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SCI-110 for Alzheimer Disease and Agitation

Primary Purpose

Alzheimer Disease

Status

Recruiting

Phase

Phase 2

Locations

Israel

Study Type

Interventional

Intervention

SCI -110

About this trial

This is an interventional treatment trial for Alzheimer Disease

Eligibility Criteria

60 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

The Israeli Medical Center for Alzheimer'sRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SCI -110

Arm Description

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.

Outcomes

Primary Outcome Measures

drop-out's

Number of drop-out subjects' due to poor tolerability

Adverse Events

Number of study treatment (SCI -110) related Adverse Events (AEs) from Baseline (visit 2, day 1) to end of treatment.

Secondary Outcome Measures

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).

rescue medication

Frequency of use of rescue medication to control agitation (Frequency of rescue medication use = number of drug administration(s) regardless of dose

Change in Mini Mental State Exam (MMSE)

Change from Baseline (visit 2, day 1) to end of treatment in Mini Mental State Exam (MMSE)

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

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

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

Full Information

NCT ID

NCT05239390

First Posted

July 25, 2021

Last Updated

February 3, 2022

Sponsor

The Israeli Medical Center for Alzheimer's

1. Study Identification

Unique Protocol Identification Number

NCT05239390

Brief Title

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

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Recruiting

Study Start Date

December 29, 2021 (Actual)

Primary Completion Date

June 29, 2023 (Anticipated)

Study Completion Date

June 29, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The Israeli Medical Center for Alzheimer's

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alzheimer Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

SCI -110

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

SCI -110

Other Intervention Name(s)

Dronabinol and PEA

Intervention Description

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.

Primary Outcome Measure Information:

Title

drop-out's

Description

Number of drop-out subjects' due to poor tolerability

Time Frame

up to 64 days

Title

Adverse Events

Description

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

Secondary Outcome Measure Information:

Title

Change in the Cohen Mansfield Agitation Inventory (CMAI).

Description

Change from Baseline to end of treatment in agitation measured by the Cohen Mansfield Agitation Inventory (CMAI).

Time Frame

up to 64 days

Title

rescue medication

Description

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

Title

Change in Mini Mental State Exam (MMSE)

Description

Change from Baseline (visit 2, day 1) to end of treatment in Mini Mental State Exam (MMSE)

Time Frame

up to 64 days

Title

Change in Sleep Disorders Inventory

Description

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

Title

Change in The Edinburgh Feeding Evaluation in Dementia Scale

Description

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

Title

Change in cognitive measures from Baseline (visit 2, day 1) to end of treatment measured in SIB-8 8-item Severe Impairment Battery

Description

Change in SIB-8 8-item Severe Impairment Battery

Time Frame

up to 64 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yehoshua Klapper

Phone

+972-3-5342221

josh@alzheimer.org.il

First Name & Middle Initial & Last Name or Official Title & Degree

Hila Manor

Phone

+972-508697886

manor483@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alexander Kaplan

Organizational Affiliation

The Israeli Medical Center for Alzheimer's

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Israeli Medical Center for Alzheimer's

City

Ramat Gan

ZIP/Postal Code

56621

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yehoshua Klapper

Phone

+972-3-5342221

josh@alzheimer.org.il

First Name & Middle Initial & Last Name & Degree

Hila Manor

Phone

+972-50-8697886

manor483@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

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SCI-110 for Alzheimer Disease and Agitation

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