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

Launched by MCLEAN HOSPITAL · Aug 29, 2019

Keywords

ClinConnect Summary

This clinical trial is studying a special solution containing cannabidiol (CBD), which is a compound found in cannabis, to see if it can help reduce anxiety and agitation in older adults who have mild cognitive impairment or mild to moderate Alzheimer's Disease. The trial will last for eight weeks and is open to individuals between the ages of 55 and 90 who have been diagnosed with Alzheimer's or mild cognitive impairment and experience significant anxiety.

To participate, individuals must have a score between 15 and 30 on a standard memory test and have a caregiver who can attend study visits. It's important that participants do not have serious medical conditions, recent substance abuse issues, or certain mental health disorders. Participants will take the CBD solution under the guidance of researchers and will be closely monitored throughout the study to assess its effects. If you're considering this trial, make sure to talk to your healthcare provider to see if it might be a good fit for you or your loved one.

Gender

ALL

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