NCT07272811 Neurocognitive Assessment Platform 4 Alzheimer
| NCT ID | NCT07272811 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS San Raffaele |
| Condition | MCI |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2021-12-15 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2021-12-15 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The aging population in Europe is leading to an increase in neurodegenerative diseases, such as Alzheimer's disease (AD), which is expected to affect 152 million people worldwide by 2050. In Italy, there are approximately 1.2 million cases of dementia, with 600,000 attributed to AD. Given the limited effectiveness of current pharmacological treatments, there is a growing need for early, non-pharmacological interventions to slow disease progression and improve the quality of life for patients and caregivers. The Neurocognitive Assessment Platform 4 Alzheimer (NAP4A) study aims to create a digital platform for the early detection of amnestic mild cognitive impairment (MCIa), considered an intermediate stage between normal aging and dementia. The platform uses non-invasive biometric tools, including EEG, blood flow sensors, and eye-tracking devices, to collect neurophysiological and behavioral data. The study will involve 100 participants aged 55 to 80, divided into two groups: one with individuals diagnosed with MCIa and a control group of healthy participants. Over 12 months, regular assessments will be conducted to identify markers that predict the progression from MCIa to AD. The goal is to develop advanced diagnostic tools that support early and targeted interventions.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07272811 clinical trial?
This trial is open to participants of all sexes, aged 55 Years or older, up to 80 Years, studying MCI. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07272811 currently recruiting?
Yes, NCT07272811 is actively recruiting participants. Contact the research team at canu.elisa@hsr.it for enrollment information.
Where is the NCT07272811 trial being conducted?
This trial is being conducted at Milan, Italy.
Who is sponsoring the NCT07272811 clinical trial?
NCT07272811 is sponsored by IRCCS San Raffaele. The trial plans to enroll 100 participants.