The United States Patent and Trademark Office has issued a patent to India Globalization Capital Inc. for the treatment of Alzheimer’s disease using THC.
India Globalization, which develops cannabinoid-based therapies for indications such as Alzheimer’s disease and pain, has been issued the patent, entitled ‘Ultra-Low dose THC as a potential therapeutic and prophylactic agent for Alzheimer’s Disease‘, for the treatment.
The company, which hopes that its formula could help to provide relief for the potential 50 million people across the globe which are expected to be impacted by Alzheimer’s disease by 2030, entered into an exclusive license agreement with the University of South Florida with respect to the patent application and the associated research conducted on Alzheimer’s disease.
THC clinical trials
The original application was initiated by the University of South Florida and filed on 1 August, 2016.
The granted patent relates to India Globalization’s proprietary formulation, IGC-AD1, which is the subject of the company’s placebo-controlled Multiple Ascending Dose (MAD) Phase 1 clinical trial to establish the safety and tolerability of the formula that uses THC on patients suffering from Alzheimer’s disease.
The trial aims to obtain United States Food and Drug Administration (FDA) approval.
The company recently announced the completion of Cohort 3 in the trial. For Cohort 1, the company administered one dose of IGC-AD1 per day, in Cohort 2 the doses were increased to two per day, and the treatment will be increased to three doses for this final Cohort 3.
Participants have been monitored daily for safety, and for particular behavioural changes using the Neuropsychiatric Inventory scale. The Phase 1 trial is currently anticipated to conclude by September 2021 and the Data and Safety Monitoring Committee (DSMC) for the clinical trial will review the data from Cohort 3. India Globalization will report its findings from all three Cohorts to the FDA.
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