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Not yet recruitingPhase 2 / PHASE3

Cannabidiol's Role in Dementia Management

Cannabidiol's Role in Dementia Management: Evaluating Cognitive, Quality of Life, and Well-being Outcomes in Malaysia

Asset

Cannabidiol

Listed sites

1

Recruiting sites

-

Enrollment

486

estimated

Study population

Mixed / unspecified dementia

Key I/E criterion

Age ≥50

Primary endpoints

ADAS-CogNeuropsychiatric Inventory (NPI)Sleep quality, latency, duration, efficiency, disturbances

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDCBDA102223
NCT IDNCT06514066

Timeline

Milestones

Study first posted2024-07-23actual
Last update posted2024-07-23actual
Study start2024-09-01estimated
Primary completion2025-10-01estimated
Study completion2025-10-01estimated

Assets

Drug assets

Study populations

Who this study enrolls

Mixed / unspecified dementia

Eligibility

Who can enroll

Minimum age50 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. 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.

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

1. Cannot fulfil all the requirement as above.

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.

Endpoints (4)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Behavior / neuropsychiatric
2
Global cognition
1
Caregiver / quality of life
1

Global cognition

1 endpoint
Primary/protocol endpoint

Cognitive Function: The Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-COG)

Time frame:6 months

ADAS-Cog

descriptive

Behavior / neuropsychiatric

2 endpoints
Primary/protocol endpoint

Psychological well-being/ assesses psycho-behavioral symptomatology (the Neuropsychiatric Inventory NPI scoring system)

Time frame:6 months

Neuropsychiatric Inventory (NPI)

event count, event

Primary/protocol endpoint

Sleep quality, latency, duration, efficiency, disturbances, and daytime dysfunction, evaluated using the Pittsburgh Sleep Quality Index (PSQI)

Time frame:6 months

ratio, descriptive

Caregiver / quality of life

1 endpoint
Primary/protocol endpoint

Overall quality of life (QOL-AD Questionnaire)

Time frame:6 months

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.