CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 523 enrolled
Drug / intervention
buntanetap/posiphen +1 moredrug
Likely dose
Not stated in record
Key inclusion· 6
  • ✓Diagnosis of idiopathic Parkinson Disease according to MDS Clinical Diagnostic Criteria
  • ✓Hoehn & Yahr score 1, 2, or 3 in ON-state and OFF-state <2 hours per day
  • ✓Age 40-85 years
  • ✓MMSE score 22-30 and ability to live independently without caregiver
Key exclusion· 10
  • ✕History of psychiatric disorder (schizophrenia, bipolar disorder, major depression); stable mild depression on SSRI/SNRI acceptable
  • ✕QTc interval ≥475ms (Fridericia corrected) or long QT syndrome history
  • ✕Bradycardia <50 bpm or tachycardia >100 bpm on ECG at screening
  • ✕Uncontrolled Type 1 or Type 2 diabetes (HbA1c >7.5%)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05357989
NCT05357989Phase 3Completed
CompareCT.gov

A 6-month Prospective, Randomized, Double-blind, Placebo-controlled Clinical Trial Investigating the Efficacy, Safety, and Tolerability of Two Different Doses of Buntanetap or Placebo in Patients With Early Parkinson's Disease

Annovis Bio Inc.·interventional·Posted May 3, 2022·Updated Mar 3, 2025

In Brief

A Phase 3 clinical trial evaluating buntanetap/posiphen and Placebo for Parkinson's Disease, Idiopathic. Completed, enrolled 523 participants across 69 sites in 6 countries.

Detailed Summary

The purpose of this study is to measure safety and efficacy of buntanetap/posiphen capsules compared with placebo capsules in participants with early PD. Study details include: * The study duration will be up to 7-8 months. * The double-blind treatment duration will be up to 6 months. * There will be 5 in-clinic visits and 7 phone calls

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParkinson's Disease, Idiopathic
CountriesGermany, Hungary, Italy, Poland, Spain, United States
CollaboratorsTFS Trial Form Support

Timeline

Phase 3CompletedFinished
2023202420252026
First PostedMay 3, 2022
Enrollment StartAug 3, 2022
Primary CompletionDec 4, 2023
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 4.2 years ago

Interventions

buntanetap/posiphendrug

HPMC (vegetarian source) capsule shells

Placebodrug

HPMC (vegetarian source) capsule shells