Life's End Benefits of cannaBidiol and tetrahYdrocannabinol

NCT05644262 | Active Not Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: ATRI-007R01AG068324R01AG095004
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 10

Brief Summary

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.

Conditions

Agitation; Dementia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in agitation as measured by the Cohen-Mansfield Agitation Inventory (CMAI) at 2 weeks

  The Cohen-Mansfield Agitation Inventory (CMAI) assesses the average frequency of manifestations of agitated behaviors in elderly persons over a 1-week period. The CMAI is a questionnaire consisting of 29 agitated behaviors, each rated on a 7-point frequency scale. In addition to the frequency of each behavior, informants/caregivers will be asked to use a 5-point scale to rate the disruptiveness of each behavior. For this study, the CMAI will target behaviors observed by knowledgeable informants/informed caregivers. Expanded descriptions of the behaviors will be provided to the informant/caregiver to be used as a reference during the interview.

  Baseline, Day 7 and Day 14

Secondary Outcomes (2)

• Change from Baseline in agitation as measured by the Cohen-Mansfield Agitation Inventory (CMAI) at 12 weeks

  Baseline, Day 7, Day 14, Week 4, Week 8 and Week 12

• Clinical Global Impression of Change in Behavior (CGIC-B)

  Baseline, Day 7, Day 14, Week 4, Week 8 and Week 12

Study Arms (2)

T2:C100

EXPERIMENTAL

Drug: T2:C100

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

T2:C100 DRUG

The active study intervention, T2:C100, is an oral combination of tetrahydrocannabinol (THC) and cannabidiol (CBD) in a digestible oil. T2:C100 is a full spectrum oral solution with five non-reactive ingredients: delta-9-tetrahydrocannabinol (THC), cannabidiol (CBD), a pharmaceutical grade medium chain triglyceride (MCT) oil, and two flavoring agents (lemon and peppermint). During the double-blind treatment period, participants will receive 1mL study drug (T2:C100) twice daily for Baseline - Day 7 (approximately 1 week), and then will increase to 2mL study drug twice for the remainder of the double-blind treatment period (Day 7 - Week 12 (approximately 11 weeks)). Participants who enter the Open Label Extension will receive 1mL study drug (T2:C100) twice daily for Week 12 - Week 13 (approximately 1 week), and will then increase to 2mL study drug twice daily for the remainder of the Open Label Extension (Week 13 - Week 26 (approximately 23 weeks)).

Also known as: TRC/CBD oral combination

T2:C100

Placebo DRUG

Matching placebo in a digestible oil. The placebo contains only three non-reactive ingredients: medium chain triglyceride (MCT) oil and two flavoring agents (lemon and peppermint). During the double-blind treatment period, participants will receive 1mL placebo twice daily for Baseline - Day 7 (approximately 1 week), and then will increase to 2mL placebo twice for the remainder of the double-blind treatment period (Day 7 - Week 12 (approximately 11 weeks)).

Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of signed and dated informed consent from participant or legally authorized representative.
• Person of any sex/gender 40 years of age or older.
• Ability to take or be administered liquid medication.
• Meets DSM-V criteria for Major Neurocognitive Disorder.
• Current clinically significant agitation as demonstrated by an NPI-agitation subscale of 4 or above at Screening.
• Meets at least one of the following requirements:
• Currently enrolled in out-patient or in-patient hospice care.
• Stage 6d on the Functional Assessment Staging Test (FAST).
• Score of 12 or more according to the Advanced Dementia Prognostic Tool (ADEPT) as implemented by the Mitchell Index.
• 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.
• Has a third-party clinician (e.g., hospice, palliative care, PCP) who is responsible for medical management of the participant outside the study.
• 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).
• 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).
• NOTE: Other knowledgeable informants/informed caregivers may contribute to informant-based scales; however, the site should identify an informant who will be able to serve as the primary source of information.
• As assessed by investigator, participant is likely to be able to comply with the protocol for a minimum of 2 weeks.

You may not qualify if:

• Use of cannabinoids or other forms of marijuana in the 3 weeks prior to Baseline, as based on self-report.
• 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).
• 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.

Sponsors & Collaborators

• Alzheimer's Clinical Trials Consortium: collaborator
• Alzheimer's Therapeutic Research Institute: collaborator
• National Institute on Aging (NIA): collaborator
• University of Southern California: lead
• Medical University of South Carolina: collaborator

Study Sites (10)

Georgetown University

Washington D.C., District of Columbia, 20007, United States

Location

Howard University

Washington D.C., District of Columbia, 20059, United States

Location

Melgar-Caro Medcenter and Community Research (MCMCR)

Miami, Florida, 33145, United States

Location

University of South Florida

Tampa, Florida, 33612, United States

Location

University of Kentucky

Lexington, Kentucky, 40504, United States

Location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Case Western Reserve University

Beachwood, Ohio, 44122, United States

Location

Ralph H. Johnson VA Medical Center

Charleston, South Carolina, 29401, United States

Location

Vanderbilt University Medical Center Center for Cognitive Medicine

Nashville, Tennessee, 37212, United States

Location

Related Links

• ATRI Studies Page
• LiBBY Study Website

MeSH Terms

Conditions

Psychomotor Agitation; Dementia; Alzheimer Disease

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior; Brain Diseases; Central Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Tauopathies; Neurodegenerative Diseases

Study Officials

• Paul Aisen, MD

  Alzheimer's Therapeutic Research Institute

  STUDY DIRECTOR

• Jacobo Mintzer, MD

  Ralph H. Johnson Veterans Affairs Medical Center (VAMC)

  PRINCIPAL INVESTIGATOR

• Brigid Reynolds, NP

  Georgetown University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 16, 2022
• First Posted: December 9, 2022
• Study Start: December 18, 2023
• Primary Completion: April 30, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

US (10)