Active clinical trials for "Alzheimer Disease"

This study will evaluate the effectiveness of a 3-week reminiscence intervention applied during bathing persons with Alzheimer's disease (AD) in decreasing resistiveness to care (RTC), relieving patient discomfort, and improving spouse caregiver appraisals of burden, capabilities and confidence while bathing the patient. Reminiscence provides opportunities for the patient to feel good and recall pleasant memories, easily done by caregivers in a home setting. Home visits and telephone calls from trained nurses provide coaching and practice for caregivers for the preliminary phase of this study. Each couple will be enrolled in the study for approximately 9 weeks. The study will recruit 100 patient/spouse caregiver couples randomly divided into one of two groups: reminiscence with coaching, or bathing support (control). Bathing support will be provided to participants in both conditions including: individualized assessment; education regarding bathing techniques for people with dementia; and individualized problem solving. In addition to the bathing support intervention, participants in the experimental group will receive a pleasant memories interview and reminiscence script with coaching for implementation. Caregivers will keep a journal of their experiences in bathing the care recipient.

The specific aims of this study are to: Test the immediate effectiveness of the intervention to reduce caregiver upset with targeted disruptive behaviors (primary outcome). Hypothesis: Caregivers in the intervention group will report less upset with target behaviors at 4-months in comparison to caregivers in the control group. Test the immediate effectiveness of the intervention to reduce caregiver burden (secondary outcome). Hypothesis: Caregivers in the intervention group will report less burden at 4-months in comparison to caregivers in the control group. Test the immediate effectiveness of the intervention to reduce the frequency of occurrence of targeted disruptive behaviors in persons with dementia (secondary outcome). Hypothesis: Caregivers in the intervention group will report a decrease in the frequency of occurrence of targeted behaviors at 4-months in comparison to caregivers in the control group. Test the maintenance effect of intervention at 6-months on caregiver upset and burden and targeted disruptive behaviors. Hypothesis: Compared to usual care, caregivers in intervention will maintain reduced upset and burden and report less occurrences of targeted behaviors from 4 to 6-months. Assess the cost of the intervention and its cost effectiveness. We have also received funding to conduct a supplementary study to evaluate the effect of the nurse intervention on behavior reduction and caregiver distress. The specific aims of this supplementary study arm are to: 1) describe the prevalence and type of medical conditions among control group participants who receive the nurse intervention, 2) describe for those with a detected medical condition/problem, the number of caregivers who follow-up with physicians and the type of physician follow-up/treatment that occurs; 3) evaluate whether control group participants who receive the nurse intervention report reduced disruptive behaviors and caregiver upset at 6 weeks (pre-post comparison); and 4) for control group participants who receive the nurse intervention, compare the level of disruptive behaviors and caregiver upset 4 months from entry into this study arm with the results in the Project ACT experimental group (who received the multi-component intervention).

Main objective: To verify the effectiveness of a cognitive rehabilitation program in Alzheimer patients, based on virtual reality, delivered remotely, at the patient's home, with two distinct methods: a tablet or an App (on the patient's smartphone). Total treatment duration: 2 months. Main endpoint: Post rehabilitation assessment of the patient's cognitive level; Secondary endpoints: assessment of patients' quality of life quality of life and patients' and caregivers' satisfaction. The neuropsychological assessment of the patients includes: Mini Mental State Examination (primary outcome), quality of life in Alzheimer's disease (QoL-AD), Geriatric Depression Scale (GDS). The following questionnaires will be submitted to caregivers: Beck Depression Inventory-II (BDI), System Usability Scale (SUS).

This is an open-label, 3-arm study to compare tolerability of three different titration and dosing schedules of the AC-OLE-01-VA formulation of tricaprilin. Following a screening of up to 28 days, eligible participants will be initially randomised to one of 2 arms (Arm 1 or Arm 2). Arms 1 and 2 will be completed in advance of Arm 3 with all subsequent participants allocated to Arm 3.

Despite well-documented disparities in Alzheimer's disease and related dementia (AD) prevalence, incidence, treatment, and mortality, individuals from disadvantaged backgrounds (e.g. racial/ethnic minorities and socioeconomically disadvantaged persons) are under-represented in clinical research. Existing research recruitment approaches are rarely designed to accommodate the priorities, concerns, and constraints relevant to participants from diverse backgrounds. To address these gaps, the investigators developed a research recruitment and engagement model, the Participant Oriented Research Engagement Model that centers and prioritizes relational aspects of research engagement, research participant needs, and systematically address socioeconomic determinants (i.e. unmet needs) that may limit accessibility of research. The investigators propose to test the effectiveness of the Brain Health Community (BHC) Registry recruitment and engagement intervention, as compared to standard research recruitment strategies in modifying enrollment rates, participant satisfaction, and engagement. The investigators hypothesize that the BHC Registry will yield greater enrollment rates, higher satisfaction, and better ratings of relational engagement.

Open-label, single-dose study to assess the absorption, metabolism, excretion and mass balance of [C14] CT1812

The OPTIMAL is designed to teach staff to effectively engage residents in eating using individualized, person-centered behavioral strategies. The purpose of this study is to develop and refine OPTIMAL and evaluate its feasibility, fidelity, and usefulness. First, the investigators will develop OPTIMAL through systematic integration of four PCMC principles, prior work on multilevel facilitators and barriers to engaging residents in eating, and our systematic review of mealtime difficulties and targeted behavioral strategies. The investigators will use mixed methods (i.e., focus groups, a pilot two-group parallel cluster RCT) to refine and test OPTIMAL. The investigators will enroll staff (N=20), families of residents (N=20), and residents (N=20) in nursing homes (NHs). Participants will be randomly assigned to one of two treatment groups: 1) OPTIMAL (i.e., training sessions, ongoing mentoring, biweekly facilitations), and 2) education control (i.e., training sessions only). In each treatment group, data will be collected at 3-time points: baseline (T1), immediately post-intervention (6 weeks post-baseline, T2), and 6-week post-intervention (12 weeks post-baseline, T3). At each time point, the investigators will assess the quality of staff engagement and resident outcomes and collect videotaped observations of dyadic mealtime interaction (videos) over 6 meals in 2 consecutive days (2 breakfasts, 2 lunches, 2 dinners) for each staff-resident dyad. The investigators will use Cue Utilization and Engagement in Dementia (CUED) mealtime video coding scheme, an innovative, feasible, and reliable tool that our team has developed and validated, to assess a) staff PCMC&TCMC behaviors, b) resident mealtime difficulties and intake success rate using videos collected in this study. The specific aims are: Develop, evaluate, and refine OPTIMAL intervention protocol and training materials. The investigators will integrate evidence from literature and prior work to develop the intervention protocol and training materials, addressing resident mealtime difficulties, targeted PCMC strategies, and establishment of individualized PCMC plans. Separate focus group interviews of staff and family participants on the acceptability and appropriateness of the intervention protocol and training materials will be conducted before pilot testing. Data obtained will be used to refine the intervention protocol and training materials before pilot testing. Determine feasibility, fidelity, and usefulness of OPTIMAL. Feasibility on participant identification, recruitment, consent, and retention will be evaluated descriptively. Fidelity will be assessed on a) delivery of treatment (staff attendance to training sessions), b) receipt of treatment (staff knowledge and self-efficacy pre- & post-training), and c) enactment of treatment skills (staff PCMC&TCMC behaviors, quality of staff engagement). Focus group interviews of staff to assess the usefulness of OPTIMAL will be conducted after T3. Describe resident outcomes (Exploratory). The investigators will measure and describe resident mealtime difficulties, eating performance, intake success rate, body weight, and body mass index using descriptive statistics overtime for two treatment groups. Data obtained will inform estimates of effect sizes for a future larger-scale trial.

This study is designed to obtain basic information on three PET imaging tracers developed to detect tau pathology in the brain. In this study, healthy control participants and participants with AD will be studied. Information collected will include brain and plasma kinetics, tissue distribution (in the brain), radiation dosimetry, and test-retest variability of the signal in the brain. The study will consist of Part 1, Part 2A, and Part 2B. During Part 1, imaging data will be assessed on an ongoing basis and based on data, one tracer will be prioritized over the other two tracers. The tracer selected will be further investigated in Part 2A and Part 2B.

This study is being done for the following reasons: To determine the safety of LY2886721 and any side effects that may be associated with it and to see how much of the study drug is in the blood and the cerebrospinal fluid (CSF) when one dose is given to healthy participants and participants diagnosed with Alzheimer's disease. It will also look at how safe and tolerable the study drug is when given to healthy participants in higher doses. This research study is being conducted in three groups, referred to as Groups (Cohorts) A, B, or C. Group A will enroll participants with Alzheimer's disease while Groups B and C will enroll healthy participants. For Group A or B, participation in this research study could last up to 34 days. For Group C, participation could last up to 60 days.

A randomized controlled trial designed to test the effectiveness of a psychological intervention based on group therapy for the caregivers of Alzheimer's disease patients. The intervention consists of 14 sessions of a cognitive-behavioral psychological group therapy. This study aims to demonstrate that Alzheimer's patients' caregivers can benefit from group counseling, with an improvement in mood state, quality of life, perceived burden and a decrease in anxiety and depression. Two evaluations will be done: before the therapy sessions (basal) and when intervention is finished (final).