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Mild Cognitive Impairment clinical trials

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NCT ID: NCT06379594 Enrolling by invitation - Clinical trials for Mild Cognitive Impairment

UK Based Remote Brain Health Clinic (BHC) for Patients With Mild Cognitive Impairment (MCI)

BHC
Start date: June 20, 2022
Phase:
Study type: Observational [Patient Registry]

This project aims to understand the feasibility, acceptability and real-world evidence of a novel UK-based remote brain health clinic for patients with mild cognitive impairment (MCI). A timely and accurate diagnosis of dementia is a priority in the UK and MCI is indicative of future risk of cognitive decline. An accurate etiological diagnosis of MCI (MCI-subtyping - distinguishing those who are likely to go on to develop dementia and those who are not) is vital for treatment planning. Whilst the assessment of molecular biological markers (biomarkers) for etiological diagnosis of MCI and Alzheimer's disease (AD) is increasingly recommended and employed internationally, the uptake is low in UK memory clinics. The Brain Health Clinic (BHC) has been specifically designed as a state-of-the-art diagnostic centre for those with MCI. Procedures will include a range of clinical and biomarker assessments, with molecular biomarkers based on lumbar puncture and cerebrospinal fluid (CSF) analysis. Additionally, the clinic will employ remote neuropsychiatric assessments using digital and telephonic methods. This allows for regular contact, whilst adhering to changes in clinical practice and national guidance due to the COVID-19 pandemic. Our overarching objectives are to first establish the acceptability and feasibility of the remote Brain Health Clinic and its novel clinical and biomarker assessment programme. Then secondly establish the impact of care under the Brain Health Clinic on i) care management decisions (e.g. follow-up and treatment planning); ii) time to etiological diagnosis of MCI (MCI-subtyping); and iii) time to diagnosis of dementia and severity of dementia at the time of diagnosis.

NCT ID: NCT06245031 Enrolling by invitation - Alzheimer Disease Clinical Trials

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

Start date: February 29, 2024
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT06221579 Enrolling by invitation - Clinical trials for Mild Cognitive Impairment

An Intergenerational, Cognitively Enriched Intervention for MCI Patients and Their Children.

MCI-project
Start date: September 13, 2023
Phase: N/A
Study type: Interventional

In 2018, approximately 50 million people received a diagnosis of dementia, which is projected to triple by 2050. To mitigate the increase in dementia, it is crucial to prevent cognitive decline in at risk groups, such as older adults with mild cognitive impairment (MCI). Recent research has demonstrated that combining physical (PA) and cognitive activities yields positive effects on the cognitive health of older adults. However, it is essential to explore effective ways of implementing this approach for MCI patients as it may help prevent dementia. An intergenerational program offers a novel and innovative method to achieve this goal by involving both older and younger generations in a single (exercise) program aimed at promoting the health behavior of both groups. Engaging children in an intergenerational, cognitively enriched exercise program for MCI patients primarily benefits the older adults while also providing advantages for the adult children. Therefore, this intergenerational project serves as a valuable and motivating force to enhance the physical, cognitive, and psychosocial health of MCI patients, with a secondary aim of positively impacting the adult children. Phase 1 of this project (=current study) involves developing the intergenerational, cognitively enriched exercise program. This will be accomplished using a theoretical framework in combination with a co-creation approach, which actively involves MCI patients in the intervention development. Ten thinkaloud interviews (lasting approximately 2 hours) will be conducted with MCI patients and one of their adult children. The insights gained from these interviews will be used to adapt an existing exercise intervention for MCI patients according to their specific needs. Prior to the interview, participants will also be asked to complete a short questionnaire that collects basic demographic information.

NCT ID: NCT06029114 Enrolling by invitation - Healthy Clinical Trials

MR Elastography of Cognitive Impairment

Start date: October 11, 2023
Phase:
Study type: Observational

The purpose of this research is to further investigate the potential of brain stiffness as a novel biomarker for Alzheimer's disease.

NCT ID: NCT06023446 Enrolling by invitation - Alzheimer Disease Clinical Trials

Can (Optical Coherence Tomography) Pictures of the Retina Detect Alzheimer's Disease at Its Earliest Stages?

Start date: September 29, 2023
Phase:
Study type: Observational

Years before someone experiences the symptoms of Alzheimer's disease, a compound called amyloid beta (Aβ) builds up in the brain. Excess Aβ - directly or indirectly - causes many of the symptoms of Alzheimer's dementia. However, recent studies of the FDA-approved drugs lecanemab (Leqembi®) and aducanumab (Aduhelm®) indicate that removing Aβ from the brain doesn't stop Alzheimer's. Clearly, there are other problems that need to be fixed. The investigators are interested in the cause of Aβ buildup. Non-neuronal support cells, called glia, keep neurons healthy by regulating water and nutrient levels for the neurons. They also help clear Aβ away from neurons. Maybe Aβ builds up when glia are unhealthy. Glia are very hard to study in the brain. Luckily, the light-sensing part of the eye - the retina - is an extension of the brain. The investigators study glia in the retina to learn about glia in the brain. To study retinal glia, the investigators take pictures of the retina with optical coherence tomography (OCT). OCT is safe, painless, and is used in many eye clinics to look at the structure of the retina. When the investigators take OCT pictures under a bright light, and compare those to OCT pictures collected in darkness, it gives the investigators information about glial function. In a study published in 2020 ("Optical coherence tomography reveals light-dependent retinal responses in Alzheimer's disease") the investigators showed that this functional OCT measurement was different in people with Alzheimer's dementia, compared to age-matched healthy adults. The goal of this observational study is to compare people at a pre-dementia stage of Alzheimer's disease to people who do not have any signs at all of Alzheimer's disease. By "pre-dementia stage", the investigators mean people who are either cognitively normal, or have mild cognitive impairment, but have had a medical test that shows the chemical beginnings of Alzheimer's disease. Members of the comparison group will also be cognitively normal, or have mild cognitive impairment, but had a medical test that shows utterly no signs of Alzheimer's disease. The main question this study, is whether functional OCT can tell these two groups apart. If so, that would: - Help build the case for glial health being important in the earliest stages of Alzheimer's, which in turn could lead to new treatment strategies, and - Suggest that functional OCT might be used as an early (pre-dementia) screening test for Alzheimer's disease Participants will: - undergo a brief eye exam (the investigators will not dilate pupils for this study) - undergo a paper-and-pencil cognitive test (to help verify "normal" or "mild cognitive impairment" status) - take brief one-page survey to collect demographic information (like age) - permit limited access to pre-existing medical or research records (to verify the presence/absence of the chemical beginnings of Alzheimer's disease) - take several OCT pictures of both eyes, in light and after 2 minutes of darkness (several rounds of images are taken) The expectation is that all study procedures will fit within 2 hours of one day.

NCT ID: NCT06017505 Enrolling by invitation - Alzheimer Disease Clinical Trials

Integrating eSAGE With EHR Data Using Machine Learning for the Early Detection and Monitoring of Cognitive Impairment in Individuals

Start date: June 1, 2024
Phase:
Study type: Observational

The goal of this observational trial is to leverage the electronic Self-Administered Gerocognitive Examination (eSAGE), a variety of metadata (a set of data that describes and gives information about other data) collected during eSAGE testing, electronic health records (EHR) information, and advanced machine learning (ML) techniques to develop a new tool that can aid in early-stage prediction of individuals with cognitive impairments.

NCT ID: NCT05978804 Enrolling by invitation - Dementia Clinical Trials

Home-based tDCS in Frontotemporal Dementia or Alzheimer's Disease

Start date: August 10, 2023
Phase: N/A
Study type: Interventional

The primary objective of this research is to evaluate the effects of non-invasive brain stimulation and computerized cognitive training on executive functioning in individuals with Primary Progressive Aphasia (PPA), mild cognitive impairment (MCI), or dementia. In this study, investigators will use transcranial direct current stimulation (tDCS) to stimulate the left dorsolateral prefrontal cortex (DLPFC). Previous studies have demonstrated that tDCS over the DLPFC led to improvements in attention deficit caused by stroke, Parkinson's Disease, and major depression as well as language deficits caused by neurodegenerative conditions such as primary progressive aphasia or mild cognitive impairment. The investigators seek to expand on this literature by investigating how anodal tDCS paired with and without cognitive training will impact executive functioning in PPA with Frontotemporal Dementia or Alzheimer's Disease pathology and Mild Cognitive Impairment/Alzheimer's Disease (e.g. shifting, updating, monitoring, and manipulation).

NCT ID: NCT05770479 Enrolling by invitation - Clinical trials for Mild Cognitive Impairment

Assessing and Improving the Durability of Compensatory Cognitive Training for Older Veterans

AID-CCT
Start date: July 1, 2023
Phase: N/A
Study type: Interventional

Veterans have numerous risk factors (e.g., PTSD, TBI, cerebrovascular problems) for later-life cognitive and functional decline. Evidence supports the effectiveness of strategy-based cognitive rehabilitation therapies, including compensatory cognitive training (CCT), for such decline. However, questions remain about the length of time that CCT-driven improvements in cognitive and everyday function last, and whether additional 'booster' training sessions could provide additional benefit to aging Veterans who previously underwent treatment. This study examines the long-term durability of CCT in Veterans aged 55+ and provides an opportunity to develop and pilot test a series of CCT booster sessions that can be personalized toward individual everyday functional goals.

NCT ID: NCT05584241 Enrolling by invitation - Alzheimer Disease Clinical Trials

Behavioral Change Following Alzheimer's Disease (AD) Biomarker Disclosure

SHARED III
Start date: February 20, 2023
Phase: N/A
Study type: Interventional

The proposed project will assess long-term changes to health/lifestyle, advanced planning, and research engagement that Black and White patients with Amnestic Mild Cognitive Impairment (aMCI) make following disclosure of positron emission tomography-based amyloid and tau burden and associated risk of conversion to Dementia-Alzheimer's Type. Healthcare access will be explored as potential barrier to or facilitator of behavior change.

NCT ID: NCT05532657 Enrolling by invitation - Aging Clinical Trials

ACHIEVE Brain Health Follow-Up Study

ACHIEVE-BHFU
Start date: January 12, 2023
Phase: Phase 3
Study type: Interventional

The ACHIEVE Brain Health Follow-Up Study is a 3-year follow-up to the Aging and Cognitive Health Evaluation in Elders (ACHIEVE) randomized study to determine the long-term effect of hearing intervention vs. successful aging/delayed hearing intervention on rates of cognitive decline and incident mild cognitive impairment or dementia.