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NCT07533084
The goal of this experimental multicentric intervention study is to validate, in Italian, the dynamic Neurocognitive Adaptation (dNA) Scale, which has already been validated in English, among a healthy elderly population (aged 65 and older) residing in Italy and patients with dementia or Alzheimer's Disease. dNA is a questionnaire designed to assess both current and past levels of engagement in physical, cognitive, creative, and social activities. The study aims to recruit a total of 265 participants with mild cognitive impairment, subjective memory complaints, or dementia. These participants will be distributed among the 8 recruitment centers. Neuropsychological data, subjective measures, and MRI data will be collected and analyzed to address the following research questions: 1) Is there a positive correlation between scores on the dNA Scale and cognitive efficiency, as reflected in neuropsychological measures, such as episodic memory and executive functions? 2) Is there a correlation between dNA scores and improved functional connectivity within neural networks, such as the Default Network (DN)? Participants recruited at the participating clinical centers will undergo: * A clinical interview, during which demographic and medical history information will be collected. The dNA Scale will be administered, along with a questionnaire assessing adherence to dietary habits typical of a Mediterranean diet (14-Item Mediterranean Diet Adherence Screener; MEDAS). * A neuropsychological assessment, aimed at evaluating general cognitive function with a particular focus on episodic memory and executive functions. The following tests will be administered: Mini-Mental State Examination (MMSE) or, alternatively, Montreal Cognitive Assessment (MoCA); Rey Auditory Verbal Learning Test (RAVLT); Trial Making Test (TMT) Form B; Digit Span Forward and Backward (WAIS or WAIS-III); and the Stroop Test. * Self-report questionnaires designed to assess depressive symptoms using the Geriatric Depression Scale (GDS) and anxiety symptoms using the Geriatric Anxiety Scale (GAS) (or alternatively the State-Trait Anxiety Inventory, STAI). Finally, the Cognitive Reserve Index Questionnaire will be administered to estimate Cognitive Reserve (CRIq). * Where available, MRI data previously acquired for clinical or diagnostic purposes will be included in the study and analyzed by the principal investigator.
NCT05592678
The goal of this clinical trial is to demonstrate potential improvements in clinical trial methods relating to dementia and cognitive decline. The main questions it aims to answer are: * Can an intervention's outcome be better assessed by a latent variable ("δ") integrating cognitive performance with functional status? * Can latent biomarkers of δ guide the selection of an intervention that will modulate dementia severity? * Can a latent variable, derived from information collected remotely from caregivers, preselect subjects most likely to respond to the intervention? * Is the effect of the intervention in fact medicated by changes in the targeted biomarker? In this case, the biomarker will be a latent variable derived from several proteins measured in blood (i.e., so-called "adipokines"). The intervention will be donepezil, a medication approved for the treatment of Alzheimer's Disease, but only recently associated with adipokine changes. Participants with cognitive impairment and their caregivers will be interviewed by telephone and those newly prescribed donepezil by their provider for cognitive impairment will be recruited and enrolled. On the basis of the caregiver's report, the cognitively impaired subjects will be assigned to two groups based on a prediction of their response to donepezil. Researchers will compare those groups to see if dementia severity, as measured by δ, improves in predicted responders, and whether the change in the d-score is mediated by changes in adipokines.
NCT07549074
The research aims to investigate the effectiveness of a new short-term multicomponent intervention to promote the bio-psycho-social-spiritual health of older adults with MCI to improve their cognitive abilities. In this study, the multicomponent intervention consists of healthy lifestyle psychoeducation and cognitive stimulation. This study is a double-blind, clustered, randomized, controlled, four-arm parallel group study. 200 eligible older adults with MCI are openly recruited into activity groups in local elderly centres. The activity groups are randomly allocated to three intervention groups (i.e., multicomponent intervention, cognitive stimulation and lifestyle psychoeducation) and a control group in a 1:1:1:1 ratio. The participants with MCI are blinded on group allocation and kept uninformed which type of intervention they are receiving. An investigator, blinded to group allocation and intervention, assess outcomes using standardized assessment tools before and after the intervention and after 3 months.
NCT07526480
This clinical trial will evaluate a multi-level scalable intervention called Improving Dementia Care (IDC). The investigators hypothesize that IDC will increase dementia detection in patients with impaired cognition more than the control condition, Enhanced Usual Care (EUC), over 6 months.
NCT07529015
The goal of this clinical trial is to determine whether acoustic stimulation during sleep can enhance slow-wave sleep (SWS), improve cognitive function, and reduce AD-related pathology in individuals with mild cognitive impairment (MCI), compared with cognitively healthy participants. The main questions it aims to answer are: 1. Does acoustic stimulation increase SWS (e.g., slow oscillation and sleep spindle activity) in individuals with MCI? 2. Does enhancing SWS lead to improvements in memory and cognitive performance? 3. Does acoustic stimulation influence plasma p-tau217 levels as a marker of underlying Alzheimer's disease pathology? Researchers will compare participants receiving acoustic stimulation during sleep with those not receiving stimulation to evaluate its effects on sleep architecture, cognition, and plasma biomarkers. Participants will: * Undergo sleep recordings to assess sleep architecture, including SWS, slow oscillations, and sleep spindles * Receive acoustic stimulation during sleep across multiple nights * Complete cognitive assessments, particularly memory-related tasks * Provide blood samples to measure plasma p-tau217 levels * Provide clinical and demographic information for analysis
NCT07101380
The goal of this clinical trial is to learn whether a mobile-based personalized physical activity program called SuperBrain BOOM is safe and works to improve cognitive function, physical performance, mood, and quality of life in older adults (ages 50-85) with mild cognitive impairment (MCI). The main questions it aims to answer are: Can SuperBrain BOOM be safely and effectively used by people with MCI? Does the program help improve cognitive and physical function? Do participants stay engaged and complete the program as expected? Researchers will compare: A mobile intervention group using SuperBrain BOOM (on tablet or smartphone) A control group receiving usual care Participants will: Use a tablet or smartphone to follow a personalized physical activity program for 12 weeks Complete clinical assessments on cognition, physical ability, mood, and nutrition Be monitored for safety and program adherence using automatically collected data
NCT06669546
This study aims to explore a non-invasive way to improve memory and slow cognitive decline in older adults by enhancing sleep quality. Dementia, a leading cause of death worldwide, is often associated with disturbed sleep, particularly the loss of deep, slow-wave sleep (SWS). SWS is important for memory and clearing waste from the brain. Poor SWS can worsen memory loss and allow harmful waste to build up, which may increase the risk of dementia. The investigators are testing whether phase-locked auditory stimulation (PLAS) can improve SWS in people at a mild stage of cognitive impairment. PLAS uses short sounds played at specific moments to strengthen slow-wave brain activity during sleep. The investigators previous laboratory based research has shown that this can improve memory and help with clearing waste from the brain. Now, the investigators want to test this in a real-world setting, over a longer period, which is unfeasible in a laboratory setting. In this study, 60 older adults will use home-use devices that deliver either real or sham (soundless) PLAS across two different 4-week periods. Memory will be tested using engaging "serious games." Before and after each experimental period, blood samples will be taken to measure dementia-related markers, and cognitive batteries will be performed. The investigators expect that PLAS will improve sleep, and that this will have a downstream effect on memory and brain clearance, potentially slowing the process of cognitive decline. If successful, this could lead to the development of an affordable treatment that helps people maintain brain health and prevent dementia.
NCT04075435
This is an open label, eight week, clinical trial of a proprietary high CBD/low THC sublingual solution for the treatment of clinically significant anxiety and agitation in individuals with mild cognitive impairment (MCI) or mild to moderate Alzheimer's Disease (AD).
NCT07117916
Background: The Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER) was the first to show that multidomain lifestyle interventions can enhance brain health and reduce cognitive decline. However, the clinical effectiveness and delivery of the FINGER model within primary care settings remain unexplored. The aim of the STRONGER 60+ trial is to evaluate both the clinical effectiveness and real-world delivery of an adapted FINGER-based intervention in primary care. Methods and analysis: This 6-month randomized controlled clinical effectiveness trial will be conducted in primary care and will include adults aged 60 and older with vascular or lifestyle-related risk factors for dementia. A total of 96 participants will be randomized to either a structured, supervised multidomain lifestyle intervention or a self-guided version of the same program. The intervention includes nutritional guidance, physical exercise, cognitive training, social engagement, and management of vascular and metabolic risk factors. Data will be collected at baseline, 6 months (primary endpoint), and 12 months post-randomization. The primary outcome is the change in a composite healthy lifestyle score at 6 months. In addition, the study will explore delivery processes and stakeholder (participant and healthcare professional) perspectives using both qualitative and quantitative methods.
NCT07366346
The goal of this clinical trial is to develop a five-week virtual cognitive training intervention for people with Mild Cognitive Impairment (MCI) based off an existing eight-week intervention. The main question it aims to answer is: • Is five weeks of training as good as eight weeks in improving cognition, quality of life, daily functioning, and mood, and in reducing caregiver burden? Researchers will compare five weeks of cognitive training to eight weeks of training to see if the shorter version is as effective as the full training. Participants will complete all activities virtually: * Complete a screening visit with a study partner (typically a family member, roommate, or close friend) to determine eligibility to participate in the study * Complete some tests of memory and thinking and some questionnaires * Attend weekly two-hour group cognitive training sessions with a trained group leader, for five or eight weeks * Redo the questionnaires and tests of memory and thinking immediately after completing the training, and three months after completing the training
NCT07127133
This study tests an innovative system and service for collecting objective, consistent, and in-community gait parameters suitable for use as AD/ADRD biomarkers. The system is designed to be affordable, scalable, and practical for longitudinal, unsupervised, in-community use by older adults, including those with dementia symptoms. This study will be performed in two parts and involves collecting gait data from participants using the leg module and insole device either (1) for several hours in a lab setting (in-lab testing) or (2) within their home and community for 1 week (in-community testing). Thirty people who are healthy, have mild cognitive impairment, or who have Alzheimer's disease or related dementia will be recruited to participate in the in-lab testing, in which they will perform walking tasks and cognitive testing for several hours within a lab environment. After completion of in-lab testing, 120 individuals who are healthy, have mild cognitive impairment, or who have Alzheimer's disease or related dementia will be recruited to participate in the in-community testing, in which they will wear the insole and ankle device within their community for 1-week for collection of gait data in real world settings.
NCT03653156
The aim of this study is to establish and perfect the China Cognition and Aging Study (China COAST) cohort, to clarify the epidemiology, influencing factors, genetic characteristics, pathogenesis, disease characteristics and diagnosis and treatment status of dementia and its subtypes in China. It is of great significance to establish a relatively comprehensive national database of cognitive disorders, improve the clinical diagnosis and treatment level of cognitive disorders, and formulate prevention and treatment strategies for dementia. The primary aims of China COAST are as follows: 1. To use the prospective cohort to establish a large database research platform, so as to provide comprehensive epidemiological data, clinical and neuropsychological evaluation data, biological samples, and laboratory tests and imaging data. 2. To update the prevalence and incidence rate of dementia and its subtypes every 2-3 years, and clarify the conversion pattern from normal elderly to MCI and from MCI to dementia. 3. To explore the known or unknown protective and risk factors of dementia and its major subtypes (AD, VaD, other dementia). 4. To discover new pathogenic genes and susceptible genes of dementia and its major subtypes (AD and VaD), as well as new mutation sites of known pathogenic genes. To study the genetic variation, mutation and polymorphism of PSEN1, PSEN2, APP and APOE genes in dementia patients, and to understand their distribution and roles in the pathogenesis. 5. To study the biomarkers (body fluid, genetics, imaging) with diagnostic value of MCI, AD (sporadic and familial) and VaD, to define their cut-off values, and to establish prediction models. 6. To study the diagnostic criteria of cognitive normal, MCI, dementia and their subtypes (clinical and molecular subtypes) in the cohort, and to make psychological assessment scales with high sensitivity and specificity, and in line with the characteristics of Chinese people. 7. To find potentially modifiable risk factors for dementia and to study the prevention and intervention effect of non-pharmacological treatment on APOE ε4 carriers, MCI and AD or other dementia patients，which included improvements in education, nutrition, health care, and lifestyle changes. This needs a long time follow-up. 8. To explore the relationship between dementia as well as its major subtype AD and cerebral and systemetic circulatory disorders (for example, mixed dmentia), as well as potential therapeutic strategies. 9. To carry out investigation and researches about dementia related education, improve the awareness of dementia, and strengthen the management of dementia. 10. To investigate the level of stigma and discrimination and its influencing factors in patients with Alzheimer's disease and their caregivers.
NCT07474038
Mild cognitive impairment (MCI) is associated with increased risk of progression to dementia, highlighting the need for accessible interventions to support cognitive health. This randomized controlled trial will evaluate the safety and efficacy of a 12-month artificial intelligence (AI)-supported cognitive rehabilitation program for older adults with MCI. Participants will be recruited from an existing research study conducted within Kaiser Permanente Southern California and randomized 1:1 to either (1) AI-supported cognitive rehabilitation or (2) usual care alone. The intervention combines clinician-delivered telehealth cognitive rehabilitation sessions with daily AI-guided cognitive exercises and education. The primary outcome is change in global cognition at 6 months measured by the Montreal Cognitive Assessment (MoCA)-BLIND. Secondary outcomes at 6 and 12 months include additional measures of cognition, subjective memory, goal attainment, mood, and loneliness. Exploratory outcomes include engagement with the AI intervention and health-related behavioral outcomes derived from electronic health record data. Participant safety will be monitored throughout the study through adverse event tracking, review of AI interactions for safety concerns, and predefined procedures for responding to psychological or clinical risk. This study will determine whether integrating AI-guided cognitive exercises with clinician-delivered rehabilitation improves cognitive and related outcomes in older adults with MCI compared to usual care.
NCT07466615
This study aims to investigate the effects of sensory integration training on cognitive functions, quality of life, and social participation in older adults with Mild Cognitive Impairment (MCI)
NCT06780917
The goal of this observational study is to validate the Creyos online cognitive assessment platform in individuals with mild cognitive impairment, or remitted major depressive disorder. The main objectives of this research are: 1. To confirm the feasibility of administering the Creyos cognitive battery to older adults with Mild Cognitive Impairment MCI) or Major Depressive Disorder in remission (rMDD). 2. To determine whether the Creyos battery can detect changes in cognition that are predictive of changes on paper-and-pencil neuropsychological testing ("gold standard") over up to five years. Participants will complete both in-person neuropsychological testing yearly as well as the Creyos online battery quarterly for up to 5 years, to allow us to compare performance on these two batteries over time.
NCT07449117
The purpose of this study is to investigate the immediate effects of non-invasive temporal interference stimulation (TIS) targeting the striatum on sentence processing and brain connectivity in patients with neurodegenerative diseases.
NCT06397469
The goals of the proposed research are to first determine the minimal and/or optimal dose of a digital intervention required for cognitive enhancement, and then to examine the impact of several potential moderators of treatment effects (i.e., cognitive decline, AD polygenic hazard score, cardiovascular risk, and race/ethnicity). This knowledge gained from his high-impact study with transform the field of cognitive interventions, paving the way for a precision medicine model for cognitive enhancing interventions that improve quality of life for older adults and individuals with cognitive deficits at risk of developing dementia.
NCT07420426
This study aims to develop an automated instant message-delivered intervention (i.e., EMI) for people with mild cognitive impairment, and to investigate the feasibility and effectiveness of the intervention.
NCT07422857
This study is to evaluate the efficacy and safety of \[18F\]-APN-1607 Injection in PET imaging for detecting AD-related cognitive impairment.
NCT07402590
This study aims to evaluate the efficacy and safety of Elevvo AudiStim, a sleep auditory stimulation device, as a symptomatic treatment for patients with amnestic mild cognitive impairment (aMCI).