Clinical trial NCT06896201: Comfortage - AD Prevention Strategies
Official title: Comfortage - Integration of Biomarkers, Genetic and Clinical Risk Factors for AD Prevention Strategies
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Alzheimer Disease
Subjective Cognitive Impairment
Mild Cognitive Impairment
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2025-03-26
Enrollment: 200
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Interventional, cross-sectional, clinical trial without drug and without device
Primary purpose: PREVENTION

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


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

Primary outcomes:
measure: Changes in cognitive performance and quality of life through cognitive scales (MiniMental State Examination)
timeFrame: after 36 months
measure: Changes in cognitive performance and quality of life through cognitive scales (Clinical Dementia Rating Scale)
timeFrame: after 36 months
measure: Changes in cognitive performance and quality of life through cognitive scales (Activities of the Daily Living)
timeFrame: after 36 months
measure: Changes in cognitive performance and quality of life through cognitive scales (Instrumental activities of the daily living)
timeFrame: after 36 months
measure: Changes in cognitive performance and quality of life through questionnaires (Quality of sleep)
timeFrame: after 36 months
measure: Changes in cognitive performance and quality of life through questionnaires (Cognitive reserve)
timeFrame: after 36 months
Secondary outcomes:
measure: Measure of improvement in cognitive functioning
timeFrame: after 36 months
measure: Measure of improvement in cognitive functioning
timeFrame: after 36 months
measure: Measure of improvement in quality of life
timeFrame: after 36 months
measure: Measure of improvement in quality of life
timeFrame: after 36 months
measure: inflammatory blood biomarker levels
timeFrame: after 36 months
measure: Measure of improvement in user satisfaction
timeFrame: after 36 months
measure: Measure of changes in brain connectivity
timeFrame: after 36 months
Other outcomes:
Locations:
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