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23 active trials for Alzheimers

Persons With Dementia and Their Extended Family Caregivers

Immediate family members provide the vast majority of care for relatives with Alzheimer's disease, but their availability as caregivers is shrinking. Societal trends, such as declining birthrates and rising divorce rates among middle-aged and older adults raise questions about the sustainability of traditional approaches to family care. At the same time, greater longevity and various social movements, legal and policy changes, and social problems have led to a much broader array of family structures. Older adults now have expanded family boundaries beyond the level of the nuclear family. Their lives are embedded and closely linked to their adult grandchildren, siblings, nieces/nephews as well as non-biological kin, including step-kin- any of whom may become their primary caregiver. An examination of the experiences of these extended family caregivers (CG) and the home and community-based services (HCBS) they use and need to assist with their relatives' care, as well as barriers to service use, will inform delivery of HCBS aimed at ameliorating care-related stressors and improving the quality of life of persons with Alzheimer's disease and other dementias. The study aim is to learn about different relational types of extended family members' paths to dementia caregiving, how they manage their care responsibilities, what HCBS and informal support they use to meet the needs of the person with dementia (PwD), and the resultant effects on the PwD and their own well-being. A mixed-methods design will be used to understand the issues faced by the CG and their use of HCBS to care for the PwD. Using an extensive network with organizations in Virginia to identify extended family CG, a telephone interview comprised of open-ended questions, standard items and structured measures, followed by a semi-structured 8-day diary interview of daily experiences with HCBS, will be administered to 240 extended family members who serve as the primary CG of a PwD living in the community. Study findings will advance scientific knowledge about extended family CG and their use of HCBS beyond that which has emerged from the literature focused on nuclear family CG, providing a more elaborated conception of caregiving that acknowledges the transformations occurring in family life today. This expanded understanding will provide new and relevant information for HCBS/programs designed to support family CG.

Blacksburg, VirginiaStart: August 2021
Validation of a Novel Self-Administered Cognitive Assessment Tool (CogCheck) in Patients With Mild and Major Neurocognitive Disorder Predominantly Due to Alzheimer's Disease

Due to the demographical development, age-related diseases will drastically increase over the next decades. To face this healthcare challenge, early and accurate identification of cognitive impairment is crucial. The assessment of neurocognitive functioning ideally requires a tool that is short, easy to administer and interpret, and has high diagnostic accuracy. In this context, the use of computerized test batteries is receiving increasing attention. Compared to paper-pencil tests, computerized test batteries have many advantages. The possibility to measure reaction times may provide additional information. Moreover, test questions are always presented the exact same way, examiner-related bias is eliminated, and results are available immediately after examination. Due to the ability to adjust the level of difficulty to the performance of the individual, floor and ceiling effects may be minimized. Additionally, costs are reduced, and fewer materials and less trained personnel are required. Finally, big data approaches and the use of machine learning algorithms are becoming more popular in the field of clinical diagnostics, and computerized cognitive test batteries may facilitate future data collection to this aim. In 2014, we developed a self-administered tablet computer program for the iPad (CogCheck) to assess preoperative cognitive functioning in surgery patients. The cognitive tests used in the CogCheck application are identical or similar to the paper-and-pencil tests that are currently used in dementia diagnostics. Replacing some of the paper-and-pencil tests by a computerized test battery may facilitate the routine neuropsychological examinations. Thus, we aim to investigate the diagnostic accuracy and user-friendliness of CogCheck when applied in a cognitively impaired patient sample. In a first step, the diagnostic properties of CogCheck will be examined by differentiating between healthy controls and patients with mild or major neurocognitive disorder (NCD) predominantly due to Alzheimer's disease (AD). Data from healthy controls have been collected (EKNZ Req-2016-00393) in a previous normative study of CogCheck. Thus a further aim is to investigate the user-friendliness of CogCheck in patients with mild or major NCD predominantly due to AD. The primary aim of our study is to investigate the diagnostic accuracy of CogCheck for patients with mild or major NCD predominantly due to AD in a German-speaking population. Secondary aims are: (1) to examine the user-friendliness of CogCheck in patients with mild or major NCD predominantly due to AD, (2) to compare the results between cognitively healthy individuals (EKNZ Req-2016-00393) and patients with mild or major NCD predominantly due to AD on each of the CogCheck subtest, (3) to establish an algorithm with the CogCheck subtests that optimally distinguishes between cognitively healthy controls (EKNZ Req-2016-00393) and patients with mild or major NCD predominantly due to AD, (4) to compare the diagnostic properties of CogCheck with the ones of the currently used paper-pencil tests.

Basel, BSStart: July 2021
Rural Dementia Caregiver Project

These caregivers are a vulnerable group due to their physical isolation and well-documented rural disparities in health care access and quality. Many rural dementia caregivers experience serious health consequences due to caregiving responsibilities that can limit their ability to maintain their caregiving role. Thus, there is a pressing need for effective, scalable, and accessible programs to support rural dementia caregivers. Online programs offer a convenient and readily translatable option for program delivery because they can be accessed by caregivers in the home and at the convenience of the user. Building Better Caregivers is an online 6-week, interactive, small-group self-management, social support, and skills-building workshop developed for caregivers of individuals with Alzheimer's disease or related dementia. The investigators will conduct a hybrid effectiveness-implementation randomized controlled trial that will enroll and randomize 640 rural dementia caregivers into two groups: 320 in the intervention (workshop) group and 320 in the attention control group. Caregivers will be recruited throughout the United States. Primary outcomes will be caregiver stress and depression symptoms. The investigators hypothesize that stress scores and depression symptoms will be significantly improved at 12 months in the intervention group versus control group. The investigators will also identify key strengths (facilitators) and weaknesses (barriers) of workshop implementation. The investigators will use the RE-AIM implementation framework and a mixed methods approach to identify implementation characteristics pertinent to both caregivers and rural community organizations. If the Building Better Caregivers workshop is proven to be effective, this research has the potential to open new research horizons, particularly on how to reach and effectively support isolated dementia caregivers in rural areas with an intervention that is scalable, even in low-resourced settings. If the workshop can achieve its goals with rural dementia caregivers, some of those most isolated, it would also be expected to be scalable in other low-resourced settings (e.g., in urban or suburban environments).

San Francisco, CaliforniaStart: June 2020
Improving Everyday Task Performance Through Repeated Practice in Virtual Reality.

There are very few effective interventions that promote functional independence in people with Alzheimer's disease (AD) and related dementias. This R21 project is the first step in the long-term goal of developing an effective, enjoyable, portable, and inexpensive non-immersive virtual reality (VR) training intervention for improving the performance of everyday tasks. The investigators' VR training approach is built upon the results of past studies that show 1) when people with AD repeatedly practice daily tasks they subsequently perform them more completely and without error; and 2) healthy people are able to transfer skills learned in VR-contexts to tasks in the real world. This R21 study will obtain preliminary data to inform a future randomized clinical trial through three aims: Aim 1) To test the hypothesis that individuals with mild-moderate AD will show improved performance on an everyday task after repeatedly practicing the task in a non-immersive VR setting; Aim 2) To explore usability and acceptability of the VR training as well as associations between individual differences variables (e.g., cognitive abilities, demographics) and training effects. To test Aim 1, 40 participants with mild to moderate AD will be recruited to complete daily VR Training sessions for one week. VR Training will include repeated practice of a single, everyday task in a non-immersive VR-context (VR Breakfast or VR Lunch; counterbalanced across participants). The primary outcome measure is performance of the real-life version of the trained task, which will be collected before and at two time points after training, compared to performance of an untrained, control task of comparable difficulty, and scored from video by coders blinded to training task/condition. To evaluate Aim 2, all participants and an informant will complete interviews and questionnaires and participants will complete tests of cognitive abilities. Usability and acceptability of the VR training will be evaluated and associations between participant variables and VR Training results will be explored. If the proposed hypothesis is supported and results show that training effects generalize from virtual to real tasks in the study sample, then VR training of custom and individualized tasks will be investigated in a future randomized, controlled clinical trial for maintaining and improving functional abilities in people with mild to moderate AD.

Philadelphia, PennsylvaniaStart: January 2021
Assessing an Intergenerational Music Program Delivered by Adolescents to Older Adults With Declining Cognition

Intergenerational music programming has been shown to benefit both young people and older adults in terms of quality of life, social connection, and promotion of positive cross-age attitudes. During a time that older adults are facing increasing social isolation, a need exists to offer meaningful programming that can reach older adults living with memory loss. The investigators want to assess if an intergenerational music program that is delivered by adolescent music facilitators is feasible and appropriate to both the young musicians and the older adult participants. This program will be designed on Zoom but will able to be delivered in the same manner in-person, offering it flexibility to reach a variety of participants. This program is unique in that it brings together two populations who have shown to be positively affected by engaging in music - adolescents and older adults with memory loss. As a result of this work, teenage musicians will be empowered to adapt and share a music program utilizing best research practices and create new connections with an older generation. Older adults will receive a research-informed music program that will be geared to helping their musical understanding and participation, as well as an opportunity to create new connections with a younger generation. Findings from this work will generate a music program with clearly defined ingredients that can be delivered and is accepted by both its facilitators and participants, providing a foundation for future studies to assess outcomes such as social connection, cognitive benefits, and emotional well-being. This program will be built carefully utilizing stakeholder engagement from the adolescent facilitators and older adult participants. Specifically, for Aim 1 the investigators will explore the feasibility of the music program by its facilitators by conducting in-depth interviews with a sample of adolescent facilitators before, during, and after they administer the music intervention to discuss how best to adapt the program, as well as collecting observations of the older adults to confirm engagement in the program. For Aim 2 the investigators will assess its fidelity as the adolescent facilitators implement the program and are assessed for adherence and competence. For Aim 3, the investigators will assess its appropriateness, as adolescent facilitators and older adults will engage in focus groups.

Pittsburgh, PennsylvaniaStart: January 2021