Identification of Biomarkers Sensitive to Disease Progression in Patients With Mild Cognitive Impairment

Summary

THE STUDY WILL BE A TWO-PART RESEARCH

PART A and PART A extended:

1. To implement a "common" MRI acquisition protocol in multiple centers across Europe (Pharma-COG partners).
2. Apply the common MRI protocol on phantoms and human subjects to characterize, compare and minimize test-retest variability across the MR sites of WP5 for all the quantitative metrics that will be later assessed on patients.

PART B: By collecting clinical, biochemical, neuroimaging, neuropsychological and neurophysiological data in Mild Cognitive Impairment patient, we aim to:

1. To develop a biomarker MATRIX (made of a combination of biological secondary endpoints) which is more sensitive than the changes observed in the loss of hippocampal volume (primary endpoint) and correlate with the neuropsychological progression and conversion (clinical secondary endpoints).
2. To develop a biomarker MATRIX (made of a combination of biological secondary endpoints) at baseline which is more predictive of the loss of hippocampal volume (primary endpoint) and neuropsychological progression (clinical secondary endpoint) in MCI patients.
3. To harmonize the biomarker MATRIX collection and qualify multiple centres across Europe

Conditions

• MILD COGNITIVE IMPAIRMENT

Interventions

PROCEDURE

Lumbar puncture

All the patients will be divided in two groups based on their Aβ 1-42 levels measured in the cerebro-spinal fluid obtained form a lumbar puncture: in low Aβ1-42 (positive aMCI patients CSFP) and high Aβ1-42 (Negative aMCI patients CSFN). The threshold of Aβ1-42 used to divide the patient will be 500 (ng/L) based on Sjogren criteria (2001). Timeframe of lumbar punctures: every 18 months during 2 years (T0 and T18) or 3 years (T0, T18 and T36).

Sponsors & Collaborators

• European Union

  collaborator OTHER

• Qualissima

  lead OTHER

Principal Investigators

• Giovanni Frisoni, MD, MP · Istituto di Ricovero e Cura a Carattere Scientifico, San Giovanni di Dio Fatebenefratelli, Brescia, Italy

• Mira Didic, MD · Université de la Méditerranée, Service de Neurologie et Neuropsychologie, Marseille France

• Jose-Luis Molinuevo, PhD · Institut d'Investigacions Biomèdiques August Pi I Sunyer, Barcelona, Spain

• Regis Bordet, MD · Université Lille 2, Lille, France

• Pierre Payoux, MD · Institut National de la Santé et de la Recherche Médicale, Toulouse, France

• Peter Schönknecht, MD · Universitätsklinikum Leipzig, Department of Psychiatry and Nuclear Medicine, Leipzig, Germany

• Jens Wiltfang, MD · Universitaet Duisburg-Essen, Department of Psychiatry and Nuclear Medicine, Duisburg-Essen, Germany

• Flavio Mariano Nobili, MD · IRCCS Azienda Ospedaliera Universitaria San Martino-IST

• Magda Tsolaki, MD · Greek Association of Alzheimer's disease and related disorders, Thessaloniki, Greece

• Lucilla Parnetti, MD · Università di Perugia, Clinica Neurologica, Centro Disturbi della Memoria, Perugia, Italy

• Paolo Maria Rossini, MD · Università Cattolica del Sacro Cuore, Policlinico Agostino Gemelli, Istituto di Neurologia, Roma, Italy

• Andrea Soricelli, MD · Istituto di Ricerca Diagnostica e Nucleare, University of Naples Parthenope, Napoli, Italy

• Philip Scheltens, MD · VUmc Alzheimercentrum

Study Design

Allocation

NA

Purpose

PREVENTION

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

50 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2011-12-31

Primary Completion

2015-08-31

Completion

2015-10-31

Countries

• France
• Germany
• Greece
• Italy
• Netherlands
• Spain

Study Locations