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Dementia, Mild clinical trials

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NCT ID: NCT06455163 Recruiting - Dementia, Mild Clinical Trials

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

EE
Start date: June 1, 2021
Phase: N/A
Study type: Interventional

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).

NCT ID: NCT06382194 Recruiting - Depression Clinical Trials

Decision Making Tool for Firearm Storage

Start date: April 1, 2024
Phase: N/A
Study type: Interventional

This is a one-arm pilot study testing the feasibility and acceptability of a decision aid about safe firearm storage.

NCT ID: NCT06292741 Recruiting - Dementia, Mild Clinical Trials

Autonomic Involvement in Patient With Cognitive Decline

Start date: January 11, 2023
Phase: N/A
Study type: Interventional

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

NCT ID: NCT06162026 Recruiting - Clinical trials for Cognitive Impairment

Cognitive Screening Made Easy for PCPs - R33 Phase

Start date: February 2, 2024
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT06147479 Recruiting - Dementia Clinical Trials

Cognitive Stimulation in Daily Activities for People Living With Early to Middle Stage Dementia

CS-ADL
Start date: November 3, 2023
Phase: N/A
Study type: Interventional

The goal of this study is to test the effect of CS-ADL is on people living with early to middle stage dementia. The main questions it aims to answer are: - What is the effect of CS-ADL on the ability of people with early to middle stage dementia to carry out their everyday activities? - What is the effect of CS-ADL on the memory, mood, communication, and quality of life of people living with early to middle stage dementia? Participants will take part in a group program that lasts 7 weeks, with one session per week, lasting two hours. Participants will take part in rewarding and stimulating activities, for example discussion, reminiscence, music, and practical activities such as baking, cooking, gardening. Participants will be asked to complete a variety of questionnaires before and after taking part in the group. Researchers will compare a group receiving CS-ADL to a group receiving their usual care, to explore whether CS-ADL works well in comparison to typical treatment provided by the health services.

NCT ID: NCT06125951 Recruiting - Alzheimer Disease Clinical Trials

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

XanaMIA
Start date: April 12, 2024
Phase: Phase 2
Study type: Interventional

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 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.

NCT ID: NCT05894954 Recruiting - Clinical trials for Mild Cognitive Impairment

Precision Medicine Approach for Early Dementia & Mild Cognitive Impairment

EVANTHEA
Start date: July 31, 2023
Phase: Phase 3
Study type: Interventional

The goal of this clinical trial is to compare a precision medicine approach to the standard-of-care for people with mild cognitive impairment or early-stage dementia. Precision medicine approach starts with the completion of many tests and then the study doctor uses the test results to carefully prepare a treatment plan that is best for the individual person to help treat many of the underlying causes of mild cognitive impairment or early-stage dementia. The main question the study aims to answer is: • Does the precision medicine approach improve memory (cognitive function) better than the current standard-of-care treatment in people with mild cognitive impairment or early-stage dementia during a 9-month treatment period? This is a randomized clinical trial which means that a group of people that meet the study requirements will be assigned at random or by chance (like toss of a coin) to receive either the precision medicine treatment or the current gold standard (standard-of-care). People assigned to the precision medicine group will receive precision medicine for 9-months while those assigned to the standard-of-care group will follow that approach for 9-months, followed by an opportunity to receive up to six months of precision medicine, if desired. Participants will be asked to: - Have their blood drawn for extensive lab testing and collect urine and stool samples as well - Carefully follow instructions received from their study doctor and study team - Make lifestyle changes as prescribed by the study doctor and study team based on your precision medicine program - Take supplements and medications prescribed by the study doctor. - Once officially in the study (after meeting study entry or screening requirements), participate in ten (10) monthly visits with the study doctor, and other members of the study team as scheduled. - Complete cognitive tests at scheduled visits during the study - Have a study partner with you during visits and to help support you on the program Researchers will compare test results between the two study groups to see if the precision medicine approach improves those tests results over the time of the study, resulting in the improvement of cognition over a 9-month treatment period.

NCT ID: NCT05728801 Recruiting - Clinical trials for Age-related Cognitive Decline

Decoding the Cognitive Trajectory of Hong Kong SuperAgers: a Longitudinal Follow-up Study

Start date: June 1, 2022
Phase:
Study type: Observational

This is a prospective follow-up study conducted at the Department of Psychiatry, The Chinese University of Hong Kong. The participants, including high-performing elderly (SuperAgers), normal ageing elderly and neurocognitive disorder (NCD) patients will be re-invited from our previous cohort (2013-2014) (N=488).

NCT ID: NCT05673759 Recruiting - Alzheimer Disease Clinical Trials

Event-Related Potential (ERP) Components in Clinical Diagnosis

Start date: March 6, 2023
Phase:
Study type: Observational

In this study, the investigators will use a novel electroencephalogram (EEG) system that participants will wear during a single in-person research session to investigate whether ERPs are now ready for validation as a tool clinicians can easily implement to increase diagnostic accuracy and confidence. This EEG will not be used to treat, cure, mitigate or diagnosis any disease and there will be no safety or efficacy data collected about the machine for any purpose including support of FDA submission. The investigators will compare the ERP data to that of neuropsychological testing in order to determine the degree of correlation between these two measures. Questionnaires on cognition, mood, and fluency will be administered prior to the EEG to establish a baseline. ERP data from the EEG session will be compared with the results of the neuropsychological battery in order to determine whether the implementation of ERPs in the existing workflow of clinicians can aid in diagnostic accuracy, thus altering clinical management.

NCT ID: NCT05637801 Recruiting - Alzheimer Disease Clinical Trials

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

Hope
Start date: December 13, 2022
Phase: N/A
Study type: Interventional

This is a randomized, double-blind, sham-controlled, adaptive-design pivotal study of sensory stimulation in subjects with mild to moderate Alzheimer's disease. Approximately 530 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).