Clinical trial NCT04075435: Cannabidiol Solution for the Treatment of Behavioral Symptoms in Older Adults With Mild Cognitive Impairment or Alzheimer's Dementia
Official title: Open-Label Trial of a Cannabidiol Solution for the Treatment of Behavioral Symptoms in Older Adults With Mild Cognitive Impairment or Alzheimer's Dementia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Alzheimer Disease
Anxiety
Agitation,Psychomotor
Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease
Keywords: cannabidiol
older adults
dementia
Lead sponsor: Mclean Hospital
Sponsor class: OTHER
Collaborators: name: Spier Family Foundation
First posted: 2019-08-30
Enrollment: 12
Sex: ALL
Minimum age (years): 55
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is an open label trial; all participants will receive active drug.
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: 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:
measure: Total of clinician impression column on anxiety domain of the NPI-C
timeFrame: Continuous, weeks 0-8
Secondary outcomes:
measure: Total score on the Generalized Anxiety Disorder 7 scale
timeFrame: Continuous, week 0-8
measure: Number of serious adverse events
timeFrame: Continuous, weeks 0-8
measure: Week 8 MMSE total score compared to baseline MMSE total score
timeFrame: longitudinal: screening/baseline and week8
measure: Score on the confusion assessment method
timeFrame: Continuous screening weeks 0-8, dichotomous
measure: Number and severity of side effects reported
timeFrame: Continuous, weeks 0-8
Other outcomes:
measure: Total clinical impression column score on neuropsychiatric inventory agitation and aggression domains (NPI-C)
timeFrame: Continuous, weeks 0-8
measure: Total score of Cohen-Mansfield Inventory (CMAI)
timeFrame: Continuous, weeks 0-8
measure: Total Score of Zarit Caregiver Burden Interview
timeFrame: Continuous, weeks 0-8
measure: Stability of anxiety and agitation reduction using anxiety domain of NPI-C and GAD-7
timeFrame: Months 3, 6, 9, and 12 of the optional follow-up phase
measure: Stability of caregiver burden reduction
timeFrame: Months 3, 6, 9, and 12 of the optional follow-up phase
Locations:
city: Belmont
country: United States
facility: McLean Hospital
state: Massachusetts
Study officials:
affiliation: Mclean Hospital
name: Staci Gruber, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mclean Hospital
name: Ipsit V Vahia, MD
role: PRINCIPAL_INVESTIGATOR
References: