Identification of biomarkers sensitive to disease progression in patients with Mild Cognitive Impairment. Two-part Research: Part A

• Conditions: Healthy SubjectsMild Cognitive ImpairmentAlzheimer's disease / Alzheimer dementia; F00.0; F00.1; F00.2; F00.9; F06.7; Dementia in Alzheimer disease with early onset; Dementia in Alzheimer disease with late onset; Dementia in Alzheimer disease, atypical or mixed type; Dementia in Alzheimer disease, unspecified

• Registration Number: DRKS00003721
• Lead Sponsor: QUALISSIMA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04-18
• Study Completion: 2012-09-19
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Participants will be (i) healthy volunteers (between 50 and 80 years old) and/or (ii) subjects (between 50 and 80 years old), who will perform a 3T-MRI for reasons such as migraine, headache, auditory or visual symptoms, paresthesias, and whose scan will be negative (see exclusion criteria below). Such subjects will be selected and asked to perform additional sequences according to the part A study protocol.

Exclusion Criteria

-Ischaemic lesions already detected in a previous scan
-Head injury with loss of consciousness > 24 hours
-Current substance abuse
-Current therapy with steroids or current chemotherapy
-Loss of weight > 5 kg in the last 6 months
-Systemic disease with frequent involvement of the CNS (lupus, HIV, rheumatoid arthritis)
-CNS disease diagnosed by a specialist or in treatment (such as epilepsy, ictus)
-Cerebral metastasis or CNS primary tumour still benign (except for pituitary microadenoma)
-Suspected multiple sclerosis + MRI evidence of white matter lesions
-Suspected recent stroke + MRI evidence of infarct
-Aneurysm > 10 mm and arteriovenous malformations (except for venous angioma)
-Dysgenesia of central nervous system

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Magnetic Resonance Imagery protocol [ Time Frame: Two sessions, one week apart] [ Designated as safety issue: No ]<br><br>The Magnetic Resonance Imagery protocol comprises a localiser or scout run, 4 structural-volumetric MRI sequences (i.e. 2 MP-RAGE, 1 FLAIR and 1 T2*), a resting state functional MRI acquisition (i.e. rsfMRI) and a diffusion tensor scan (i.e. DTI) that will be conducted at the magnetic field strength of 3T. <br><br>The main parameter of efficacy will be the reliability of the acquired MRI data (in terms of their correct acquisition and limited variability).