IGC-AD1 Trial on Agitation in Dementia Due to Alzheimer's — IGC-AD1-P2  

Depression Clinical Trial

Official title: 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

Clinical Trial Summary

The purpose of this study is to assess the efficacy of an oral medication, IGC-AD1 that is a natural THC-based (Tetrahydrocannabinol) formulation, administered in micro doses, twice a day, on symptomatological Agitation, in patients with mild to severe dementia from Alzheimer's.

Clinical Trial Description

This is a placebo-controlled, multi-site, parallel, double blind, randomized study. Enrollment is open for Participants ages 60 and above with mild to severe dementia due to Alzheimer's Disease, with established symptomatological Agitation, for a minimum of two weeks prior to enrollment, with Agitation due to other etiologies, or recent, or transient Agitation symptoms ruled out. Clinical Agitation is established with a baseline NPI-12 (Agitation Domain only) score ≥ 4 as well as meeting the IPA criteria for Agitation.

The medication is titrated to BID over two days and down over two days at End of Trial (EOT). Caregivers will monitor and record in a logbook vitals daily using Sponsor provided scales and logbook.

Safety will be monitored with daily calls to the Participant/Caregiver dyad for the first four days followed by calls every third day till EOT. Week two is an on-site visit with week-four being optional.

Both solicited AEs and non-solicited AEs will be monitored, assessed, graded, and tabulated. Solicited AEs include the following: somnolence, falls, dizziness, asthenia, nausea, suicidal ideation, tachycardia, bradycardia, hypertension and hypotension, and BMI.

The primary objective of the study is to assess the efficacy of IGC-AD1 on Agitation as scored by the CMAI between baseline and EOT with the secondary objective being acute efficacy as measured by the CMAI between baseline and week two. There are several exploratory objectives included elsewhere. The trial will also have blood draws for sparse Pharmacokinetics (PK). ;

Related Conditions & MeSH terms

• Aggression
• Agitated; State, Acute Reaction to Stress
• Agitation,Psychomotor
• Alzheimer Disease
• Anxiety
• Caregiver Burden
• Dementia
• Depression
• Memory Impairment
• Psychomotor Agitation
• Stress Disorders, Traumatic, Acute

• NCT number: NCT05543681
• Study type: Interventional
• Source: India Globalization Capital Inc
• Contact: Evelyn Gutierrez
• Phone: 3013394270
• Email: egutierrez@igcpharma.com
• Status: Recruiting
• Phase: Phase 2
• Start date: October 11, 2022
• Completion date: June 30, 2025