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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Dronabinol - Manufactured by Pharmaceutics International, Inc., Hunt Valley, MD 21031, USA. Dronabinol Capsules (dronabinol solution in sesame oil in soft gelatin capsules) are 2.5 mg - cream, oblong, soft-gel capsules. In an NDC 49884-867-02 Bottle of 60 capsules packaged in a well-closed container and stored in a locked refrigerator, 2° to 8°C. Protect from freezing, in accordance with the Israeli legal requirements (Israel Narcotic Drugs Act). Storage conditions should be monitored on a daily basis. PEA - Manufactured by Pharmacies Inc. 767 Front st. Suite 202. Catasauqua, PA 18032 www.pharmacures.com. 1-888-334-3130. 400 mg PEA tablets, in a 60 mL barrier bottle, 30/400 mm, Bottle of 30 capsules packaged in a well-closed container and stored in RT (20° to 25°C). Storage conditions should be monitored on a daily basis.
The Israeli Medical Center for Alzheimer's
Ramat Gan, Israel
RECRUITINGdrop-out's
Number of drop-out subjects' due to poor tolerability
Time frame: up to 64 days
Adverse Events
Number of study treatment (SCI -110) related Adverse Events (AEs) from Baseline (visit 2, day 1) to end of treatment.
Time frame: up to 64 days
Change in the Cohen Mansfield Agitation Inventory (CMAI).
Change from Baseline to end of treatment in agitation measured by the Cohen Mansfield Agitation Inventory (CMAI).
Time frame: up to 64 days
rescue medication
Frequency of use of rescue medication to control agitation (Frequency of rescue medication use = number of drug administration(s) regardless of dose
Time frame: up to 64 days
Change in Mini Mental State Exam (MMSE)
Change from Baseline (visit 2, day 1) to end of treatment in Mini Mental State Exam (MMSE)
Time frame: up to 64 days
Change in Sleep Disorders Inventory
Change in quality of sleep from Baseline (visit 2, day 1) to end of treatment measured in Sleep Disorders Inventory
Time frame: up to 64 days
Change in The Edinburgh Feeding Evaluation in Dementia Scale
Change in appetite from Baseline (visit 2, day 1) to end of treatment measured in The Edinburgh Feeding Evaluation in Dementia Scale
Time frame: up to 64 days
Change in cognitive measures from Baseline (visit 2, day 1) to end of treatment measured in SIB-8 8-item Severe Impairment Battery
Change in SIB-8 8-item Severe Impairment Battery
Time frame: up to 64 days
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