida (USF) - University of South Florida College of Medicine- Parkinson's Disease and Movement Disorders Center

    Tampa, Florida, 33613-4808

  • The Movement Disorder Clinic (MDC) of Oklahoma

    Tulsa, Oklahoma, 74136-6372

  • ClinCloud, LLC

    Viera, Florida, 32940

  • Conquest Research, LLC

    Winter Park, Florida, 32789

Other trials in United States

Germany7 sites

  • Kliniken Beelitz GmbH - Neurologisches Frachkrankenhaus fur Bewegungsstoerungen / Parkinson

    Beelitz, Brandenburg, 14547

  • Neurologie Berlin - Gemeinschaftspraxis Dr. Ehret / Dr. von Pannwitz

    Berlin, 12163

  • Alexianer St. Joseph-Krankenhaus Berlin-Weissensee

    Berlin, 13088

  • Klinik und Poliklinik fur Neurologie - Universitatsklinikum Carl Gustav Carus an der Techischen Universitat

    Dresden, Saxony, 01307

  • Curiositas-ad-sanum GmbH

    Haag, Bavaria, 83527

  • Paracelsus-Kliniken Deutschland GmbH & Co. KGaA - Paracelsus-Elena-Klinik Kassel

    Kassel, Hesse, 34128

  • University Hospital Muenster

    Münster, North Rhine-Westphalia, 48149

Other trials in Germany

Poland7 sites

  • Specjalistyczna Praktyka Lekarska Dr. Stanislaw Ochudlo

    Katowice, Silesian Voivodeship, 40-097

  • Pratia MCM Krakow

    Krakow, Lesser Poland Voivodeship, 30-727

  • Unicardia Specjalstyczne Centrum Leczenia Chorob Serca I Naczyn&Unimedica Specjalistyczne Centrum Medyczne

    Krakow, Lesser Poland Voivodeship, 31-271

  • Krakowska Akademia Neurologil Sp. z o.o. - Centrum Neurologii Klinicznej

    Krakow, Lesser Poland Voivodeship, 31-505

  • NEURO-CARE Sp. z o.o. Sp. Komandytowa

    Siemianowice Śląskie, Silesian Voivodeship, 41-100

  • RCMed Oddzial Sochaczew

    Sochaczew, Masovian Voivodeship, 96-500

  • MTZ Clinical Research Powered by Pratia

    Warsaw, Masovian Voivodeship, 02-172

Other trials in Poland

Spain7 sites

  • Policlinica Gipuzkoa - Centro de Invesigacion Parkinson (CIP)

    Donostia / San Sebastian, Gipuzkoa, 20014

  • Hospital General Universitario de Elche

    Elche, Alicante, 03203

  • Universidad de Navarra - Clinica Universidad de Navarra (CUN) - Madrid

    Madrid, 28027

  • Universidad de Navarra - Clnica Universidad de Navarra (CUN) - Pamplona

    Pamplona, Navarre, 31008

  • Universidad Complutense de Madrid (UCM) - Hospital Universitario Infanta Sofia

    San Sebastián de los Reyes, Madrid, 28701

  • Hospital Universitaris General de Catalunya (HGC)

    Sant Cugat del Vallès, Barcelona, 8195

  • Hospital Universitario Virgen del Rocio (URVR - Instituto de Biomedicina de Sevilla (IBIS)

    Seville, 41015

Other trials in Spain

Italy3 sites

  • Universita degli Studi di Salerno - Centro per le Malattie Neurodegenerative

    Baronissi, Campania, 84081

  • San Raffaele Cassino - Centro di Cura e Prevenzione per il Parkinson

    Cassino, Lazio, 3043

  • San Raffaele Pisana - Centro per la Cura e la Diagnosi del Parkinson

    Rome, Lazio, 163

Other trials in Italy

Hungary2 sites

  • Debreceni Egyetem Klinikai Központ Neurológiai Klinika (Kenézy Gyula Campus, Neurológiai Osztály)

    Debrecen, H-4032

  • PTE AOK Neurologiai Klinika

    Pécs, H-7623

Other trials in Hungary

About this study

Official title: A 6-month Prospective, Randomized, Double-blind, Placebo-controlled Clinical Trial Investigating the Efficacy, Safety, and Tolerability of Two Different Doses of Buntanetap or Placebo in Patients With Early Parkinson's Disease

The purpose of this study is to measure safety and efficacy of buntanetap/posiphen capsules compared with placebo capsules in participants with early PD.

Study details include:

  • The study duration will be up to 7-8 months.
  • The double-blind treatment duration will be up to 6 months.
  • There will be 5 in-clinic visits and 7 phone calls
Read the detailed description

450 early Parkinson's Disease (PD) patients will be randomized to 10mg, 20 mg of buntanetap/posiphen or placebo. They will undergo a Screening Visit, and if they provide informed consent and are considered eligible per the inclusion and exclusion criteria, will proceed to participate in the treatment period. Randomized participants will visit the clinic for the first-time dosing in clinic with administration of 10 mg or 20mg of buntanetap/posiphen or placebo, followed by an at home dosing period of 6 months, with daily administration of 10 mg or 20mg of buntanetap/posiphen or Placebo. Participants will be required to visit clinics 1 month, 2 months, 3 months, and 6 months (end-of-trial), where they will undergo study procedures that include safety assessments (AE and concomitant medication monitoring, 12-lead ECGs, clinical laboratory testing, vital signs assessments, and physical examinations) and psychometric tests (MDS-United Parkinson's Disease Rating Scale (MDS-UPDRS), Clinical Global Impression of Severity (CGIS), Wechsler Adult Intelligence Scales (WAIS), Mini-Mental State Examination (MMSE)) and Participant Global Impression of Change (PGIC). At the end of blood sampling, the subjects will need to stay for a minimum of 1 hour of observation. After all end-of-study procedures are complete, the subject will be discharged to home. A 24-hour follow-up call will occur after all clinical visits to assess the participants current condition and if there are any additional adverse events to report.

Buntanetap/posiphen has shown to improve PD subjects' mobility. MDS-UPDRS sum of score of Part II + Part III and Total score of all four parts will be measured to assess its improvement on PD subjects daily living, mobility and complications. PGIC will also be measured to assess its effect.

Buntanetap/posiphen has shown to reduce inflammation and preserve axonal integrity and synaptic functions as well as neurotoxic proteins in previous Phase 2a studies. In this study we plan to measure plasma glial fibrillary acidic protein (GFAP), neurofilament light (NFL) and potentially TDP43.

Reports of adverse events (AEs) and serious adverse events (SAEs) during exposure to buntanetap/posiphen will be collected to evaluate if there are any significant clinical safety issues for the study population. Extensive clinical and laboratory safety data already exist for buntanetap/posiphen; therefore, these safety measures will be sufficient in the proposed study.

For clinical, functional, and cognitive assessment measures, The subjects will be administered the Hoehn \& Yahr and the MMSE for determination of inclusion into the study. The MDS-UPDRS and PGIC will be administered for subjects' movement and daily function. The Coding subtest from the WAIS 4th edition will serve as a sensitive measure of Central Nervous System (CNS) dysfunction. MMSE will also be measured to assess subjects' cognitive change.

Being tested
buntanetap/posiphen, Placebo
Keywords
Parkinson's
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

    Also called Posiphen Tartrate, ANVS401

    HPMC (vegetarian source) capsule shells

  • PlaceboDrug

    HPMC (vegetarian source) capsule shells

Study groups in NCT05357989
Study groupRoleWhat they receive
10 mg buntanetap/posiphenExperimentalBuntanetap/posiphen 10 mg oral capsule with daily administration for a period of 6 months
Receives: Drug: buntanetap/posiphen
20 mg buntanetap/posiphenExperimentalBuntanetap/posiphen 20 mg oral capsule with daily administration for a period of 6 months
Receives: Drug: buntanetap/posiphen
PlaceboPlacebo comparatorPlacebo oral capsule with daily administration for a period of 6 months
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline to Month 6 in MDS-UPDRS Part II (OFF-state)

    Change in the Score from the MDS- Unified Parkinson's Disease Rating Scale (UPDRS) Parts II from Baseline to the End of Trial. MDS-UPDRS Part II (Motor experiences of daily living) has 13 items and the score ranges from 0-52, with higher scores reflecting greater severity.

    Measured: Baseline and 6 months visits

Secondary outcomes (1)

  1. Change From Baseline to Month 6 in the MDS-UPDRS Part III (OFF-state)

    MDS-UPDRS Part III (motor examination) has 18 items and ranges from 0-132, with higher scores reflecting greater severity.

    Measured: Baseline and 6 months visits

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 May 2022
  2. Study start3 Aug 2022
  3. Primary completion4 Dec 2023
  4. Study completion4 Dec 2023

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
523 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05357989
Sponsor's protocol ID
ANVS-22001
Status last verified
Feb 2025
First submitted
19 Apr 2022
Last updated
3 Mar 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing buntanetap/posiphen in people with Parkinson's Disease, Idiopathic, run by Annovis Bio Inc. at 69 sites in 6 countries.

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 28 inclusion and 16 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: finished, as of the sponsor's last update on 3 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 69 sites in United States, Germany, Poland, Spain, Italy and 1 more country. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

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?

Yes. Results are posted in the registry (first posted 3 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline to Month 6 in MDS-UPDRS Part II (OFF-state) (time frame: Baseline and 6 months visits). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05357989.

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 3 Mar 2025.

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