Comfortage - AD Prevention Strategies

Official title

Comfortage - Integration of Biomarkers, Genetic and Clinical Risk Factors for AD Prevention Strategies

Overview

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

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 behavi
• 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, neu
• 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 fo
• 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 Vivosma
• 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 d
• 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 individual
• 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 incl

Primary outcome measures

• Changes in cognitive performance and quality of life through cognitive scales (MiniMental State Examination) [Time frame: after 36 months]
• Changes in cognitive performance and quality of life through cognitive scales (Clinical Dementia Rating Scale) [Time frame: after 36 months]
• Changes in cognitive performance and quality of life through cognitive scales (Activities of the Daily Living) [Time frame: after 36 months]
• Changes in cognitive performance and quality of life through cognitive scales (Instrumental activities of the daily living) [Time frame: after 36 months]
• Changes in cognitive performance and quality of life through questionnaires (Quality of sleep) [Time frame: after 36 months]
• Changes in cognitive performance and quality of life through questionnaires (Cognitive reserve) [Time frame: after 36 months]

Secondary outcome measures (7)

• Measure of improvement in cognitive functioning [Time frame: after 36 months]
• Measure of improvement in cognitive functioning [Time frame: after 36 months]
• Measure of improvement in quality of life [Time frame: after 36 months]
• Measure of improvement in quality of life [Time frame: after 36 months]
• inflammatory blood biomarker levels [Time frame: after 36 months]
• Measure of improvement in user satisfaction [Time frame: after 36 months]
• Measure of changes in brain connectivity [Time frame: after 36 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06896201 · 7334

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗