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RecruitingPhase 2

Effects of THC-Free CBD Oil on Agitation in Patients With Alzheimer's Disease

Lead sponsor

Eastern Virginia Medical School

Asset

Cannabidiol

Listed sites

Recruiting sites

Enrollment

estimated

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 4-28

Primary endpoints

•Agitation and aggression•Caregiver burden•The participant's quality of life

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

NCT IDNCT04436081

Org study IDRI-03368

Timeline

Milestones

Study first posted2020-06-17actual

Study start2021-02-26actual

Last update posted2023-02-16actual

Primary completion2024-03estimated (month precision)

Study completion2024-03estimated (month precision)

Assets

Drug assets

Cannabidiol

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

Maximum age90 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Males/females over 50 years old.

•Have a diagnosis of dementia due to AD or mixed AD with another type of dementia.

•A Mini-Mental State Exam score (MMSE) between 4 and 28 inclusive.

•Presence of agitation with a Neuropsychiatric Inventory (NPI)-agitation/aggression subscore > 3.

•Participants and their informal caregivers must be fluent in English (includes reading, writing, and speech) and able to give informed consent.

•For patients treated with cognitive-enhancing medications (cholinesterase inhibitors (ChEI) and/or memantine), the dosage must be stable for at least 1 month (30 days). If the ChEI and/or memantine has been discontinued, patients may enroll after 15 days.

•Eligible caregivers must either live with the participant or have a minimum of 4 hours of daily contact with them

Exclusion criteria

•Diagnosis of non-AD or non-mixed dementias.

•Very mild dementia or advanced dementia (MMSE: greater than 28 or less than 4).

•NPI-agitation-aggression score < 3.

•Having a serious or unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease which might confound assessment of safety outcomes as determined by the study physician.

•Presence or history of other serious psychiatric disorders or neurological conditions (e.g. psychotic disorders, bipolar disorder or schizophrenia).

•Current abuse of/dependence on marijuana, current drug abuse, current alcohol abuse.

•Having seizure disorders.

•Pregnant or breastfeeding

•Indication of baseline delirium as determined by the Confusion Assessment Method (CAM).

•Current use of lithium.

•Inability to swallow CBD oil softgels.

•Changes in dosage of anti-depressives within 4 weeks before randomization and during the study.

•Changes in dosage of antipsychotics or benzodiazepines within 1 week prior to randomization and during the study.

•Contraindications to CBD oil (history of hypersensitivity to any cannabinoid).

•Frequent falling due to orthostatic hypotension.

•Use of tricyclic antidepressants (TCA), fluoxetine, and/or carbamazepine. -Patients who reside in nursing homes.

Endpoints (7)

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

Caregiver / quality of life

Global cognition

1 endpoint

Secondary/protocol endpoint

Assessment of change in cognitive skills.

Time frame:Three times during the 15 weeks of study enrollment.

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Behavior / neuropsychiatric

3 endpoints

Primary/protocol endpoint

Change in agitation and aggression.

Time frame:Every two weeks for 15 weeks during study enrollment.

change from baseline, improvement

Secondary/protocol endpoint

Assessment of change in neuropsychiatric symptoms.

Time frame:Three times during the 15 weeks of study enrollment.

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/protocol endpoint

The effect of CBD oil on sleep quantity measured by Fitbit

Time frame:Measured on a daily basis during the 15 weeks of study enrollment.

descriptive

Caregiver / quality of life

3 endpoints

Primary/protocol endpoint

Change in caregiver burden.

Time frame:Three times during the 15 weeks of study enrollment.

change from baseline, improvement

Primary/protocol endpoint

Change in the participant's quality of life.

Time frame:Three times during the 15 weeks of study enrollment.

change from baseline, improvement

Primary/protocol endpoint

Change in caregiver's quality of life.

Time frame:Three times during the 15 weeks of study enrollment.

change from baseline, improvement

Publications (13)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

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.