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A 6-month & 18-month Prospective, Randomized, Placebo-controlled, Double-blind Dual Clinical Trial Investigating Efficacy and Safety of Buntanetap in Treating Participants of Early Alzheimer's Disease

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Trial Profile

A 6-month & 18-month Prospective, Randomized, Placebo-controlled, Double-blind Dual Clinical Trial Investigating Efficacy and Safety of Buntanetap in Treating Participants of Early Alzheimer's Disease

Status: Not yet recruiting
Phase of Trial: Phase III

Latest Information Update: 14 Jan 2025

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At a glance

  • Drugs Buntanetap (Primary)
  • Indications Alzheimer's disease
  • Focus Registrational; Therapeutic Use
  • Sponsors Annovis Bio
  • Most Recent Events

    • 07 Jan 2025 According to Annovis Bio Inc, 6-month symptomatic data to potentially support a New Drug Application (NDA) filing.
    • 07 Jan 2025 According to Annovis Bio Inc, company announced that the FDA has accepted an updated protocol for the pivotal Phase 3 AD study, which is slated to begin in January 2025.
    • 07 Jan 2025 According to Annovis Bio Inc, the protocol has been amended The original protocol design proposed two separate trials: a 6-month symptomatic study and an 18-month disease-modifying study. Under the revised protocol, these studies are now integrated into a single 6/18-month trial, which will include a 6-month data readout focused on symptomatic effects, followed by an additional 12-month assessment to evaluate the disease-modifying potential of buntanetap.

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