Neurocognitive Assessment Platform 4 Alzheimer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age55-80
SponsorIRCCS San Raffaele
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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)
Disqualifiers
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)
Trial 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.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
100 Participants
are grouped into 2 trial groupsGroup A: aMCI patients
Group B: Healthy Controls
Trial outcomes
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)
Time frame
12 monthsSecondary outcomes
1
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)
Time frame
12 months2
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
Time frame
12 monthsSponsors and contacts
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Source ClinicalTrials.gov