Buntanetap for Parkinson's Disease

Recruiting at 24 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Annovis Bio Inc.

Must be taking: Anti-parkinsonian, Cholinesterase inhibitors

Must not be taking: Antidepressants, Antipsychotics

Disqualifiers: Schizophrenia, Bipolar, Major depression, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

Compensation: Varies

Number of Visits: Unknown

Duration: 36 months

500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the long-term safety of a new treatment called buntanetap for people with Parkinson's Disease (PD). It is open to two groups: those who participated in previous buntanetap trials and those currently receiving deep brain stimulation (DBS) therapy. Participants must have been diagnosed with Parkinson's Disease and, if in Cohort 2, received DBS treatment for at least a year. The goal is to assess the safety of buntanetap over 36 months.

As a Phase 2, Phase 3 trial, this research measures the treatment's effectiveness in an initial, smaller group and represents the final step before FDA approval. It offers participants a chance to contribute to advancing PD treatment.

Will I have to stop taking my current medications?

The trial requires that your current medications be stable for at least 4 weeks before screening. You can continue taking standard Parkinson's medications, certain mood stabilizers, and anticonvulsants if they have been stable. Check with the trial team for any specific prohibited medications.

Is there any evidence suggesting that buntanetap is likely to be safe for humans?

Research has shown that buntanetap is generally safe for people with Parkinson's Disease (PD). Studies have found that doses up to 80mg once a day are safe, which is more than double the 30mg dose planned for this trial. In past trials, independent safety boards, responsible for monitoring serious side effects, have given buntanetap high safety ratings. No major safety issues have been reported so far. ^{1 2 3 4 5}

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

Buntanetap is unique because it offers a novel approach to treating Parkinson's disease. Unlike traditional treatments like levodopa, which primarily aim to manage symptoms by increasing dopamine levels, Buntanetap targets the underlying disease process. It works by inhibiting certain enzymes that are thought to contribute to neurodegeneration. This new mechanism of action has the potential to slow down disease progression, which is why researchers are enthusiastic about its possibilities.

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

Research shows that buntanetap may help treat Parkinson's disease (PD). In earlier studies, it significantly improved both movement and cognitive issues in people with PD. Patients taking buntanetap showed noticeable symptom reductions on a standard Parkinson's rating scale. The treatment was safe and well-tolerated, with evidence indicating it reduces harmful proteins linked to PD. These findings suggest that buntanetap could effectively manage Parkinson's disease symptoms. Participants in this trial will join different cohorts, with some receiving buntanetap alongside deep brain stimulation (DBS) treatment. ^{3 6 7 8 9}

Who Is on the Research Team?

Laurie Sanders, Ph.D.

Principal Investigator

Duke Clinical Research Institute

Are You a Good Fit for This Trial?

This trial is for people with Parkinson's Disease (PD). Cohort 1 is by invitation only for those who've been in past buntanetap trials. Cohort 2 includes PD patients undergoing deep brain stimulation. Participants must pass a screening to take buntanetap daily.

Inclusion Criteria

I have been diagnosed with Parkinson's disease based on specific criteria.

I was in a PD trial with buntanetap and may need a legal representative if my mental test score is low.

I have someone who can come with me to my study visits.

Exclusion Criteria

Bradycardia (<50 bpm) or tachycardia (>100 bpm) on the ECG at screening and deemed medically significant by the PI.

Imminent risk of self-harm or harm to others.

I have been diagnosed with cancer or a malignant tumor in the last year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

6 weeks

Treatment

Participants receive buntanetap 30mg QD for long-term safety assessment

36 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Buntanetap

Trial Overview

The study tests the long-term safety of a drug called buntanetap, given as a daily dose over three years to two groups: previous trial participants and those receiving deep brain stimulation therapy.

How Is the Trial Designed?

Group I: Cohort 2 - buntanetap Experimental Treatment 1 Intervention

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

Group II: Cohort 1 - buntanetap Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Annovis Bio Inc.

Lead Sponsor

Trials

6

Recruited

1,700+

Duke Clinical Research Institute

Collaborator

Trials

69

Recruited

242,000+

Citations

1.

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.

2.

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 ...

3.

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.

4.

neurologylive.com

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

Buntanetap Improves Motor, Nonmotor and Cognitive ...

In patients diagnosed with PD for longer than 3 years, use of buntanetap resulted in measurable declines in Movement Disorder Society-Unified ...

5.

annovisbio.com

annovisbio.com/press-release/annovis-reports-new-biomarker-data-linking-amyloid-co-pathology-to-accelerated-cognitive-decline-in-parkinsons-patients

Annovis Reports New Biomarker Data Linking Amyloid Co- ...

As anticipated, buntanetap treatment led to significant cognitive improvement in Parkinson's patients with amyloid co-pathology. This response ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07284784

A Study of Buntanetap in Participants With PD

This study will examine the long-term safety of buntanetap in participants with PD. This will be a 36-month open-label safety study.

7.

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: Parkinson's Trial Continues Phase III Buntanetap

In the Parkinson's Disease phase II trials, buntanetap was shown to improve body and motor function. It is easily administered as a single pill taken once daily ...

8.

annovisbio.com

annovisbio.com/press-release/annovis-announces-open-label-extension-study-for-parkinsons-disease-patients

Annovis Announces Open-Label Extension Study for ...

“By following patients over an extended period, we will further measure buntanetap's safety and evaluate its sustained benefits on both motor and cognitive ...

9.

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.