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

Anxiety Clinical Trial

— CBD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04075435
• Other study ID #: 2019P002466
• Status: Recruiting
• Phase: Early Phase 1
• Start date: January 11, 2021
• Est. completion date: September 15, 2024

Study information

• Verified date: March 2024
• Source: Mclean Hospital
• Contact: Rosain C Ozonsi, BS
• Phone: 617-855-2511
• Email: rozonsi[@]mclean.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: September 15, 2024
• Est. primary completion date: September 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 90 Years

Eligibility

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 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

Related Conditions & MeSH terms

• Agitation,Psychomotor
• Alzheimer Disease
• Anxiety
• Behavioral Symptoms
• Cognitive Dysfunction
• Dementia
• Psychomotor Agitation

Intervention

Drug:
• high CBD/low THC sublingual solution
Hemp derived solution to be administered sublingually twice daily.

Locations

Country	Name	City	State
United States	McLean Hospital	Belmont	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Mclean Hospital	Spier Family Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Total clinical impression column score on neuropsychiatric inventory agitation and aggression domains (NPI-C)	Exploratory measure to see reduction in agitation and aggression symptoms	Continuous, weeks 0-8
Other	Total score of Cohen-Mansfield Inventory (CMAI)	Exploratory measure to see reduction in agitation symptoms	Continuous, weeks 0-8
Other	Total Score of Zarit Caregiver Burden Interview	Exploratory downstream reduction in caregiver burden	Continuous, weeks 0-8
Other	Stability of anxiety and agitation reduction using anxiety domain of NPI-C and GAD-7	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	Months 3, 6, 9, and 12 of the optional follow-up phase
Other	Stability of caregiver burden reduction	Exploratory investigation into reduction of caregiver burden using the Zarit Caregiver Burden Interview during the optional follow-up phase	Months 3, 6, 9, and 12 of the optional follow-up phase
Primary	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	Total score on the Generalized Anxiety Disorder 7 scale	Secondary Outcome Measure of anxiety reduction	Continuous, week 0-8
Secondary	Number of serious adverse events	Secondary Outcome Measure of safety defined by absence of serious adverse events	Continuous, weeks 0-8
Secondary	Week 8 MMSE total score compared to baseline MMSE total score	Secondary Outcome Measure of safety as defined by lack of treatment emergent cognitive impairment as measured by the Mini Mental Status Exam (MMSE)	longitudinal: screening/baseline and week8
Secondary	Score on the confusion assessment method	Secondary Outcome Measure of safety defined as absence of treatment emergent delirium as measured by the Confusion Assessment Method (CAM)	Continuous screening weeks 0-8, dichotomous
Secondary	Number and severity of side effects reported	Secondary Outcome Measure of safety defined as a low number of emergent somatic side effects as measured by the Medication Side Effects Questionnaire	Continuous, weeks 0-8