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Trial record 2 of 12 for:    cbd | Alzheimer Disease

Cannabidiol Solution for the Treatment of Behavioral Symptoms in Older Adults With Alzheimer's Dementia (CBD)

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ClinicalTrials.gov Identifier: NCT04075435
Recruitment Status : Recruiting
First Posted : August 30, 2019
Last Update Posted : March 10, 2021
Sponsor:
Collaborator:
Spier Family Foundation
Information provided by (Responsible Party):
Staci Gruber, Ph.D., Mclean Hospital

Tracking Information
First Submitted Date  ICMJE August 29, 2019
First Posted Date  ICMJE August 30, 2019
Last Update Posted Date March 10, 2021
Actual Study Start Date  ICMJE January 11, 2021
Estimated Primary Completion Date January 11, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 26, 2021)
Total of clinician impression column on anxiety domain of the NPI-C [ Time Frame: Continuous, weeks 0-8 ]
Measure of Anxiety Domain on the Neuropsychiatric Inventory-Clinician scale
Original Primary Outcome Measures  ICMJE
 (submitted: August 29, 2019)
  • Anxiety Domain on the Neuropsychiatric Inventory-Clinician scale [ Time Frame: Continuous, weeks 0-10 ]
    Total of clinician impression column on anxiety domain of the NPI-C
  • Total score on the Generalized Anxiety Disorder 7 scale [ Time Frame: Continuous, week 0-10 ]
    Total score on the Generalized Anxiety Disorder 7 scale
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 26, 2021)
  • Total score on the Generalized Anxiety Disorder 7 scale [ Time Frame: Continuous, week 0-8 ]
    Secondary Outcome Measure of anxiety reduction
  • Number of serious adverse events [ Time Frame: Continuous, weeks 0-8 ]
    Secondary Outcome Measure of safety defined by absence of serious adverse events
  • Week 8 MMSE total score compared to baseline MMSE total score [ Time Frame: longitudinal: screening/baseline and week8 ]
    Secondary Outcome Measure of safety as defined by lack of treatment emergent cognitive impairment as measured by the Mini Mental Status Exam (MMSE)
  • Score on the confusion assessment method [ Time Frame: Continuous screening weeks 0-8, dichotomous ]
    Secondary Outcome Measure of safety defined as absence of treatment emergent delirium as measured by the Confusion Assessment Method (CAM)
  • Number and severity of side effects reported [ Time Frame: Continuous, weeks 0-8 ]
    Secondary Outcome Measure of safety defined as a low number of emergent somatic side effects as measured by the Medication Side Effects Questionnaire
Original Secondary Outcome Measures  ICMJE
 (submitted: August 29, 2019)
  • Safety defined by absence of serious adverse events [ Time Frame: Continuous, weeks 0-10 ]
    Number of serious adverse events
  • Safety as defined by lack of treatment emergent cognitive impairment as measured by the Mini Mental Status Exam (MMSE) [ Time Frame: longitudinal: week 0,10 ]
    Week 10 MMSE total score compared to baseline MMSE total score
  • Safety defined as absence of treatment emergent delirium as measured by the Confusion Assessment Method (CAM) [ Time Frame: Continuous, weeks 0-10 ]
    Score on confusion assessment method
Current Other Pre-specified Outcome Measures
 (submitted: February 26, 2021)
  • Total clinical impression column score on neuropsychiatric inventory agitation and aggression domains (NPI-C) [ Time Frame: Continuous, weeks 0-8 ]
    Exploratory measure to see reduction in agitation and aggression symptoms
  • Total score of Cohen-Mansfield Inventory (CMAI) [ Time Frame: Continuous, weeks 0-8 ]
    Exploratory measure to see reduction in agitation symptoms
  • Total Score of Zarit Caregiver Burden Interview [ Time Frame: Continuous, weeks 0-8 ]
    Exploratory downstream reduction in caregiver burden
  • Stability of anxiety and agitation reduction using anxiety domain of NPI-C and GAD-7 [ Time Frame: Months 3, 6, 9, and 12 of the optional follow-up phase ]
    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
  • Stability of caregiver burden reduction [ Time Frame: Months 3, 6, 9, and 12 of the optional follow-up phase ]
    Exploratory investigation into reduction of caregiver burden using the Zarit Caregiver Burden Interview during the optional follow-up phase
Original Other Pre-specified Outcome Measures
 (submitted: August 29, 2019)
  • Reduction in Agitation Symptoms [ Time Frame: Continuous, weeks 0-10 ]
    Total clinical impression column score on neuropsychiatric inventory agitation domain (NPI-C)
  • Reduction in Agitation Symptoms [ Time Frame: Continuous, weeks 0-10 ]
    Total score of Cohen-Mansfield Inventory (CMAI)
  • Reduction in Caregiver Burden [ Time Frame: Continuous, weeks 0-10 ]
    Total Score of Zarit Caregiver Burden Interview
 
Descriptive Information
Brief Title  ICMJE Cannabidiol Solution for the Treatment of Behavioral Symptoms in Older Adults With Alzheimer's Dementia
Official Title  ICMJE Open-Label Trial of a Cannabidiol Solution for the Treatment of Behavioral Symptoms in Older Adults With Alzheimer's Dementia
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 mild to moderate Alzheimer's Disease.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
This is an open label trial; all participants will receive active drug.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Alzheimer Disease
  • Anxiety
  • Agitation,Psychomotor
Intervention  ICMJE Drug: high CBD/low THC sublingual solution
Hemp derived solution to be administered sublingually twice daily.
Study Arms  ICMJE 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.
Intervention: Drug: high CBD/low THC sublingual solution
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 29, 2019)
12
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 11, 2022
Estimated Primary Completion Date January 11, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Diagnosis of probable Alzheimer's Dementia via criteria from McKhann et al.
  2. MMSE score of 15-24 (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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Kaitlin McManus, BA 617-855-3192 kmcmanus@mclean.harvard.edu
Contact: Rosemary Smith, BS 617-855-2908 rsmith@mclean.harvard.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04075435
Other Study ID Numbers  ICMJE 2019P002466
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Staci Gruber, Ph.D., Mclean Hospital
Study Sponsor  ICMJE Mclean Hospital
Collaborators  ICMJE Spier Family Foundation
Investigators  ICMJE
Principal Investigator: Brent P Forester, MD, MSc Mclean Hospital
Principal Investigator: Staci Gruber, PhD Mclean Hospital
PRS Account Mclean Hospital
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP