Active clinical trials for "Alzheimer Disease"

This study will assess the psychosocial and behavioral impacts of receiving Alzheimer's disease genetic risk assessment incorporating APOE genotypes among Latinos in northern Manhattan. The investigators will conduct a longitudinal, community-based study with a mixed methods design. Participants will be randomized to learn about their lifetime risk of late-onset Alzheimer's disease (AD) based either on (a) Latino ethnicity and family history alone (genotype nondisclosure group), or (b) the same factors plus APOE genotype (genotype disclosure group). Responses will be evaluated at 6 weeks, 9 months, and 15 months after risk assessment. In the quantitative component of the study, the investigators will assess psychosocial outcomes, memory test performance, and health-related behaviors. In the qualitative component of the study, the investigators will investigate the lived experience of receiving personal AD risk information, using a stress and coping theoretical framework.

This research study is being done to learn more about inflammation in the brain using Positron Emission Tomography/Computed Tomography (PET/CT) imaging in people with Alzheimer's Disease/Mild Cognitive Impairment or healthy controls. If the subject agrees to be in this study, she/ he will have a PET/CT scan using the investigational radiotracer [18F]NOS. A subject with a specific genetic polymorphism may also agree to be in the sub-study in which she/he will have another PET/CT scan using the investigational tracer [11C]PBR28 for comparison with the FNOS [18F]NOS scan. For subjects who agree to this sub-study they may undergo the brain PET/CT scan with [11C]PBR28 either on the same day as the [18F]NOS PET/CT or on another day. The subject may have a screening visit before the PET/CT scan visit if the investigator needs to confirm the subject is able to be in the study. A blood sample will be taken before the scans. Additional blood samples will be taken during the PET scans. Subjects must also agree to have an MRI scan for this research study if she/he has not had a recent scan that the study doctor decides can be used for this study.

The estimated annual cost of dementia in Canada is $15 billion, with a projected cumulative economic burden of $800 billion by 2038. Effective prevention of dementia at a population level will need to include lifestyle factors such as promoting higher levels of physical activity. Physical inactivity is a modifiable risk factor for Alzheimer disease (AD) and cognitive decline, but the mechanisms by which physical activity exerts its protective effect on the brain remain unknown. Motivated by the need to develop strategies to prevent and treat AD and related dementias (ADRD), the investigators' overall research goal is to discover why the aging brain develops ADRD. To achieve this goal the investigators adopt a translational physiology approach (i.e., study of physiology from molecule/cell to population) to investigate how exercise improves cognitive performance, and the underlying mechanisms by which exercise prevents and/or slows down age-related declines in brain health and cognition. This approach allows the investigators to determine how physiological function is related to ADRD, with important implications for health. The investigators' prior work demonstrated a significant relationship between fitness, vascular regulation and cognition in older adults free of overt disease. These findings have implications for vascular cognitive impairment and ADRD, in which hypoperfusion and dysregulation of cerebral blood flow are thought to be important pathophysiological factors. The investigators' central hypothesis is that regular aerobic exercise mitigates age-related decreases in vascular function and cerebrovascular reserve, which in turn benefits cognition. Work by the investigators and others has provided the necessary data justifying a randomized controlled trial to evaluate the role of exercise in the prevention of ADRD. The investigators are well equipped to undertake this trial; the investigators have dedicated institutional support and necessary expertise in vascular regulation, cognition, aging, neuroimaging and genetics. The overall objective of this proposal is to test an exercise intervention for secondary prevention of ADRD in adults between 50 and 80 years old who are at increased risk for ADRD (with memory impairment symptoms but without dementia). The rationale for this trial is the urgent need for dementia prevention: an exercise intervention, which harnesses a translational physiology framework, holds such promise. The investigators will conduct this trial to determine the effects of aerobic exercise on the development of age-associated cognitive decline and dementia. The exercise intervention is designed with input from Alberta Health Services, the universal healthcare provider for Albertans, so that the intervention can be readily adopted into clinical practice if this trial is successful. The trial will address three specific aims. SPECIFIC AIM 1: Determine the independent effect of exercise on cognitive performance in previously inactive older adults at increased risk of ADRD. The investigators hypothesize that participants randomized to our six-month aerobic exercise intervention will perform better on cognitive tests, compared to control participants randomized to a stretching-toning exercise group. SPECIFIC AIM 2: Determine underlying biological mechanisms that influence cognitive performance after exercise training. The investigators hypothesize that exercise improves cognition due to changes at molecular/cellular (biomarkers), vascular (cerebral blood flow, cerebrovascular reserve), anatomical and functional (neuroimaging), and behavioural (sleep quality) levels. Further, the investigators hypothesize that ADRD-specific genetic risk scores, reflective of targeted genetic variants, moderate exercise-related cognitive and brain outcomes. SPECIFIC AIM 3: Determine the extent to which changes in cognition, resting cerebral blood flow and cerebrovascular reserve persist 12 months after participants complete a 6-month exercise training intervention. The investigators hypothesize that the effects of improved aerobic fitness will be maintained over time as a function of persistent lifestyle changes and behavioural support programs. This trial will provide evidence needed to make clinical recommendations for exercise programs in adults at risk for ADRD, with the goal of preventing dementia. Given the investigators' extensive stakeholder input, this intervention will be easily translated to other jurisdictions. This research into the mechanisms of effect for exercise will identify patient subgroups most likely to benefit, surrogate outcome markers for use in future trials to refine intervention dose/duration, and new therapeutic targets for future interventions.

The investigators aim to compare the effects of a 6-month moderate intensity exercise training (ET) intervention to a low intensity flexibility exercise control condition (FC) on brain function, cognition, and physical function in cognitively healthy and physically inactive older adults (ages 60-80). Apolipoprotein E epsilon4 (APOE-ε4) allele carriers are known to be at substantially greater risk for cognitive decline and Alzheimer's disease (AD). Cognitively intact APOE-ε4 allele carriers, and non-carriers, will be randomly assigned to 6-months of either supervised moderate intensity aerobic exercise training (ET) or supervised flexibility exercise control (FC). The ET and FC each contain a group based exercise component and are run in local retirement communities near College Park, MD, or on the University of Maryland College Park campus. The primary aims of the study are to compare pre-intervention to post-intervention changes in episodic memory performance and MRI biomarkers.

This study aimed to pilot test a non-pharmacological (behavioral) treatment program targeting improved cognition through improving 24-h sleep-wake cycle in people with mild cognitive impairment (MCI) or mild Alzheimer's disease. A treatment program incorporating bright light therapy and a modified cognitive behavioral therapy for insomnia will be developed to address 24-hour patterns of sleep. We will then pilot test its feasibility and explore its preliminary effects on improving sleep/napping and cognition in patients with MCI or mild Alzheimer's disease.

In the current study, we will examine how daily paced breathing affects plasma amyloid beta levels and the rate of learning in older adults. Healthy adults aged 50-70 who meet all eligibility criteria will be invited to this study. Participants will be randomly assigned to one of the two conditions: 1) Daily memory and attention training followed by a paced breathing protocol designed to increase relaxation or 2) Daily memory and attention training followed by a paced breathing protocol to increase alertness. Participants will be asked to complete pre and post intervention cognitive testing online, engage in 10 weeks of daily brain training (starting Week 2) and 9 weeks of paced breathing (starting Week 3) at home. They will also be asked to come in for lab visits on Weeks 2, 7 and 12 to provide blood and urine samples to assess amyloid beta levels and to complete magnetic resonance imaging scans to assess perivascular space volume.

In prior work, this team developed a telehealth primary care model (TIPC), designed in close partnership with patients and clinicians to address a widespread increase in telehealth use during the COVID-19 pandemic. This research team will test the TIPC intervention to assess support for patients among a population of persons with dementia (PwD) over the course of 24 months. This study's aims are 1) to explore the impact of the TIPC intervention on patient-important outcomes, engagement with community-based support provided through insurers, advanced care planning (primarily identification of health-care proxy), and patterns of hospice and healthcare utilization in the target population and 2) to evaluate patient, caregiver, and clinical team perspectives of feasibility and acceptability of a TIPC model, and apply findings from this work to the development of a larger randomized control trial designed to assess long-term efficacy of TIPC intervention.

This is a randomized controlled trial over 5 years, using Stage II of the NIH-defined stage model for behavioral intervention development. We will evaluate the efficacy of the sleep intervention program (Care2Sleep) on sleep, health status measures, and quality of life (for dyads), and inflammation (for caregivers only). Eligible participants will be randomly assigned to in-person Care2Sleep, telehealth Care2Sleep, or to an in-person education control group. The Care2Sleep programs and the control education program will consist of five sessions. The intervention and control programs will begin after baseline assessment and randomization. Posttreatment assessments will be performed immediately after the last session and at 6-month follow-up.

The proposed research project aims to answer the question "Are immersive technology systems effective in the management and treatment of patients with BPSD?". This project is composed of three phases and the current study is the second phase. The phase 2 trial aims to create an immersive technology system for managing the behavioral and psychological symptoms of dementia and determine its clinical effectiveness, safety, usability, and acceptability among patients with mild to moderate Alzheimer's disease.

A Phase 1b Multiple Ascending Dose Study of the Safety and Tolerability of BMS-984923 in Healthy Older Adults and Patients with Alzheimer's Disease