Clinical Research Directory

Buddy-Up Dyadic Physical Activity Program for Persons With Dementia and Family Caregivers

The global cost of dementia is over 818 billion, and a further rise is expected in the next decade. While family caregiving is the backbone of the formal care service, promoting "living well with dementia" needs to extend to a dyadic perspective to address the needs of persons with dementia (PwD) and their caregivers. Unique to dementia caregiving, imbalanced exchange in the assistance, interaction, relationship and autonomy between the partners in a care dyad always challenges their social interaction and relationships. Such eroding dyadic dynamics not only worsens the mental health of caregivers, but also compromises the quality of caregiving, fosters more dementia deterioration, and eventually complicates the caregiving process. Nevertheless, least attention is directed to dyadic dynamics in promoting living well with dementia. Partner exercise is designed in a way which requires collaboration of two members to enable the workout of each other. In addition to the benefits of exercise on dementia symptom control and caregiver's stress management, partner exercise provides a meaningful encounter to encourage reciprocity, collaboration and relationship closeness within the care dyad. This is a sequential mixed-method study including a multicenter RCT to evaluate the effects of the 16-week enhanced BUDPA and a descriptive qualitative study to explore the care dyad's overall engagement experience and perceptions. The study will be conducted in 8 elderly community centres operated by four NGOs. The primary aim of the study investigates the effects of a 16-week enhanced BUDPA program on the health and dyadic dynamic of the persons with dementia and their family caregivers (Objective 1-3). The secondary aim explores dyads' overall experience in program engagement, particularly in terms of perceived benefits, challenges, and experience in self-directed practice (Objective 4). The primary outcomes include PwD's cognitive function and caregivers' mood status. We hypothesize that the 16-week enhanced BUDPA program will be more effective than usual care immediately post-test (T1: week 16) and 3 months (T2: week 29) and 6 months thereafter (T3: week 42) in: 1. improving cognitive function, NPS and HRQL of persons with mild to early-moderate dementia. 2. improving the affect, positive aspects of caregiving, and HRQL of family caregivers. 3. improving the dyadic dynamic between the person with dementia and family caregiver in a dyad.

Development of Pressure Sensor Based Dementia and Fall Prevention Program for Older Adults

The goal of this intervention program is to test the effectiveness of pressure sensor based dementia and fall prevention program for improving cognitive and physical functions of community dwelling older adults. The main purposes of this study are: 1. Develop a pressure sensor based exercise mat and linked software programs to be used for group training sessions for cognitive and balance training of older adults at a community senior center. 2. Evaluate efficacy of the program to improve cognitive and physical functions of older adults via a pilot study and a main study with randomized control trial design. Older adults will be asked to participate in a group training session that was lead by a fitness coach using a pressure sensor mat, a standing monitor, and a linked software programs. They will be asked to stand on the mat, which is set in front of a monitor to show positions of the mat where they place their foots. The monitor screen will guide them to conduct either a balancing exercise for fall prevention or a cognitive exercise such as memory game or quiz game for dementia prevention. Researchers will compare age and gender matched control group in a main study to see if cognitive and balancing functions of intervention group is better than the control group by conducting pre and post surveys and physical examinations. A pilot study will examine pre-post changes in the intervention group without the control group.

GLP-1/GCG Dual Agonist in Type 2 Diabetes With Early Dementia (LIGHT-COG Study)

The LIGHT-COG study is a 76-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group clinical trial. A total of 420 type 2 diabetes patients with early dementia are randomized 1:1 to either the active treatment group (receiving subcutaneous injections of mazdutide weekly, with stepwise dose escalation to a maintenance dose per protocol) or the placebo group (receiving matched placebo injections). The primary objective is to evaluate the potential disease-modifying effects of mazdutide on cognitive dysfunction in type 2 diabetes.

Effect of 10 mg Xanamem on Dementia Due to Alzheimer's Disease

Xanamem® is being developed as a potential treatment for symptomatic, early stages of Alzheimer's Disease (AD) and Major Depressive Disorder (MDD). This XanaMIA Phase 2b/3 study is to investigate the safety, tolerability, and efficacy of Xanamem in in mild or moderate dementia due to AD. Trial participants will be randomized to either receive 10mg of Xanamem once daily or a placebo for 36 weeks at a 1:1 ratio in a double-blinded fashion. Participants who have completed the main trial will be eligible to participate in an open-label phase, which involves treatment with 10mg Xanamem once daily for a treatment period of up to a maximum of 108 weeks. The OLE is intended to finish when all participants have completed at least 60 weeks of treatment and a follow-up visit 4 weeks later.

A Pivotal Study of Sensory Stimulation in Alzheimer's Disease (Hope Study, CA-0011)

This is a randomized, double-blind, sham-controlled, adaptive-design pivotal study of sensory stimulation in subjects with mild to moderate Alzheimer's disease. Up to approximately 670 subjects will be randomized to 12 months of daily treatment with either Active or Sham Sensory Stimulation Systems. Efficacy will be measured using the Alzheimer's Disease Cooperative Study- Activities of Daily Living (ADCS-ADL) assessment and a combined statistical test (CST) of the ADCS-ADL and the Mini-Mental State Exam (MMSE).

Cognitive Screening Made Easy for PCPs - Administrative Supplement

This project will facilitate early detection of cognitive decline in older adults through development and implementation of an automated risk assessment and cognitive screening tool for use in primary care. By providing an automated tool developed specifically to address the needs of PCPs, it will be easier to screen for cognitive impairment, increasing the number of older adults who are screened and thus identified and treated.

Cognitive Screening Made Easy for PCPs - R33 Phase

This project will facilitate early detection of cognitive decline in older adults through development and implementation of an automated risk assessment and cognitive screening tool for use in primary care. By providing an automated tool developed specifically to address the needs of PCPs, it will be easier to screen for cognitive impairment, increasing the number of older adults who are screened and thus identified and treated.

Pain With Dementia

The purpose of the study is to develop a caregiver-assisted pain coping skills training program for older adults who have pain and mild to moderate dementia and are living at home with a family caregiver. The investigators are planning to recruit 30 patient-caregiver dyads (60 individuals).

The Brain Health Champion Study

6-month, randomized, controlled investigation measuring the effect of increased clinical contact and personalization compared to standard physician counseling on adherence to consensus-based, brain health recommendations for patients with subjective cognitive decline, mild cognitive impairment, and early dementia or patients who are at risk for developing these conditions.

Tau PET Outcomes With Anti-amyloid Immunotherapies

This is an imaging study of patients with mild Alzheimer's disease receiving amyloid-targeting therapy and under the care of neurologists at Mayo Clinic in Rochester, MN.

Adaptation of the Uniform Data Set for Telematic Administration

The present project is an evolution of the previous RIN 2019 study aimed at validating and standardizing the Uniform Data Set (UDS) for dementia, a battery of tests exploring various cognitive domains (memory, language, praxis, executive functions) and involving partial tablet-based computerization for data collection. In the present study, a UDS-based instrument that can be used in remote examiner-assisted telematic administration will be validated. This will be followed by standardization of the same on a sample of healthy subjects.

Autonomic Involvement in Patient With Cognitive Decline

Prospective interventional study with a device for comparing autonomic parameters among patients with different forms of cognitive decline

The "Let's Talk Tech" Tool to Support Decision Making About Technology Use

The goal of this research is to educate people about different technologies to support care at home when someone is experiencing memory difficulties. "Let's Talk Tech" is a new tool to educate people about technologies commonly used to support care and monitor safety, and help families talk about their feelings about them to understand each other's perspectives. The goal of this clinical trial is to learn if "Let's Talk Tech" helps people feel more prepared to make decisions about technologies. Researchers will compare Let's Talk Tech to usual care (no intervention) to see if Let's Talk Tech increases peoples' preparedness and confidence to make decisions about technologies. Participants will: * Use the Let's Talk Tech web application together with their study partner that takes up to an hour or do nothing. * Complete three surveys. The second survey will be taken within 2 weeks of the first and the last survey will be taken 3 months after the first.

Developing a Nonpharmacological Pain Intervention for Community-dwelling Older Adults With Dementia

The purpose of this study is to develop an exercise treatment program for knee osteoarthritis that works well for people with memory problems. This study will include two parts. Participants can choose to participate in either or both parts. In Part 1 (not a clinical trial) - The investigators are inviting the following people to participate in an interview: 1. Individuals aged 60 years or older who do not live in a nursing home and have both memory issues and knee pain. 2. Care partners of people with knee pain and memory issues. A care partner can be a family member or friend who helps regularly. 3. Clinicians (exercise physiologists or rehabilitation therapists like physical and occupational therapists) who have worked with older adults with memory issues and knee pain. The goal of these interviews is to learn from the experiences of people with memory issues and knee pain and those who care for them. From these interviews, the investigators hope to design a non-drug, tailored physical activity program that will be interesting and helpful in managing knee pain for older adults with memory problems. For people with memory problems and knee pain and their care partners: The investigators will ask some questions to determine eligibility to participate in the study. Those who qualify for the study will be invited to participate in an interview that could be completed online or in person (Philadelphia, PA). The interview could last up to 90 minutes (1 and a half hours) and can be completed as one or multiple sessions. For clinicians: Participants will engage in a 90-minute focus group with other clinicians where lunch will be served if in person. Those participating in an online focus group will receive a gift card equal to the value of lunch. In Part 2 (a clinical trial) - The program developed in Part 1 will be tested. The program will be physical activity-based. Specific program details for part 2 will be provided as they emerge. Participants can choose to sign up for either or both parts. Signing up for Part 1 does not mean participants have to sign up for Part 2. Please contact us for any questions.

Eerder Erbij: The Path Towards Offering Timely Support for People With Dementia and Their Caregivers

INTRODUCTION AND RATIONALE It has been estimated that at least 50% of the home living persons with dementia in the Netherlands receive little or no formal care and support (Zorgstandaard Dementie, 2013). Reasons why persons with dementia and their informal caregivers receive no formal care vary, include absence of diagnosis, denial of illness, embarrassment or the complexity of the care and referral system. A common concern among health care professionals is that by the time the person with dementia or informal caregiver do seek or receive formal care it may be too late. The difficulties at home may already be so severe that there is little that community-based care can do and admission to residential care may follow soon after. Appropriate support at an earlier stage may prevent more serious difficulties and postpone admission to residential care. Therefore, health care professionals are looking for strategies to reach persons with dementia and caregivers in an earlier stage of dementia and encourage them to accept some form of help or support. The rationale of this study is to investigate how persons living with dementia and their close others can be encouraged to accept support and whether support at an early stage is effective in preventing severe deterioration in wellbeing, behavioural difficulties and high care costs later on. OBJECTIVES * Estimate the effect of EE on caregiver self-efficacy compared to usual care * Estimate the effect of EE on the total care costs of caregiver and person with dementia compared to usual care * Estimate the cost-effectiveness and cost-utility of EE compared to usual care * Perform a process evaluation to monitor delivery of EE and experiences of persons with dementia, caregivers and care professionals * Explore treatment responsiveness of EE in terms of self-efficacy and quality of life STUDY DESIGN Pragmatic, cluster randomised controlled trial. STUDY POPULATION Informal caregivers and people with early-stage dementia, who are community dwelling and receive little or no dementia-related formal ADL care. INTERVENTION The intervention (Eerder Erbij, EE) is a person-centred, manual-based intervention consisting of education, information and a support group. MAIN STUDY PARAMETERS/ENDPOINTS Primary: self-efficacy. Cost-utility: EQ5D, RUD. Secondary: quality-of-life, caregiver burden. DATA COLLECTION Measurements consist of questionnaires (total duration is approximately 1 hour; administered at home; take place at baseline, 3, 6, and 12 months).

Paper-Based and Smartphone-Based Memory Supports

Alzheimer's disease and related dementias lead to marked declines in daily functioning, independence, and quality of life. One of the earliest cognitive changes in these conditions is impairment in prospective memory, or the ability to remember future intentions such as taking medications at a given time. Prior intervention studies that targeted prospective memory used mnemonic strategies or cognitive training, but these approaches resulted in modest gains in clinical populations. By contrast, a Stage I pilot trial indicated that smartphone-based memory aids (reminder apps) can be accepted and used by persons with mild cognitive impairment and mild dementia to improve both subjective and objective prospective memory performance. The investigators will now test for efficacy, durability, and generalizability of benefits across diverse samples in a Stage II randomized controlled trial. Some 200 participants with mild cognitive impairment or mild dementia will be recruited, half of whom will be from digitally-disadvantaged backgrounds (low socioeconomic status, rural, or historically underrepresented groups). Participants will complete baseline assessments and then be randomly assigned to a smartphone reminder app intervention or an active control condition that uses a paper- based memory support system. Across a 4-week intervention period, participants will complete patient-selected and experimenter-assigned prospective memory assessments and receive booster training sessions to promote self-efficacy with the intervention/control system. Durability of effects will be assessed at 3-month and 6-month follow-up sessions. As a secondary aim, study partners will be simultaneously enrolled to collect informant ratings, track how much study partners assist the participants, and determine whether improving prospective memory in patients improves quality of life in study partners (e.g., by reducing the double to-do list burden of remembering for themselves and for care recipients). As a third aim, the investigators will identify barriers and facilitators to smartphone interventions in digitally-disadvantaged individuals who have historically been underrepresented in technology and dementia research.

Extension to a Pivotal Study of Sensory Stimulation in Alzheimer's Disease (OLE Hope Study, CA-0015)

This is an open-label extension for a multicenter, randomized, double-blind, sham-controlled, adaptive design pivotal study. Participants who complete the Hope Study (CA-0011) will be eligible to consent for screening to enroll in the OLE Hope Study (CA-0015). All participants will be treated with an Active Sensory Stimulation System (GS120) for 60 minutes daily for up to 12 months. There will be no Sham treatment group or randomization involved in this study.

PUMCH Dementia Longitudinal Cohort Study

The PUMCH Dementia Cohort is a hospital-based, observational study of Chinese elderly with cognitive impairment.

Multi-Center Study of Sensory Stimulation to Improve Brain Function

The Overture Study is a randomized, controlled, single-blind multi-center clinical trial using the GammaSense Stimulation system to study safety, tolerability, and efficacy in people with mild to moderate cognitive impairment.