Neurocognitive Assessment Platform 4 Alzheimer

Обзор

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.

Первичные конечные точки

• Development of NAP4A Platform [Срок оценки: 12 months]

Вторичные конечные точки (2)

• Early diagnosis of aMCI at risk of conversion to AD [Срок оценки: 12 months]
• Identify the main predictive markers [Срок оценки: 12 months]

Критерии участия

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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Италия · 1 центр

• IRCCS San Raffele — Milan

Публикации

• 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
• 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
• 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
• 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
• 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- PMID 21514249
• 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

Идентификаторы

NCT: NCT07272811 · NAP4A2020

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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