523 Participants Needed

Buntanetap for Early Parkinson's Disease

Recruiting at 117 trial locations
LT
MM
CF
MA
Overseen ByMelissa A Gaines
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

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.
See 16 more

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.
See 13 more

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
3Treatment groups
Experimental Treatment
Placebo Group
Group I: 20 mg buntanetap/posiphenExperimental Treatment1 Intervention
Buntanetap/posiphen 20 mg oral capsule with daily administration for a period of 6 months
Group II: 10 mg buntanetap/posiphenExperimental Treatment1 Intervention
Buntanetap/posiphen 10 mg oral capsule with daily administration for a period of 6 months
Group III: PlaceboPlacebo Group1 Intervention
Placebo oral capsule with daily administration for a period of 6 months

Find a Clinic Near You

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+
Unbiased ResultsWe believe in providing patients with all the options.
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Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
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