Cerebrospinal Fluid (CSF) Biomarkers Alzheimer's Disease (AD) and Non-AD Dementias
To establish a cutoff value using a ratio of CSF tau to Aβ42 (tau/Aβ42) for distinguishing patients wth mild to moderate Alzheimer's disease (AD) from health elderly control subjects. The investigators hypothesize that a cutoff can be found that has at least 80% sensitivity and 60% specificity.
|Study Design:||Observational Model: Case Control
Time Perspective: Cross-Sectional
|Official Title:||Investigation of Biomarkers of Disease State in Alzheimer's Disease and Non-AD Dementias|
- Ratio of CSF tau to Aβ42 (tau/Aβ42) [ Time Frame: CSF will be collected at Visit 1 (up to 30 days after the screening visit) ] [ Designated as safety issue: No ]CSF will be collected in clinic and shipped frozen to Merck's Clinical Development Lab for testing. Any remaining samples will be kept up to 20 years.
Biospecimen Retention: Samples With DNA
Blood, urine and cerebral spinal fluid.
|Study Start Date:||July 2012|
|Study Completion Date:||December 2013|
|Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Collection of CSF
This study will enroll 50 AD subjects, 50 normal controls and approximately 20 subjects with non-AD dementia. There will be 2 visits (up to 30 days apart), and a telephone follow-up visit.
This protocol does not include treatment of subjects. Lumbar puncture and phlebotomy are routine clinical tasks and are associated with a low level of risk. All adverse events will be documented and reviewed by the PI.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01730430
|United States, North Carolina|
|Duke Health Center at Morreene Road|
|Durham, North Carolina, United States, 27705|
|Principal Investigator:||James Burke, MD, PhD||Duke UMC|