Clinical Research Directory

Recombinant Herpes Zoster Vaccine for Prevention of Cardiovascular Events and Dementia

DAN-ZOSTER is a nationwide randomized study investigating whether vaccination against herpes zoster (shingles) can reduce the risk of cardiovascular disease and dementia in older adults. Herpes zoster is caused by reactivation of the varicella-zoster virus and becomes more common with increasing age. Some observational studies have suggested that vaccination against herpes zoster may also lower the risk of heart attacks, strokes, and dementia, but this has not been confirmed in randomized clinical trials. In this study, approximately 162,000 adults aged 65 years or older living in Denmark will be randomly assigned to either receive the recombinant herpes zoster vaccine (Shingrix®) or receive no vaccine. Participants in the vaccine group will receive two doses given 2-6 months apart. Participants will be identified and invited using Danish national registries and digital mail systems. Information about health outcomes will be collected through nationwide health registries during follow-up. The main outcomes of the study are major cardiovascular events (heart attack, stroke, or cardiovascular death) and new diagnoses of dementia. The goal of the study is to determine whether herpes zoster vaccination can help prevent these conditions in older adults.

CommunityRx-Dementia + Peer Navigation (CRxDpeer)

The CRxDpeer intervention, delivered by a trained peer navigator, in practice called a "peer mentor", includes three evidence-based components: (a) focused education about common social (e.g., food and housing insecurity) and caregiving (e.g., respite and end of life care) needs, (b) activation of personalized community resource information for social and caregiving needs through delivery of a resource list (HealtheRx) at the baseline encounter and coaching on how to communicate with service providers, coordinate services and manage social support (e.g., connect with their peer navigator, reach out to friends or relatives for support, identify support groups, etc.) and (c) ongoing navigation-focused support meant to boost the baseline intervention, including a series of proactive text messages over 12 months. During this time, the subject can respond to and communicate with the peer navigator for ongoing support.

Fostering Positive Care Interactions in Assisted Living

The purpose of this study is to improve the quality of staff-resident care interactions particularly among residents living with Alzheimer's disease or related dementias (ADRD ) by testing the Fostering Positive Care Interactions in Assisted Living (FPCI-AL) intervention. This study will be a critical first step in determining the sample size needed to test the efficacy of a practical approach to improving the quality of care interactions for assisted living residents living with ADRD, ultimately enhancing behavioral outcomes such as decreasing behavioral symptoms of distress, reducing resistiveness to care, and optimizing engagement in care tasks.

Sleep Enhancement for Older Adults Living With Memory Loss And Their Care Partners

The purpose of this study is to determine if a 6-week videoconference intervention to teach skills to improve sleep is practical, acceptable, and helpful to persons living with memory loss, cognitive impairment, and/or dementia and care partners, individually or together.

Technology Assisted Cognitive Behavioural Therapy Intervention for Anxiety in People Living With Cognitive Impairment

This study is a randomized controlled trial (RCT) of a remotely-delivered, technology-assisted psychotherapy program, supported by an innovative software platform for people with cognitive impairment experiencing anxiety.

Neurofilament Light Chain And Voice Acoustic Analyses In Dementia Diagnosis

This cohort study aims to determine if a blood test can aid with diagnosing dementia in anyone presenting with cognitive complaints to a single healthcare network. The investigators will measure levels of a brain protein, Neurofilament light chain (Nfl), and assess changes in language using speech tests. Participants will have a single blood test and speech test, and will be followed up at 12-months to complete questionnaires and cognitive scales over the phone. The speech test will also be completed again at 12-months. Individuals at risk of a genetic dementia syndrome will be eligible to complete optional genetic testing involving an 'at home' saliva sample.

Preventing Medication Mismanagement in People Living With Dementia Through Automated Medication Dispensing With Facial Recognition and Video Observation

Globally, \>47M individuals live with dementia, with new incidence of 7.7M annually. Medication mismanagement is one of the most common and concerning risk factors in people with dementia (PwD), as it leads to undertreatment, emergency room visits, hospital admissions/readmissions, and serious adverse events. 3M older U.S. adults are admitted to nursing homes due to drug-related adherence problems with costs \>$14B/year. Furthermore, 30% of hospital admissions of older adults are drug related with 11% attributed to medication non-adherence and 17% to adverse drug reactions. While Alzheimer's disease (AD) \& type 2 diabetes mellitus (DM) individually have considerable morbidity \& mortality, they often occur together, worsening adverse outcomes, quality of life, \& care costs. This is especially true as the AD/DM combination creates a complex balancing act of med management \& symptom monitoring in older populations. While the goal is to keep older adults with dementia at home as long as possible, these challenges lead to untold personal \& family suffering, as well as billions in potentially avoidable healthcare costs annually. The HiDO-ALZ platform will solve these challenges by automating medication administration for PwD to eliminate mismanagement, decrease caregiver burden, reduce healthcare utilization, and facilitate PwD to age in place. HiDO is being developed as an automated, AI driven medication dispensing and direct observation platform to optimize adherence. The device integrates medication dispensing, dose administration time, medication synchronization, \& pair of front-facing cameras to validate the right meds, right route, right time, right dosage to the right patient (5R's). Cameras record every dose using facial recognition \& provide real -time medication consumption recordings. Through cloud connectivity, providers \& caregivers have access to video observation logs, dose administration time, adherence trends, \& longitudinal adherence via web dashboard. Patients \& caregivers can easily setup complex medication protocols in minutes using a smartphone app. The device then alerts patients and dispenses up to 7 different types of meds simultaneously, with up to 90 days of medication. Connected data sources including remote blood pressure and weight measurements, as well as electronic health record lab results and videoconferencing integrate in a single dashboard. The project will build on successful Phase I, in which the medication dispensing unit was updated with modifications for dementia, passed all bench testing, and was successfully validated in pilot usability with dementia subjects. Phase II will expand the foundation with four Aims: 1) Enhance device with remote sensors for diabetes management, expanded data integration, and video conferencing, 2) Test enhanced platform for usability in dementia subjects, 3) Transition the design to formal manufacturing process to ensure system meets performance standards and regulatory requirements \& produce pre-production devices for testing, \& 4) Conduct in-home clinical trial to demonstrate adherence and efficacy.

The Impact of Music Intervention on Sleep

The primary purpose of this Stage 1b NIH-funded clinical trial (K23AG073618, PI Petrovsky) is to determine the efficacy of a 1-month music intervention (Calming Music Personalized for Sleep Enhancement in PeRsons living with Dementia, CoMPoSER) on health outcomes in 72 dyads (144 participants) of persons living with dementia (PLWD) and their caregivers (Stage 1b). The secondary purpose of this research project is to examine the mechanism of stress reduction and sustained effects of the music intervention on PLWD and caregiver well-being. We will evaluate the acceptability of the mobile application CoMPoSER in a pilot RCT and determine the impact of the mobile application CoMPoSER on PLWD (sleep latency, sleep efficiency, wake after sleep onset, total sleep time, sleep quality) and caregiver (perceived stress and well-being) outcomes.

EFFECT OF FACE-TO-FACE AND VIRTUAL REALITY-BASED SALUTOGENESIS NURSING CARE IN PATIENTS WITH DEMENTIA

The purpose of this clinical study is to examine the effects of nursing care based on the Salutogenesis Model on the sense of coherence (meaningfulness, comprehensibility, and manageability) and quality of life of people living with dementia. The study will also evaluate whether delivering this nursing care face-to-face or through virtual reality leads to similar or different benefits, and whether these benefits are maintained over time. The main questions this study aims to answer are: Does face-to-face nursing care based on the Salutogenesis Model help people living with dementia strengthen their sense of coherence, cope better with daily life, and improve their quality of life? Does delivering the same nursing care using virtual reality lead to similar or different effects on sense of coherence and quality of life compared to face-to-face care? Do the positive effects of this nursing care continue after the intervention has ended? Researchers will compare three groups to answer these questions: a group receiving face-to-face nursing care based on the Salutogenesis Model, a group receiving the same nursing care using virtual reality, and a control group receiving usual care. Participants will take part in the study over a period of several months. During the study, participants will be asked to: Take part in nursing care sessions once a week for eight weeks Complete questionnaires that assess sense of coherence and quality of life Complete these questionnaires at the start of the study, after the eight-week nursing care program is completed (mid-term follow-up), and approximately three months after the interventions have ended (final follow-up) These assessments aim to evaluate both the short-term effects of the nursing care and whether these effects are sustained over the longer term. The results of this study are expected to contribute to the development of more supportive and innovative nursing care approaches for people living with dementia and to provide evidence on the use of virtual reality as a supportive tool in nursing care.

Feasibility of a Dyadic Music-based Intervention for Persons Living With Dementia and Their Care Partners

This study examines the feasibility, acceptability, and preliminary outcomes of a structured music-based intervention for individuals living with dementia and their family care partners.

Enhancing Shared Decision-making to Guide Care for People With Dementia and Diabetes

The goal of this study is to test CGM ASSIST. This is a digital tool that uses an interactive information display-an easy-to-read screen designed to help people with dementia (or memory loss) and diabetes, as well as their caregivers and doctors. Managing diabetes is often difficult for people with memory issues. This study uses a Continuous Glucose Monitor (CGM), which is a device that tracks blood sugar levels in real-time. CGM ASSIST adds a new way to see this data through interactive displays. These displays show clear information and medical guidelines to help patients and caregivers make sense of the glucose readings. The study aims to: * Increase Awareness: Help patients and caregivers recognize the dangers of low blood sugar (hypoglycemia) and how to treat it. * Improve Teamwork: Encourage "shared decision-making," where patients, caregivers, and doctors work together to make health choices. * Test Feasibility: See if it is easy and helpful for people with memory loss to use these interactive displays in their daily lives. * Understand Experiences: Learn how the thoughts and feelings of patients and families affect how they manage diabetes. By using these interactive displays, the researchers hope to make it easier for families to understand their health needs and communicate better with their medical team. Participants will: * Answer a survey about how they manage their diabetes * Learn how to use a Continuous Glucose Monitor and wear it for 14 days * Answer 3 brief telephone surveys during these 14 days * Complete a clinic visit with their doctor and answer a final survey on how this visit went using the CGM ASSIST report

Developing a New EEG Method for the Early Diagnosis of Dementia

This is a non-invasive study investigating whether EEG, which is used in routine clinical care can be useful in diagnosing dementia. Novel in house developed software will analyse EEG data for this purpose from people with Alzheimer's disease and healthy volunteers.

Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) Diet in Stroke Patients Patients

To test the effects of a 2- to 3-year intervention of the MIND diet versus usual post-stroke care on cognitive decline, the characteristic feature of dementia, and on brain biomarkers of Alzheimer's Disease (AD) and vascular disease in a Phase Ill randomized controlled trial of 250 patients hospitalized for acute ischemic stroke, aged 55 years or older, and without dementia who are discharged home following hospitalization.

Genetic Characterization of Movement Disorders and Dementias

Background: There are two basic types of movement disorders. Some cause excessive movement, some cause slowness or lack of movement. Some of these are caused by mutations in genes. On the other hand, dementia is a condition of declining mental abilities, especially memory. Dementia can occur at any age but becomes more frequent with age. Researchers want to study the genes of families with a history of movement disorders or dementia. They hope to find a genetic cause of these disorders. This can help them better understand and treat the diseases. This study will not be limited to a particular disorder, but will study all movement disorders or dementias in general. This study will perform genetic testing to identify the genetic causes of movement disorders and dementia. Today, genetic testing can be done to analyze multiple genes at the same time. This increases the chances of finding the genetic cause of movement disorders and dementias. Objectives: To learn more about movement disorders and dementia, their causes, and treatments. Eligibility: Adults and children with a movement disorder or dementia, and their family members. Healthy volunteers. Design: Participants will be screened with medical history and blood tests. Some will have physical exam. Participants will give a blood sample by a needle in the arm. This can be done at the clinic, by their own doctor, or at home. Alternatively, a saliva sample may be provided if a blood sample cannot be obtained. Participants can opt to send an extra blood sample to a repository for future study. Genetic test will be done on these samples. The samples will be coded. The key to the code will remain at NIA. Only NIA investigators will have access to the code key. Participants can request to receive results of the tests. Participation is generally a single visit. Participants may be called back for extra

Decoding Death and Dying in People With Dementia by Digital Thanotyping

How can healthcare professionals recognize that a person with dementia is at the end of life? When people are dying, their physical, mental, and social abilities are gradually declining. No reliable method of predicting perceived dying currently exists although the technology is available (sensors, algorithms). The aim of Decoding Death and Dying in Dementia by Digital thanotyping (5-D) is to provide methods and tools to diagnose and describe dying to an unprecedented level of accuracy and robustness, within a timespan larger than is possible now, focusing on the case of dying people with dementia as one of the most vulnerable and difficult to study groups. 5-D combines clinical assessment tools with wearable sensing technology to monitor a) pain and distressing symptoms, b) behavioral and psychological symptoms in dementia (BPSD), c) oral changes, and to decode "the point of no return" as the beginning of perceived dying. To obtain this outcome in nursing home patients with dementia, the investigator will test the main hypothesis: from monitoring the evolution of thanotype components over time and their interdependencies, the prediction of the "point of no return" is possible. The objectives of 5-D are: O1. Collect data using sensors and validated assessment scales. O2. Develop estimation methods for BPSD from sensor measurements. O3. Develop digital tools to capture the expression of pain. O4. Determine the relationship between breathing and oral symptoms. O5. Develop models for symptom interdependencies at the end of life and the "point of no return". O6. Perform human-in-the-loop validation of developed tools, models, and algorithms. The ground-breaking interdisciplinary novelty of 5-D endeavors to enhance the understanding of end-of-life underlying pain and symptoms in people with dementia. Advancing our theoretical knowledge to uncover how, when, and why perceived dying can be identified opens the doors for transferable research across several scientific fields

Impact of Social Support Through Personalized Visits on Behavioral Symptoms in Residential Care

The objective of this study was to determine if individual social support sessions with personalized conversation prompts could have an impact on behavioral symptoms of dementia. The primary research questions this study wanted to answer were: 1. Does social support through personalized social visits improve behavioral symptoms of dementia? 2. Does social support through personalized visits affect loneliness in adults with dementia in residential care? 3. Do hospitalization visits (emergency room evaluations or inpatient behavioral admissions) change as a result of social support visits? 4. Does the level of dementia impact outcomes such as behavioral symptoms, loneliness levels, or engagement? 5. Do adults with dementia in residential care enjoy social support visits?

Alzheimer's Disease Neuroimaging Initiative 4

The Alzheimer's Disease Neuroimaging Initiative 4 (ADNI4) is a non-randomized, longitudinal, natural history study designed to validate biomarkers, improve clinical trial design, and advance understanding of Alzheimer's disease across the full disease spectrum. Building on the success of ADNI1, ADNI-GO, ADNI2, and ADNI3, ADNI4 integrates clinical, cognitive, imaging, genetic, and fluid biomarker data to characterize disease progression and predict cognitive decline. ADNI4 includes both in-clinic and remote cohorts and a small complementary sub-cohort, Together Exploring Aging Minds (TEAM-ADNI), which evaluates community-based recruitment and longitudinal data collection approaches.

Anesthesia and Perioperative Neurocognitive Disorders in the Elderly Patients Undergoing Hip Fracture Surgery Platform Trial (ANDES Platform Trial)

The ANDES Platform Trial is a pragmatic, multicenter, adaptive randomized controlled platform trial in patients aged 65 years or older undergoing surgery for hip fracture. The trial evaluates whether enhanced anesthesia techniques reduce perioperative neurocognitive disorders compared with standard anesthesia care. The platform includes two randomization processes. In the first randomization, eligible participants are assigned to an active platform intervention-currently a preoperative regional nerve block or perioperative intravenous lidocaine infusion-or to a shared standard-anesthesia control. Participants for whom general anesthesia is planned may also enter a second, nested randomization and are assigned in a fixed 1:1 ratio to total intravenous anesthesia or volatile inhalational anesthesia, regardless of whether they participate in the first randomization. A non-surgical cognitive control cohort is included to characterize changes in cognitive test performance over time without exposure to surgery or study interventions. The Data Monitoring Committee reviews accumulating trial data and makes recommendations to the Trial Steering Committee, which determines whether platform interventions should continue, be modified, advance, or stop.

The WeACT Program for Family Caregivers of People Living With Dementia

The goal of this clinical trial is to learn whether WeACT, a self-paced, web-based program, is feasible and helpful for adult family caregivers of a relative living with dementia. WeACT is based on acceptance and commitment therapy (ACT), which teaches skills to handle difficult thoughts and feelings and take steps toward what matters most. The main questions this study aims to answer are: * Can caregivers complete WeACT as planned? * Do caregivers show improvements in mental health and coping after using WeACT? * What are caregivers' experiences with the program, and what suggestions do they have to improve it? Participants will: * Complete six self-paced weekly online modules and use the daily practice section during the program. * Complete online questionnaires before starting and after completing the program. * Take part in one online interview about their experience.

Improving PCP Advance Care Planning for People With ADRD

This study will test the Dementia Advance Care Planning (AD ACP) Toolkit intervention to usual care in facilitating goals of care (GOC) discussions between People Living with Dementia (PLwD) and primary care team members over an 18-month period. The primary outcome is to assess the frequency and quality of GOC discussions with PLwD. Secondary outcomes include the identification of preferred surrogates, assessment of decisional capacity, and the completion of portable ACP orders. This randomized clinical trial aims to determine if the AD ACP Toolkit can enhance ACP practices and improve care planning outcomes for PLwD compared to the standard care approach.

Jigsawdio Multisensory Platform for People With Mild Cognitive Impairment, Alzheimer's Disease, or Related Dementias

This study will evaluate Jigsawdio, a personalized multisensory jigsaw puzzle platform, for adults aged 60 years and older with mild cognitive impairment or mild dementia. Approximately 80 participants will be randomly assigned to either the Jigsawdio group or a control group using standard dementia-friendly jigsaw puzzles. Both groups will complete two 30- to 40-minute puzzle sessions per week for six weeks, for a total of 12 sessions. Jigsawdio combines transparent physical puzzle pieces with personalized images, stories, and audio presented through an iPad. The study will compare changes in depression, anxiety, quality of life, cognition, engagement, satisfaction, and program feasibility. Assessments will be completed at baseline, after the six-week program, and at a 12-week follow-up. Information may also be collected from participants' caregivers or informants.

Prediction and Prevention of Postoperative Mortality and Morbidity

This study will contribute to creating a prospective and automated preoperative risk assessment algorithm for predicting 30-day mortality, major adverse cardiac and cerebrovascular events (MACCE), and postoperative neurocognitive outcomes following elective cardiac and vascular surgery in older adults. It will evaluate associations between perioperative factors and longer-term neurocognitive outcomes, including postoperative neurocognitive disorder and dementia. In addition, this study will assess scalable, multimodal preoperative and intraoperative interventions to improve perioperative outcomes. This study will explore two main hypotheses: 1. Preoperative personalized prehabilitation with proactive cognitive and behavioral interventions will improve postoperative cognitive outcomes, morbidity, and mortality in high-risk elderly surgical patients. 2. Proactive bundled intraoperative interventions are superior to reactive standard of care in reducing postoperative cognitive outcomes, MACCE, and mortality. Expected Outcome: Improved EHR algorithm will have higher predictive accuracy for MACCE and mortality while predicting postoperative cognitive outcomes.

Web-Based Psychoeducation for Dementia Caregivers

Behavioral and psychological symptoms of dementia (BPSD), such as agitation, anxiety, depression, sleep disturbance, and apathy, are common among people with dementia and often increase the burden on family caregivers. Many caregivers have limited knowledge and confidence in managing these symptoms. This study aims to evaluate the effectiveness of a 6-week web-based psychoeducation and BPSD symptom-monitoring program in improving caregivers' self-efficacy in managing BPSD. Community-dwelling family caregivers of people with dementia will be recruited through healthcare, care, or community service settings and related activities in Taiwan. Participants will be assigned sequentially to either an intervention group receiving web-based psychoeducation, BPSD symptom monitoring, and usual care, or a control group receiving usual care alone. The primary outcome is caregiver self-efficacy. Secondary outcomes include BPSD severity and caregiver burden.

Combating Alzheimer's Through Sleep and Exercise

The Combating Alzheimer's through Sleep and Exercise (CASE) study is an exploratory, hypothesis-generating trial designed to: (1) assess whether improvements in sleep are associated with improvements in cognitive performance and cardiovascular and metabolic health; (2) evaluate the effects of structured, moderate-level aerobic and anaerobic exercise on cognitive performance and cardiovascular and metabolic health; (3) examine the combined, potentially synergistic effects of both interventions on cognitive performance and cardiovascular and metabolic health; and (4) investigate the role of light exposure as a potential modulator of sleep parameters.