Phase
Condition
Dementia
Manic Disorders
Williams Syndrome
Treatment
T2:C100
Placebo
Clinical Study ID
Ages > 40 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Provision of signed and dated informed consent from participant or legallyauthorized 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-agitationsubscale 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 trialmedication, during the first 12 weeks of the study.
Has a third-party clinician (e.g., hospice, palliative care, PCP) who is responsiblefor medical management of the participant outside the study.
In the opinion of the investigator, resides in an environment suitable to conduct aclinical trial (i.e., study intervention can be administered and concomitantmedication 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 theadministration of study drug, and participate in study visits and informant-basedassessments (usually requires at least 5 hours of contact per week). NOTE: Other knowledgeable informants/informed caregivers may contribute toinformant-based scales; however, the site should identify an informant who will beable to serve as the primary source of information.
As assessed by investigator, participant is likely to be able to comply with theprotocol for a minimum of 2 weeks.
Exclusion
Exclusion Criteria:
Use of cannabinoids or other forms of marijuana in the 3 weeks prior to Baseline, asbased on self-report.
Suspected or known allergic reactions, adverse reactions, or hypersensitivity tocannabinoids 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 interventionwithin the previous 30 days or five half-lives of the investigational product,whichever is longer.
Any condition, which in the opinion of the site PI, Data and Coordinating Center,regulatory sponsor, or Project Lead/Protocol PI, makes the participant unsuitablefor inclusion.
Study Design
Connect with a study center
Banner Sun Health Research Institute
Sun City, Arizona 85351
United StatesSite Not Available
The Neuron Clinic
Chula Vista, California 91910
United StatesSite Not Available
Sun Valley Research Center
Imperial, California 92251
United StatesSite Not Available
The Neuron Clinic
San Marcos, California 92069
United StatesSite Not Available
Georgetown University
Washington, District of Columbia 20007
United StatesActive - Recruiting
Howard University
Washington, District of Columbia 20059
United StatesSite Not Available
Galiz Research
Hialeah, Florida 33016
United StatesSite Not Available
Melgar-Caro Medcenter and Community Research (MCMCR)
Miami, Florida 33145
United StatesActive - Recruiting
James A. Haley Veterans' Hospital
Tampa, Florida 33612
United StatesSite Not Available
University of South Florida
Tampa, Florida 33612
United StatesActive - Recruiting
Rush University Medical Center
Chicago, Illinois 60612
United StatesSite Not Available
University of Kentucky
Lexington, Kentucky 40504
United StatesActive - Recruiting
Pennington Biomedical Research Center
Baton Rouge, Louisiana 70808
United StatesActive - Recruiting
University of Maryland
Baltimore, Maryland 21201
United StatesSite Not Available
Case Western Reserve University
Beachwood, Ohio 44122
United StatesActive - Recruiting
University of Pittsburgh
Pittsburgh, Pennsylvania 15213
United StatesSite Not Available
Ralph H. Johnson VA Medical Center
Charleston, South Carolina 29401
United StatesActive - Recruiting
Vanderbilt University Medical Center Center for Cognitive Medicine
Nashville, Tennessee 37212
United StatesActive - Recruiting
Baylor Scott & White AT&T Medical Center
Dallas, Texas 75231
United StatesSite Not Available
University of Washington SBICR
Seattle, Washington 98108
United StatesSite Not Available
University of Washington SIBCR / VA Puget Sound
Seattle, Washington 98108
United StatesSite Not Available
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