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Cerebrospinal Fluid Biomarkers in Alzheimer's Disease and Other Dementias


This observational study seeks to define a biomarker that will distinguish people with Alzheimer's disease from healthy, elderly control subjects. The study will enroll 50 subjects with Alzheimer's, 50 normal controls and approximately 20 subjects with non-Alzheimer's dementia. There will be two visits (up to 30 days apart), and a telephone follow-up visit.

Minimum Age Maximum Age Gender Healthy Volunteers
55 Years 85 Years Both Yes
July 2012
December 2013

All Participants

  • Ability to read at a 6th grade level; history of academic achievement and/or employment sufficient to exclude mental retardation
  • Results of clinical laboratory tests, physical examination, and vital signs within normal limits or clinically acceptable to the investigator within 28 days prior to enrollment
  • Participant or his/her legal representative must sign the informed consent form after the scope and nature of the investigation have been explained

Normal Controls

  • Clinical Dementia Rating (CDR) score of 0; Mini-Mental State Examination (MMSE) score of 28 or higher
  • Z-score of at least -1.0 in each cognitive domain of memory (including delayed recall), language, executive function and attention, and visuoconstruction, with neuropsychological tests of choice and adjustment for age, gender, and education level if indicated

Participants with Alzheimer's

  • Diagnosis of probable Alzheimer's disease (MMSE score between 15 and 26 inclusive; clear history of cognitive and functional decline during at least 1 year that is either documented in medical records or from a person who knows the subject well)
  • MRI or CT scan that is consistent with a diagnosis of Alzheimer's within 12 months prior to enrollment

  • History of stroke
  • Rosen-modified Hachinski Ischemia Score of greater than 4
  • Evidence of a clinically relevant or unstable neurological or psychiatric disorder other than Alzheimer's disease
  • History of alcoholism or drug dependency/abuse within 5 years before enrollment
  • Clinically significant, uncontrolled medical condition that could pose a significant medical risk to the participant
  • Participation within the last 2 months in a clinical trial of a novel therapeutic agent or participation ever in a clinical trial of an Alzheimer's vaccine
  • Pregnancy

The biomarker is measured by a ratio of the levels of two proteins, tau and Aβ42, found in cerebrospinal fluid. The investigators hypothesize that a cutoff value can be found that has at least 80 percent sensitivity and 60 percent specificity. This study will enroll 50 participants with Alzheimer's disease, 50 normal controls, and approximately 20 subjects with non-Alzheimer's dementia. There will be two visits (up to 30 days apart) and a telephone follow-up visit. This protocol does not include treatment for Alzheimer's or any other dementia. A lumbar puncture and blood tests will be done.

Name City State Zip Status Primary Contact
Duke Health Center at Morreene Road
Durham North Carolina 27705

Duke University

  • Merck

Name Role Affiliation
James Burke, MD, PhD Principal Investigator Duke University Medical Center

Name Phone Email
Ann Herrin 919-668-2157


Investigation of Biomarkers of Disease State in Alzheimer's Disease and Non-AD Dementias