As of today, there is no FDA-approved treatment for agitation in AD. Hence, it is still
considered an unmet need.
Sporadic observation in healthy or diagnosed individuals indicated that cannabis products, in
particular, THC have calming and anti-anxiety effects. These observations are supported by
basic science data as well as animal experiments.
SCI -110 is a combination of (1) dronabinol, the active ingredient in an FDA-approved
synthetic analog of tetrahydrocannabinol, the psychoactive molecule in the cannabis plant,
and (2) palmitoylethanolamide.
In the present study, the starting daily dose for all subjects is 2.5 mg dronabinol and 800
mg PEA and will be gradually increased (every 3 days an addition of 2.5 mg dronabinol per
day, with no change in the PEA dose) to a maximum of 12.5 mg Dronebinol and 800 mg PEA per
day. The study product will be given orally, twice daily, to add-on the medical treatment.
Study Duration per patient is up to 64 days: a. screening (3-21 days); b. treatment phase:
(1) titration (15-23 days) of dronabinol from 2.5 to 12.5 mg or up to the maximal subject's
tolerated dose (2) Stabilization phase (10 days) until end of treatment on the highest
subject's daily tolerated dose. c. follow-up phase (7 days) - until the end-of-study.
During the study, the tolerability of the drug, its safety (vital signs, physical
examinations, blood, and urine tests and side effects follow-up) as well as changes in
subject's condition (using CMAI, MMSE, SIB-8 questionnaires), appetite and sleep quality
(SDI) will be followed.