Brief Summary:

This is a superiority, parallel group, double blinded, randomized, powered, multi-site, and placebo-controlled study.

Ages 60 and above Participants with mild to severe dementia due to Alzheimer's Disease, with established and persistent symptomatological Agitation, for a minimum of two weeks rather than those with Agitation due to other etiologies, or recent, or transient Agitation symptoms. This is established using the NPI-12 (Agitation Domain only ≥ 4) during the screening process.

Number or Participants:146 (73 for each arm) plus 10% dropout for a total of 164 Participants.

The length of treatment: 42 days Length of the Study: 50-57 days.

Study Drug:IGC-AD1 is a non-sterile solution for oral or sublingual administration. The oral solution contains 2 active ingredients, cannabis based, tetrahydrocannabinol (THC) and Melatonin.

Primary Objective: To assess the efficacy of IGC-AD1 in Participants with symptomatological Agitation associated with mild to severe dementia due to AD, in a six-week, placebo-controlled trial, using the CMAI.

Secondary Objective:To assess acute efficacy of IGC-AD1 on symptomatological Agitation, in dementia due to AD, in a two-week placebo-controlled trial using CMAI.