Neurocognitive Assessment Platform 4 Alzheimer (NAP4A2020)

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.

Study Overview

• Status: Recruiting
• Conditions: Alzheimer Disease; MCI; AMCI - Amnestic Mild Cognitive Impairment; MCI Conversion to Dementia

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Elisa Canu, PhD; Phone Number: 00390226433051; Email: canu.elisa@hsr.it
• Study Contact Backup: Name: Virginia Sanchini, PhD; Email: sanchini.virginia@hsr.it

Study Locations

• Italy
  • Italy
    • Milan, Italy, Italy, 20132
      • Recruiting
      • IRCCS San Raffele
      • Contact: Massimo Filippi, MD; Phone Number: 00390226433054; Email: filippi.massimo@hsr.it
      • Contact: Elisa Canu, PhD; Email: canu.elisa@hsr.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The study will involve around 100 participants aged 55-80, including 50 with aMCI (single or multiple domain) and 50 healthy controls. Patients will be recruited from the Neurology Unit or dementia care clinics at IRCCS Ospedale San Raffaele. Healthy controls will be selected from the general population based on the study's inclusion and exclusion criteria.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
aMCI patients; Individuals diagnosed with single- or multi-domain amnestic MCI (aMCI)
Healthy Controls; Healthy individuals (with similar sex, age, and education level to the aMCI group)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Development of NAP4A Platform	To create a digital tool for fast and easy cognitive and behavioral assessment to examine the preclinical stage of Alzheimer's: Neurocognitive Assessment Platform 4 Alzheimer (NAP4A)	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Early diagnosis of aMCI at risk of conversion to AD	To identify aMCI individuals at an early stage who are at risk of progression to AD using the Neurocognitive Assessment Platform 4 Alzheimer (NAP4A)	12 months
Identify the main predictive markers	To develop probability markers that predict the likelihood of aMCI individuals converting to AD based on data from the Neurocognitve Assessment Platform 4 Alzheimer	12 months

Collaborators and Investigators

• Sponsor: IRCCS San Raffaele

Publications and helpful links

General Publications

• Albert MS, DeKosky ST, Dickson D, Dubois B, Feldman HH, Fox NC, Gamst A, Holtzman DM, Jagust WJ, Petersen RC, Snyder PJ, Carrillo MC, Thies B, Phelps CH. The diagnosis of mild cognitive impairment due to Alzheimer's disease: recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimers Dement. 2011 May;7(3):270-9. doi: 10.1016/j.jalz.2011.03.008. Epub 2011 Apr 21.
• Petersen RC, Morris JC. Mild cognitive impairment as a clinical entity and treatment target. Arch Neurol. 2005 Jul;62(7):1160-3; discussion 1167. doi: 10.1001/archneur.62.7.1160. No abstract available.
• Bherer L. Cognitive plasticity in older adults: effects of cognitive training and physical exercise. Ann N Y Acad Sci. 2015 Mar;1337:1-6. doi: 10.1111/nyas.12682.
• Zucchella C, Sinforiani E, Tamburin S, Federico A, Mantovani E, Bernini S, Casale R, Bartolo M. The Multidisciplinary Approach to Alzheimer's Disease and Dementia. A Narrative Review of Non-Pharmacological Treatment. Front Neurol. 2018 Dec 13;9:1058. doi: 10.3389/fneur.2018.01058. eCollection 2018.
• Yankner BA, Lu T, Loerch P. The aging brain. Annu Rev Pathol. 2008;3:41-66. doi: 10.1146/annurev.pathmechdis.2.010506.092044.
• Sun Z, van de Giessen M, Lelieveldt BP, Staring M. Detection of Conversion from Mild Cognitive Impairment to Alzheimer's Disease Using Longitudinal Brain MRI. Front Neuroinform. 2017 Feb 24;11:16. doi: 10.3389/fninf.2017.00016. eCollection 2017.

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2021
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: November 26, 2025
• First Submitted That Met QC Criteria: November 26, 2025
• First Posted (Actual): December 9, 2025

Study Record Updates

• Last Update Posted (Actual): January 22, 2026
• Last Update Submitted That Met QC Criteria: January 20, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Dementia; Tauopathies; Neurodegenerative Diseases; Alzheimer Disease
• Other Study ID Numbers: NAP4A2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No