Comfortage - AD Prevention Strategies

Not Applicable

Not yet recruiting

• Conditions: Alzheimer Disease; Subjective Cognitive Impairment; Mild Cognitive Impairment
• Interventions: Diagnostic Test: Neuropsychological Assessments and Other Questionnaires; Biological: Blood Exams, Fluid Biomarkers, Genetics; Other: Connectivity Analysis; Device: Physical Activity; Device: Healthentia; Device: Eligence; Other: Nutrition

• Registration Number: NCT06896201
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief Summary

Study is Interventional, cross-sectional, clinical trial without drug and without device

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-26
• Study Start: 2025-03
• Study First Submitted QC: 2025-03-19
• Last Update Submitted: 2025-03-19
• Study First Posted: 2025-03-26
• Last Update Posted: 2025-03-26
• Primary Completion: 2027-03
• Study Completion: 2027-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SCD/MCI	Neuropsychological Assessments and Other Questionnaires	This 2 years study will include 100 individuals from two distinct clinical categories: * subjects with subjective cognitive decline * subjects with mild cognitive decline
SCD/MCI	Blood Exams, Fluid Biomarkers, Genetics	This 2 years study will include 100 individuals from two distinct clinical categories: * subjects with subjective cognitive decline * subjects with mild cognitive decline
SCD/MCI	Connectivity Analysis	This 2 years study will include 100 individuals from two distinct clinical categories: * subjects with subjective cognitive decline * subjects with mild cognitive decline
SCD/MCI	Physical Activity	This 2 years study will include 100 individuals from two distinct clinical categories: * subjects with subjective cognitive decline * subjects with mild cognitive decline
SCD/MCI	Healthentia	This 2 years study will include 100 individuals from two distinct clinical categories: * subjects with subjective cognitive decline * subjects with mild cognitive decline
SCD/MCI	Eligence	This 2 years study will include 100 individuals from two distinct clinical categories: * subjects with subjective cognitive decline * subjects with mild cognitive decline
SCD/MCI	Nutrition	This 2 years study will include 100 individuals from two distinct clinical categories: * subjects with subjective cognitive decline * subjects with mild cognitive decline

Primary Outcome Measures

Name	Time	Method
Changes in cognitive performance and quality of life through cognitive scales (MiniMental State Examination)	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)	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)	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)	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)	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)	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 Outcome Measures

Name	Time	Method
Measure of improvement in cognitive functioning	after 36 months	A greater than 20% improvement in cognitive functioning, as measured by standardized cognitive assessment tool as MontReal Cognitive Assessment (MOCA), after a 2-year intervention period
Measure of improvement in quality of life	after 36 months	A greater than 35% improvement in quality of life, assessed through validated questionnaire as cognitive reserve (CRIq), following the 2-year intervention period
inflammatory blood biomarker levels	after 36 months	Measurable and clinically relevant changes in AD neurodegenerative and inflammatory blood biomarker levels after the 2-year intervention period, correlating these changes with cognitive outcomes
Measure of improvement in user satisfaction	after 36 months	A greater than 45% improvement in user satisfaction and interaction with the novel tools and interventions, as measured by satisfaction questionnaire , after the 2-year intervention period
Measure of changes in brain connectivity	after 36 months	Measurable and clinically relevant changes in brain connectivity as resulted by electroencephalography (EEG) analyses after the 2-year intervention period, correlating these changes with cognitive outcomes.; Regarding EEG analysis, data will be acquired during four successive 5-min runs of alternating eyes-open and eyes-closed conditions using a high-density EEG (128 cephalic electrodes). Frequency bands of interest will be delta (2-4 Hz), theta (4-8 Hz), alpha1 (8-10.5 Hz), alpha2 (10.5-13 Hz), beta1 (13-20 Hz), beta2 (20-30 Hz) and gamma (30-40 Hz).