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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. Identifier: NCT04075435
Recruitment Status : Recruiting
First Posted : August 30, 2019
Last Update Posted : February 21, 2020
Spier Family Foundation
Information provided by (Responsible Party):
Brent Forester, Mclean Hospital

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.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Anxiety Agitation,Psychomotor Drug: high CBD/low THC sublingual solution Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
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
Official Title: Open-Label Trial of a Cannabidiol Solution for the Treatment of Behavioral Symptoms in Older Adults With Alzheimer's Dementia
Estimated Study Start Date : March 1, 2020
Estimated Primary Completion Date : November 1, 2021
Estimated Study Completion Date : November 1, 2021

Arm Intervention/treatment
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.
Drug: high CBD/low THC sublingual solution
Coconut oil based solution of 20mg/ml CBD and 0.58mg/ml THC to be administered sublingually.

Primary Outcome Measures :
  1. 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

  2. Total score on the Generalized Anxiety Disorder 7 scale [ Time Frame: Continuous, week 0-10 ]
    Total score on the Generalized Anxiety Disorder 7 scale

Secondary Outcome Measures :
  1. Safety defined by absence of serious adverse events [ Time Frame: Continuous, weeks 0-10 ]
    Number of serious adverse events

  2. 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

  3. 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

Other Outcome Measures:
  1. Reduction in Agitation Symptoms [ Time Frame: Continuous, weeks 0-10 ]
    Total clinical impression column score on neuropsychiatric inventory agitation domain (NPI-C)

  2. Reduction in Agitation Symptoms [ Time Frame: Continuous, weeks 0-10 ]
    Total score of Cohen-Mansfield Inventory (CMAI)

  3. Reduction in Caregiver Burden [ Time Frame: Continuous, weeks 0-10 ]
    Total Score of Zarit Caregiver Burden Interview

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   60 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04075435

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Contact: Ellie Ash, BA 617-855-2589
Contact: Miranda Skurla, BS 617-855-3272

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United States, Massachusetts
McLean Hospital Recruiting
Belmont, Massachusetts, United States, 02478
Contact: Brent Forester, MD    617-855-3622   
Principal Investigator: Brent P Forester, MD         
Sponsors and Collaborators
Mclean Hospital
Spier Family Foundation
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Principal Investigator: Brent p Forester, MD, MSc Mclean Hospital
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Responsible Party: Brent Forester, Chief, Division of Geriatric Psychiatry, Mclean Hospital Identifier: NCT04075435    
Other Study ID Numbers: 2019P002466
First Posted: August 30, 2019    Key Record Dates
Last Update Posted: February 21, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Brent Forester, Mclean Hospital:
older adults
Additional relevant MeSH terms:
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Alzheimer Disease
Psychomotor Agitation
Behavioral Symptoms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Neurologic Manifestations
Psychomotor Disorders
Neurobehavioral Manifestations