Comfortage - Integration of Biomarkers, Genetic and Clinical Risk Factors for AD Prevention Strategies
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 200
- Primary Endpoint
- Changes in cognitive performance and quality of life through cognitive scales (MiniMental State Examination)
Overview
Brief Summary
Study is Interventional, cross-sectional, clinical trial without drug and without device
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Masking Description
This study do not involve drug
Eligibility Criteria
- Ages
- 50 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •subjective cognitive decline, defined as self-experienced persistent decline in cognitive capacity in comparison with a previously normal status and unrelated to an acute event; normal performance on standardised cognitive tests adjusted for age, sex, and education; decline cannot be explained by psychiatric or other neurologic disease, medical disorder, medication, or substance use; no functional impact on daily life activities
- •mild cognitive decline, defined as persistent decline in cognitive performance (in comparison with a previous status) reported by the subject or by an informed caregiver; or observed by change on longitudinal cognitive testing; cognitive performance below expected range for that individual based on cognitive test performance (adjusted for age, sex, and education); performs daily life activities independently (but cognitive difficulty may result in detectable but minimal functional impact on the more complex activities of daily life, either self-reported or corroborated by a study partner); Clinical Dementia Rating Scale = 0.5
- •Ability to sign and understand the informed consent form
Exclusion Criteria
- •Age under 50 or over 85 years
- •Non-native Italian speakers
- •Non degenerative and secondary forms of dementia
- •Previous or current participation in clinical trials with anti-amyloid agents
Arms & Interventions
SCD/MCI
This 2 years study will include 100 individuals from two distinct clinical categories:
- subjects with subjective cognitive decline
- subjects with mild cognitive decline
Intervention: Neuropsychological Assessments and Other Questionnaires (Diagnostic Test)
SCD/MCI
This 2 years study will include 100 individuals from two distinct clinical categories:
- subjects with subjective cognitive decline
- subjects with mild cognitive decline
Intervention: Blood Exams, Fluid Biomarkers, Genetics (Biological)
SCD/MCI
This 2 years study will include 100 individuals from two distinct clinical categories:
- subjects with subjective cognitive decline
- subjects with mild cognitive decline
Intervention: Connectivity Analysis (Other)
SCD/MCI
This 2 years study will include 100 individuals from two distinct clinical categories:
- subjects with subjective cognitive decline
- subjects with mild cognitive decline
Intervention: Physical Activity (Device)
SCD/MCI
This 2 years study will include 100 individuals from two distinct clinical categories:
- subjects with subjective cognitive decline
- subjects with mild cognitive decline
Intervention: Healthentia (Device)
SCD/MCI
This 2 years study will include 100 individuals from two distinct clinical categories:
- subjects with subjective cognitive decline
- subjects with mild cognitive decline
Intervention: Eligence (Device)
SCD/MCI
This 2 years study will include 100 individuals from two distinct clinical categories:
- subjects with subjective cognitive decline
- subjects with mild cognitive decline
Intervention: Nutrition (Other)
Outcomes
Primary Outcomes
Changes in cognitive performance and quality of life through cognitive scales (MiniMental State Examination)
Time Frame: after 36 months
Statistically significant differences in changes in cognitive performance and quality of life after a 2-year intervention period, stratified by clinical, genetic, connectivity, and/or biomarker profiles through cognitive scales as MiniMental State Examination.
Changes in cognitive performance and quality of life through cognitive scales (Clinical Dementia Rating Scale)
Time Frame: after 36 months
Statistically significant differences in changes in cognitive performance and quality of life after a 2-year intervention period, stratified by clinical, genetic, connectivity, and/or biomarker profiles through cognitive scale as Clinical Dementia Rating Scale (CDR-SB).
Changes in cognitive performance and quality of life through cognitive scales (Activities of the Daily Living)
Time Frame: after 36 months
Statistically significant differences in changes in cognitive performance and quality of life after a 2-year intervention period, stratified by clinical, genetic, connectivity, and/or biomarker profiles through cognitive scale as Activities of the Daily Living (ADL).
Changes in cognitive performance and quality of life through cognitive scales (Instrumental activities of the daily living)
Time Frame: after 36 months
Statistically significant differences in changes in cognitive performance and quality of life after a 2-year intervention period, stratified by clinical, genetic, connectivity, and/or biomarker profiles through cognitive scale as Instrumental Activities of the Daily Living (IADL) scales.
Changes in cognitive performance and quality of life through questionnaires (Quality of sleep)
Time Frame: after 36 months
Statistically significant differences in changes in cognitive performance and quality of life after a 2-year intervention period, stratified by clinical, genetic, connectivity, and/or biomarker profiles through questionnaire as the quality of sleep (Pittsburgh scale).
Changes in cognitive performance and quality of life through questionnaires (Cognitive reserve)
Time Frame: after 36 months
Statistically significant differences in changes in cognitive performance and quality of life after a 2-year intervention period, stratified by clinical, genetic, connectivity, and/or biomarker profiles through questionnaires as the cognitive reserve (CRIq).
Secondary Outcomes
- Measure of improvement in cognitive functioning(after 36 months)
- Measure of improvement in quality of life(after 36 months)
- inflammatory blood biomarker levels(after 36 months)
- Measure of improvement in user satisfaction(after 36 months)
- Measure of changes in brain connectivity(after 36 months)