Digital platform for early detection of Alzheimer-related memory impairment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study at IRCCS San Raffaele in Milan will enroll about 100 participants aged 55–80 divided into healthy controls and people with amnestic mild cognitive impairment (aMCI). Participants will undergo non-invasive recordings (EEG, eye-tracking, and blood flow sensors) alongside standardized cognitive testing to collect neurophysiological and behavioral data. The project aims to build a digital assessment platform to identify patterns that distinguish early aMCI from normal aging. No drug interventions are involved; data will be used to train and validate detection algorithms.

Why it matters

Who can join: the full rules

Inclusion criteria common to both experimental groups:

* Signature of informed consent
* Age between 55 and 80 years
* Absence of functional impact on daily living activities or minimal impact on instrumental activities

Specfic inclusion criteria for Healthy Controls recruitment:

* Normal global cognitive efficiency (Mini Mental State Examination scores of 28 or higher)
* Absence of specific cognitive deficits (memory and other cognitive domains) that are abnormal for age, sex, and education level (1.5 standard deviations below the mean for age- and education-matched controls), as assessed by objective, standardized cognitive tests.

Specific inclusion criteria for aMCI recruitment:

* Cognitive difficulties reported by the individual, their family member, or their primary care physician
* Normal global cognitive efficiency (Mini Mental State Examination score within 0.5 standard deviations of the average for age- and education-matched control subjects).
* Specific cognitive deficits related to memory or multi-domain cognitive impairments (involving memory and other cognitive domains) that are atypical for the individual's age (1.5 standard deviations below the average for age- and education-matched controls), as determined by objective, standardized cognitive tests.

Exclusion Criteria:

* Rejection of informed consent
* Important sensory deficits (e.g., hearing loss or hypovisus)
* Current or previous history of psychiatric illness
* Current or previous degenerative pathology of the central nervous system (CNS)
* Presence of systemic diseases in anamnesis
* Presence of cerebrovascular events in anamnesis
* Use of alcohol or psychotropic substances in anamnesis

Where it's running

• IRCCS San Raffele
  Milan, Italy, Italy Recruiting

Study contacts

• Study coordinator: Elisa Canu, PhD
• Email: canu.elisa@hsr.it
• Phone: 00390226433051

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.