Cerebrospinal Fluid (CSF) Biomarkers Alzheimer's Disease (AD) and Non-AD Dementias
|ClinicalTrials.gov Identifier: NCT01730430|
Recruitment Status : Completed
First Posted : November 21, 2012
Last Update Posted : April 22, 2014
|Condition or disease|
|Alzheimer's Disease Dementias|
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.
|Study Type :||Observational|
|Actual Enrollment :||40 participants|
|Observational Model:||Case Control|
|Official Title:||Investigation of Biomarkers of Disease State in Alzheimer's Disease and Non-AD Dementias|
|Study Start Date :||July 2012|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||December 2013|
Collection of CSF
- 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) ]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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|