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Trial record 2 of 11 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

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.

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
Actual Study Start Date : January 11, 2021
Estimated Primary Completion Date : January 11, 2022
Estimated Study Completion Date : January 11, 2022


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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Total score on the Generalized Anxiety Disorder 7 scale [ Time Frame: Continuous, week 0-8 ]
    Secondary Outcome Measure of anxiety reduction

  2. Number of serious adverse events [ Time Frame: Continuous, weeks 0-8 ]
    Secondary Outcome Measure of safety defined by absence of serious adverse events

  3. 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)

  4. 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)

  5. 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


Other Outcome Measures:
  1. 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

  2. Total score of Cohen-Mansfield Inventory (CMAI) [ Time Frame: Continuous, weeks 0-8 ]
    Exploratory measure to see reduction in agitation symptoms

  3. Total Score of Zarit Caregiver Burden Interview [ Time Frame: Continuous, weeks 0-8 ]
    Exploratory downstream reduction in caregiver burden

  4. 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

  5. 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



Information from the National Library of Medicine

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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
Criteria

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

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 ClinicalTrials.gov identifier (NCT number): NCT04075435


Contacts
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Contact: Kaitlin McManus, BA 617-855-3192 kmcmanus@mclean.harvard.edu
Contact: Rosemary Smith, BS 617-855-2908 rsmith@mclean.harvard.edu

Locations
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United States, Massachusetts
McLean Hospital Recruiting
Belmont, Massachusetts, United States, 02478
Contact: Brent Forester, MD    617-855-3622    bforester@mclean.harvard.edu   
Principal Investigator: Brent P Forester, MD         
Principal Investigator: Staci Gruber, PhD         
Sponsors and Collaborators
Mclean Hospital
Spier Family Foundation
Investigators
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Principal Investigator: Brent P Forester, MD, MSc Mclean Hospital
Principal Investigator: Staci Gruber, PhD Mclean Hospital
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Responsible Party: Staci Gruber, Ph.D., Directory, Cognitive and Clinical Neuroimaging Core; Director, Marijuana Investigations for Neuroscientific Discovery (MIND), Mclean Hospital
ClinicalTrials.gov Identifier: NCT04075435    
Other Study ID Numbers: 2019P002466
First Posted: August 30, 2019    Key Record Dates
Last Update Posted: March 10, 2021
Last Verified: March 2021
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 Staci Gruber, Ph.D., Mclean Hospital:
cannabidiol
older adults
Additional relevant MeSH terms:
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Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Psychomotor Disorders
Dementia
Psychomotor Agitation
Behavioral Symptoms
Tauopathies
Dyskinesias
Neurologic Manifestations
Neurobehavioral Manifestations