NCT07272811Recruiting
Neurocognitive Assessment Platform 4 Alzheimer
Source: ClinicalTrials.gov · Last updated 22 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 100 (estimated)
- First submitted
- 26 Nov 2025
- Start date
- 15 Dec 2021
- Primary completion date
- 30 Jun 2026
- Lead sponsor
- IRCCS San Raffaele
- Diseases
- Alzheimer disease
- NCT number
- NCT07272811
What you commit to
- Study type: Observational
- Planned participants: 100
- From 15 Dec 2021 to the primary completion date, 30 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current or previous history of psychiatric illness
- Current or previous degenerative pathology of the central nervous system (CNS)
Other illness
- Presence of systemic diseases in anamnesis
Other
- Rejection of informed consent
- Important sensory deficits (e.g., hearing loss or hypovisus)
- Presence of cerebrovascular events in anamnesis
- Use of alcohol or psychotropic substances in anamnesis
Who the study is looking for
- 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.
Age in the registry: 55 years to 80 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IRCCS San Raffele Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.