RECRUITING

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

Conditions

Alzheimer Disease Anxiety Agitation,Psychomotor cannabidiol older adults

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

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

Quick Facts

Study Start:2021-01-11

Study Completion:2025-07-16

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04075435

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:55 Years to 90 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 55-90 years old (inclusive)	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

Inclusion Criteria

Exclusion 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 55-90 years old (inclusive)

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

Contacts and Locations

Study Contact

Rosain C Ozonsi, BS

CONTACT

617-855-2511

rozonsi@mclean.harvard.edu

Rosemary Smith, MS

CONTACT

617-855-2908

rsmith@mclean.harvard.edu

Principal Investigator

Staci Gruber, PhD

PRINCIPAL_INVESTIGATOR

Mclean Hospital

Ipsit V Vahia, MD

PRINCIPAL_INVESTIGATOR

Mclean Hospital

Study Locations (Sites)

McLean Hospital

Belmont, Massachusetts, 02478

United States

Collaborators and Investigators

Sponsor: Mclean Hospital

Staci Gruber, PhD, PRINCIPAL_INVESTIGATOR, Mclean Hospital
Ipsit V Vahia, MD, PRINCIPAL_INVESTIGATOR, Mclean Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-01-11

Study Completion Date2025-07-16

Study Record Updates

Study Start Date2021-01-11

Study Completion Date2025-07-16

Terms related to this study

Keywords Provided by Researchers

cannabidiol
older adults

Additional Relevant MeSH Terms

Alzheimer Disease
Anxiety
Agitation,Psychomotor