Buntanetap for Early Parkinson's Disease

Recruiting at 117 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

523 Participants Needed

Trial Summary

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.

What is the purpose of this trial?

This trial is testing a new pill called buntanetap/posiphen to help people with early Parkinson's Disease. The pill aims to reduce brain inflammation and protect nerve cells, which could improve movement and daily activities. The study will compare the effects of the pill over several months.

Eligibility Criteria

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

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

Treatment Details

Interventions

• Buntanetap
• Placebo

Participant Groups

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+