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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04075435
Recruitment Status : Recruiting
First Posted : August 30, 2019
Last Update Posted : February 21, 2020
Sponsor:
Collaborator:
Spier Family Foundation
Information provided by (Responsible Party):
Brent Forester, Mclean Hospital

Tracking Information
First Submitted Date  ICMJE August 29, 2019
First Posted Date  ICMJE August 30, 2019
Last Update Posted Date February 21, 2020
Estimated Study Start Date  ICMJE March 1, 2020
Estimated Primary Completion Date November 1, 2021   (Final data collection date for primary outcome measure)
Current 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current 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
Original Secondary Outcome Measures  ICMJE Same as current
Current 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
Original Other Pre-specified Outcome Measures Same as current
 
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, ten week, clinical trial of a proprietary high CBD/low THC sublingual solution (20mg/ml CBD and 0.58mg/ml THC) 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
Coconut oil based solution of 20mg/ml CBD and 0.58mg/ml THC to be administered sublingually.
Study Arms  ICMJE All subjects
This arm will include all subjects, who will receive active drug in accordance with the following dosage schedule: for the first week of enrollment, the dose will be 0.5milliliters (mL) of the solution containing 20milligrams/milliliters (mg/mL) CBD and 0.58mg/ml THC twice daily (BID), for a daily total of 20mg CBD and 0.58mg THC. At the Week 1 visit, the dose will be increased to 1.0mL BID, for a daily total of 40mg CBD and 1.16mg THC. At the Week 4 visit, the study physician may increase the dose to 1.5mL BID, for a daily total of 60mg CBD and 1.74mg THC. This higher dose will be used if no clinical improvement is noted with the lower dose.
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 November 1, 2021
Estimated Primary Completion Date November 1, 2021   (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, or any personality disorder, as determined by the Mini International Neuropsychiatric Interview (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: Ellie Ash, BA 617-855-2589 eash@mclean.harvard.edu
Contact: Miranda Skurla, BS 617-855-3272 mskurla@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 Brent Forester, Mclean Hospital
Study Sponsor  ICMJE Mclean Hospital
Collaborators  ICMJE Spier Family Foundation
Investigators  ICMJE
Principal Investigator: Brent p Forester, MD, MSc Mclean Hospital
PRS Account Mclean Hospital
Verification Date February 2020

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