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
IGC Pharma, LLC
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.
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…
Eligibility
- Age range
- 60+ years
- Sex
- All
- Healthy volunteers
- No
To be eligible to participate in this study, the participant must meet all the following criteria: Inclusion Criteria 1. Participant and/or Caregiver must provide a signed and dated ICF prior to any study procedures. 2. Must have a Caregiver who is able and willing to comply with all required study procedures. 3. The Caregiver must be known to the Participant and must be able to use electronic devices such as a cell phone, video conference over a laptop or cell phone, weighing scale, and be able to learn to take blood pressure, among others. 4. Based on local practice, Participants that cann…
Interventions
- DrugIGC-AD1-Active
A non-sterile solution for oral administration.
- DrugIGC-AD1-Placebo
A non-sterile solution for oral administration similar in color and texture to the Active.
Locations (30)
- ClinCloud, LLCMaitland, Florida
- ClinCloud, LLCMelbourne, Florida
- Central Miami Medical InstituteMiami, Florida
- Visionary Investigators NetworkMiami, Florida
- Miami Jewish HealthMiami, Florida
- Neurostudies Inc.Port Charlotte, Florida