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

Running, not enrolling · Early Phase 1

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

In brief

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).

Key facts

Study ID

NCT04075435

Run by

Mclean Hospital

People needed

12

Starts

2021-01-11

Expected to finish

2026-12-01

Last updated by the study team

2026-03-30

Who can join

Age: 55 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• McLean Hospital — Belmont, Massachusetts, United States

Full record on ClinicalTrials.gov

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