Overview

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

Status:
Not yet recruiting

Trial end date:
2023-03-01

Target enrollment:

Participant gender:

Summary

The study will be 6-month placebo-controlled double-blind study (subjects, care givers, investigators and the sponsor will be blinded to the subjects' treatment). Study drugs will be 10 mg, 20mg of Buntanetap, or matching placebo, taken once a day in the morning. Qualified subjects will be randomly assigned at a 1:1:1 ratio to one of the three treatment arms: Buntanetap 10 mg, Buntanetap 20 mg, and placebo, through an Interactive Randomization System, after a screening period of up to 30 days. The total duration of open-label study participation will be 6-7 months. MDS-United Parkinson's Disease Rating Scale (MDS-UPDRS), Participant Global Impression of Change (PGIC), Weschler Adult Intelligence Scales (WAIS) coding, and Mini-Mental State Examination (MMSE) will be assessed by trained clinicians. All efforts will be made to ensure subjects will be assessed by the same clinician throughout the study. Participants should stop SOC Parkinson's medications 12 hrs before clinical visit to ensure clinical off-stage during visit.

Phase:

Phase 2

Details

Lead Sponsor:

Annovis Bio Inc.

Collaborator:

TFS Trial Form Support

Treatments:

Phenserine