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The Effect of Cannabis on Dementia Related Agitation and Aggression

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ClinicalTrials.gov Identifier: NCT03328676
Recruitment Status : Recruiting
First Posted : November 1, 2017
Last Update Posted : April 23, 2019
Sponsor:
Information provided by (Responsible Party):
TO Pharmaceuticals

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.


Condition or disease Intervention/treatment Phase
Agitation Related to Dementia Drug: Cannabis Drug: Placebo oil Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A Phase II, Randomized, Double-blind, Placebo-controlled Trial
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : December 7, 2017
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia Marijuana

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.

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.




Primary Outcome Measures :
  1. Proportion of subjects achieving a Cohen-Mansfield Agitation Inventory (CMAI) ≥ 4-point decrease during the treatment period. [ Time Frame: week 16 ]


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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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) < 23.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03328676


Locations
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Israel
Laniado Hospital Recruiting
Netanya, Israel
Contact: Vered Hermush, Dr.    0097298609138    vered.hermush@gmail.com   
Sponsors and Collaborators
TO Pharmaceuticals
Investigators
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Principal Investigator: Vered Hermush, Dr Laniado Hospital Geriatric Department

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Responsible Party: TO Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03328676     History of Changes
Other Study ID Numbers: TO_D02_2016
First Posted: November 1, 2017    Key Record Dates
Last Update Posted: April 23, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dementia
Psychomotor Agitation
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms