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

• ClinicalTrials.gov Identifier: NCT04075435
• Recruitment Status: Recruiting
• First Posted: August 30, 2019
• Last Update Posted: January 18, 2023
• Sponsor: Mclean Hospital
• Collaborator: Spier Family Foundation
• Information provided by (Responsible Party): Staci Gruber, Ph.D., Mclean Hospital

Study Description

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 mild to moderate Alzheimer's Disease.

Condition or disease	Intervention/treatment	Phase
Alzheimer Disease; Anxiety; Agitation,Psychomotor	Drug: high CBD/low THC sublingual solution	Early Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 12 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: This is an open label trial; all participants will receive active drug.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Open-Label Trial of a Cannabidiol Solution for the Treatment of Behavioral Symptoms in Older Adults With Alzheimer's Dementia
• Actual Study Start Date: January 11, 2021
• Estimated Primary Completion Date: September 15, 2023
• Estimated Study Completion Date: September 15, 2023

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

1. Total score on the Generalized Anxiety Disorder 7 scale [ Time Frame: Continuous, week 0-8 ]
   Secondary Outcome Measure of anxiety reduction
2. Number of serious adverse events [ Time Frame: Continuous, weeks 0-8 ]
   Secondary Outcome Measure of safety defined by absence of serious adverse events
3. 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)
4. 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)
5. 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 Outcome Measures:

1. 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
2. Total score of Cohen-Mansfield Inventory (CMAI) [ Time Frame: Continuous, weeks 0-8 ]
   Exploratory measure to see reduction in agitation symptoms
3. Total Score of Zarit Caregiver Burden Interview [ Time Frame: Continuous, weeks 0-8 ]
   Exploratory downstream reduction in caregiver burden
4. 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
5. 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

Eligibility Criteria

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

Criteria

Inclusion Criteria:

1. Diagnosis of probable Alzheimer's Dementia via criteria from McKhann et al.
2. MMSE score of 15-24 (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

Contacts and Locations

Contacts

Contact: Rosain C Ozonsi, BS; 617-855-2511; rozonsi@mclean.harvard.edu

Contact: Rosemary Smith, BS; 617-855-2908; rsmith@mclean.harvard.edu

Locations

United States, Massachusetts

McLean Hospital; Recruiting

Belmont, Massachusetts, United States, 02478

Contact: Brent Forester, MD 617-855-3622 bforester@mclean.harvard.edu

Principal Investigator: Brent P Forester, MD

Principal Investigator: Staci Gruber, PhD

Sponsors and Collaborators

Mclean Hospital

Spier Family Foundation

Investigators

• Principal Investigator: Brent P Forester, MD, MSc; Mclean Hospital
• Principal Investigator: Staci Gruber, PhD; Mclean Hospital

More Information

• Responsible Party: Staci Gruber, Ph.D., Directory, Cognitive and Clinical Neuroimaging Core; Director, Marijuana Investigations for Neuroscientific Discovery (MIND), Mclean Hospital
• ClinicalTrials.gov Identifier: NCT04075435
• Other Study ID Numbers: 2019P002466
• First Posted: August 30, 2019
• Last Update Posted: January 18, 2023
• Last Verified: January 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Staci Gruber, Ph.D., Mclean Hospital:

cannabidiol; older adults

Additional relevant MeSH terms:

Alzheimer Disease; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Psychomotor Disorders; Dementia; Psychomotor Agitation; Behavioral Symptoms; Tauopathies; Dyskinesias; Neurologic Manifestations; Neurobehavioral Manifestations