RecruitingEarly Phase 1NCT04075435

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

Sponsor

Mclean Hospital

Enrollment

12 participants

Start Date

Jan 11, 2021

Study Type

INTERVENTIONAL

Conditions

Anxiety Alzheimer Disease Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease Agitation,Psychomotor

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

Min Age: 55 YearsMax Age: 90 Years

Inclusion Criteria7

Diagnosis of probable Alzheimer's Dementia via criteria from McKhann et al., or MCI
MMSE score of 15-30 (inclusive)
Clinically significant degree of anxiety, as defined by a Clinical Impression total column score of ≥4 on the Anxiety domain of the NPI-C
A health care proxy available to sign consent on behalf of the participant (if applicable)
A caregiver who spends at least 10 hours per week with the subject who is able to attend all study visits
Participants and their study partner must be fluent in English
Must be 55-90 years old (inclusive)

Exclusion Criteria11

Serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease, which might confound assessment of safety outcomes.
Seizure disorder
Lifetime diagnosis of bipolar disorder, schizophrenia, schizoaffective disorder, as determined by the MINI
Current episode of major depression, as determined by the MINI
Active substance abuse or dependence within the past 6 months, as determined by the MINI
Delirium (as measured by the CAM)
Current inpatient hospitalization
Current regular use of cannabinoid products (\>1 use per month)
Positive urine screen for THC at the screening or baseline visit
Allergy to coconut
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