Butler Hospital Research Studies

CALMA Study

Written by Butler Hospital | July 8, 2025

What is the CALMA Study?

CALMA is a 6 week, 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.

What is the purpose of the CALMA Study?

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.

Eligibility

  • Men and women ages 60 and older
  • Diagnosis of Mild Cognitive Impairment or Alzheimer’s disease
  • Symptoms of agitation, aggression, irritability, or restlessness
  • Have a caregiver who maintains daily contact with the study participant and commits to complying with the study procedures

Interested participants can contact the Memory and Aging Program Outreach Team at (401) 455-6402 or by sending an email to memory@butler.org to discuss additional eligibility criteria.