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

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01730430
First received: October 17, 2012
Last updated: April 18, 2014
Last verified: April 2014
  Purpose

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.


Condition
Alzheimer's Disease
Dementias

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Investigation of Biomarkers of Disease State in Alzheimer's Disease and Non-AD Dementias

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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

Blood, urine and cerebral spinal fluid.


Enrollment: 40
Study Start Date: July 2012
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Collection of CSF
  1. Those with Alzheimer's disease
  2. Those with non-Alzheimer's disease dementia
  3. Healthy elderly volunteers

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.

  Eligibility

Ages Eligible for Study:   55 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Duke Memory Disorders Clinic

Criteria

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

    1. the National Institute of Neurological and Communicative Diseases and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria, and
    2. 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

    1. documented in medical records or
    2. 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01730430

Locations
United States, North Carolina
Duke Health Center at Morreene Road
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Duke University
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: James Burke, MD, PhD Duke UMC
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01730430     History of Changes
Other Study ID Numbers: Pro00033660
Study First Received: October 17, 2012
Last Updated: April 18, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Duke University:
non-AD dementias
healthy elderly controls

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on October 19, 2014