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390 active trials for Alzheimer Disease

Sleep Disturbance and Emotion Regulation Brain Dysfunction as Mechanisms of Neuropsychiatric Symptoms in Alzheimer's Dementia

Recent findings suggest that sleep disruption may contribute to the generation and maintenance of neuropsychiatric symptoms including anxiety, depression, agitation, irritation, and apathy while treating sleep disruption reduces these symptoms. Impairments in the neural systems that support emotion regulation may represent one causal mechanism mediating the relationship between sleep and emotional distress. However, this model has not yet been formally tested within a sample of individuals with or at risk for developing Alzheimer's Disease (AD) This proposal aims to test a mechanistic model in which sleep disturbance contributes to neuropsychiatric symptoms through impairments in fronto-limbic emotion regulation function in a sample of individuals at risk for developing, or at an early stage of AD. This study seeks to delineate the causal association between sleep disruption, fronto-limbic emotion regulation brain function, and neuropsychiatric symptoms. These aims will be achieved through a mechanistic, randomized 2-arm controlled trial design. 150 adults experiencing sleep disturbances and who also have cognitive impairment with the presence of at least mild neuropsychiatric symptoms will be randomized to receive either a sleep manipulation (Cognitive Behavioral Therapy for Insomnia CBT-I; n=75) or an active control (n=75). CBT-I improves sleep patterns through a combination of sleep restriction, stimulus control, mindfulness training, cognitive therapy targeting dysfunctional beliefs about sleep, and sleep hygiene education. Neuropsychiatric symptoms, fronto-limbic functioning, and sleep disruption will be assessed at baseline and at the end of the sleep manipulation through functional Magnetic Resonance Imaging (fMRI), clinical interviews, PSG recordings, and self-report questionnaires. Neuropsychiatric symptoms (anxiety and depression) and sleep disturbance (actigraphy, Insomnia Severity Index, and sleep diaries) will be assayed at baseline and each week throughout the sleep manipulation to assess week-to-week changes following an increasing number of CBT-I sessions. Wristwatch actigraphy will be acquired from baseline to the end of the sleep manipulation at week 11. Neuropsychiatric symptoms and sleep will be assessed again at six months post-manipulation.

Start: May 2021
Care of Persons With Dementia in Their Environments (COPE) in Programs of All-Inclusive Care of the Elderly (PACE)

The protocol is organized into three Phases - In Phase I an online training program will be developed in "Care of Persons with Dementia in their Environments" (COPE) -an evidence-based bio-behavioral dementia program -using state-of-the science simulation and best online learning practices. In addition an automated approach to fidelity monitoring using computational linguistics (automatic classification programs) will be developed. In Phase II, ten long term care community-based (PACE) organizations will be randomized into two groups; 5 PACE organizations will serve as the "control" site in which staff training will be provided via the traditional high intensity face-to-face training in the COPE program. 5 PACE organizations will serve as the comparison and staff will be trained using the online COPE training program. Phase II will evaluate the whether an online training program is the same or better in improving PACE staff competency and fidelity to COPE principles and protocols compared to a high intensity face-to-face traditional form of training. In Phase III the efficacy of the COPE program on PACE participant outcomes by type of COPE training will be evaluated. Each of the PACE organizations will enroll 5 persons with dementia and their caregivers in the study. This will yield 50 family dyads (25 dyads in traditional training sites and 25 dyads in online training sites). Dyads will be followed for 4 months. Non-inferiority analysis will be used to assess whether dyads will yield the same or better outcomes regardless of how PACE staff were trained.

Start: May 2021