Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2/PHASE3
486 participants
INTERVENTIONAL
2024-09-01
2025-10-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Group A
Subjects will receive placebo for the first three months. After transitioning from the placebo, subjects will be titrated with 200 mg CBD for the first two weeks. Subsequent to this period, they will be administered 400 mg CBD for the remaining two and a half months.
Cannabidiol Oil
The 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.
Group B
For the initial two weeks, subjects will be given 200 mg CBD. Following this titration period, they will receive 400 mg CBD for the remaining two and a half months. Then, subjects will receive placebo for the remaining of the study.
Cannabidiol Oil
The 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.
Interventions
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Cannabidiol Oil
The 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.
Eligibility Criteria
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Inclusion Criteria
2. 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.
3. 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.
4. 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.
5. Ability to Comply: Participants' caregivers must be willing and able to comply with all study procedures and requirements needed by the study. The caregivers must ensure that the participants has the ability to ingest oral medication, and they need to complete surveys on behalf of the participants on their phone, record log seizures (if applicable), and bring the patients to attend all necessary study visits.
6. Health Status: Participants must be in a health state, as determined by the investigator that will not put them at undue risk of harm from participating in the study or interfere with the study's ability to achieve its objectives.
7. Additional Criteria for Cancer Patients: Cancer patients must not be on any active chemotherapy and radiation treatment, as determined by the investigator.
The exact specifications of these criteria will be determined in consultation with Malaysian clinical experts and will be clearly defined in the study's protocol. These criteria are intended to ensure the study's results are valid, reliable, and applicable to the target population.
Exclusion Criteria
2. 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.
3. 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.
4. 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.
5. Hypersensitivity: Individuals with known hypersensitivity to CBD or any component of the study formulation.
50 Years
ALL
No
Sponsors
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UPM Consultancy & Services Sdn. Bhd.
UNKNOWN
Pure Life Collective Pte Ltd
UNKNOWN
Hospital Pengajar Universiti Putra Malaysia
OTHER
Responsible Party
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Locations
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Hospital Sultan Abdul Aziz Shah
Serdang, Selangor, Malaysia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CBDA102223
Identifier Type: -
Identifier Source: org_study_id
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