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The Effect of Cannabis on Dementia Related Agitation and Aggression

Primary Purpose

Agitation Related to Dementia

Status
Completed
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
Cannabis
Placebo oil
Sponsored by
TO Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Agitation Related to Dementia

Eligibility Criteria

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

Inclusion Criteria:

  • Male or female subjects > 60 years old.
  • Written informed consent from participants legally authorized representative.
  • Subjects who are residing either in an institutionalized setting (e.g. dementia unit, nursing home, assisted living facility, or other residential care facility) or in a non-institutionalized setting where the subject is not living alone and is receiving 24-hour supervision via home health care or a family member. Subjects must have been at their current location for at least 14 days before screening and plan to remain at the same location for the duration of the trial.
  • Diagnosis of Dementia (NCD) according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) Criteria for at least 6 months prior to screening.
  • Mini-Mental State Examination (MMSE) < 26.
  • Clinically relevant Behavioral and Psychological Symptoms of Dementia (BPSD) operationally defined as NPI-NH agitation/ aggression sub score of ≥3 at screening.
  • Documented history of clinically relevant BPSD.
  • Ability to participate in study evaluation and ingest oral medication.
  • Subjects will be on stable concomitant medications regimen for the treatment of BPSD for at least one month prior to the screening visit.
  • Subjects will be on stable concomitant medications regimen for the treatment of concurrent conditions for at least one month prior to the screening visit.

Exclusion Criteria:

  • Patients receiving any of the following medications: Astemizole, Cisapride, Pimozide or Terfenadine.
  • The agitation/aggression is attributable to concomitant medications, environmental conditions or psychiatric condition.
  • Patients with severe heart disease.
  • Subjects suffering from Epilepsy.
  • Subjects suffering from anxiety disorder.
  • Subjects who had psychiatric condition in the past OR suffering from psychosis.
  • Schizophrenia OR family history of Schizophrenia OR any other mental disorder.
  • Subjects with any other condition, which in the judgment of the investigator would prevent the subject from completing the study.
  • Any condition that the Investigator believes would interfere with the intent of the study or would make participation not in the best interest of the patient.
  • Patients suffering from alcohol and/or substance abuse
  • Surgery within 30 days prior to screening or scheduled surgery during the study period.

Sites / Locations

  • Laniado Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

"Avidekel " cannabis oil 20:1 CBD:THC

placebo oil

Arm Description

The cannabis oil will be mad out of extract from the Avidekel strain and olive oil. Avidekel oil containing Δ9-Tetra-Hydrocannabinol (Δ9-THC) and Cannabidiol (CBD) in a 1:20 ratio and at a concentration of 30% CBD and 1.5% Δ9-THC. Each Avidekel oil drop is approximately 0.04 ml in volume containing about 12 mg CBD and 0.6 mg Δ9-THC.

Patients in the control group will receive placebo.

Outcomes

Primary Outcome Measures

Change in score of Cohen-Mansfield Agitation Inventory (CMAI)
Proportion of subjects achieving a decrease of four or more points on the Cohen-Mansfield Agitation Inventory (CMAI), a 29-item scale that measures the types and frequencies of agitated behaviors, each rated on a 7-point scale of frequency, where higher scores indicate greater agitation severity.

Secondary Outcome Measures

Change in score of Neuropsychiatric Inventory-Nursing Home Version (NPI-NH)
Proportion of subjects with change in score of Neuropsychiatric Inventory-Nursing Home Version (NPI-NH). The greater the NPI-NH score, the more severe and frequent the behavioral disturbances

Full Information

First Posted
October 29, 2017
Last Updated
March 7, 2022
Sponsor
TO Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT03328676
Brief Title
The Effect of Cannabis on Dementia Related Agitation and Aggression
Official Title
A Phase II, Randomized, Double-blind, Placebo-controlled Trial to Investigate the Efficacy and Safety of Avidekel Oil for the Treatment of Subjects With Agitation Related to Dementia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
December 7, 2017 (Actual)
Primary Completion Date
August 18, 2019 (Actual)
Study Completion Date
August 18, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TO Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The most common syndrome in patients with severe dementia is agitated behavior, which is often characterized by a combination of violent behavior (physical or verbal), restlessness, and inappropriate loudness. The treatment options for this syndrome are limited and lead to severe side effects. In vivo experiments on animals and clinical studies on adults show that cannabinoids could have a beneficial effect on behavioral disorders in general, and in dementia-related disorders in particular. Additionally, medical cannabis patients have reported that cannabis aids in pain relief, increased appetite, and a sense of calm and peace of mind. Elderly patients suffering from dementia that experience this syndrome could also benefit from other quality of life aspects of the cannabis treatment such as reduction in medication consumption, weight gain and improvement of sleep.
Detailed Description
In this randomized, double-blind placebo-controlled trial, 60 patients will be randomly assigned to receive either CBD-A (30:1) cannabis rich low THC oil (30% CBD and 1% THC) or a placebo oil. The primary efficacy endpoint was a decrease of four or more points on the Cohen-Mansfield Agitation Inventory (CMAI) score by week 16, as compared to baseline. Secondary endpoints included improvement of other neurobehavioral symptoms. The following questionnaires will be administered by trained staff at every visit: The CMAI, a to measure the types and frequencies of agitated behaviors, and the Neuropsychiatric Inventory-Nursing Home Version (NPI-NH) to measure behavioral disturbances.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Agitation Related to Dementia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
A Phase II, Randomized, Double-blind, Placebo-controlled Trial
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
"Avidekel " cannabis oil 20:1 CBD:THC
Arm Type
Experimental
Arm Description
The cannabis oil will be mad out of extract from the Avidekel strain and olive oil. Avidekel oil containing Δ9-Tetra-Hydrocannabinol (Δ9-THC) and Cannabidiol (CBD) in a 1:20 ratio and at a concentration of 30% CBD and 1.5% Δ9-THC. Each Avidekel oil drop is approximately 0.04 ml in volume containing about 12 mg CBD and 0.6 mg Δ9-THC.
Arm Title
placebo oil
Arm Type
Placebo Comparator
Arm Description
Patients in the control group will receive placebo.
Intervention Type
Drug
Intervention Name(s)
Cannabis
Other Intervention Name(s)
CBD-A
Intervention Description
Patients will receive study medication as drops applied under the tongue 3 times a day - morning, noon and evening, at a minimum of 4hr apart between administrations.
Intervention Type
Drug
Intervention Name(s)
Placebo oil
Other Intervention Name(s)
olive oil and chlorophyll
Intervention Description
Patients will receive study medication as drops applied under the tongue 3 times a day - morning, noon and evening, at a minimum of 4hr apart between administrations.
Primary Outcome Measure Information:
Title
Change in score of Cohen-Mansfield Agitation Inventory (CMAI)
Description
Proportion of subjects achieving a decrease of four or more points on the Cohen-Mansfield Agitation Inventory (CMAI), a 29-item scale that measures the types and frequencies of agitated behaviors, each rated on a 7-point scale of frequency, where higher scores indicate greater agitation severity.
Time Frame
week 16
Secondary Outcome Measure Information:
Title
Change in score of Neuropsychiatric Inventory-Nursing Home Version (NPI-NH)
Description
Proportion of subjects with change in score of Neuropsychiatric Inventory-Nursing Home Version (NPI-NH). The greater the NPI-NH score, the more severe and frequent the behavioral disturbances
Time Frame
week 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female subjects > 60 years old. Written informed consent from participants legally authorized representative. Subjects who are residing either in an institutionalized setting (e.g. dementia unit, nursing home, assisted living facility, or other residential care facility) or in a non-institutionalized setting where the subject is not living alone and is receiving 24-hour supervision via home health care or a family member. Subjects must have been at their current location for at least 14 days before screening and plan to remain at the same location for the duration of the trial. Diagnosis of Dementia (NCD) according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) Criteria for at least 6 months prior to screening. Mini-Mental State Examination (MMSE) < 26. Clinically relevant Behavioral and Psychological Symptoms of Dementia (BPSD) operationally defined as NPI-NH agitation/ aggression sub score of ≥3 at screening. Documented history of clinically relevant BPSD. Ability to participate in study evaluation and ingest oral medication. Subjects will be on stable concomitant medications regimen for the treatment of BPSD for at least one month prior to the screening visit. Subjects will be on stable concomitant medications regimen for the treatment of concurrent conditions for at least one month prior to the screening visit. Exclusion Criteria: Patients receiving any of the following medications: Astemizole, Cisapride, Pimozide or Terfenadine. The agitation/aggression is attributable to concomitant medications, environmental conditions or psychiatric condition. Patients with severe heart disease. Subjects suffering from Epilepsy. Subjects suffering from anxiety disorder. Subjects who had psychiatric condition in the past OR suffering from psychosis. Schizophrenia OR family history of Schizophrenia OR any other mental disorder. Subjects with any other condition, which in the judgment of the investigator would prevent the subject from completing the study. Any condition that the Investigator believes would interfere with the intent of the study or would make participation not in the best interest of the patient. Patients suffering from alcohol and/or substance abuse Surgery within 30 days prior to screening or scheduled surgery during the study period.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vered Hermush, Dr
Organizational Affiliation
Laniado Hospital Geriatric Department
Official's Role
Principal Investigator
Facility Information:
Facility Name
Laniado Hospital
City
Netanya
Country
Israel

12. IPD Sharing Statement

Citations:
PubMed Identifier
36148467
Citation
Hermush V, Ore L, Stern N, Mizrahi N, Fried M, Krivoshey M, Staghon E, Lederman VE, Bar-Lev Schleider L. Effects of rich cannabidiol oil on behavioral disturbances in patients with dementia: A placebo controlled randomized clinical trial. Front Med (Lausanne). 2022 Sep 6;9:951889. doi: 10.3389/fmed.2022.951889. eCollection 2022.
Results Reference
derived
PubMed Identifier
34532852
Citation
Bosnjak Kuharic D, Markovic D, Brkovic T, Jeric Kegalj M, Rubic Z, Vuica Vukasovic A, Jeroncic A, Puljak L. Cannabinoids for the treatment of dementia. Cochrane Database Syst Rev. 2021 Sep 17;9(9):CD012820. doi: 10.1002/14651858.CD012820.pub2.
Results Reference
derived
PubMed Identifier
33660625
Citation
Solomon HV, Greenstein AP, DeLisi LE. Cannabis Use in Older Adults: A Perspective. Harv Rev Psychiatry. 2021 May-Jun 01;29(3):225-233. doi: 10.1097/HRP.0000000000000289.
Results Reference
derived

Learn more about this trial

The Effect of Cannabis on Dementia Related Agitation and Aggression

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