MedPath

Medicinal cannabis use among dementia patients

Phase 1
Recruiting
Conditions
Dementia
Neurological - Dementias
Registration Number
ACTRN12619000474156
Lead Sponsor
niversity of Notre Dame Australia
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
50
Inclusion Criteria

Live within a residential aged care facility,
• Aged 65 year or older,
• Have a diagnosis of dementia, and display at least 3 behavioural symptoms associated with dementia
• Able to speak English,
• Known compliance to taking medication, and
• Not bed ridden.

Note those with mild dementia will be able to consent to participant in the study themselves. Those with moderate-to-severe dementia, their next of kin can consent on their behalf if they wish, but will need to speak with an independent medical practitioner prior to their involvement in the study (This is in keeping with the recent changes made to the Western Australian Guardianship and Administration Act of 1990).

Exclusion Criteria

To minimize the likelihood of an adverse event, people with certain health conditions or on some medications will be excluded from the study. These include:
-Diagnosed of one or more of the following conditions:
-Frontotemporal or Lewy body dementia
-Neurodegenerative disease (Epilepsy or recurrent seizure, Anorexia nervosa)
-Significant psychiatric disorder other than BPSD associated with underlying condition
-Parkinson’s disease
-Significant cardiovascular disease (eg arrhythmias, fibrillation, CHF, angina) clinically uncontrolled in the last year Significant cardiovascular disease (eg arrhythmias, fibrillation, CHF, angina) clinically uncontrolled in the last year
-History of myocardial infarction with manifestations of active cardiac ischemia in the last year
-Clinical event of a stroke within the last 6 months
-Significant liver disease or presence of hepatic encephalopathy (where there are grounds to suspect liver disease excluded as per Child-Pugh classification B or C)
-Significant renal impairment (where there are grounds to suspect kidney disease excluded as per calculated GFR beneath 60ml/min)
-Taking medications that may interact with cannabis metabolism such as Primidone, Phenobarbital, Carbamazepine, Rifampicin, Rifabutin, Troglitazone, Hypericum perforatum, and valproic acid.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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