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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
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| 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 |
| 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 |
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Inclusion criteria common to both experimental groups:
Specfic inclusion criteria for Healthy Controls recruitment:
Specific inclusion criteria for aMCI recruitment:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elisa Canu, PhD | Contact | 00390226433051 | canu.elisa@hsr.it | |
| Virginia Sanchini, PhD | Contact | sanchini.virginia@hsr.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS San Raffele | Recruiting | Milan | Italy | 20132 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30619031 | Background | 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. | |
| 18039130 | Background |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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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 |
| Yankner BA, Lu T, Loerch P. The aging brain. Annu Rev Pathol. 2008;3:41-66. doi: 10.1146/annurev.pathmechdis.2.010506.092044. |
| 16009779 | 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. |
| 25773610 | 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. |
| 21514249 | 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. |
| 28286479 | 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. |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |