Clinical Research Directory

Tailored Brain Health Insights Through Nurturing Knowledge-based Change - Stakeholder-driven, Human-centered, AI-powered Refinement for Prevention

The goal of this clinical trial is to evaluate whether an AI-powered digital brain health coaching intervention can improve modifiable brain health risk factors in community-dwelling adults aged 40 and above in Singapore. The main question it aims to answer is: does the use of BLAZE, an AI-powered digital brain health coaching intervention, lead to a greater improvement in Brain Care Score (BCS) compared to usual care at 6 months? Researchers will compare participants receiving BLAZE to those receiving usual care (waitlist control) to see if BLAZE leads to greater improvements in brain health risk factors, behavioural outcomes, quality of life, and cost-effectiveness. Participants will: * Be randomly assigned to either receive BLAZE immediately for 12 months or be placed on a waitlist receiving usual care for the first 6 months before receiving BLAZE for a further 6 months * Complete a series of assessments at baseline, 6 months, and 12 months including the Brain Care Score, physical function tests, cognitive assessments, quality of life measures, and lifestyle behaviour questionnaires * If assigned to the intervention group, interact with BLAZE via a WhatsApp-based platform that delivers personalised brain health recommendations, behavioural nudges, educational content, and goal-setting support based on their individual Brain Care Score profile

The INSPIRE -Faith Study: Intervention Strategies for Preserving Intellectual Resilience and Engagement

The INSPIRE-Faith Study, initiated by the Healthy Minds Initiative, is a community-based research project aimed at demonstrating the impact of lifestyle factors on cognitive health and the prevention of dementia. Conducted in collaboration with the American College of Lifestyle Medicine, Charles Drew University, UCLA, Stanford University and Crenshaw Christian Center, this study focuses on all communities that are affected by lifestyle-dependent diseases. The study involves 2,000 participants aged 55 and older and aims to implement targeted community relevant interventions to enhance cognitive function and overall brain health.

A Study of Caregiver Connections Via Technology in Dementia

This research is being done to develop a unique matching process for caregivers of persons living with dementia, such as Alzheimer's disease, Lewy body dementia, frontotemporal degeneration, or other dementia syndromes. Dementia caregivers often assume greater caregiving burden than do non-dementia caregivers, and the caregiving duration tends to be longer. Many caregivers do not have the adequate support they need. Peer-to-peer support has been shown to improve quality of life, more engagement with services, improve caregiver health, and reduce hospitalizations in the person they are caring for. This study will help determine whether caregivers of persons with dementia would find a technology-based caregiver matching program valuable for the purpose of emotional support.

A Study of Donanemab (LY3002813) in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 5)

The reason for this study is to assess the safety and efficacy of donanemab in participants with early Alzheimer's disease. The study duration including screening and follow-up is up to 93 weeks.

Management of Age-Related Auditory Decline and Early Warning of Its Co-occurring Dementia

Against the backdrop of global population aging, age-related hearing loss (ARHL) has reached epidemic proportions and is increasingly recognized as an independent risk factor for cognitive decline and other major neurodegenerative diseases. This study aims to systematically develop an integrated framework for the early warning, precise assessment, and intervention management of ARHL. Using a national multicenter design, the project will establish a prospective cohort of more than 3,000 older adults. We will integrate multimodal data including audiological tests, cognitive function assessments, and blood biomarkers, and employ artificial intelligence and unsupervised machine learning methods to address critical bottlenecks in the field: the unclear mechanistic link between ARHL and cognitive decline, and the lack of validated predictive tools. Specifically, this study will: (1) develop data-driven clinical classification criteria for ARHL; (2) create a personalized "Hearing Health Clock" predictive model; (3) identify minimally invasive blood biomarkers for early detection of cognitive impairment; and (4) formulate a multidimensional early dementia screening program suitable for community-wide implementation. The findings will provide scientific evidence and practical tools for the prevention and control of hearing and cognitive health risks in older adults in China.

Effectiveness of a Culturally Adapted Online Education Program (iSupport-Korea) for Family Caregivers of People With Dementia

This randomized controlled trial evaluates the effectiveness of iSupport-Korea, a culturally adapted online education program for family caregivers of people with dementia. A total of 160 caregivers will be randomly assigned to either the intervention or control group and followed for 4 months. The investigators hypothesize that the intervention group will show greater improvements in care-related quality of life, caregiver self-efficacy, and family decision-making self-efficacy.

Digitally Supported Lifestyle Programme to Promote Brain Health Among Older Adults

Previous research has shown that a healthy lifestyle, including a balanced diet, physical and social activity, and management of vascular risk factors can support both cardiovascular and brain health. In a landmark Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER), a multimodal lifestyle programme had clear benefits on older adults' cognition, functioning, and quality of life. The LETHE study utilises novel technologies and digital tools to deliver an optimised and more personalised FINGER-type multimodal lifestyle intervention. A total of 160 digitally skilled older adults (age 60-77) with risk factors for dementia but without substantial cognitive impairment will be recruited in Austria, Finland, Italy, and Sweden. Participants will be randomly assigned in a 1:1 ratio to the structured ICT-assisted multimodal lifestyle program (intervention group) or a self-guided lifestyle program (control group). Duration of the study and the intervention is 24 months. The multimodal lifestyle program covers the following domains: physical activity, nutrition, cognitive activity, vascular risk management, social interaction, sleep, and relaxation. The structured intervention program follows a hybrid model where regular in-person, individual and group-based intervention activities led by professionals are supported with activities in the LETHE mobile phone application. The self-guided (control) group receives relevant health advice and is recommended and encouraged to independently implement healthy lifestyle changes that are suitable and fit in with their daily routine. Control group will have access to a simplified version of the LETHE app without any structured, scheduled activities or personalized content. The primary objective of the LETHE trial is to test the feasibility of a digitally supported multimodal lifestyle program (i.e., retention rate, adherence to intervention), and assess change in dementia risk based on validated risk scores (CAIDE, LIBRA). Other objectives include testing the intervention effects on lifestyle and risk factors, cognition, function, health-related quality of life, health literacy, physical functioning, and dementia-related biomarkers. To this aim, a range of personal, lifestyle, and health-related data will be collected both actively and passively with the help of digital devices. Attitudes towards digital tools and experiences of trial participation will also be explored.

Rocking Chair Therapy in Elderly With Dementia: Its Effects on Agitation

Patients with dementia exhibit a wide range of behavioral symptoms which include mood disturbances (e.g depression, anxiety), behavior and activity disturbances (e.g agitation, aggression, wandering) and psychotic symptoms (e.g hallucinations and delusions). Behavioral disturbances are a major source of caregiver burden and an important contributor to the decision to admit AD patients to institutionalized long-term care. Among the innovative approaches, rocking chair therapy has been introduced as a potential means for reducing agitation in elderly with dementia. Only few studies evaluated the effect of this therapy on the behavioral symptoms in elderly with cognitive impairment. The results were promising, but not sufficiently significant. We propose to perform this study having as a main goal to evaluate the effect of the rocking chair therapy in agitation for home care residents with dementia. The secondary aim of the study will be the evaluation of psychoactive drugs use as well as pain killers. Cohen Mansfield agitation inventory will be employed for the pre- and post-therapy evaluation. Included subjects will be installed in groups of five, rocking chairs will be placed away from other residents in a semicircle in a corner of the dayroom. The therapy sessions will be held every afternoon, for two hours, under the supervision of the unit psychologist and a master's degree psychology student. During the daily session, each resident should be encouraged to actively rock to reach the goal of 60 minutes of rocking accumulated per day. The total duration of the therapy period will be 6 weeks. The use of pharmacological restraint (neuroleptics, anxiolytics) and pain killers will be evaluated before, during and after the six weeks therapy. The expected outcome is a reduction of agitation among elderly with dementia, as well as a reduction in the use of pharmacological restraint and pain killers.

Palliative Care for Patients With Dementia

A multi-site, single-blinded, parallel, randomized-controlled trial to evaluate the effectiveness of a novel model of in-home palliative care for dementia patients and their family caregivers. From inpatient and outpatient settings associated with four hospitals across New York City, patients with advanced dementia and their family caregivers will be randomized to intervention or augmented control.

Music for Pain and Dementia

This study aims to provide mechanistic insights into how group drumming as a music-based intervention (MBI) affects pain responses and nociceptive function in individuals with Alzheimer's Disease (AD), mild dementia or mild cognitive impairment (MCI). Heart rate (HR), heart rate variability (HRV), and brain activity will be measured during communal drumming with their dyadic partners and others. Brain activity, blood pressure, cognitive abilities, blood hormone levels, and static and dynamic pain will also be measured during sessions pre and post the 8-week community drum circle. Investigators will leverage various measurement techniques including, but not limited to, electroencephalography (EEG), quantitative sensory testing (QST), behavioral, surveys, and physiological monitoring to study the impact of group drumming on pain and brain activity in AD and inter-dyad synchrony.

Brain Attack Surveillance in Corpus Christi--Cognitive (BASIC-Cognitive)

The Mexican American population in the U.S. is rapidly growing and aging. This project seeks to determine the prevalence and outcomes of cognitive impairment and dementia in Mexican Americans. It also seeks solutions to help patients with cognitive impairment and dementia and their caregivers get the resources they need.

Knowledge and Interpersonal Skills to Develop Enhanced Relationships (KINDER)

The Knowledge and Interpersonal Skills to Develop Enhanced Relationships (KINDER) intervention was developed to prevent psychological elder abuse (EA) and promote high-quality caregiving by lowering relationship strain and developing CG resourcefulness. The goal of this two-arm, randomized control trial is to determine the efficacy of KINDER at mitigating psychological EA by family caregivers to persons living with dementia and to describe how the intervention may work to reduce psychological EA.

Clinical and Genetic Study of Neurodegenerative Disorders With Cognitive Impairment

Patients with different types of dementia will be recruited and evaluated in national hospital departments for their usual neurological follow-ups. A blood sample will be proposed in the field of this research project, and the biological material will be stored at the DNA and Cell Bank of Institut de Fédératif Recherche (IFR) of Neurosciences (Pitié-Salpêtrière Hospital, Paris). The clinical research network is already set up for Alzheimer's disease and frontotemporal dementias, which permits an evaluation according to a clinical standardized protocol. Among these disorders, a monogenic sub-group has been identified. In Alzheimer's disease, it is associated with the APP, PSEN1 and PSEN2 genes, which account only for 75% of the familial forms with early onset. In frontotemporal dementias, the tau gene mutations account only for 10% of the cases with an autosomal dominant inheritance. The identification of familial forms with a genetic inquiry in the relatives is essential for a greater knowledge of the molecular bases of forms not caused by the known genes, using linkage approaches and candidate gene analysis. The familial forms are also useful for identifying the modifier genes. In the multifactorial forms, the aim is to assemble a wide cohort of patients and controls matched for localizing and identifying susceptibility genetic factors. The strategies will use a candidate gene approach, and in the near future, studies of single nucleotide polymorphisms (SNPs) spread out in the whole genome. Meanwhile, similar approaches, particularly with candidate genes, could be used for identifying predictive factors of tolerance and response to the treatment. Finally, correlations will be performed with seric markers according to each kind of dementia. Specialized clinical teams in diagnosis and follow-up in dementias are assembled for this project, and in the study of neurological disorders of genetic origin.

Trial-Ready Cohort-Down Syndrome (TRC-DS)

The purpose of the Trial-Ready Cohort - Down Syndrome (TRC-DS) is to enroll 120 healthy adults with Down syndrome (DS), between the ages of 25-55, into a trial ready cohort (TRC), and up to 550 participants in total including co-enrolled in the Alzheimer Biomarkers Consortium - Down Syndrome (ABC-DS) study. Participants enrolled in the TRC-DS will undergo longitudinal cognitive and clinical assessment, genetic and biomarker testing, as well as imaging and biospecimen collection. Using these outcome measures, researchers will analyze the relationships between cognitive measures and biomarkers of Alzheimer's disease (AD) to identify endpoints for AD clinical trials in DS that best reflect disease progression. To learn more about the study and participating sites, visit our study website at: https://www.trcds.org/. TRC-DS is collaborating with the Alzheimer's Disease Biomarker Consortium-Down Syndrome (ABC-DS) to allow study participants to be concurrently enrolled in both ABC-DS and TRC-DS, referred to as "co-enrollment". ABC-DS is a longitudinal, observational research study that is overseen at University of Pittsburgh Coordinating Center. ABC-DS participants who express interest in potentially joining a clinical trial in the future and who meet TRC-DS eligibility criteria, may choose to co-enroll in TRC-DS at an ABC-DS Site. Co-enrolled participants will adhere to the ABC-DS protocol and schedule of activities, but agree to share their data with the TRC-DS team and to receive invitations for future participation in clinical trials. Fore more information on ABC-DS please visit https://www.nia.nih.gov/research/abc-ds or http://abcds.pitt.edu/.

Assessing Cognitive Decline at Home

Neuropsychiatric symptoms (NPS) refer to a range of mental and emotional issues that can be observed through how patients move, perform daily tasks, and express feelings on their faces. In this study, the investigators want to find ways to accurately and unobtrusively track these symptoms in people's homes over time. Our goals are to note when these symptoms happen, predict potential problems, and gather clear data to help doctors make accurate diagnoses. To do this, the investigators will first collect information from participants who have in-home sensors. the investigators will then use special computer programs that can recognize everyday activities and identify features that connect to scores from the Mild Behavioral Impairment Checklist (MBI-C). These scores will be compared to a questionnaire (NPIQ) filled out by caregivers or family members, along with any relevant information from doctors about the patients' symptoms. The investigators aim to see how these features can help differentiate between types of NPS, such as mood changes and agitation. Finally, the investigators will create a dashboard for doctors that summarizes the patterns of these symptoms in patients, making it easier to monitor and manage their mental health.

Remote Game-based Exercise Program for Cognitive and Motor Function Improvement

As our population ages, more older adults face motor-cognitive declines, increasing their risk of falls and fear of falling. Exercise is an effective way to maintain cognitive function, as supported by recent studies. However, those with poor motor and cognitive abilities often struggle to visit rehabilitation centers, leading to high dropout rates and low adherence to unsupervised programs. A remote exercise program tailored for individuals with cognitive impairments is urgently needed to preserve cognitive function, promote independent living, and reduce related costs. Researchers aim to develop an in-home system for adults with mild cognitive issues or dementia, designed to improve balance and cognition while being remotely supervised through telemedicine.

Neuroimaging Markers of Alzheimer Disease: a Longitudinal Population Study

It is now acknowledged that Alzheimer's disease is characterized by a long period of pathophysiological change. Developing new strategies to achieve diagnoses as early as possible has become a major goal for therapies aimed at slowing the progression of this disease. While diagnoses currently rely principally on clinical neuropsychology, the typical diagnostic criteria of NINCDS-ADRDA are inapplicable in the early stage of the disease. The goal of our project is to identify very early imaging markers for Alzheimer's disease among patients with no report of cognitive difficulties. In order to achieve this goal, we propose a longitudinal study in an elderly population cohort.

Study of Methylphenidate to Treat Gait Disorders And Attention Deficit In Parkinson's Disease (PARKGAIT-II)

Therapeutic management of gait disorders in very advanced Parkinson's disease (PD) patients can sometimes be disappointing, since dopaminergic drug treatments and subthalamic nucleus (STN) stimulation are more effective for limb-related Parkinsonian signs than for gait disorders. Gait disorders could be also partly related to noradrenergic system impairment, pharmacological modulation of both dopamine and noradrenaline pathways could potentially improve the symptomatology. The investigators have demonstrated using an open label study on 17 advanced PD patients that chronic, high doses of methylphenidate (MPD) improved gait, freezing of gait, motor symptoms and attention in the absence of L-Dopa and increased the intensity of response of these symptoms to L-Dopa (Devos et al., 2007). The investigators aimed to confirm their results using a randomized, double-blind, placebo-controlled, parallel-group, multicentric trial. The investigators will assess the clinical value of chronic, high doses (1 mg/kg/day) of MPD vs placebo in 88 non demented PD patients suffering from severe gait disorders with freezing despite their use of optimal dopaminergic doses and eventually STN stimulation parameters. Efficacy will be assessed directly and on video in the absence of L-Dopa and again after acute administration of the drug, both before and after a 3-month course of MPD, using Stand Walk Sit test (primary criteria), the "Freezing Of Gait trajectory", RGSE scale, the UPDRS scores, the dyskinesia rating scale, Achiron scales and using auto-questionnaires of Giladi, ABC scale and PDQ 39. Attention will be assessed using reactions times. Drowsiness will be assessed using Epworth and Parkinson's disease Sleep Scales. Apathy and depression will be monitored with Lille Apathy Rating Scale, MADRS, BPRS, MINI and psychiatric interview. Cardiologic and general tolerance will be also monitored. This study could lead to propose methylphenidate with a good efficacy/ risk balance in advanced PD patients suffering from severe gait disorders with freezing of gait, drowsiness and attention deficit.

Predictors Of Cognitive Decline Using Digital Devices

The overall aim of this study is to find out if people with cognitive difficulties will wear and use different types of digital technology, and if they will allow data from that technology and their clinical profile to be collected. Participants will be patients in Essex Memory clinic and their partners/carers. The digital technology used will include a smartwatch, a sleep headband and two smartphone applications, which have been selected as part of the Early Detection of Neurodegenerative Disease (EDoN) initiative. The investigators will also investigate how the digital data can be analyzed together with routinely captured clinical data using machine learning models, a complex type of statistical analysis. The aim of the wider EDoN initiative is to combine digital and clinical data to develop machine learning models which can predict individuals' risk of developing dementia decades before the onset of symptoms.

Tele-Savvy for Latino Caregivers

Latino caregivers of individuals with Alzheimer's disease and related dementias experience high levels of stress burden and depressive symptoms and are underrepresented in caregiver intervention research. Tele Savvy is an evidence based caregiver education program that focuses on developing caregiver mastery skills. This study aims to culturally adapt the Tele Savvy intervention for Latino caregivers and evaluate its preliminary efficacy in a Stage 1b single arm clinical trial. The intervention is delivered remotely and includes weekly group sessions and asynchronous instructional videos. Primary outcomes focus on caregiver mastery with secondary outcomes including stress burden depressive symptoms and self efficacy.

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.

Swedish Palliative Care Guide (S-PCG) at Nursing Homes

Palliative care aims to improve the quality of life for patients and families who are affected life-threatening, incurable disease. The care should be person-centred, but it is not entirely clear how this is best achieved. The Institute for Palliative Care, Lund, has developed the Swedish Palliative Care Guide (S-PCG) which support for a person-centred approach throughout the palliative care process. The aim of this study is to improve palliative care for people living at nursing homes, including people with dementia and cognitive impairment, this will be achieved by providing support for health care staff working with this group of patients, investigating evidence for a palliative care the support tool, the Swedish Palliative Care Guide (S-PCG) part 2, and integrating the palliative care approach earlier in the disease trajectory, to improve the quality of care for this patient group. The research questions will be explored from the perspective of the patient, the family, and the staff.

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.

An Open Platform of Serious Games for Cognitive Intervention

Computer games are increasingly utilized as tools for studying cognitive skills, aging, individual differences, and development. They offer a unique advantage by presenting challenges that more closely mirror the complexities and demands of everyday tasks compared to traditional laboratory experiments, clinical tests, and standardized assessments. Our team took an innovative step in this direction by developing a suite of tablet-based games, titled VibrantMinds. These games, varying in type, are designed to measure diverse cognitive indicators, acting as proxies for assessments typically conducted using paper-and-pencil tests in clinical settings. VibrantMinds games have been specifically crafted to be user-friendly and engaging for older adults, including those with dementia. Our studies have shown that these individuals not only find the games accessible but also exhibit measurable improvement in gameplay, suggesting potential benefits for cognitive skill training. Building on this foundation, we are now poised to conduct an in-depth investigation into the actual effectiveness of serious computer games (SCGs) for cognitive enhancement and their application in real-world settings for older adults. This next phase of research will leverage the VibrantMinds platform to carry out studies aimed at validating software-defined indicators of cognitive function and measuring the impact of game-based interventions on cognitive abilities, health-related quality of life, and other significant real-life outcomes. The anticipated results promise to expand our understanding of the potential for new technologies in cognitive assessment and intervention. Moreover, by employing machine learning analysis of the data collected through VibrantMinds, we aim to develop a taxonomy that correlates game complexity and player performance with conventional clinical instruments for assessing cognitive status and functioning.