Clinical Trial on Agitation in Alzheimer's Dementia

Phase 2

Recruiting

• Conditions: Alzheimer Disease; Agitation,Psychomotor; Care Giving Burden; NPS; Aggression
• Interventions: Drug: IGC-AD1-Active; Drug: IGC-AD1-Placebo

• Registration Number: NCT05543681
• Lead Sponsor: IGC Pharma, LLC

Brief Summary

The purpose of this study is to assess the efficacy of the oral medication IGC-AD1, a THC-based (Delta-9-Tetrahydrocannabinol) formulation administered twice a day on Agitation in patients with mild to severe dementia from Alzheimer's.

Detailed Description

CALMA is a multi-center, double-blind, randomized, placebo-controlled clinical trial. The study targets participants aged 60 and older with mild to severe Alzheimer's dementia who have exhibited clinically significant agitation for at least two weeks prior to enrollment. Agitation caused by other conditions or transient symptoms must be ruled out. Eligibility is determined by a baseline Neuropsychiatric Inventory (NPI-12), Agitation subscale score of ≥4 and the International Psychogeriatric Association (IPA) criteria for agitation.

The investigational medication is an oral solution containing two active ingredients: delta-9 tetrahydrocannabinol (THC) and melatonin. The treatment is administered for 42 days, followed by a two-day taper period at the end of the study.

Safety oversight includes daily calls on days 2, 3, and 4, transitioning to calls every third day thereafter. These calls will review study partners logbook entries, changes in concomitant medications, and adverse events.

The primary objective of the study is to evaluate the efficacy of IGC-AD1 on agitation, measured by changes in the Cohen-Mansfield Agitation Inventory (CMAI) scores from baseline to the End of treatment (EOT). The secondary objective is to assess efficacy by examining CMAI score changes from baseline to week two. Additionally, exploratory objectives are outlined in separate documentation.

Blood samples will be collected during the trial for sparse pharmacokinetic (PK) analysis, blood-based CNS biomarker, and genotyping.

Study Timeline

• Study First Submitted: 2022-09-14
• Study First Submitted QC: 2022-09-14
• Study First Posted: 2022-09-16
• Study Start: 2022-10-11
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-28
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 164

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Comparator: IGC-AD1Active	IGC-AD1-Active	IGC-AD1-Active, oral solution with two APIs (THC and melatonin).
Placebo Comparator: IGC-AD1 Placebo	IGC-AD1-Placebo	IGC-AD1-Placebo, oral solution similar to Active in color, taste, and texture, with excipients but without APIs.

Primary Outcome Measures

Name	Time	Method
Agitation	Baseline to week six	Change in mean Cohen Mansfield Agitation Inventory (CMAI) score

Secondary Outcome Measures

Name	Time	Method
Acute Agitation	Baseline to week two	Change in mean Cohen Mansfield Agitation Inventory (CMAI) score

Trial Locations

Locations (19)

Butler Hospital, Brown University; 🇺🇸 Providence, Rhode Island, United States

Hamilton Health Sciences , Mcmaster University; 🇨🇦 Hamilton, Ontario, Canada

ClinCloud, LLC; 🇺🇸 Melbourne, Florida, United States

Global Medical Institutes Florida, LLC; 🇺🇸 Miami, Florida, United States

Miami Jewish Health; 🇺🇸 Miami, Florida, United States

Neurostudies Inc.; 🇺🇸 Port Charlotte, Florida, United States

BayCare Health System Inc.; 🇺🇸 Saint Petersburg, Florida, United States

MedStar Franklin Square Medical Center Neurology; 🇺🇸 Baltimore, Maryland, United States

Medstar Georgetown University Hospital Neurology; 🇺🇸 Clinton, Maryland, United States

Medstar Montgomery Medical Center; 🇺🇸 Olney, Maryland, United States

Dent Neurosciences Research Center; 🇺🇸 Amherst, New York, United States

Lynn Health Science Institute (LHSI); 🇺🇸 Oklahoma City, Oklahoma, United States

Senior Adults Specialty Research; 🇺🇸 Austin, Texas, United States

Baycrest Academy, University of Toronto; 🇨🇦 Toronto, Ontario, Canada

Douglas Hospital Research Center, McGill university; 🇨🇦 Montréal, Quebec, Canada

Grupo de Neurociencias de Antioquia, Universidad de Antioquia; 🇨🇴 Medellín, Antioquia, Colombia

Instituto Sanacoop; 🇵🇷 Bayamón, Puerto Rico

SCB Research Center; 🇵🇷 Bayamón, Puerto Rico

University of Puerto Rico; 🇵🇷 Rio Piedras, Puerto Rico