Cerebrospinal Fluid (CSF) Biomarkers Alzheimer's Disease (AD) and Non-AD Dementias

Completed

Conditions studied: Alzheimer's Disease, Dementias

In brief

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.

Key facts

Study ID

NCT01730430

Run by

Duke University

People needed

40

Starts

2012-07-01

Expected to finish

2013-12-01

Last updated by the study team

2014-04-22

Who can join

Age: 55 and older, up to 85. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Each subject must be ≥ 55 to ≤ 85 years of age.
• Each subject must be able to read at a 6th grade level, as determined by the investigator, and must have a history of academic achievement and/or employment sufficient to exclude mental retardation.
• Each subject must have results of clinical laboratory tests, a physical examination, vital signs within normal limits or clinically acceptable to the investigator within 28 days prior to enrollment.
• Each subject (or legal representative) must sign the informed consent form after the scope and nature of the investigation have been explained to them, and before screening assessments.
• Additional Inclusion Criteria for Normal Controls:
• Must have a global Clinical Dementia Rating (CDR) score of 0.
• Must have a Mini-Mental State Examination (MMSE) score ≥ 28.
• Must have a Z-score ≥ -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.
• Additional Inclusion Criteria for AD Subjects:
• Must meet the criteria for a diagnosis of probable AD based on both
• the National Institute of Neurological and Communicative Diseases and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria, and
• the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM IV TR) criteria for AD.
• Must have an MMSE score ≥ 15 and ≤ 26.
• Must have a clear history of cognitive and functional decline over at least one year that is either
• documented in medical records or
• documented by history from an informant who knows the subject well.
• Must have an MRI or CT scan that is consistent with a diagnosis of AD within 12 months prior to enrollment.
• Exclusion Criteria for AD Subjects and Normal Controls
• The subject has a Rosen modified Hachinski Ischemia Score > 4.
• The subject has a known history of stroke.
• The subject has evidence of a clinically relevant or unstable neurological or psychiatric disorder (for AD subjects - other than AD).
• The subject has a history of alcoholism or drug dependency/abuse within the last 5 years before enrollment.
• The subject has an ongoing uncontrolled, clinically significant medical condition such that, in the judgment of the investigator, a subject's participation in the trial would pose a significant medical risk to the subject.
• The subject has participated within the last two months in a clinical trial of a novel therapeutic agent (e.g. bapineuzumab) or has ever been in a clinical trial of an AD vaccine.
• Pregnancy

Where it is running

• Duke Health Center at Morreene Road — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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