Neurocognitive Assessment Platform 4 Alzheimer

NCT07272811 | Recruiting DMC

• 1 other identifier: NAP4A2020
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

MCI; MCI Conversion to Dementia; AMCI - Amnestic Mild Cognitive Impairment; Alzheimer Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Early diagnosis of aMCI at risk of conversion to AD

  12 months

• Identify the main predictive markers

  12 months

Study Arms (2)

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)

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

IRCCS San Raffele

Milan, Italy, 20132, Italy

RECRUITING

Related Publications (6)

• 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.

  PMID: 30619031 BACKGROUND

• Yankner BA, Lu T, Loerch P. The aging brain. Annu Rev Pathol. 2008;3:41-66. doi: 10.1146/annurev.pathmechdis.2.010506.092044.

  PMID: 18039130 BACKGROUND

• 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.

  PMID: 16009779 BACKGROUND

• 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.

  PMID: 25773610 BACKGROUND

• 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.

  PMID: 21514249 BACKGROUND

• 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.

  PMID: 28286479 BACKGROUND

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Elisa Canu, PhD

CONTACT

00390226433051; canu.elisa@hsr.it

Virginia Sanchini, PhD

CONTACT

sanchini.virginia@hsr.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: November 26, 2025
• First Posted: December 9, 2025
• Study Start: December 15, 2021
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)