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

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).

Study Overview

• Status: Recruiting
• Conditions: Anxiety; Alzheimer Disease; Agitation,Psychomotor
• Intervention / Treatment: Drug: high CBD/low THC sublingual solution

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Rosain C Ozonsi, BS; Phone Number: 617-855-2511; Email: rozonsi@mclean.harvard.edu
• Study Contact Backup: Name: Rosemary Smith, MS; Phone Number: 617-855-2908; Email: rsmith@mclean.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Belmont, Massachusetts, United States, 02478
      • Recruiting
      • McLean Hospital
      • Principal Investigator: Staci Gruber, PhD
      • Contact: Ipsit V Vahia, MD; Phone Number: 617-855-3291; Email: ivahia@mclean.harvard.edu
      • Principal Investigator: Ipsit Vahia, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 60-90 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: All subjects; This arm will include all subjects, individuals will administer a high CBD, low THC full spectrum sublingual solution twice daily on a variable dosing schedule.	Drug: high CBD/low THC sublingual solution; Hemp derived solution to be administered sublingually twice daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total of clinician impression column on anxiety domain of the NPI-C	Measure of Anxiety Domain on the Neuropsychiatric Inventory-Clinician scale	Continuous, weeks 0-8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total score on the Generalized Anxiety Disorder 7 scale	Secondary Outcome Measure of anxiety reduction	Continuous, week 0-8
Number of serious adverse events	Secondary Outcome Measure of safety defined by absence of serious adverse events	Continuous, weeks 0-8
Week 8 MMSE total score compared to baseline MMSE total score	Secondary Outcome Measure of safety as defined by lack of treatment emergent cognitive impairment as measured by the Mini Mental Status Exam (MMSE)	longitudinal: screening/baseline and week8
Score on the confusion assessment method	Secondary Outcome Measure of safety defined as absence of treatment emergent delirium as measured by the Confusion Assessment Method (CAM)	Continuous screening weeks 0-8, dichotomous
Number and severity of side effects reported	Secondary Outcome Measure of safety defined as a low number of emergent somatic side effects as measured by the Medication Side Effects Questionnaire	Continuous, weeks 0-8

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total clinical impression column score on neuropsychiatric inventory agitation and aggression domains (NPI-C)	Exploratory measure to see reduction in agitation and aggression symptoms	Continuous, weeks 0-8
Total score of Cohen-Mansfield Inventory (CMAI)	Exploratory measure to see reduction in agitation symptoms	Continuous, weeks 0-8
Total Score of Zarit Caregiver Burden Interview	Exploratory downstream reduction in caregiver burden	Continuous, weeks 0-8
Stability of anxiety and agitation reduction using anxiety domain of NPI-C and GAD-7	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	Months 3, 6, 9, and 12 of the optional follow-up phase
Stability of caregiver burden reduction	Exploratory investigation into reduction of caregiver burden using the Zarit Caregiver Burden Interview during the optional follow-up phase	Months 3, 6, 9, and 12 of the optional follow-up phase

Collaborators and Investigators

• Sponsor: Mclean Hospital
• Collaborators: Spier Family Foundation
• Investigators: Principal Investigator: Staci Gruber, PhD, McLean Hospital; Principal Investigator: Ipsit V Vahia, MD, McLean Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2021
• Primary Completion (Estimated): September 15, 2024
• Study Completion (Estimated): September 15, 2024

Study Registration Dates

• First Submitted: August 29, 2019
• First Submitted That Met QC Criteria: August 29, 2019
• First Posted (Actual): August 30, 2019

Study Record Updates

• Last Update Posted (Actual): March 8, 2024
• Last Update Submitted That Met QC Criteria: March 7, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: older adults; cannabidiol
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurocognitive Disorders; Neurodegenerative Diseases; Dyskinesias; Psychomotor Disorders; Tauopathies; Cognition Disorders; Aberrant Motor Behavior in Dementia; Psychomotor Agitation; Dementia; Alzheimer Disease; Cognitive Dysfunction; Behavioral Symptoms
• Other Study ID Numbers: 2019P002466

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No