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

NCT ID: NCT04075435

Last Updated: 2025-05-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-11
• Study Completion Date: 2026-01-16

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).

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

high CBD/low THC sublingual solution

Intervention Type: DRUG

Hemp derived solution to be administered sublingually twice daily.

Interventions

high CBD/low THC sublingual solution

Hemp derived solution to be administered sublingually twice daily.

Intervention Type: DRUG

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

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Spier Family Foundation

UNKNOWN

Sponsor Role: collaborator

Mclean Hospital

OTHER

Sponsor Role: lead

Responsible Party

Staci Gruber, Ph.D.

Directory, Cognitive and Clinical Neuroimaging Core; Director, Marijuana Investigations for Neuroscientific Discovery (MIND)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Staci Gruber, PhD

Role: PRINCIPAL_INVESTIGATOR

Mclean Hospital

Ipsit V Vahia, MD

Role: PRINCIPAL_INVESTIGATOR

Mclean Hospital

Locations

McLean Hospital

Belmont, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Emily H Kim, BS

Role: CONTACT

ekim76@mgb.org

617-855-2562

Rosemary Smith, MS

Role: CONTACT

rsmith@mclean.harvard.edu

617-855-2908

Facility Contacts

Ipsit V Vahia, MD

Role: primary

ivahia@mclean.harvard.edu

617-855-3291

Other Identifiers

2019P002466

Identifier Type: -

Identifier Source: org_study_id