The Effect of Cannabis on Dementia Related Agitation and Aggression
The Effect of Cannabis on Dementia Related Agitation and Aggression
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.
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.