Cannabidiol's Role in Dementia Management
Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age50+
SponsorHospital Pengajar Universiti Putra Malaysia
About this trial
This trial investigates the therapeutic benefits of cannabidiol (CBD) for Dementia patients in Malaysia. As dementia becomes increasingly prevalent worldwide, there's a pressing demand for impactful remedies. This research will delve into CBD's influence on cognitive functions, daily activities, mental health, and overall life quality of dementia sufferers. Utilizing a range of established assessment instruments, including the ADAS-COG subscale for cognitive effects, the NPI score for psychological well-being, and the QOLAD questionnaire for life quality, we aim to discern CBD's potential in ameliorating the conditions of those with dementia. This study's results could shape novel treatment methods and improved care for dementia patients, benefiting not just Malaysia but the world at large.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age: Participants (male and female) must be 50 years of age or older at the time of enrollment. This criterion is necessary to ensure that participants can legally provide informed consent for their participation.
Diagnosis: Participants must have a confirmed diagnosis of mild to severe dementia based on DSM-5 and Clinical Dementia Rating (CDR). Diagnosis should be confirmed by either neurologist, psychiatrist or geriatrician that attend the pattients.
Stability of Condition: Participants' disease status must be stable at the time of enrollment, as determined by the investigator. For example, seizure frequency for those with epilepsy should be consistent for a specified period (e.g., the past three months) before study entry.
Consent: The caregivers of the participants must provide written informed consent to participate in the study. The consent form must be read, understood, and signed by the caregivers before any study-specific procedures are performed.
Disqualifiers
Cannot fulfil all the requirement as above.
Substance Use: Active usage of substances/medications such as cocaine, opiates, benzodiazepines, barbiturates, amphetamines, morphine, methadone, methamphetamines, oxycodone, phencyclidine, tricyclic antidepressants, tetrahydrocannabinol, buprenorphine, methylenedioxymethamphetamine, propoxyphene.
Concurrent Treatments: Participants currently participating in another clinical trial or using other experimental treatments for their condition. Participants who have used any medication, dietary supplements (and/or grapefruit juice), or combination of medications and supplements known to alter the metabolism of, or interact with CBD (bupropion, rifampin, barbiturates, phenothiazines, cimetidine, etc.) 14 days prior to and during the duration of the study.
Significant Health Risks: Participants with significant cardiovascular, hepatic, renal, respiratory, or psychiatric disease, which, in the investigator's opinion, would place the participant at undue risk or interfere with the results of the study. History of impaired renal function or elevated liver enzymes at prescreening. The exclusionary lab values are: 3x nl AST/ALT, 1.5x bilirubin or eGFR less than 30 ml/min. Having present or past medical conditions, including a DSM-5 Axis I psychiatric disorder, history of cardiac disease, arrhythmias, neurological disease of central origin, head trauma, and seizures.
Trial design
Design model
Crossover
Treatments tested in this trial
Cannabidiol Oil
DrugThe study intervention involves the administration of high purity Cannabidiol (CBD) in vegan soft gel capsule form. Dosing will range between 200 mg and 400 mg and will be administered twice daily. The CBD capsule is water-soluble to improve its bioavailability and absorption in the body.
Treatment groups
486 Participants
are divided into 2 treatment groupsGroup A: Group AOther 1 intervention
Group B: Group BOther 1 intervention
Trial outcomes
Primary outcomes
1
Cognitive Function: The Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-COG)
To evaluate cognitive functions using the Alzheimer's Disease Assessment Scale-Cognitive subscale. The ADAS-COG consists of 11 tasks: Word Recall Task, Naming Objects and Fingers, Following Commands, Constructional Praxis, Ideational Praxis, Orientation, Word Recognition Task, Remembering Test Directions, Spoken Language, Comprehension, and Word-Finding Difficulty .
Time frame
6 months2
Psychological well-being/ assesses psycho-behavioral symptomatology (the Neuropsychiatric Inventory NPI scoring system)
To measure psychological well-being. The NPI evaluates neuropsychiatric symptoms through domains including delusions, hallucinations, dysphoria, anxiety, agitation/aggression, euphoria, disinhibition, irritability, apathy, and aberrant motor activity, each with 7-8 specific sub-questions assessing severity and frequency.
Time frame
6 months3
Sleep quality, latency, duration, efficiency, disturbances, and daytime dysfunction, evaluated using the Pittsburgh Sleep Quality Index (PSQI)
To evaluate sleep quality, latency, duration, efficiency, disturbances, and daytime dysfunction. The PSQI consists of 19 individual items, which are combined to form seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Each component is scored on a 0-3 scale, and the sum of these scores yields one global score.
Time frame
6 months4
Overall quality of life (QOL-AD Questionnaire)
To gauge overall quality of life. QOL-AD is a 15-question tool used for assessing the quality of life in patients diagnosed with dementia.
Time frame
6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Hospital Pengajar Universiti Putra Malaysia
Lead sponsor
UPM Consultancy & Services Sdn. Bhd.
Collaborator
Pure Life Collective Pte Ltd
Collaborator
Source ClinicalTrials.gov
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