New study explores effects of THC in Alzheimer’s patients

A new study is making progress in its exploration of the effects of THC in Alzheimer’s patients.

Researchers believe that THC, in combination with other drugs, may improve quality of life for patients with Alzheimer’s and provide relief for caregivers.

In the Phase one, placebo-controlled study, 12 participants will receive a cannabinoid-based investigational new drug, IGC-AD1, over three 14-day periods, with the dose increasing in each period.

The first of three levels of dosing of IGC-AD1 has now been completed in the first five of twelve patients suffering from Alzheimer’s disease.

The phase one, placebo controlled trial hopes to learn how fast, or how slow, an elderly patient with Alzheimer’s and a specific variation of the gene CYP2C9 metabolizes THC, the psychoactive component of cannabis.

Once enrolled, patients undergo additional blood draws to assess variations of the gene CYP2C9.

Follow-up blood draws then continue at specific time intervals to assess the amount of formulation in the patient’s system and the amount of time it takes patients to metabolize the active ingredients in IGC-AD1.

This is an important insight into drug interaction, as the gene CYP2C9 makes an enzyme that metabolizes THC as well as around 100 other medications, including those commonly prescribed for pain, cholesterol, and seizures, among others.

The trial is being conducted by IGC Pharma LLC, a subsidiary of India Globalization Capital (IGC).

“While it has taken a long time to get to this trial, with many hurdles crossed along the way, including restrictions due to the Covid-19 pandemic, we are excited to have begun administering IGC-AD1, which uses a plant-derived cannabinoid, in an active trial,” said Ram Mukunda, CEO of IGC.

“While others have focused on CBD, the non-psychoactive component of cannabis, our trial is focused on THC, the psychoactive component.

“There is no known cure for Alzheimer’s disease, but we believe that THC, in combination with other drugs, may help with the management of Alzheimer’s patients, improve patient lifestyle, and bring a certain degree of relief for their caregivers.”

A Phase one trial is the first human trial in a multi-step process designed to obtain regulatory approval for the marketing of a new pharmaceutical drug.

Mukunda continued: “Our Phase one study is a placebo-controlled study. IGC-AD1 will be administered for three 14-day periods, called cohorts, with the dose-escalated as low, medium, and high for each cohort.

“The participants are monitored daily, and data is collected to determine safety based on solicited and unsolicited adverse events.

“We are also monitoring changes in certain behavioural aspects of patients to better inform designs for the anticipated next phase of trials that will test efficacy on specific symptoms.”

Find out more information about the trial here.