Development of operational research diagnostic criteria for diagnosis of Alzheimer's disease in the preclinical/predementia phase and implementation of SOPs for imaging and CSF biomarkers in Memory Clinics. An integrated care pathway for early diagnosis and best management in the National Health Service of five Italian regions.

Funded by the Italian Ministry of Health (RF, Bando Ricerca Finalizzata 2011/2012)


Alzheimer disease (AD) is one of the main causes of disability and dependence in old people. The development of national programs to improve early diagnosis and disease management is an imperative need. The present project has two primary objectives:

  1. Development of operational research criteria for early recognition of typical and atypical forms of AD based on a multi-factorial protocol which integrates clinical, imaging, and molecular data;
  2. Implementation of SOPs for imaging and CSF biomarkers in Expert Memory Clinics of the NHS, and dissemination and implementation of an integrated care pathway for dementia at the community setting in different Italian Regions.


Recruitment and clinical evaluation of the study population (Subjective Cognitive Complain (SCC n=100), pre-Mild Cognitive Complain (pre-MCI n=100), MCI (n=100), mild Alzheimer’s Disease (AD, n=100) and healthy controls n=100) will be carried out in eight expert Memory Clinics from four Italian regions. All individuals will undergo comprehensive neuropsychological and neuropsychiatric batteries at baseline and at 12 and 24 months and will undergo lumbar puncture for CSF analysis, MRI and PET measures of metabolic activity (FDG-PET and amyloid-PET).


Simultaneously, an integrated care pathway shared with general practitioners (GPs), Memory Clinics and Community Care Services, based on the available evidence, will be started, in order to timely make diagnosis and intervention to the patients, and to access to a care coordination plan.

This aim will be reached through educational programs addressed to GPs, which will be focused on promoting primary care prevention measures, improving the diagnostic skills of GPs, appropriateness of patients’ referral to specialist care and management of dementia in Memory Clinics. Moreover, clinicians of the selected Memory clinics will be trained in the use of recent biomarkers extraction techniques (e.g. visual and automated assessment of MRI and PET images; CSF biomarkers interpretation).


Early diagnosis and patient stratification will provide a crucial opportunity for clinical trials and timely intervention with disease-modifying drugs that are under development. The implementation of a comprehensive system of care process will have a major impact on National Health Service with direct translation into clinical practice.



InstitutionCityPrincipal Investigators
WP1Fondazione IRCCS Istituto Neurologico “Carlo Besta”.MilanoDr. Fabrizio Tagliavini
WP2Dipartimento di Medicina Nucleare e Divisione di Neuroscienze dell’Università Vita-Salute San Raffaele. MilanoProf.ssa Daniela Perani
WP3Laboratorio di Neuropsichiatria dell’IRCCS Fondazione Santa Lucia.RomaProf. Gianfranco Spalletta
WP4Laboratorio di Neuroimaging e Epidemiologia Alzheimer dell’IRCCS Centro San Giovanni di Dio Fatebenefratelli.BreasciaProf. Giovanni Frisoni
WP5Regione Lombardia, Direzione Generale Sanità, Milano.Con delega alla Direzione Scientifica Fondazione IRCCS Istituto Neurologico “Carlo Besta”.MIlanoDr. Maurizio Bersani, con delega alla Dr.ssa Graziella Filippini.