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Company gets Health Canada approval to test cannabis for Alzheimer’s

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No objection letter allows the company to explore drug formulation for easing dementia-related agitation

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India Globalization Capital, Inc. (IGC) has received a green light to move forward with a Phase 2 trial exploring the efficacy of its drug formulation on Alzheimer’s disease-related agitation.

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In a press release this week, IGC reports it has received a no objection letter from Health Canada for approval of the drug trial.

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Per Health Canada, all clinical trial applications (CTAs) are subject to a 30-day default review period from the date the complete application has been received by the federal department. Once accepted for review, applications are forwarded for clinical and/or quality evaluation and then either authorized (a no objection letter is issued) or rejected (a not satisfactory notice is issued).

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With the no objection letter in hand, India Globalization Capital is moving forward with its “Phase 2, Multi-Center, 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.”

The trial synopsis notes the aim to assess the efficacy of the oral medication, which is described as “a natural THC-based formulation, administered in microdoses, twice a day” for agitation in patients with mild to severe dementia from Alzheimer’s disease.

Caregivers will monitor and record vitals daily over the course of the placebo-controlled study, the synopsis notes. Enrolment is open to those aged 60 and older who have established agitation for at least two weeks before enrolment.

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A study published in 2020 noted “evidence suggests that the utilization of marijuana products containing both tetrahydrocannabinol (THC) and cannabidiol (CBD) or CBD alone have been effective and safe for use in older people with agitation associated with dementia.”

While cannabinoids were shown to be well tolerated and have few short-term side-effects, unlike first-line medications used for dementia behaviours, “further research regarding the safety, efficacy, and variability of these products in older people is needed,” study authors added.

Receipt of the no objection letter means IGC can begin the trials on IGC-AD1 at sites throughout Canada, company CEO Ram Mukunda said in the statement.

The company already has three testing sites signed up and is in negotiations to also get several more sites up and running in Florida, Maryland and Montreal, Makunda reports.

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The array of sites will allow IGC “to recruit a diverse population that reflects the demographics of the disease. Receiving this approval is a milestone in our progress toward gaining FDA (U.S. Food and Drug Administration) approval and increases the number of patients with Alzheimer’s that we can enrol,” he added.

The drug formulation “recently commenced Phase 2 of clinical trials required by the FDA and demonstrated in Alzheimer’s cell lines the potential to be effective in suppressing or ameliorating a key protein that is responsible for Aβ plaques — a key hallmark of the disease,” adds the company, which develops cannabinoid-based formulations for treating disease and has lines of various CBD-based consumer products.

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