PILOT/DEMONSTRATION PROJECTS The primary purpose of the CREATE RDCRC pilot/demonstration research program is to promote biomarker discovery and validation for ALS and related disorders through a small research grant program that funds studies of potential biomarkers during their early stages of development. Priority is given to projects with the most promising clinical research potential. The activities of the CREATE Consortium - longitudinal evaluation of patients with familial and sporadic disease, collection of deep phenotypic data, and the establishment of a repository of biological samples (blood, urine, cerebrospinal fluid) that has been annotated clinically in a detailed manner - are all expected to enhance and facilitate biomarker discovery through the pilot/ demonstration research program. The first pilot/demonstration project will focus on early development of a cerebrospinal fluid biomarker for ALS. Potential projects in subsequent years include development of a urinary biomarker of disease progression and a neuroimaging marker of the imbalance between cortical inhibition and excitability. The CREATE RDCRC will utilize a "request for applications" on an annual basis, to solicit applications and to select the most promising project for funding.

Public Health Relevance

Discovery and validation of both wet and dry biomarkers is recognized as a high priority for ALS and related disorders research. Broadly speaking, biomarkers might facilitate diagnosis, improve our ability to predict prognosis, to demonstrate the biological effect of an investigative therapeutic agent, to predict response to therapy, to monitor disease progression, or even to predict future risk of disease in asymptomatic people at genetic risk for disease.

Agency
National Institute of Health (NIH)
Institute
National Institute of Neurological Disorders and Stroke (NINDS)
Type
Specialized Center--Cooperative Agreements (U54)
Project #
1U54NS092091-01
Application #
8929489
Study Section
Special Emphasis Panel (ZTR1-CI-8 (01))
Program Officer
Gubitz, Amelie
Project Start
2014-09-30
Project End
Budget Start
2014-09-30
Budget End
2015-06-30
Support Year
1
Fiscal Year
2014
Total Cost
$63,055
Indirect Cost
$13,375
Name
University of Miami School of Medicine
Department
Type
DUNS #
052780918
City
Coral Gables
State
FL
Country
United States
Zip Code
33146
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