- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01730430
Cerebrospinal Fluid (CSF) Biomarkers Alzheimer's Disease (AD) and Non-AD Dementias
Investigation of Biomarkers of Disease State in Alzheimer's Disease and Non-AD Dementias
Study Overview
Status
Conditions
Detailed Description
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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North Carolina
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Durham, North Carolina, United States, 27705
- Duke Health Center at Morreene Road
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Additional Inclusion and Exclusion Criteria for Subject with non-AD dementias
- Standard clinical diagnostic criteria accepted by the field for non-AD dementias should be used by the Institution.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Collection of CSF
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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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.
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CSF will be collected at Visit 1 (up to 30 days after the screening visit)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: James Burke, MD, PhD, Duke UMC
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00033660
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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