Biomarkers

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ResearchersAgainstAlzheimer's would like to thank Roche Diagnostics for their support of this project.
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Multi-modal Neuroimaging

Method of Measurement (Pre-analytical Tools)
Blood/Plasma
Imaging
CSF
Biomarker Measured
Amyloid
Use
Diagnostic
Susceptibility/risk
Stage of Development
Clinical trials
Active vs Completed Trials
Active
Aim/Results

To 1. identify, compare and combine the predictive markers of AD, 2. better understand the pathophysiologic mechanisms of AD, and 3. study the ability of different neuroimaging techniques to monitor AD's evolution. Subjects are evaluated using neuropsychological tests of episodic memory (encoding vs. retrieval), executive functions (inhibition, flexibility, and updating processes), self-judgment, theory of mind, mental imagery and verbal fluency. A FDG-PET measure of resting state glucose consumption, an AV45-PET measure of amyloid deposition as well as anatomical, resting-state and activation fMRI scans are performed for each volunteer. In addition, blood and cerebro-spinal fluid samples will be performed to determine different biomarkers (Aβ1-40, Aβ1-42 and tPA as circulating blood proteins and Aβ40, Aβ42, tau and its phosphorylated form in CSF). The investigators also study the polymorphism of Apolipoprotein E as a genetic risk factor of AD. (IMPA+)

Target Population/ Population Being Studied

One hundred and twenty healthy controls (40 young, 40 middle age and 40 elderly), 40 Mild Cognitive Impairment patients (MCI; i.e. isolated memory impairment and increased risk of developing AD) and 30 AD patients will be selected. Participants with increased risk of developing AD and without objective evidence will be also studied: 50 asymptomatic subjects from families carrying a genetic mutation with an autosomal dominant transmission (NORMA) and 40 Subjective Cognitive Impairment patients (SCI). (IMAP+)

Length of Current Trial
3 years (IMPA+)
Number of Trial Participants

295 (IMPA+)

Estimated Trial Completion
December 2021 (Primary completion date)
What is Required from Patients

Invasive lumbar puncture, discomfort, recovery time in clinic to decrease risk of spinal fluid leakage, blood draw, injection of PET dye, entering an fMRI machine (can induce claustrophobia), multiple in clinic visits

What is Required from the Health System

fMRI machine, PET scanner, dyes, cognitive tests, physican who can preform a lumbar puncture as well as a clinic designed for this testing, phlebotomist, equipped lab (e.g., centrifuge), a way to measure the peptide (e.g.,mass spectrometer, protein assay kit, ELISA, or western blot)

Sponsor

University Hospital, Caen; Institut National de la Santé Et de la Recherche Médicale, France

  1. “Multi-modal Neuroimaging in Alzheimer's Disease (IMAP).” ClinicalTrials.gov. Accessed October 10, 2019. https://clinicaltrials.gov/ct2/show/NCT01554202?term=biomarker&recrs=abdf&cond=Alzheimer+Disease&draw=4&rank=31

  2. “Multi-modal Neuroimaging in Alzheimer's Disease (IMAP+).” ClinicalTrials.gov. Accessed October 10, 2019. https://clinicaltrials.gov/ct2/show/NCT01638949?term=biomarker&recrs=abdf&cond=Alzheimer+Disease&draw=2&rank=19