INTERVENTIONALACTIVE NOT RECRUITINGNCT04075435
Open-Label Trial of a Cannabidiol Solution for the Treatment of Behavioral Symptoms in Older Adults With Mild Cognitive Impairment or Alzheimer's Dementia
This is an open label, eight week, clinical trial of a proprietary high CBD/low THC sublingual solution for the treatment of clinically significant anxiety and agitation in individuals with mild cognitive impairment (MCI) or mild to moderate Alzheimer's Disease (AD).
Locally preserved from ClinicalTrials.govOpen ClinicalTrials.gov↗last source update 2026-03-30
What this record can show
Protocol only - no registry results posted
This locally preserved record separates the registered protocol from source-reported registry results. Neither is a treatment recommendation.
Registry facts
Study at a glance
- Phase
- EARLY PHASE1
- Enrollment
- 12 (ESTIMATED)
- Start date
- 2021-01-11
- Sponsor
- Mclean Hospital
- Design
- NA · SINGLE GROUP · TREATMENT
- Locations
- 1
- Results record
- Not present in registry snapshot
Alzheimer DiseaseAnxietyAgitation,PsychomotorMild Cognitive Impairment (MCI) Due to Alzheimer's Diseasecannabidiololder adultsdementia
Linked local records
Related local records
Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.
Cannabinoids and active compounds
Medicines
No exact medicine-name link was found.
Interventions
What was registered
DRUGhigh CBD/low THC sublingual solution
Hemp derived solution to be administered sublingually twice daily.
Eligibility
Population and criteria
- Sex
- ALL
- Minimum age
- 55 Years
- Maximum age
- 90 Years
- Healthy volunteers
- Not 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
primary outcomes
primary measures
Total of clinician impression column on anxiety domain of the NPI-C
Time frame: Continuous, weeks 0-8
Measure of Anxiety Domain on the Neuropsychiatric Inventory-Clinician scale
secondary outcomes
secondary measures
Total score on the Generalized Anxiety Disorder 7 scale
Time frame: Continuous, week 0-8
Secondary Outcome Measure of anxiety reduction
Number of serious adverse events
Time frame: Continuous, weeks 0-8
Secondary Outcome Measure of safety defined by absence of serious adverse events
Week 8 MMSE total score compared to baseline MMSE total score
Time frame: longitudinal: screening/baseline and week8
Secondary Outcome Measure of safety as defined by lack of treatment emergent cognitive impairment as measured by the Mini Mental Status Exam (MMSE)
Score on the confusion assessment method
Time frame: Continuous screening weeks 0-8, dichotomous
Secondary Outcome Measure of safety defined as absence of treatment emergent delirium as measured by the Confusion Assessment Method (CAM)
Number and severity of side effects reported
Time frame: Continuous, weeks 0-8
Secondary Outcome Measure of safety defined as a low number of emergent somatic side effects as measured by the Medication Side Effects Questionnaire
other outcomes
other measures
Total clinical impression column score on neuropsychiatric inventory agitation and aggression domains (NPI-C)
Time frame: Continuous, weeks 0-8
Exploratory measure to see reduction in agitation and aggression symptoms
Total score of Cohen-Mansfield Inventory (CMAI)
Time frame: Continuous, weeks 0-8
Exploratory measure to see reduction in agitation symptoms
Total Score of Zarit Caregiver Burden Interview
Time frame: Continuous, weeks 0-8
Exploratory downstream reduction in caregiver burden
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
Exploratory investigation into the stability of anxiety reduction using the anxiety domain score on the NPI-C and the GAD-7 during the optional follow-up phase
Stability of caregiver burden reduction
Time frame: Months 3, 6, 9, and 12 of the optional follow-up phase
Exploratory investigation into reduction of caregiver burden using the Zarit Caregiver Burden Interview during the optional follow-up phase
Publications
Locally readable linked articles
0No exact PMID-linked public article is currently readable locally.
Snapshot provenance
- Snapshot
- c79569bc-12dc-403e-8461-051610d70e81
- Retrieved
- 11/09/2026, 14:54:12
- SHA-256
- fe514e6b391ad60c88f5fcc8deb4552524258c8ce352e3ce59d6957e88b6dafd