Cannabinoid Shown Safe, Lowers Agitation in Alzheimer’s Patients

Cannabis plant (Michael Fischer, Pexels.com)

15 Nov. 2023. A clinical trial in a small group of participants suggests a cannabinoid drug is safe and well-tolerated, and reduces agitation among patients with Alzheimer’s disease. Initial results of the trial are published today in a news release from the biotechnology company SciSparc Ltd., developer of the experimental drug tested in the trial, and are not yet peer-reviewed.

SciSparc, in Tel Aviv, Israel, develops treatments for central nervous system diseases with cannabinoids, derived from the cannabis sativa plant. Cannabinoids are substances that contain varying amounts of tetrahydrocannabinol or THC, the mind-altering compound in cannabis, as well as cannabidiol and some 100 other chemicals. Research with cannabinoids indicates some of these compounds have beneficial effects with few adverse effects for treating mental health disorders, with the Food and Drug Administration approving cannabinoid drugs for some forms of epilepsy, and nausea and vomiting in cancer patients undergoing chemotherapy.

SCI-110 is SciSparc’s lead product, in clinical trials for tourette syndrome, obstructive sleep apnea, and now agitation from Alzheimer’s disease. Some people with Alzheimer’s disease and other dementias experience behavior changes including increased fidgeting, restlessness, and agitation. The symptoms may result from changes in the environment of patients such as new caregivers, or fear and fatigue from the disease itself. But the agitation can be damaging to the well-being of both the patient and caregivers, with few options other than calming the patient, removing possible triggers from the environment, and a few medications.

Older adults with Alzheimer’s disease experiencing agitation

SCI-110 is a combination of the cannabinoid drug dronabinol made with synthetic THC, approved by FDA to treat nausea and vomiting in chemotherapy recipients, and the endocannabinoid compound palmitoylethanolamide, or PEA. Endocannabinoids are lipid or natural oil compounds that maintain and protect the central nervous system, by producing enzymes for synthesizing and degrading endocannabinoids as well as by engaging cannabinoid receptors. SciSparc produces SCI-110 as an oral drug.

The clinical trial is a mid-stage study testing SCI-110 among up to 20 patients in an Alzheimer’s care center in Tel Aviv. Taking part in the trial are older adults, age 60 to 85, experiencing agitation but not responding to their current medications. Participants are given SCI-110 twice a day for 64 days with the dose of dronabinol in the drug increased every three days up to 12.5 milligrams. There is no control or comparison group.

The study team is looking mainly for safety indicators in reports of adverse effects and the number of dropouts from the study. But the researchers are also tracking behavioral indicators including a standard agitation assessment inventory, a sleep disorders index, a feeding and eating evaluation scale for dementia patients, measures of impairment, and use of rescue medications.

SciSparc says results from 18 participants show the trial achieved its primary objectives of safety and tolerability, but does not give quantitative data on adverse effects or study drop outs. The company did report a 23 percent decline in agitation symptoms among participants, according to scores on the standard Cohen Mansfield Agitation Inventory. And the scores on the Edinburgh Feeding Evaluation in Dementia Scale, says SciSparc, show fewer eating difficulties. No other behavioral results are reported.

More from Science & Enterprise:

• Small Biz Grant Supports Regenerative Alzheimer’s Treatment
• NIH Challenge Seeks Early Alzheimer’s Indicators with A.I.
• NIH Award Funds A.I. to Detect Alzheimer’s in Clinical Notes
• Alzheimer’s Assn Collecting Real-World Therapy Data
• Digital Biomarkers Reveal Alzheimer’s Gender Differences

We designed Science & Enterprise for busy readers including investors, researchers, entrepreneurs, and students. Except for a narrow cookies and privacy strip for first-time visitors, we have no pop-ups blocking the entire page, nor distracting animated GIF graphics. If you want to subscribe for daily email alerts, you can do that here, or find the link in the upper left-hand corner of the desktop page. The site is free, with no paywall. But, of course, donations are gratefully accepted.

*     *     *