View clinical trials related to Lewy Body Disease.
Filter by:The PACE-DLB Study is for people with at least moderate dementia with Lewy bodies (DLB) and their primary caregiver. The study's goals are to learn more about the experiences of people with DLB and their caregivers as DLB progresses, and what happens as the end of life of the person with DLB approaches. Participants are enrolled through one of five Lewy Body Dementia Association (LBDA) Research Center of Excellence clinics, or directly via the LBDA. People with DLB will enroll into the study along with their primary informal caregiver, such as the family member or friend who is involved in most of their care and attends the majority of their medical appointments. A legally authorized representative (LAR) for the person with DLB will consent to participate in the study on the person's behalf. If the person with DLB resists taking part in the study, the pair will not be enrolled. The study consists of questionnaires about the progression of the person's dementia and the experiences of the caregiver. The person with DLB will complete one questionnaire themselves if they are able to. If the pair is enrolled at a LBDA Research Center of Excellence clinical site, and completes study visits in-person, a brief physical exam of the person with DLB will be completed by a clinician. Study participation will last for three years, or until the person with DLB dies. Study visits take place every six months, either virtually or in person at a clinical study site. If the person with DLB dies during the study, the caregiver will complete one final virtual study visit three months afterward. Specific Aims of the PACE-DLB Study: 1. To determine predictors of the end of life (death within 6 months) in the DLB population. Hypotheses: Predictors of death within 6 months for individuals with DLB will include symptoms (e.g. worsening hallucinations, fluctuations) not captured in existing dementia end-of-life prediction tools. 2. To identify whether change in caregiver measures can predict the end of life in the DLB. Hypotheses: The investigators hypothesize that there will be worsening caregiver burden, depression, grief, and quality of life preceding the last 6 months of life, controlling for variables such as resilience, support, and living situation. 3. To identify the impact of demographics, health care factors, and specific DLB symptoms on patient quality of life and caregiver experiences at the end of life of the person living with DLB. Hypotheses: Location (rural, urban, suburban), provider experience (e.g. specialist vs not), patient residence (e.g. home, skilled nursing), degree of behavioral symptoms, caregiver type (spouse vs child vs other), and caregiver characteristics (self-efficacy, perceived social support, resilience, and coping) will affect patient and informal caregiver experiences at the patient's end of life, including patient and caregiver quality of life and caregiver well-being, depression, burden, grief, and satisfaction with end-of-life care.
Due to COVID-19, the routine treatment for dementia, Cognitive Stimulation Therapy (CST), is currently suspended in multiple countries. Access to treatment is, therefore, paramount. The investigators seek to bridge the current treatment gap with a virtual and individual form of CST, called Virtual Individual Cognitive Stimulation Therapy (V-iCST). This psychosocial intervention was adapted from the key principles of CST and developed within the Medical Research Council (MRC) framework for complex interventions. The investigators aim to evaluate the feasibility and acceptability of V-iCST in a Randomized Controlled Trial. This is a feasibility randomized controlled trial (RCT) for Virtual Individual Cognitive Stimulation Therapy (V-iCST), an evidence-based teletherapy for people with mild to moderate dementia. This psychosocial intervention is adapted from a routine and established dementia treatment, Cognitive Stimulation Therapy, and developed within the Medical Research Council (MRC) framework for complex interventions.
This is a Phase II, randomized, placebo-controlled, double-blind, crossover study on the CNS and pharmacodynamic effects of CST-103 co-administered with CST-107 in 4 subject populations with Neurodegenerative Disorders.
TOPHAT (Trial of Ondansetron as a Parkinson's HAllucinations Treatment) is a double blind, individually randomized, placebo-controlled, parallel group, flexible dose trial of ondansetron (8-24mg/day) as a treatment for Parkinson's hallucinations, with a 12-week primary outcome and follow-up to 24 weeks.
A Study to Evaluate NYX-458 in Subjects With Mild Cognitive Impairment or Mild Dementia Associated With Parkinson's Disease or Prodromal or Manifest Lewy Body Dementia
The present study aims at combining biochemical methods with various types of imaging techniques to identify the pathophysiology of Alzheimer's disease (AD). The main interest is to find markers associated with the very early steps in the pathology of this disease. The investigators shall thus screen for i) molecules in cerebrospinal fluid (CSF) and plasma specific for AD, and ii) brain imaging markers (e.g. MRI and PET) that correlate to detailed clinical assessments. Biomarkers of interest would then be useful to: 1. Enable accurate detection of the disease early on. Such biomarkers need to specifically reflect the very early pathophysiology of AD and distinguish it from disorders with similar symptomatology, such as other types of dementia and major depression. The sensitivity and specificity of these biomarkers in combination with clinical assessment should be of at least 90%. 2. Enable prediction of the course of events of the disease, such as the disease rate in individual patients. Biomarkers that can predict the pattern of future symptoms will be extremely valuable. 3. Allow monitoring of early effects of new disease-modifying therapies (so-called surrogate biomarkers). Currently clinical therapeutic trials for AD require large patient groups together with long-term treatment. Both size of the groups and treatment time will be reduced with the help of surrogate biomarkers. 4. Study the pathogenesis of the disease. Biomarkers can be used to investigate in detail early alterations in AD patients. For instance, changes in the levels of certain molecules in CSF together with genetic predisposition could then be correlated to clinical signs and changes detectable by brain imaging. This can lead to identification of new therapeutic targets that could easily be monitored in future trials.