Findings from what is thought to be the first human trial of a THC-based drug in Alzheimer’s patients, suggest it may alleviate symptoms of dementia.
Preliminary findings from a Phase 1 clinical trial on a new THC-based drug, show evidence of clinical improvements in anxiety, depression, and agitation in Alzheimer’s patients.
The investigational new drug, IGC-AD1, has been developed by cannabis healthcare company, India Globalization Capital (ICG), and is designed to treat certain symptoms of Alzheimer’s disease.
Alzheimer’s disease impacts around 50 million people worldwide, with the vast majority of these facing debilitating symptoms, including anxiety, depression, and agitation.
Agitation in dementia patients can include excessive physical movement and verbal activity, restlessness, pacing, belligerence, aggression, screaming, crying, and wandering.
Currently, there is no FDA-approved medication to alleviate symptoms of dementia, such as agitation, due to Alzheimer’s disease.
This is the first human clinical trial combining low doses of THC with another molecule to treat symptoms of dementia in Alzheimer’s patients.
According to IGC, the data collected over the course of the Phase 1 trial, saw evidence of clinical improvements in anxiety, depression, and agitation.
On the anxiety and depression scales, researchers documented a decrease of approximately 50 per cent to 60 per cent in patients who received the drug.
They also documented a decrease in agitation of approximately 35 per cent to 60 per cent in patients who received the drug.
Based on the preliminary data obtained to date, IGC estimates that the most effective dosage of the drug may be once or twice per day, depending on the symptom.
THC, a naturally occurring cannabinoid produced by the cannabis plant, is known for being a psychoactive substance that can impact mental processes in a positive or negative way depending on dosage.
The IGC trial is based on low or micro-dosing, which is thought to potentially have a promising effect on Alzheimer’s patients.
The results of the study have now been submitted to the FDA for approval.
Although this data is no guarantee that further studies will produce positive results, the company said in a statement: “IGC is encouraged by these initial promising and exciting results, as the potential to improve the quality of life of Alzheimer’s patients and their caregivers could be significant if similar results are repeated in future trials with larger patient pools.
“We are in the process of using the results from this Phase 1 study to design and subsequently pursue, based on FDA approval, a placebo-controlled, multi-site trial with a significantly expanded patient population to further test the efficacy of IGC-AD1 on agitation, anxiety, and depression in Alzheimer’s patients.”
IGC-AD1 is an investigational new drug that has not been approved as a medication by any regulatory body in any country.
IGC-AD1’s safety and efficacy will need to be further established through trials on larger and more diverse groups of Alzheimer’s patients.
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