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Progress and Needs in Biomarker Standardization and

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Progress and Needs in Biomarker
Standardization and Harmonization in AD
Jim Hendrix
Director, Global Science Initiatives
Alzheimer’s Association
CAMD / FDA 2014 Annual Workshop
Alzheimer’s Association
2014 Alzheimer’s Disease Facts and Figures
o More than 5 million Americans living with Alzheimer’s
o Including 200,000 <65 with younger-onset.
o 1 in 9 over age 65 and 1 in 3 over age 85
o Over 15 million people providing care / support for
someone with Alzheimer’s or related dementia
Possible Prevention of
Alzheimer’s?
Advances in Early
Detection
Targeted biochemical
Genetics
Protein production
& clearance rates
Epidemiology
Proteomics
Structural Neuroimaging
Neuropsychometric tests
Functional and Molecular Imaging
Emerging Early Biomarkers
/ Diagnostics
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Outcome Measures: Cognitive / Functional Assessments
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Imaging
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CAMD
Global Biomarker Standardization Consortia (GBSC)
Blood-Based Biomarkers
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PET A (ADNI: Alzheimer’s Disease Neuroimaging Initiative)
PET Tau (proposed for use in clinical research)
MRI - Hippocampal Volume (Harmonized Protocol - HarP)
CSF (ATau)
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ADCOMS (CAMD / C-Path)
Global Biomarker Standardization Consortia (GBSC)
Professional Interest Area (ISAART)
Genetic Testing
Others
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Eye Test
Smell Test
Amyloid PET Imaging / Alzheimer’s
Disease Neuroimaging Initiative (ADNI)
RED = maximum uptake
VIOLET = minimum uptake
Clark et al. (2011) JAMA 305(1).
WW-ADNI
WW-ADNI
C-ADNI
K-ADNI
J-ADNI
E-ADNI
NA-ADNI
T-ADNI
I-ADNI
B-ADNI
ArgADNI
A-ADNI
HarP (Harmonized Hippocampal
Manual Segmentation Protocol)
Leaders: Giovanni Frisoni & Cliff Jack
CSF Biomarkers / Global Biomarkers
Standardization Consortium (GBSC)
•
•
Potentially detects early biological changes
Identify and monitor the biochemical effect of a
drug candidate in clinical trials
Alzheimer's Association Quality Control Program
• Goals for the QC program
– monitor CSF biomarker levels between clinical laboratories
– harmonize levels and facilitate the use of CSF biomarkers
in clinical routine
– monitor assay performance and batch-to-batch variation for
assays
– stimulate / motivate Biotech companies (kit vendors) to
produce high quality assays
Spinal
column
Image from
http://reidhosp.adam.com/content.as
px?productId=39&pid=1&gid=003768
IRMM/IFCC CSF Project
•
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One of 7 institutes of the Joint Research Centre of the European Commission
Has made a formal decision to assist in the development of reference materials
for CSF Aβ42.
Blood-Based Biomarkers
GAAIN Lead Investigator
Receives Rare NIH Award, $23M
Collaboration for
Alzheimer’s Prevention
Summary: Why Biomarker
Qualification?
May lower the risk and shorten timelines for drug
development.
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Hypothesis– Drug candidates failed in clinical trials because
they were tested too late in the course of the disease.
Test drug candidates earlier in the disease progression but
without an accurate biomarker this is a risky and expensive
strategy.
May lead to diagnostic test for clinical use.
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Value in knowing for patients and their families.
Prevention or delay may be possible with life style
interventions.
FDA is an essential partner in this effort
AAIC 2015:
A Shameless Plug
alz.org
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