Buntanetap for Early Parkinson's Disease

No longer recruiting at 125 trial locations

Overseen By Melissa A Gaines

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Annovis Bio Inc.

Must not be taking: CYP3A4 inhibitors/inducers

Disqualifiers: Schizophrenia, Bipolar, Major depression, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 10

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called buntanetap for individuals with early Parkinson's disease. The main goal is to determine the treatment's safety and effectiveness compared to a placebo (a non-active treatment). Participants will receive either 10 mg or 20 mg of the treatment, or a placebo, and will take these daily for six months. This trial may suit those diagnosed with Parkinson's who can live independently and currently manage their condition with stable medication. As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

The trial does not specify that you must stop taking your current medications. However, you need to have stable medications for at least 4 weeks before screening, and certain medications like CYP3A4 inhibitors or inducers are not allowed.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that buntanetap is safe and generally well-tolerated. Studies have found that patients with Parkinson's and Alzheimer's diseases have safely taken doses up to 80 mg per day. Therefore, the trial doses of 10 mg and 20 mg fall well within the safe range.

Other studies report that buntanetap has a strong safety record. It reduces harmful proteins and inflammation in the brain, which could aid in treating conditions like Parkinson's.

These findings suggest that buntanetap is a promising and safe treatment option for potential trial participants. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Parkinson's?

Buntanetap is unique because it targets the root cause of early Parkinson's disease by inhibiting the production of neurotoxic proteins, which is different from most current treatments that primarily focus on managing symptoms like tremors and stiffness. This medication is derived from posiphen, which has shown promise in protecting nerve cells and potentially slowing disease progression. Researchers are excited about buntanetap because it offers a novel approach to potentially alter the disease course, rather than just alleviating symptoms, providing hope for more effective long-term management of Parkinson's disease.

What evidence suggests that buntanetap might be an effective treatment for early Parkinson's disease?

Research has shown that buntanetap could be very helpful for treating early Parkinson's disease (PD). Studies indicate that it improves both movement and cognitive abilities in patients. Buntanetap also appears to reduce harmful proteins and inflammation in the brain. In this trial, participants will receive either a 10 mg or 20 mg dose of buntanetap, or a placebo. Earlier studies revealed that patients who took higher doses experienced better results. Overall, early findings suggest that buntanetap could be a beneficial treatment for people with early PD. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

Inclusion Criteria

You have an intrauterine device (IUD).

Both fallopian tubes are blocked.

You are between 40 and 85 years old.

Exclusion Criteria

You have a history of severe mental disorders like schizophrenia, bipolar disorder, or major depression, as defined by the DSM. However, if you have mild depression and are on stable treatment with certain medications, you may still be eligible.

It's okay if you have a history of seizures but only if you are taking medicine for it and your condition is stable.

You have a history of heart rhythm problems or a long QT interval on an EKG test.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive daily administration of 10 mg or 20 mg of buntanetap/posiphen or placebo for 6 months

6 months

5 visits (in-person), 7 phone calls

Follow-up

Participants are monitored for safety and effectiveness after treatment, including a 24-hour follow-up call after each clinical visit

1 month

4 follow-up calls

What Are the Treatments Tested in This Trial?

Interventions

• Buntanetap
• Placebo

How Is the Trial Designed?

Group I: 20 mg buntanetap/posiphen Experimental Treatment 1 Intervention

Buntanetap/posiphen 20 mg oral capsule with daily administration for a period of 6 months

Group II: 10 mg buntanetap/posiphen Experimental Treatment 1 Intervention

Buntanetap/posiphen 10 mg oral capsule with daily administration for a period of 6 months

Group III: Placebo Placebo Group 1 Intervention

Placebo oral capsule with daily administration for a period of 6 months

Who Is Running the Clinical Trial?

Annovis Bio Inc.

Lead Sponsor

Trials

6

Recruited

1,700+

TFS Trial Form Support

Industry Sponsor

Trials

21

Recruited

1,900+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05357989

NCT05357989 | A Double-blind Study to Investigate ... The purpose of this study is to measure safety and efficacy of buntanetap/posiphen capsules compared with placebo capsules in participants with early PD.

2. annovisbio.com annovisbio.com/press-release/annovis-bio-announces-new-data-from-phase-iii-parkinsons-study-highlighting-improvements-in-unified-parkinsons-disease-rating-scale-mds-updrs-and-cognition-after-treatment-with-buntanetap

Annovis Bio Announces New Data from Phase III ... Buntanetap showed dose-dependent and statistically significant improvements in cognition in the overall enrolled PD population. Parkinson's ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36641607/

Buntanetap, a Novel Translational Inhibitor of Multiple ... Results: Buntanetap was safe and well tolerated. Biomarker data indicated a trend in lowering levels of neurotoxic proteins and inflammatory factors and ...

4. clinicaltrialsarena.com clinicaltrialsarena.com/analyst-comment/ad-pd-2025-buntanetap-parkinsons-mild-dementia/

AD/PD 2025: Buntanetap shows promise in early ... Buntanetap showed statistically significant improvements in every primary and secondary endpoint in the per-protocol population.

5. neurologylive.com neurologylive.com/view/buntanetap-improves-motor-non-motor-cognitive-symptoms-parkinson-disease-phase-3-study

Buntanetap Improves Motor, Nonmotor and Cognitive ... Over the 3-year treatment period, buntanetap resulted in improvements in motor and nonmotor functions in patients with postural instability ...

6. annovisbio.com annovisbio.com/press-release/annovis-bio-receives-excellent-safety-rating-and-positive-recommendation-to-continue-phase-iii-trial-of-buntanetap-for-parkinsons-disease-patients-from-the-independent-data-and-safety-monitoring-board-dsmb

Annovis Bio Receives Excellent Safety Rating and Positive ... Annovis Bio Receives Excellent Safety Rating and Positive Recommendation to Continue Phase III Trial of Buntanetap for Parkinson's Disease Patients from the ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2274580724002462

Buntanetap, a Novel Translational Inhibitor of Multiple ... Results. Buntanetap was safe and well tolerated. Biomarker data indicated a trend in lowering levels of neurotoxic proteins and inflammatory factors and ...