Striving for an integrated drug-development process for neurodegeneration: the coalition against major diseases

SUMMARY Alzheimer’s and Parkinson’s diseases are the two main neurodegenerative disorders and despite the public health need, drug development for these conditions has been plagued by a high attrition rate in the late phases of evaluation. In order to improve the efficiency of the drug development process for these conditions, the Coalition Against Major Diseases was formed by the Critical Path Institute in September 2008, in collaboration with the Engelberg Center for Health Care Reform at the Brookings Institution (Washington, DC, USA), with the aim of sharing precompetitive patient level data from legacy clinical trials, and transforming those data into generalizable and shareable knowledge in the form of drug development tools for Alzheimer’s and Parkinson’s diseases. As of May 2011, Coalition Against Major Diseases has 21 members (14 pharmaceutical companies and seven patient groups), joined by the US FDA, the European Medicines Agency, the National Institute of Aging and the National Institute of Ne...

[1]  I. Olkin,et al.  Improving the quality of reports of meta‐analyses of randomised controlled trials: the QUOROM statement , 2000, Revista espanola de salud publica.

[2]  Ricardo Nitrini,et al.  Criteria for the diagnosis of Alzheimer’s disease: Recommendations of the Scientific Department of Cognitive Neurology and Aging of the Brazilian Academy of Neurology , 2011, Dementia & neuropsychologia.

[3]  C R Jack,et al.  Serial MRI and CSF biomarkers in normal aging, MCI, and AD , 2010, Neurology.

[4]  C. Jack,et al.  Hypothetical model of dynamic biomarkers of the Alzheimer's pathological cascade , 2010, The Lancet Neurology.

[5]  G. Linazasoro,et al.  Recent failures of new potential symptomatic treatments for parkinson's disease: Causes and solutions , 2004, Movement disorders : official journal of the Movement Disorder Society.

[6]  R. Petersen Mild cognitive impairment as a diagnostic entity , 2004, Journal of internal medicine.

[7]  Werner Poewe,et al.  A double-blind, delayed-start trial of rasagiline in Parkinson's disease (the ADAGIO study): prespecified and post-hoc analyses of the need for additional therapies, changes in UPDRS scores, and non-motor outcomes , 2011, The Lancet Neurology.

[8]  C. Jack,et al.  Antemortem MRI findings correlate with hippocampal neuropathology in typical aging and dementia , 2002, Neurology.

[9]  S. Papapetropoulos Preladenant in patients with Parkinson's disease and motor fluctuations: a phase 2, double-blind, randomised trial , 2011 .

[10]  Brad J Kolls,et al.  A PHASE 2 MULTIPLE ASCENDING DOSE TRIAL OF BAPINEUZUMAB IN MILD TO MODERATE ALZHEIMER DISEASE , 2010, Neurology.

[11]  Kaori Ito,et al.  Disease progression meta-analysis model in Alzheimer's disease , 2010, Alzheimer's & Dementia.

[12]  Marc R Gastonguay,et al.  Pharmacometrics as a Discipline Is Entering the “Industrialization” Phase: Standards, Automation, Knowledge Sharing, and Training Are Critical for Future Success , 2010, Journal of clinical pharmacology.

[13]  Mary Sano,et al.  Current Alzheimer's disease clinical trials: Methods and placebo outcomes , 2009, Alzheimer's & Dementia.

[14]  A. Rajput,et al.  Accuracy of Clinical Diagnosis in Parkinsonism — A Prospective Study , 1991, Canadian Journal of Neurological Sciences / Journal Canadien des Sciences Neurologiques.

[15]  S. Gacinovic,et al.  Accurate differentiation of parkinsonism and essential tremor using visual assessment of [123I]‐FP‐CIT SPECT imaging: The [123I]‐FP‐CIT study group , 2000, Movement disorders : official journal of the Movement Disorder Society.

[16]  P. Scheltens,et al.  Research criteria for the diagnosis of Alzheimer's disease: revising the NINCDS–ADRDA criteria , 2007, The Lancet Neurology.

[17]  K. Romero,et al.  The Coalition Against Major Diseases: Developing Tools for an Integrated Drug Development Process for Alzheimer's and Parkinson's Diseases , 2009, Clinical pharmacology and therapeutics.