The Italian INTERCEPTOR Project: From the Early Identification of Patients Eligible for Prescription of Antidementia Drugs to a Nationwide Organizational Model for Early Alzheimer’s Disease Diagnosis

Article type: Research Article

Authors: Rossini, Paolo Maria^{a; b; *} | Cappa, Stefano F.^{c; d} | Lattanzio, Fabrizia^e | Perani, Daniela^f | Spadin, Patrizia^g | Tagliavini, Fabrizio^h | Vanacore, Nicolaⁱ

Affiliations: [a] Area of Neuroscience, University Policlinic A. Gemelli Foundation-IRCCS, Rome, Italy | [b] Institute of Neurology, Catholic University, Rome, Italy | [c] University School for Advanced Studies IUSS Pavia, Pavia, Italy | [d] IRCCS St. John of God, Brescia, Italy | [e] Scientific Direction IRCCS INRCA, Ancona, Italy | [f] Nuclear Medicine Unit and Division of Neuroscience, IRCCS San Raffaele Scientific Institute, Vita-Salute San Raffaele University, Milan, Italy | [g] President “Associazione Italiana Malattia di Alzheimer” – AIMA, Italy | [h] Fondazione IRCCS Istituto Neurologico “Carlo Besta”, Milano, Italy | [i] National Center for Disease Prevention and Health Promotion, National Institute of Health, Rome, Italy

Correspondence: [*] Correspondence to: Paolo Maria Rossini, Largo Agostino Gemelli 1, 00168, Rome, Italy. E-mail: paolomaria.rossini@policlinicogemelli.it.

Abstract: Alzheimer’s disease is the most common age-related neurodegenerative disorder and its burden on patients, families, and society grows significantly with lifespan. Early modifications of risk-enhancing lifestyles and treatment initiation expand personal autonomy and reduce management costs. Many clinical trials with potentially disease-modifying drugs are devoted to mild cognitive impairment (MCI) prodromal-to-Alzheimer’s disease. The identification of biomarkers for early diagnosis may thus be crucial for early intervention and identification of high-risk subjects, the most appropriate target of new drugs as soon as they will be discovered. INTERCEPTOR is a strategic project by the Italian Ministry of Health and the Italian Medicines Agency (AIFA), aiming to validate the best combination (highly accurate, non-invasive, available on the whole national territory and financially sustainable) of biomarkers and organizational model for early diagnosis. 500 MCI subjects will be enrolled at baseline and followed-up for 3 years for at least 400 of them in order to define a “hub & spoke” nationwide model with recruiting (spokes) centers for MCI identification and expert (hubs) centers for risk diagnosis.

Keywords: Alzheimer’s disease, biomarkers, early diagnosis, healthcare organizational models, mild cognitive impairment, prodromal Alzheimer’s disease, public health

DOI: 10.3233/JAD-190670

Journal: Journal of Alzheimer's Disease, vol. 72, no. 2, pp. 373-388, 2019