Friday, April 26, 2024
4/26/2024
Project Summary / Abstract This project will be conducted in the context of the Alzheimer’s Clinical Trials Consortium (ACTC), which is a consulting group of over 100 sites (with 30 leading clinical sites in the Steering Committee) dedicated to Alzheimer’s disease (AD) research and the infrastructures supported by the National Institute on Aging (NIA). The goal of this research project is to develop safe and effective approaches for the treatment of hospice care-eligible, agitated subjects suffering from AD or other types of dementia (HAAD). Today, half of the subjects suffering from AD and other types of dementia will use hospice care in the last days of their life. In most cases, over 73% of them will require the use of psychoactive medications for the treatment of agitation. There is currently no approved treatment or body of research to guide physicians in the treatment of these very difficult patients. In the absence of appropriate evidence based guidelines, patients are usually treated with a combination of anti-psychotics, benzodiazepines, and opiates. However, these agents generate a variety of side effects including confusion, constipation, pruritus, and other neurological adverse events, such as tremors and muscular spasms. The aim of this project is to test the efficacy of an oral combination of two cannabinoids, tetrahydrocannabinol (THC) and cannabidiol (CBD), for the treatment of agitation in HAAD. This study is based on data from a preliminary, double-blind, placebo-controlled, cross-over study in a similar population using nabilone; a synthetic derivative of THC and an agonist at cannabinoid receptors CB1 and CB2 that showed statistically significant benefits on measures of agitation in a population similar to HAAD patients. In the current proposal, we have chosen to use a combination of THC and CBD oils because of the enhanced synergistic effects that the combination can provide while maintaining a low side effects profile. We propose a 12-week, phase 2, multicenter, randomized, double-blind, parallel-group, placebo-controlled study in HAAD patients, with primary outcomes evaluating the efficacy and tolerability of a THC/CBD oral combination at week 2 and week 12. A total daily dose of 8 mg of THC and 400 mg of CBD dissolved in digestible oil will be administered 2 times per day with a maximum of 4 mg of THC and 200 mg of CBD per dose. The study will recruit 150 HAAD subjects from 15 USA sites over a 2-year period. To facilitate recruitment and retention and to monitor long-term safety of the THC/CBD combination, completers of the double-blind study, will then have the option to participate in a 6-month, open-label extension study.
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