Trial Profile

A Phase 2, Multicenter, Double-Blind, Randomized, Placebo-Controlled, Trial of the Safety and Efficacy of IGC-AD1 on Agitation in Participants With Dementia Due to Alzheimer's Disease

Status: Recruiting

Phase of Trial: Phase II

Latest Information Update: 18 Jun 2025

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At a glance

Drugs Melatonin/tetrahydrocannabinol (Primary) ; Melatonin/tetrahydrocannabinol (Primary)
Indications Alzheimer's disease; Dementia
Focus Therapeutic Use
Acronyms CALMA; IGC-AD1-P2
Sponsors India Globalization Capital

25 Nov 2024 Interim results published in the IGC Pharma Media Release
16 Apr 2024 Interim Results demonstrating a clinically significant reduction, approaching statistical significance, in agitation in Alzheimers at week two compared to placebo, published in the IGC Pharma Inc. media release.
09 Apr 2024 According to an IGC Pharma Inc. media release, Dr. Arbelaez will support the development of the Phase 2 clinical trial of IGC-AD1, IGC Pharma's lead therapeutic candidate targeting agitation in Alzheimer's disease.

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