Comfortage - AD Prevention Strategies (Comfortage-P4)

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Not yet enrolling

Conditions: Alzheimer Disease; Mild Cognitive Impairment; Subjective Cognitive Impairment

Treatments: Other: Connectivity Analysis; Other: Nutrition; Device: Eligence; Device: Healthentia; Device: Physical Activity; Biological: Blood Exams, Fluid Biomarkers, Genetics; Diagnostic Test: Neuropsychological Assessments and Other Questionnaires

Study type: Interventional

Funder types: Other

Identifiers

NCT06896201

7334

Details and patient eligibility

About

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

Enrollment: 200 estimated patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

SCD/MCI

Other group

Description:

This 2 years study will include 100 individuals from two distinct clinical categories: * subjects with subjective cognitive decline * subjects with mild cognitive decline

Treatment:

Diagnostic Test: Neuropsychological Assessments and Other Questionnaires

Biological: Blood Exams, Fluid Biomarkers, Genetics

Device: Physical Activity

Device: Healthentia

Other: Nutrition

Device: Eligence

Other: Connectivity Analysis