NCT05543681 Clinical Trial on Agitation in Alzheimer's Dementia
| NCT ID | NCT05543681 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | IGC Pharma, LLC |
| Condition | Alzheimer Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 164 participants |
| Start Date | 2022-10-11 |
| Primary Completion | 2026-08 |
Trial Parameters
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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.
Eligibility Criteria
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 cannot consent may have Caregiver's consent provided the Caregiver has among others a) Power of Attorney, b) is a spouse, or c) a sibling or d) a child or e) a close relation. The practice of accepting consent must be consistent with established practice at the site and jurisdiction. 5. Participants must consent to CYP450 and apolipoprotein E (ApoE) genotyping, and pharmacokinetics. 6. Diagnosis of AD b
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