Comfortage - AD Prevention Strategies

Summary

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

Conditions

• Alzheimer Disease
• Subjective Cognitive Impairment
• Mild Cognitive Impairment

Interventions

DIAGNOSTIC_TEST

Neuropsychological Assessments and Other Questionnaires

A brief assessment of the cognitive status will be performed by the means of Mini-Mental State Examination (MMSE), Clinical Dementia Rating Scale (CDR-SB), Activities of the Daily Living (ADL) and Instrumental Activities of the Daily Living (IADL) scales. Moreover, extended neuropsychological assessments assessing memory, language, executive functions, attention and visuospatial perception will be conducted by trained neuropsychologists, as per clinical practice. Concerning depression and behavioural / neuropsychiatric symptoms, which are known to be relevant in cognitive decline and ageing, data will be collected by the means of Neuropsychiatric Inventory (NPI). Additional questionnaires about subjective cognitive decline, quality of sleep (Pittsburgh scale) and cognitive reserve (CRIq) will be conducted on some subgroups of subjects.

BIOLOGICAL

Blood Exams, Fluid Biomarkers, Genetics

All patients will undergo a blood samples collection at T0 and T4, as per clinical practice. Additional blood samples will be collected stored and processed according to literature recommendation-based standardized operating procedures.. Blood will be collected into EDTA tubes and will be immediately refrigerated and centrifugated at 2000x g for 10 minutes. Plasma will then be aliquoted in 0.5 ml polypropylene vials and frozen at -80°C. Levels of blood biomarkers of amyloidopathy, tauopathy, neurodegeneration and neuroinflammation will be measured using the Lumipulse G assays (Fujirebio) and the Multiplex assays for Ella (Biotechne). Whole blood samples will be used for genetic analysis, which will include the determination of APOE genotype

OTHER

Connectivity Analysis

Functional Magnetic Resonance Imaging (fMRI) and/or high-density electroencephalography (EEG) will be used to assess connectivity in selected group of subjects. EEG data will be collected during four 5-minute runs of alternating eyes-open and eyes-closed conditions using a 128-electrode high-density EEG system. The EEG spectral coherence analysis will evaluate the functional coupling between the brain areas under study. Brain connectivity measures will be computed for each frequency band and for each subject, to be used as measure of weight of the graph in a graph analyses. A subsample of subjects will be also investigated with connectivity measures of MRI by applying FA e DTI technique. All the data will be collected both at baseline and after a 2-years-period during which the prevention and intervention strategies will be performed.

DEVICE

Physical Activity

Participants will be proposed an unsupervised, monitored exercise program consisting of three 60-minute sessions of moderate-intensity aerobic exercise (40%-85% of their maximum heart rate) each week. To track exercise intensity. The activity will be personalized according to specific attitude of each subjects including walking session, bike sessions or swim sessions. The type, frequency and intensity of the activity will be recorded by means of a commercially available wearables (Garmin Vivosmart 4, Garmin Vivosmart 5) and the Healthentia application. Those non using the wearables will keep a diary of the activity. Study investigators will ensure both protocol adherence and participant safety through regular follow-up telephone contacts.

DEVICE

Healthentia

Healthentia, developed by Innovation Sprint, is a Software as a Medical Device (SaMD) designed for remote patient monitoring, virtual coaching, and automatic alerts using real-world data. It has been successfully used in over 20 studies and integrates features like teleconsultations, activity tracking, medication management, and support for wearable devices. It provides a patient companion app, offering remote patient monitoring and self-reporting, personalized advice or content in the form of dialogues. It is designed to optimize and improve patient engagement and ensure data integrity. The software facilitates daily self-reporting, providing information to patients and collecting other current data through self-reported questionnaires (health status, physical activity, quality of life, etc.), which will be crucial in order to control the adherence of patients to the program

DEVICE

Eligence

Based Platform exercising the brain and the cognitive skills through 35+ games and activities designed by specialized health experts. It offers over 30 games focusing on cognitive skills such as memory, reasoning, attention, orientation, executive functions, construction skills, and language. It allows healthcare professionals to create personalized training sessions, monitor performance in real-time, and generate detailed evaluation reports. Accessible from any device, it is aimed at individuals in early stages of dementia or rehabilitation phases. In our clinical study, subjects will be trained on seven cognitive programs, which can be executed at home with or without assistance and supervision of a Health Professional (who can easily create personalized sessions to follow-up at distance) and/or an informal carer

OTHER

Nutrition

Participants will follow a personalized nutrition plan, as per clinical practice, receiving dietary advice derived by the same scheme already used in the FINGER project on prevention. The plan focuses on balanced, nutrient-rich meals, based on the reduction of carbohydrate assumption and stable inclusion of seeds, vegetables, fish and omega 3 aliments in the diet that may protect the brain through anti-inflammatory and antioxidant properties. A diary of the meals will be recorded in a diary included in the Healthentia application. No integrated meals or nutraceutical product will be used.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  lead OTHER

Study Design

Allocation

NA

Purpose

PREVENTION

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

50 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-09-30

Primary Completion

2027-03-31

Completion

2027-03-31