A Phase 1 trial is enrolling patients with mild to severe dementia from Alzheimer’s disease to test IGC-AD1, an investigational cannabis-based treatment being developed India Globalization Capital (IGC) Pharma, a subsidiary of IGC, according to a recent press release.
In the placebo-controlled study, 12 participants will receive the medication over three 14-day periods, with the dose increasing in each period.
The study primarily aims to assess the safety of IGC-AD1. Secondary goals include measuring pharmacokinetics (how a compound enters, transits, and leaves the body), how long the medication lasts in the body, and whether individuals process it differently based on minor changes in a liver enzyme called CYP450 2C9, which plays a key role in metabolizing numerous compounds.
The company will also monitor the patients’ dementia-related behavioral aspects to help guide later trial phases.
IGC-AD1 combines small doses of cannabinoids — chemicals derived from cannabis — with other compounds into a formulation designed to help with Alzheimer’s. The potential therapy is based on the discovery, made at the University of Southern Florida, that low doses of THC — the component of marijuana associated with psychological effects, or getting “high” — bind to amyloid plaques and prevent them from aggregating, or clumping, in neurons.
Amyloid plaques are one of the main features of Alzheimer’s and are thought to play a central role in cognitive decline. These plaques are composed of small, misfolded fragments of the amyloid protein. They build to toxic levels inside neurons, leading to the death of those cells.
THC interacts with the body through several known pathways, including anti-oxidative effects, and by binding to the CB1 receptor in the central nervous system, among others. Cannabinoids have increasingly attracted attention as potential therapies for treating Alzheimer’s.
“While we cannot guarantee the time frame,” the company wrote in its release, “taking into account the upcoming holidays and current restrictions brought on by COVID-19, we expect to complete the Phase 1 study during the first half of calendar 2021.”
IGC entered into an exclusive licensing agreement with the University of Southern Florida for the patent related to the university’s discovery in 2017. The company later refiled that patent and submitted an additional patent on the formulation that it intends to investigate as an Alzheimer’s treatment. The U.S. Food and Drug Administration gave the company approval on July 30 to initiate human clinical trials of IGC-AD1.
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