IGC Pharma has reported the enrolment of two subjects at Neurostudies, a clinical research site in Port Charlotte, Florida, US, for its Phase II trial of IGC-AD1 to treat agitation in Alzheimer’s disease (AD).

The placebo-controlled, parallel, multi-site, double-blind, randomised trial will assess IGC-AD1 to treat agitation in dementia due to AD.

It will enrol a total of 146 subjects, with half of them receiving the active medication and the other half receiving a placebo.

Eligibility for enrolment includes participants aged 60 years and above who have mild to severe dementia due to AD, with a minimum two-week history of symptomatological agitation before enrolment.

Evaluating the efficacy of IGC-AD1 on agitation, as measured by the Cohen-Mansfield Agitation Inventory (CMAI) from baseline to the end of treatment (EOT), is the trial’s primary objective.

The secondary objective is to evaluate the acute efficacy of the treatment, as indicated by the CMAI scores between baseline and week two.

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IGC Pharma has so far secured contracts with 11 additional trial sites and is set to launch more sites in the US and Canada.

IGC-AD1 is characterised as a partial CB1r agonist, having anti-neuroinflammatory properties, and is also an inflammasome inhibitor.

The product’s formulation includes low doses of Tetrahydrocannabinol (THC), the main psychoactive cannabinoid seen in cannabis.

IGC-AD1 is claimed to be the first THC-based formulation to be analysed in a Phase II clinical trial for AD.

IGC Pharma CEO Ram Mukunda said: “The announcement marks another step forward in our journey to bring IGC-AD1 to market as a therapy for agitation in dementia due to Alzheimer’s.

“The initiation of patient enrolment at Neurostudies underscores our strategic approach to clinical development and reaffirms our dedication to enhancing shareholder value through innovation and scientific rigour.”

In January, IGC Pharma announced the dosing of the first patient at ClinCloud, a new clinical research site in Florida, US, for its Phase IIb clinical trial of investigational therapy IGC-AD1 for AD.