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NCT07481903
This clinical trial aims to assess whether electroacupuncture (EA) can alleviate the psychoneurological symptom cluster (including pain, fatigue, insomnia, anxiety, depression and subjective cognitive decline) in breast cancer survivors, and to evaluate the safety of this therapy. Researchers will conduct a randomized controlled trial of electroacupuncture (EA) as compared to sham electroacupuncture (SA) in breast cancer survivors with the psychoneurological symptom cluster who are currently being treated with endocrine therapy. Participants will receive 16 treatments over 8 weeks. The EA group will receive true acupuncture with continuous wave stimulation (2Hz, intensity as tolerated) administered for 30 minutes per session. The SA group will receive sham acupuncture using blunt (non-penetrating) needles that contact the skin without penetration, along with a 30-second transient device activation instead of the 30-minute continuous stimulation. Treatment outcomes for pain, fatigue, insomnia, anxiety, depression and subjective cognitive function will be assessed. The primary outcome is response rate of the psychoneurological symptom cluster after 8 weeks of treatment. Secondary outcomes include changes from baseline in the scores of each of the six psychoneurological symptoms.
NCT07457138
The goal of this multicenter prospective observational cohort study is to better understand the clinical, neuropsychological, and biological characteristics of individuals attending Brain Health Services (BHS) in the Lombardy region. The study focuses on adults with subjective cognitive decline (SCD), functional cognitive disorder (FCD), or "well worried" individuals without objective cognitive impairment. The main questions it aims to answer are: * What clinical, cognitive, and biological differences exist between individuals who are positive versus negative for Alzheimer's disease (AD) plasma biomarkers (p-tau217) at baseline? * What factors predict positivity to AD biomarkers at baseline? * How does communication of biomarker results (risk disclosure) affect psychological well-being shortly after receiving results? * What factors predict longitudinal changes in AD biomarkers over 5 years? * Do baseline biomarkers predict the development of mild cognitive impairment (MCI) or dementia during follow-up? Participants will: * Undergo standard clinical evaluation at their local BHS * Provide blood samples for plasma biomarker analysis (e.g., p-tau217, GFAP, NfL, ApoE) * Undergo neuropsychological testing and cognitive screening * Complete questionnaires assessing psychological impact and risk perception (before and after biomarker disclosure) * Undergo additional center-specific procedures when clinically indicated (e.g., MRI, lumbar puncture, polysomnography) * Be followed annually for 5 years The study plans to enroll approximately 1000 participants across multiple BHS in Lombardy and will follow them for a total duration of 7 years. The results will help clarify the role of biomarkers in early cognitive complaints and support the development of preventive strategies within BHS.
NCT07463391
Subjective cognitive decline (SCD) is considered a preclinical condition associated with an increased risk of dementia and Alzheimer's disease. Effective early behavioral interventions remain limited, and the neurobiological mechanisms underlying cognitive training effects are not fully understood, particularly in culturally specific educational contexts. This randomized, assessor-blinded, controlled clinical trial will enroll 60 individuals with SCD to evaluate the effects of a six-month structured Chinese Classics recitation training program. Participants will be randomly assigned to either an intervention group or a non-active control group. Assessments will be conducted at baseline, immediately post-intervention, and during annual follow-up. Multimodal evaluations will include neuropsychological testing, functional magnetic resonance imaging (fMRI), electroencephalography (EEG), blood biomarker profiling, gut microbiota analysis, and fecal metabolomics. The study aims to examine clinical outcomes and explore potential neurobiological and systemic correlates associated with culturally adapted cognitive training.
NCT07286448
The goal of this clinical trial is to determine whether a home-based digital cognitive-training program called RICORDO can enhance patients' ability to manage their own health and daily life when they have Mild Cognitive Impairment (MCI) or Subjective Cognitive Decline (SCD) and are 50 years of age or older. The main questions it aims to answer are: Does using RICORDO for five weeks raise the Patient Activation Measure (PAM) score more than an at-home paper-and-video education program called S.A.M.B.A.? Does RICORDO also improve cognition, everyday functioning, quality of life and mood compared with S.A.M.B.A.? Researchers will compare individuals who train with RICORDO to those who follow S.A.M.B.A. to determine which approach is more effective. Participants will be randomly assigned to one of the two groups and complete three 45-minute sessions per week at home for five weeks. They will also visit the clinic at the beginning and end of the program to complete questionnaires and take brief thinking tests.
NCT07376135
The goal of this clinical trial is to learn whether a hybrid multidomain lifestyle program can prevent cognitive decline and reduce dementia risk in community-dwelling adults in mid- to late life who are at increased risk of Alzheimer´s disease or related dementias but do not yet have significant cognitive impairment. The main question the study aims to answer are: * Whether the structured hybrid multidomain lifestyle intervention is feasible (e.g., adherence and retention rate), and how well the digital components are accepted and implemented in the intervention group. * Does the intervention reduces the overall burden of modifiable dementia risk factors and improves global cognitive performance compared with usual care. Researchers will compare participants assigned to the tailored hybrid multidomain lifestyle intervention group with those in a self-guided multimodal lifestyle advice group. Participants assigned to the intervention group will receive a plan adjusted to their individual dementia risk profile. A physician trained in motivational interviewing will review their progress continuously. The self-guided multimodal lifestyle advice group will receive rigid but comprehensible lifestyle health advice with reduced access to digital support tools. Participants will: * Complete an initial risk assessment that uses machine-learning triage to identify and prioritize their most important modifiable dementia risk factors. * Receive personalized recommendations for gradual lifestyle change, including physical activity, nutrition, cognitive training, other dementia risk-factor management (e.g. hearing impairment), stress \& sleep management, and social activities. * Use a smartphone and smartwatch to passively collect digital biomarkers and to complete questionnaires at regular intervals, so that physicians trained in motivational interviewing can adapt goals through shared decision making. * Use a study app as the central access point for the program, including educational content, progress tracking, and gamified challenges with social comparison and incentives.
NCT07212504
The goal of this clinical trial is to test whether an accelerated deep Transcranial Magnetic Stimulation (dTMS) protocol in combination with cognitive training can improve cognitive abilities in older adults with Subjective Cognitive Decline (SCD) or Mild Cognitive Impairment (MCI). The study will look at whether it is safe and tolerable to use accelerated dTMS to enhance the benefits of cognitive training in older adults, and will also gather early information on the effects of accelerated dTMS on memory and other cognitive abilities.
NCT06403345
The purpose of this study is to test the Green Activity Program that was designed with people living with memory challenges and their study partners to see if it can be done and if they enjoy the program. "Green activities" are nature activities that the person enjoys and can be done with other people or pets. For example, dog walking, hiking, outdoor yoga, and gardening are all green activities. The purpose of the program is to help people living with memory challenges participate in nature activities they enjoy. The goal of the program is to help people stay active and improve their health and well-being.
NCT06632145
The goal of this feasibility study is to test the feasibility of a group intervention program based on health management principles for older adults with Subjective Cognitive Decline (SCD). SCD is a condition where individuals feel that their memory is worsening, although standard tests do not detect it. This perceived memory decline can lead to negative feelings and self-perception, causing people to withdraw from meaningful activities. This study aims to answer three main questions: 1. Is the intervention feasible in terms of fidelity, adherence, and participant satisfaction? 2. Are the assessments used sensitive enough to identify the unique challenges faced by the SCD population and detect changes after the intervention? 3. What are the preliminary effects of the intervention on participants' perceptions of how SCD affects their daily life, mental health, and quality of life? Participants will: 1. Take part in 14 weekly group sessions focused on managing the challenges of living with SCD and improving participation in daily activities. 2. Complete assessments before and after the intervention to measure their satisfaction with the program, and track changes in their perceptions of daily life, mental health, and quality of life.
NCT06622889
Subjective cognitive decline (SCD) represents the initial clinical manifestation in the disease spectrum of Alzheimer's Disease (AD). It represents an essential stage for early prevention and treatment of cognitive impairment, making the SCD population an optimal target for prior intervention. This study aims to assess the feasibility and efficacy of an 8-week intervention targeting self-perception of aging in community-dwelling older adults with SCD.
NCT03094546
The overall objective of this study is to examine the effect of polyamine supplementation on cognitive performance and further characterization of individuals with subjective cognitive decline.