Digital platform for early detection of Alzheimer-related memory impairment
Neurocognitive Assessment Platform 4 Alzheimer
IRCCS San Raffaele · NCT07272811
The platform will be tested to see if combining EEG, eye-tracking, and blood flow sensors can detect early memory-related cognitive impairment in people aged 55–80.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 55 Years to 80 Years |
| Sex | All |
| Sponsor | IRCCS San Raffaele (other) |
| Locations | 1 site (Milan, Italy) |
| Trial ID | NCT07272811 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 55–80 who either have normal cognition (MMSE ≥28 and no domain-specific deficits) or have suspected amnestic MCI with self/family-reported memory complaints, objective domain-specific deficits, and largely preserved daily functioning.
Not a fit: People with established dementia, significant functional impairment in daily living, major uncontrolled psychiatric or neurological disorders, or those outside the 55–80 age range are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the platform could enable earlier, simpler detection of amnestic MCI using non-invasive tests, which may prompt earlier support and management.
How similar studies have performed: Previous research using EEG and eye-tracking has shown promise for detecting MCI and early Alzheimer changes, but combining multiple biometric sensors into a single validated diagnostic platform is still relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Milan, Italy
- IRCCS San Raffele — Milan, Italy, Italy (RECRUITING)
Study contacts
- Study coordinator: Elisa Canu, PhD
- Email: canu.elisa@hsr.it
- Phone: 00390226433051
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: MCI, MCI Conversion to Dementia, AMCI - Amnestic Mild Cognitive Impairment, Alzheimer Disease