1. Study Summary

1.1 Title
A pilot study on the utility of CSF and blood biomarkers in the delineation of the aetiopathology
of cognitive impairment and in the prediction of conversion of mild cognitive impairment to dementia.

This is part of a larger European Project, BIOMARKAPD involving 51 research sites worldwide with the objective of developing evidence-based guidelines for the measurement and the use of biochemical biomarkers for Alzheimer’s disease (AD) and Parkinson’s disease (PD) in clinical practice.

1.2 Design
This is a cohort study with a three-year follow up.

1.3 Objectives
The purpose of the study is to explore whether measuring biomarkers of neurodegeneration including protein fragments and other constituents in spinal fluid and in blood of patients with cognitive impairment is helpful in elucidating the underlying cause of their cognitive deficits and for those diagnosed with mild cognitive impairment (MCI), in predicting who will progress to dementia.

1.4 Population
It is aimed to recruit 150 subjects with cognitive deficits to participate in this research study.

1.5 Eligibility
Three main cohorts of patients will be investigated:
1.Patients >65 but <90 years, diagnosed with possible/ mild Alzheimer’ Disease.
2. Patients > 65 but <90 years with mild cognitive impairment (MCI).
3.Patients >45 but <65 years with cognitive deficits/ early onset neurodegeneration.

1.6 Study Duration
3 years