ACTIVE_NOT_RECRUITING

Life's End Benefits of cannaBidiol and tetrahYdrocannabinol

Conditions

Agitation Dementia hospice care-eligible agitation and dementia (HAD)alzheimer's disease alzheimer's disease dementia alzheimer's disease and related dementias

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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 a multicenter randomized double-blind placebo-controlled Phase 2 study of an oral combination of tetrahydrocannabinol (THC) and cannabidiol (CBD) compared to placebo over 12 weeks. This study is designed to test the hypothesis that treatment with an oral combination of THC/CBD will reduce agitation hospice care-eligible patients with agitation and dementia as measured by the Cohen Mansfield Agitation Inventory (CMAI) when compared to placebo at 2 weeks. This study will enroll approximately 120 participants of any gender at least 40 years of age who are hospice care-eligible with agitation and dementia (HAD). Participants will be randomized (50:50) to either active study drug (T2:C100) or placebo. The double-blind period of this study is 12 weeks. A 12 week optional open-label extension will be offered to participants who complete the double-blind period.

Official Title

Life's End Benefits of cannaBidiol and tetrahYdrocannabinol (LiBBY)

Quick Facts

Study Start:2023-12-18

Study Completion:2026-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05644262

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:40 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Provision of signed and dated informed consent from participant or legally authorized representative. 2. Person of any sex/gender 40 years of age or older. 3. Ability to take or be administered liquid medication. 4. Meets DSM-V criteria for Major Neurocognitive Disorder. 5. Current clinically significant agitation as demonstrated by an NPI-agitation subscale of 4 or above at Screening. 6. Meets at least one of the following requirements: 1. Currently enrolled in out-patient or in-patient hospice care. 2. Stage 6d on the Functional Assessment Staging Test (FAST). 3. Score of 12 or more according to the Advanced Dementia Prognostic Tool (ADEPT) as implemented by the Mitchell Index. 7. Willing to agree not to use cannabinoids in any form (e.g., topically applied, ingested, inhaled, or other form of administration), other than the trial medication, during the first 12 weeks of the study. 8. Has a third-party clinician (e.g., hospice, palliative care, PCP) who is responsible for medical management of the participant outside the study. 9. In the opinion of the investigator, resides in an environment suitable to conduct a clinical trial (i.e., study intervention can be administered and concomitant medication use can be accurately documented). 10. In the opinion of the site PI, has a study partner (may be paid or unpaid caregiver) able and willing to provide accurate information about the participant, oversee the administration of study drug, and participate in study visits and informant-based assessments (usually requires at least 5 hours of contact per week). 11. As assessed by investigator, participant is likely to be able to comply with the protocol for a minimum of 2 weeks.	1. Use of cannabinoids or other forms of marijuana in the 3 weeks prior to Baseline, as based on self-report. 2. Suspected or known allergic reactions, adverse reactions, or hypersensitivity to cannabinoids and/or components (e.g., (\<specify oil to be used in final formulation, e.g.: coconut oil; sesame oil\>) of the study drug (T2:C100 or placebo). 3. Treatment with another investigational drug or other investigational intervention within the previous 30 days or five half-lives of the investigational product, whichever is longer. 4. Any condition, which in the opinion of the site PI, Data and Coordinating Center, regulatory sponsor, or Project Lead/Protocol PI, makes the participant unsuitable for inclusion.

Inclusion Criteria

Exclusion Criteria

1. Provision of signed and dated informed consent from participant or legally authorized representative.
2. Person of any sex/gender 40 years of age or older.
3. Ability to take or be administered liquid medication.
4. Meets DSM-V criteria for Major Neurocognitive Disorder.
5. Current clinically significant agitation as demonstrated by an NPI-agitation subscale of 4 or above at Screening.
6. Meets at least one of the following requirements:
1. Currently enrolled in out-patient or in-patient hospice care.
2. Stage 6d on the Functional Assessment Staging Test (FAST).
3. Score of 12 or more according to the Advanced Dementia Prognostic Tool (ADEPT) as implemented by the Mitchell Index.
7. Willing to agree not to use cannabinoids in any form (e.g., topically applied, ingested, inhaled, or other form of administration), other than the trial medication, during the first 12 weeks of the study.
8. Has a third-party clinician (e.g., hospice, palliative care, PCP) who is responsible for medical management of the participant outside the study.
9. In the opinion of the investigator, resides in an environment suitable to conduct a clinical trial (i.e., study intervention can be administered and concomitant medication use can be accurately documented).
10. In the opinion of the site PI, has a study partner (may be paid or unpaid caregiver) able and willing to provide accurate information about the participant, oversee the administration of study drug, and participate in study visits and informant-based assessments (usually requires at least 5 hours of contact per week).
11. As assessed by investigator, participant is likely to be able to comply with the protocol for a minimum of 2 weeks.

1. Use of cannabinoids or other forms of marijuana in the 3 weeks prior to Baseline, as based on self-report.
2. Suspected or known allergic reactions, adverse reactions, or hypersensitivity to cannabinoids and/or components (e.g., (\<specify oil to be used in final formulation, e.g.: coconut oil; sesame oil\>) of the study drug (T2:C100 or placebo).
3. Treatment with another investigational drug or other investigational intervention within the previous 30 days or five half-lives of the investigational product, whichever is longer.
4. Any condition, which in the opinion of the site PI, Data and Coordinating Center, regulatory sponsor, or Project Lead/Protocol PI, makes the participant unsuitable for inclusion.

Contacts and Locations

Principal Investigator

Paul Aisen, MD

STUDY_DIRECTOR

Alzheimer's Therapeutic Research Institute

Jacobo Mintzer, MD

PRINCIPAL_INVESTIGATOR

Ralph H. Johnson Veterans Affairs Medical Center (VAMC)

Brigid Reynolds, NP

PRINCIPAL_INVESTIGATOR

Georgetown University

Study Locations (Sites)

Georgetown University

Washington D.C., District of Columbia, 20007

United States

Howard University

Washington D.C., District of Columbia, 20059

United States

Melgar-Caro Medcenter and Community Research (MCMCR)

Miami, Florida, 33145

United States

University of South Florida

Tampa, Florida, 33612

United States

University of Kentucky

Lexington, Kentucky, 40504

United States

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808

United States

University of Maryland

Baltimore, Maryland, 21201

United States

Case Western Reserve University

Beachwood, Ohio, 44122

United States

Ralph H. Johnson VA Medical Center

Charleston, South Carolina, 29401

United States

Vanderbilt University Medical Center Center for Cognitive Medicine

Nashville, Tennessee, 37212

United States

Collaborators and Investigators

Sponsor: University of Southern California

Paul Aisen, MD, STUDY_DIRECTOR, Alzheimer's Therapeutic Research Institute
Jacobo Mintzer, MD, PRINCIPAL_INVESTIGATOR, Ralph H. Johnson Veterans Affairs Medical Center (VAMC)
Brigid Reynolds, NP, PRINCIPAL_INVESTIGATOR, Georgetown University

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 Date2023-12-18

Study Completion Date2026-03

Study Record Updates

Study Start Date2023-12-18

Study Completion Date2026-03

Terms related to this study

Keywords Provided by Researchers

agitation
hospice care-eligible
dementia
agitation and dementia (HAD)
alzheimer's disease
alzheimer's disease dementia
alzheimer's disease and related dementias

Additional Relevant MeSH Terms

Agitation
Dementia