Clinical trial NCT05239390: SCI-110 for Alzheimer Disease and Agitation
Official title: Phase IIA Open-Label, to Evaluate the Safety, Tolerability, and Efficacy Trend of SCI -110 in Patients With AD and Agitation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Alzheimer Disease
Lead sponsor: The Israeli Medical Center for Alzheimer's
Sponsor class: OTHER
First posted: 2022-02-14
Enrollment: 20
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Male or female aged \>60 to \<85 years inclusive.
* Patients diagnosed according to the NINCDS criteria for AD (possible and probable).
* MMSE less than 24 at the time of screening.
* Patients who in the opinion of the investigators need medication to control agitation or whose current anti-agitation medication is ineffective or poorly tolerated
* Patients who have been taking stable dose concomitant medications for at least 1 week.
* Only individuals who have a legally appointed guardian who can sign Informed Consent Form (ICF)

Exclusion Criteria:

* Participant in other clinical trial during the last 30 days.
* Any disorder which in the investigator's opinion might jeopardize subject's safety or compliance with the protocol.
* Patients whose agitation can be attributed to a somatic disorder (Ex. urinary tract infection or urinary retention)
* Patient with uncontrolled congestive heart failure.
* Patients who get the following medications: opiates, Primidone, Phenobarbitol, carbamazepine, Rifampicin, Rifabutin, Troglitazone and Hypericum perforatum.
* Male patients who in the opinion of the investigator are at risk of urinary retention due to the anticholinergic proprieties of THC
* Subjects with known sensitivity to the active substance dronabinol or to any of the components of the drug (sesame oil, gelatin, glycerol, titanium dioxide
* Subjects that previously suffered from cannabinoids' related adverse effects.
* Subjects with a history of diagnosed Mental or Psychiatric diseases
* Patients who in the opinion of the investigator are at risk of falling beyond the risk associated with AD (example: postural hypotension, unstable blood pressure, with or without administration of anti-hypertensive medication, α1 blocker drugs used to treat benign prostatic hyperplasia
* Patients diagnosed with epilepsy

Primary outcomes:
measure: drop-out's
timeFrame: up to 64 days
measure: Adverse Events
timeFrame: up to 64 days
Secondary outcomes:
measure: Change in the Cohen Mansfield Agitation Inventory (CMAI).
timeFrame: up to 64 days
measure: rescue medication
timeFrame: up to 64 days
measure: Change in Mini Mental State Exam (MMSE)
timeFrame: up to 64 days
measure: Change in Sleep Disorders Inventory
timeFrame: up to 64 days
measure: Change in The Edinburgh Feeding Evaluation in Dementia Scale
timeFrame: up to 64 days
measure: Change in cognitive measures from Baseline (visit 2, day 1) to end of treatment measured in SIB-8 8-item Severe Impairment Battery
timeFrame: up to 64 days
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: The Israeli Medical Center for Alzheimer's
Study officials:
affiliation: The Israeli Medical Center for Alzheimer's
name: Alexander Kaplan
role: PRINCIPAL_INVESTIGATOR
References: