Actively Recruiting

Age: 55Years - 80Years
All Genders
Healthy Volunteers
ID07272811

Neurocognitive Assessment Platform 4 Alzheimer for Early Detection of Amnestic Mild Cognitive Impairment and Alzheimer's Disease

Led by IRCCS San Raffaele · Updated on 2026-01-22

100

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

The increasing aging population in Europe is leading to more cases of neurodegenerative diseases such as Alzheimer's disease (AD), which is expected to affect 152 million people worldwide by 2050. In Italy alone, there are about 1.2 million dementia cases, half of which are due to AD. Current drug treatments have limited effectiveness, so this study focuses on early, non-drug approaches to slow disease progression and improve quality of life for patients and their caregivers. This study aims to develop the Neurocognitive Assessment Platform 4 Alzheimer (NAP4A), a digital tool designed to detect amnestic mild cognitive impairment (MCIa) early. It uses non-invasive devices like EEG, blood flow sensors, and eye-tracking to gather brain and behavioral data. The study involves 100 participants aged 55 to 80, split into two groups: those diagnosed with MCIa and healthy controls matched by sex, age, and education. Assessments will be done regularly over 12 months to find markers that predict the progression to Alzheimer's. Participants will undergo regular evaluations involving neurophysiological and behavioral measurements using the digital platform. Researchers will track cognitive function and other data to identify early changes that may indicate progression from MCIa to AD. The main outcome is the development of the NAP4A platform over 12 months, alongside identifying key predictive markers. Participants' health and cognitive status will be monitored throughout the study, helping to support early diagnosis and targeted interventions.

CONDITIONS

Brief Title

Neurocognitive Assessment Platform 4 Alzheimer

Who Can Participate

Age: 55Years - 80Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent
  • Age between 55 and 80 years
  • No or minimal impact on daily living and instrumental activities
  • For healthy controls: Mini Mental State Examination score of 28 or higher and no abnormal cognitive deficits for age, sex, and education
  • For aMCI patients: Reported cognitive difficulties, Mini Mental State Examination score within 0.5 standard deviations of age- and education-matched controls, and specific memory or multi-domain cognitive impairments below average for age
Not Eligible

You will not qualify if you...

  • Refusal to give informed consent
  • Significant sensory deficits such as hearing loss or poor vision
  • Current or past psychiatric illness
  • Degenerative diseases of the central nervous system
  • History of systemic diseases
  • History of cerebrovascular events
  • Use of alcohol or psychotropic substances in medical history

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - 12 months

Participants are observed over time to assess neurocognitive function related to amnestic mild cognitive impairment and Alzheimer's disease.

Assessments throughout the 12-month period

Trial Site Locations

Total: 1 location

1

IRCCS San Raffele

Milan, Italy, Italy, 20132

Actively Recruiting

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Research Team

E

Elisa Canu, PhD

V

Virginia Sanchini, PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Frequently Asked Questions

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Published Research Related To This Trial

The Multidisciplinary Approach to Alzheimer's Disease and Dementia. A Narrative Review of Non-Pharmacological Treatment.

Chiara Zucchella, Elena Sinforiani, Stefano Tamburin...

https://pubmed.ncbi.nlm.nih.gov/30619031

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.

Marilyn S Albert, Steven T DeKosky, Dennis Dickson...

https://pubmed.ncbi.nlm.nih.gov/21514249

Detection of Conversion from Mild Cognitive Impairment to Alzheimer's Disease Using Longitudinal Brain MRI.

Zhuo Sun, Martijn van de Giessen, Boudewijn P F Lelieveldt...

https://pubmed.ncbi.nlm.nih.gov/28286479