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NCT Number: NCT07272811

Neurocognitive Assessment Platform 4 Alzheimer

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.

Recruiting

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Key information

Age range

55 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Development of NAP4A Platform

    Time frame: 12 months

    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)

Secondary outcomes

  1. Early diagnosis of aMCI at risk of conversion to AD

    Time frame: 12 months

    To identify aMCI individuals at an early stage who are at risk of progression to AD using the Neurocognitive Assessment Platform 4 Alzheimer (NAP4A)

  2. Identify the main predictive markers

    Time frame: 12 months

    To develop probability markers that predict the likelihood of aMCI individuals converting to AD based on data from the Neurocognitve Assessment Platform 4 Alzheimer

Study contacts

Contact information is provided by the study sponsor or research team.

Elisa Canu, PhD

CONTACT

[email protected]

00390226433051

Virginia Sanchini, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Registry information

Acronym: NAP4A2020

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Dec 9, 2025
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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