Cerebrospinal Fluid (CSF) Biomarkers Alzheimer's Disease (AD) and Non-AD Dementias
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|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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|