Status:
NOT_YET_RECRUITING
Comfortage - AD Prevention Strategies
Lead Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions:
Alzheimer Disease
Subjective Cognitive Impairment
Eligibility:
All Genders
50-85 years
Phase:
NA
Brief Summary
Study is Interventional, cross-sectional, clinical trial without drug and without device
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2027
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06896201
Start Date
September 1 2025
End Date
March 1 2027
Last Update
August 26 2025
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