With this research study, we want to learn if methylphenidate (Ritalin® and others) helps people with Alzheimer's disease and apathy (lack of interest or concern for things that others find moving or exciting).
The purpose of the Alzheimer's Disease Registry Study (ADRS) is to (1) create a registry that will continue to provide study-ready subjects who meet research diagnostic criteria for the different stages of AD and who have been evaluated using research instruments that allow for their participation in clinical trial research, (2) provide a platform to allow for continual follow-up with registry participants to allow for their participation in clinical trial research at different stages of the disease process, and (3) to incorporate a population of veterans and minorities suffering from AD, a population that is not proportionally represented in clinical trial research, into the registry.
By collecting data pertaining to medical history, current medication details, family history, vital signs, and memory/thinking symptom concerns and evaluating a subject's ability to perform certain tasks, such as memory and thinking tests, questions about their daily activities, and social functioning; researchers are able to determine a research subject's potential eligibility in a clinical trial research protocol.
A registry with such information would enable researchers to effectively and efficiently identify potentially eligible research subjects for the program's evolving portfolio of Alzheimer's disease-related clinical trials.
The Life's end Benefits of CannaBidiol and TetrahYdrocannabinol (LiBBY) 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.
The LiBBY Open-Label Extension (OLE) Study provides the researchers with the opportunity to further evaluate the effects of the THC/CBD oral combination as a treatment for agitation in HAD. The OLE study is designed to determine whether the benefits of THC/CBD are sustained over time, and whether participants initially receiving placebo can also benefit from the treatment. Additionally, the OLE study seeks to explore whether prolonged treatment with THC/CBD improves lifespan, quality of life, and caregiver burden—areas insufficiently studied in terminally ill dementia patients.