← Trials/Trial dossier/NCT04075435
CBD
Active not recruitingPhase EARLY_1Cannabidiol 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
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 disease•MMSE 15-30•Study 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
Timeline
Milestones
Assets
Drug assets
Study populations
Who this study enrolls
Eligibility
Who can enroll
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
Global cognition
1 endpointWeek 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 endpointsTotal of clinician impression column on anxiety domain of the NPI-C
Time frame:Continuous, weeks 0-8
Neuropsychiatric Inventory (NPI)
descriptive
Total score on the Generalized Anxiety Disorder 7 scale
Time frame:Continuous, week 0-8
descriptive
Score on the confusion assessment method
Time frame:Continuous screening weeks 0-8, dichotomous
descriptive
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
Total score of Cohen-Mansfield Inventory (CMAI)
Time frame:Continuous, weeks 0-8
change from baseline, improvement
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 endpointsTotal Score of Zarit Caregiver Burden Interview
Time frame:Continuous, weeks 0-8
change from baseline, improvement
Stability of caregiver burden reduction
Time frame:Months 3, 6, 9, and 12 of the optional follow-up phase
descriptive
Safety / tolerability / PK
2 endpointsNumber of serious adverse events
Time frame:Continuous, weeks 0-8
event count, event
Number and severity of side effects reported
Time frame:Continuous, weeks 0-8
event count, event
Provenance
Sources
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.