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

NCT04075435 | Active Not Recruiting Early Phase 1 FDA Drug

• 1 other identifier: 2019P002466
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

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

Keywords

cannabidiol; older adults; dementia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Total score on the Generalized Anxiety Disorder 7 scale

  Continuous, week 0-8

• Number of serious adverse events

  Continuous, weeks 0-8

• Week 8 MMSE total score compared to baseline MMSE total score

  longitudinal: screening/baseline and week8

• Score on the confusion assessment method

  Continuous screening weeks 0-8, dichotomous

• Number and severity of side effects reported

  Continuous, weeks 0-8

Other Outcomes (5)

• Total clinical impression column score on neuropsychiatric inventory agitation and aggression domains (NPI-C)

  Continuous, weeks 0-8

• Total score of Cohen-Mansfield Inventory (CMAI)

  Continuous, weeks 0-8

• Total Score of Zarit Caregiver Burden Interview

  Continuous, weeks 0-8

Study Arms (1)

All subjects

OTHER

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

Interventions

high CBD/low THC sublingual solution DRUG

Hemp derived solution to be administered sublingually twice daily.

All subjects

Eligibility Criteria

• Age: 55 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Spier Family Foundation: collaborator
• Mclean Hospital: lead

Study Sites (1)

McLean Hospital

Belmont, Massachusetts, 02478, United States

Location

MeSH Terms

Conditions

Alzheimer Disease; Anxiety Disorders; Psychomotor Agitation; Cognitive Dysfunction; Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Dyskinesias; Neurologic Manifestations; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior; Cognition Disorders

Study Officials

• Staci Gruber, PhD

  Mclean Hospital

  PRINCIPAL INVESTIGATOR

• Ipsit V Vahia, MD

  Mclean Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Directory, Cognitive and Clinical Neuroimaging Core; Director, Marijuana Investigations for Neuroscientific Discovery (MIND)

Model Details: This is an open label trial; all participants will receive active drug.

Study Record Dates

• First Submitted: August 29, 2019
• First Posted: August 30, 2019
• Study Start: January 11, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)