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CBD

Active not recruitingPhase EARLY_1

Cannabidiol Solution for the Treatment of Behavioral Symptoms in Older Adults With Mild Cognitive Impairment or Alzheimer's Dementia

Open-Label Trial of a Cannabidiol Solution for the Treatment of Behavioral Symptoms in Older Adults With Mild Cognitive Impairment or Alzheimer's Dementia

Lead sponsor

Mclean Hospital

Asset

high CBD/low THC

Listed sites

1

Recruiting sites

-

Enrollment

12

estimated

Study population

Alzheimer’s disease, MCI / preclinical Alzheimer’s

Key I/E criteria

Alzheimer's diseaseMMSE 15-30Study partner/caregiver required

Primary endpoint

Neuropsychiatric Inventory (NPI)

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 ID2019P002466
NCT IDNCT04075435

Timeline

Milestones

Study first posted2019-08-30actual
Study start2021-01-11actual
Last update posted2026-03-30actual
Primary completion2026-12estimated (month precision)
Study completion2026-12estimated (month precision)

Assets

Drug assets

Study populations

Who this study enrolls

Alzheimer’s diseaseMCI / preclinical Alzheimer’s

Eligibility

Who can enroll

Minimum age55 Years
Maximum age90 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. Diagnosis of probable Alzheimer's Dementia via criteria from McKhann et al., or MCI

2. MMSE score of 15-30 (inclusive)

3. Clinically significant degree of anxiety, as defined by a Clinical Impression total column score of ≥4 on the Anxiety domain of the NPI-C

4. A health care proxy available to sign consent on behalf of the participant (if applicable)

5. A caregiver who spends at least 10 hours per week with the subject who is able to attend all study visits

6. Participants and their study partner must be fluent in English

7. Must be 55-90 years old (inclusive)

Exclusion criteria

1. Serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease, which might confound assessment of safety outcomes.

2. Seizure disorder

3. Lifetime diagnosis of bipolar disorder, schizophrenia, schizoaffective disorder, as determined by the MINI

4. Current episode of major depression, as determined by the MINI

5. Active substance abuse or dependence within the past 6 months, as determined by the MINI

6. Delirium (as measured by the CAM)

7. Current inpatient hospitalization

8. Current regular use of cannabinoid products (>1 use per month)

9. Positive urine screen for THC at the screening or baseline visit

10. Allergy to coconut

11. Participants taking strong inhibitors or inducers of CYP3A4 (e.g. fluconazole, fluoxetine, fluvoxamine, ticlopidine, St. John's Wort, etc.), CYP2C19 (ketoconazole, erythromycin, etc.), or anti-epileptic drugs

Endpoints (11)

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
6
Caregiver / quality of life
2
Safety / tolerability / PK
2
Global cognition
1

Global cognition

1 endpoint
Secondary/protocol endpoint

Week 8 MMSE total score compared to baseline MMSE total score

Time frame:longitudinal: screening/baseline and week8

Mini-Mental State Examination (MMSE)

categorical status, descriptive

Behavior / neuropsychiatric

6 endpoints
Primary/protocol endpoint

Total of clinician impression column on anxiety domain of the NPI-C

Time frame:Continuous, weeks 0-8

Neuropsychiatric Inventory (NPI)

descriptive

Secondary/protocol endpoint

Total score on the Generalized Anxiety Disorder 7 scale

Time frame:Continuous, week 0-8

descriptive

Secondary/protocol endpoint

Score on the confusion assessment method

Time frame:Continuous screening weeks 0-8, dichotomous

descriptive

Other/protocol endpoint

Total clinical impression column score on neuropsychiatric inventory agitation and aggression domains (NPI-C)

Time frame:Continuous, weeks 0-8

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Other/protocol endpoint

Total score of Cohen-Mansfield Inventory (CMAI)

Time frame:Continuous, weeks 0-8

change from baseline, improvement

Other/protocol endpoint

Stability of anxiety and agitation reduction using anxiety domain of NPI-C and GAD-7

Time frame:Months 3, 6, 9, and 12 of the optional follow-up phase

Neuropsychiatric Inventory (NPI)

descriptive

Caregiver / quality of life

2 endpoints
Other/protocol endpoint

Total Score of Zarit Caregiver Burden Interview

Time frame:Continuous, weeks 0-8

change from baseline, improvement

Other/protocol endpoint

Stability of caregiver burden reduction

Time frame:Months 3, 6, 9, and 12 of the optional follow-up phase

descriptive

Safety / tolerability / PK

2 endpoints
Secondary/protocol endpoint

Number of serious adverse events

Time frame:Continuous, weeks 0-8

event count, event

Secondary/protocol endpoint

Number and severity of side effects reported

Time frame:Continuous, weeks 0-8

event count, event

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.