- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05239390
SCI-110 for Alzheimer Disease and Agitation
Phase IIA Open-Label, to Evaluate the Safety, Tolerability, and Efficacy Trend of SCI -110 in Patients With AD and Agitation
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 Overview
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Yehoshua Klapper
- Phone Number: +972-3-5342221
- Email: josh@alzheimer.org.il
Study Contact Backup
- Name: Hila Manor
- Phone Number: +972-508697886
- Email: manor483@gmail.com
Study Locations
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-
-
Ramat Gan, Israel, 56621
- Recruiting
- The Israeli Medical Center for Alzheimer's
-
Contact:
- Yehoshua Klapper
- Phone Number: +972-3-5342221
- Email: josh@alzheimer.org.il
-
Contact:
- Hila Manor
- Phone Number: +972-50-8697886
- Email: manor483@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: SCI -110
SCI -110 (Previously known as THX-110): a combination of THC (Doses: 2.5 mg - 12.5 mg per daily dose) and PEA (Dose: 800 mg per daily dose), administered together as separate pills, orally, twice daily (morning and evening - except for the initial titration dose, of 2.5 mg THC+800 mg PEA given once a day, in the morning.
|
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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
drop-out's
Time Frame: up to 64 days
|
Number of drop-out subjects' due to poor tolerability
|
up to 64 days
|
Adverse Events
Time Frame: up to 64 days
|
Number of study treatment (SCI -110) related Adverse Events (AEs) from Baseline (visit 2, day 1) to end of treatment.
|
up to 64 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in the Cohen Mansfield Agitation Inventory (CMAI).
Time Frame: up to 64 days
|
Change from Baseline to end of treatment in agitation measured by the Cohen Mansfield Agitation Inventory (CMAI).
|
up to 64 days
|
rescue medication
Time Frame: up to 64 days
|
Frequency of use of rescue medication to control agitation (Frequency of rescue medication use = number of drug administration(s) regardless of dose
|
up to 64 days
|
Change in Mini Mental State Exam (MMSE)
Time Frame: up to 64 days
|
Change from Baseline (visit 2, day 1) to end of treatment in Mini Mental State Exam (MMSE)
|
up to 64 days
|
Change in Sleep Disorders Inventory
Time Frame: up to 64 days
|
Change in quality of sleep from Baseline (visit 2, day 1) to end of treatment measured in Sleep Disorders Inventory
|
up to 64 days
|
Change in The Edinburgh Feeding Evaluation in Dementia Scale
Time Frame: up to 64 days
|
Change in appetite from Baseline (visit 2, day 1) to end of treatment measured in The Edinburgh Feeding Evaluation in Dementia Scale
|
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
Time Frame: up to 64 days
|
Change in SIB-8 8-item Severe Impairment Battery
|
up to 64 days
|
Collaborators and Investigators
Investigators
- Principal Investigator: Alexander Kaplan, The Israeli Medical Center for Alzheimer's
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurocognitive Disorders
- Neurodegenerative Diseases
- Dementia
- Tauopathies
- Alzheimer Disease
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Non-Narcotic
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Psychotropic Drugs
- Hallucinogens
- Cannabinoid Receptor Agonists
- Cannabinoid Receptor Modulators
- Dronabinol
Other Study ID Numbers
- NAVE-Sci-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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