1 Enrichment through biomarkers in clinical trials of Alzheimer's drugs in patients with mild cognitive impairment Marco Lorenzi; Michael Donohue; Donata Paternicò; Cristina Scarpazza; Susanne Ostrowitzki; Olivier Blin; Elaine Irving; Giovanni B Frisoni and the Alzheimer's Disease Neuroimaging Initiative
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Enrichment through biomarkers in clinical trials of Alzheimer's drugs in patients with mild
Marco Lorenzi; Michael Donohue; Donata Paternicò; Cristina Scarpazza; Susanne Ostrowitzki; Olivier Blin; Elaine Irving; Giovanni B Frisoni and the Alzheimer's Disease Neuroimaging Initiative. Enrichment through biomarkers in clinical trials of Alzheimer's drugs in patients with mild - PowerPoint PPT Presentation
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Enrichment through biomarkers in clinical trials
of Alzheimer's drugs in patients with mild
cognitive impairmentMarco Lorenzi; Michael Donohue; Donata Paternicò; Cristina Scarpazza;
Susanne Ostrowitzki; Olivier Blin; Elaine Irving; Giovanni B Frisoni and the Alzheimer's Disease Neuroimaging Initiative
2Frisoni et al. Nat Rev Neurol 2010
100%
0%
Ma
rke
r a
bn
orm
ality
(%
)
Normal MCI Dementia
Clinical Trials on MCI
Frisoni et al, 2010 -Jack et al, 2010
Earliest stage for recruiting patients with
Alzheimer’s Disease
Maximal effectiveness of treatments with drugs
3
Clinical Trials on MCI
Feldman et al. 2007, Loy and Schneider, 2006, Petersen et al., 2005, Raschetti et al., 2007, Salloway et al., 2004 Potential Cause:
(Visser et al, 2005)
MCI population inhomogeneity
NO significant treatment effect
~50% converters to
Alzheimer
~50% non converters
Trials with anti-dementia drugs on MCI
4
Enrichment of the statistical population with true AD cases
A strategy to increase the statistical power
MCI future converters
MCI non converters
Definition of an optimal marker for screening
SCREENED POSITIVE
SCREENED NEGATIVE
• Maximize true AD screened-in
(true positive rate)
• Minimize true AD screened-out
(false negative rate)
Aim of the studyInvestigate the enrichment properties of the different