The Effect of Cannabis on Dementia Related Agitation and Aggression

March 7, 2022 updated by: TO Pharmaceuticals

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Netanya, Israel
        • Laniado Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

58 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: "Avidekel " cannabis oil 20:1 CBD:THC
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.
Drug: Cannabis
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.
Other Names:
  • CBD-A
Placebo Comparator: placebo oil
Patients in the control group will receive placebo.
Drug: Placebo oil
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.
Other Names:
  • olive oil and chlorophyll

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in score of Cohen-Mansfield Agitation Inventory (CMAI)
Time Frame: week 16
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.
week 16

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in score of Neuropsychiatric Inventory-Nursing Home Version (NPI-NH)
Time Frame: week 16
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
week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TO Pharmaceuticals

Investigators

  • Principal Investigator: Vered Hermush, Dr, Laniado Hospital Geriatric Department

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 7, 2017

Primary Completion (Actual)

August 18, 2019

Study Completion (Actual)

August 18, 2019

Study Registration Dates

First Submitted

October 29, 2017

First Submitted That Met QC Criteria

October 29, 2017

First Posted (Actual)

November 1, 2017

Study Record Updates

Last Update Posted (Actual)

March 8, 2022

Last Update Submitted That Met QC Criteria

March 7, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TO_D02_2016

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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