Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05644262
Other study ID # ATRI-007
Secondary ID 5R01AG068324-03
Status Recruiting
Phase Phase 2
First received
Last updated
Start date December 18, 2023
Est. completion date December 2025

Study information

Verified date May 2024
Source University of Southern California
Contact ATRI Recruitment Unit
Phone 213-821-0569
Email libby-participate@usc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 150 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 24 week optional open-label extension will be offered to participants who complete the double-period.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date December 2025
Est. primary completion date December 2025
Accepts healthy volunteers No
Gender All
Age group 40 Years and older
Eligibility Inclusion 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). 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. 11. As assessed by investigator, participant is likely to be able to comply with the protocol for a minimum of 2 weeks. Exclusion Criteria: 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
T2:C100
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)).
Placebo
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)).

Locations

Country Name City State
United States University of Maryland Baltimore Maryland
United States Pennington Biomedical Research Center Baton Rouge Louisiana
United States Case Western Reserve University Beachwood Ohio
United States Ralph H. Johnson VA Medical Center Charleston South Carolina
United States Sun Valley Research Center Imperial California
United States University of Kentucky Lexington Kentucky
United States The Neuron Clinic San Marcos California
United States University of Washington SIBCR / VA Puget Sound Seattle Washington
United States University of South Florida Tampa Florida
United States Georgetown University Washington District of Columbia
United States Howard University Washington District of Columbia

Sponsors (5)

Lead Sponsor Collaborator
University of Southern California Alzheimer's Clinical Trials Consortium, Alzheimer's Therapeutic Research Institute, Medical University of South Carolina, National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Change from Baseline in agitation as measured by the Cohen-Mansfield Agitation Inventory (CMAI) at 12 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, Day 14, Week 4, Week 8 and Week 12
Secondary Clinical Global Impression of Change - agitation (CGICa) The Clinical Global Impression of Change - agitation (CGICa) is similar to the mADCS-CGIC in that both versions provide a systematic method for assessing clinically significant change in clinical trials as evaluated by an experienced clinician on the basis of a clinical interview and examination. It relies on both direct examination and/or observation of the participant as well as interviews with a knowledgeable informant/informed caregiver. The participant interviews that are a part of the mADCS-GGIC are not feasible in this study population and have been eliminated in the CGICa in favor of standard administration across all participants. Anchors present in the mADCS-CGIC that are not relevant in this study population have been removed and agitation-related anchors have been added to the CGICa. A skilled and experienced clinician who is blinded to treatment assignment rates the patient on a 7-point Likert scale, ranging from 1 (marked improvement) to 7 (marked worsening). Baseline, Day 7, Day 14, Week 4, Week 8 and Week 12
See also
  Status Clinical Trial Phase
Completed NCT05686486 - Gentle Gymnastics and Relationship Between Family Caregivers and Residents With Dementia in Nursing Homes N/A
Terminated NCT05451693 - Outreach-ER: A Dementia Care Intervention Program
Recruiting NCT05820919 - Enhancing Sleep Quality for Nursing Home Residents With Dementia - R33 Phase N/A
Enrolling by invitation NCT06040294 - Dementia and Disability Simulation for College Nursing Students' Senior Activity Facilitation Skills N/A
Completed NCT05114187 - An Internet-Based Education Program for Care Partners of People Living With Dementia N/A
Recruiting NCT06322121 - Vascular Aspects in Dementia: Part 2
Active, not recruiting NCT03676881 - Longitudinal Validation of a Computerized Cognitive Battery (Cognigram) in the Diagnosis of Mild Cognitive Impairment and Alzheimer's Disease
Completed NCT04426838 - Cognitive Behavioral Therapy for Insomnia for the Dementia Caregiving Dyad N/A
Recruiting NCT03462485 - Pilot Study of the Effects of Playing Golf on People With Dementia N/A
Active, not recruiting NCT03677284 - Managing Time With Dementia: Effects of Time Assistive Products in People With Dementia N/A
Completed NCT03849937 - Changing Talk Online (CHATO) Study N/A
Recruiting NCT06284213 - Biomarkers for Vascular Contributions to Cognitive Impairment and Dementia Consortium
Recruiting NCT05579236 - Cortical Disarray Measurement in Mild Cognitive Impairment and Alzheimer's Disease
Completed NCT05080777 - Pilot Pragmatic Clinical Trial to Embed Tele-Savvy Into Health Care Systems N/A
Completed NCT04571697 - A Study of Comparing Rates of Dementia and Alzheimer's Disease in Participants Initiating Methotrexate Versus Those Initiating Anti-tumor Necrosis Factor (TNF)-Alpha Therapy
Completed NCT03583879 - Using Gait Robotics to Improve Symptoms of Parkinson's Disease N/A
Recruiting NCT06033066 - Financial Incentives and Recruitment to the APT Webstudy N/A
Active, not recruiting NCT05204940 - Longitudinal Observational Biomarker Study
Recruiting NCT05684783 - Dementia Champions in Homecare
Completed NCT03147222 - Function Focused Care: Fracture Care at Home N/A