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CNS and Plasma Amyloid-Beta Kinetics in Alzheimer's Disease

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ClinicalTrials.gov Identifier: NCT02021682
Recruitment Status : Completed
First Posted : December 27, 2013
Last Update Posted : December 5, 2017
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Washington University School of Medicine

Brief Summary:
Alzheimer's disease (AD) is the most common cause of dementia and currently has no disease modifying treatments or simple accurate diagnostic tests. The goal of this project is to study how amyloid-beta (a protein thought to cause AD) is made, transported and cleared in the human body. Better understanding of these processes may lead to improved understanding of AD, earlier diagnosis and a way to evaluate treatment.

Condition or disease
Alzheimer's Disease

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Study Type : Observational
Actual Enrollment : 58 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: CNS and Plasma Amyloid-Beta Kinetics in Alzheimers's Disease; A Blood Isotope Labeled Amyloid-beta Test for Alzheimer's Disease.
Actual Study Start Date : December 2013
Actual Primary Completion Date : July 2017
Actual Study Completion Date : July 2017


Group/Cohort
Amyloid positive (Amyloidosis)
Amyloidosis defined by positive Positive emission tomography (PET)/Pittsburg Compound B (PIB) score, or low CSF Aβ42 concentration.
Amyloid negative (Control)
Amyloid negative defined by negative Positive emission tomography (PET)/Pittsburg Compound B (PIB) score or high/normal CSF Aβ42 concentration .



Primary Outcome Measures :
  1. Analysis of SILK blood and CSF Aβ isoforms [ Time Frame: Sample collection 24 - 96 hours post labeling ]
    Analysis of SILK blood and CSF Aβ isoforms will be performed. The pulse labeling blood Aβ SILK results of the amyloid positive group will be compared with the control group for Aβ38, Aβ40, Aβ42, and ratios of isoforms vs. tests of amyloidosis such as PET/PIB scan and/or CSF Aβ42 concentration.


Secondary Outcome Measures :
  1. Age [ Time Frame: Sample collection 24-96 hours post labeling ]
    SILK blood and CSF Aβ isoforms analyzed by clinical diagnosis (AD vs. controls) and Age.

  2. CSF tau/ptau [ Time Frame: Sample collection 24-96 hours post labeling ]
    SILK blood and CSF Aβ isoforms analyzed by clinical diagnosis (AD vs. controls) for CSF tau/ptau.

  3. PET/Fluoro-D-glucose (FDG) scan findings. [ Time Frame: Sample collection 24-96 hours post labeling ]
    SILK blood and CSF Aβ isoforms analyzed by clinical diagnosis (AD vs. controls) and by PET/Fluoro-D-glucose (FDG) scan findings.

  4. ApoE [ Time Frame: Sample collection 24-96 hours post labeling ]
    SILK blood and CSF Aβ isoforms analyzed by clinical diagnosis (AD vs. controls) for Apolipoprotein E (ApoE).

  5. Mutation status [ Time Frame: Sample collection 24-96 hours post labeling ]
    SILK blood and CSF Aβ isoforms analyzed by clinical diagnosis (AD vs. controls) and mutation status for AD.

  6. Cognitive measures [ Time Frame: Sample collection 24-96 hours post labeling ]
    SILK blood and CSF Aβ isoforms analyzed by clinical diagnosis (AD vs. controls) and cognitive measures.

  7. Clinical measures [ Time Frame: Sample collection 24-96 hours post labeling ]
    SILK blood and CSF Aβ isoforms analyzed by clinical diagnosis (AD vs. controls) and clinical measures.

  8. MRI [ Time Frame: Sample collection 24-96 hours post labeling ]
    SILK blood and CSF Aβ isoforms analyzed by clinical diagnosis (AD vs. controls) and by Magnetic resonance imaging (MRI) findings.


Other Outcome Measures:
  1. novel CSF biomarkers [ Time Frame: Sample collection 24-96 hours post labeling ]
    SILK blood and CSF Aβ isoforms analyzed by clinical diagnosis (AD vs. controls) for novel CSF biomarkers.

  2. novel imaging protocols [ Time Frame: Sample collection 24-96 hours post labeling ]
    SILK blood and CSF Aβ isoforms analyzed by clinical diagnosis (AD vs. controls) and by novel imaging protocols.


Biospecimen Retention:   Samples Without DNA
Plasma and cerebro spinal fluid


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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Adults from the Alzheimer's Disease Research Center and Memory and Aging Project at Washington University.
Criteria

Inclusion Criteria:

  • Member of the Memory and Aging Project at Washington University
  • Clinical Dementia Rating (CDR) and PET/ PIB scores
  • Age 60 or greater

Exclusion Criteria:

  • Clotting disorder
  • Active anticoagulation therapy
  • Active infection
  • Meningitis
  • Recent syncope
  • Currently on experimental treatment targeting Aβ or medications thought to influence Aβ production or clearance rates (benzodiazepines, muscarinic agents, or anti-epileptics)

Information from the National Library of Medicine

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): NCT02021682


Locations
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United States, Missouri
Washington University in St. Louis
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
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Principal Investigator: Randall J Bateman, MD Washington University School of Medicine
Publications:
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02021682    
Other Study ID Numbers: In Vivo metabolism of ABeta
R01NS065667 ( U.S. NIH Grant/Contract )
First Posted: December 27, 2013    Key Record Dates
Last Update Posted: December 5, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to share IPD at this time
Keywords provided by Washington University School of Medicine:

ABeta
ABeta kinetics
Alzheimer's Disease
Alzheimer's
amyloid beta
biomarker
dementia
PET/PIB
Additional relevant MeSH terms:
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Alzheimer Disease
Amyloidosis
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Proteostasis Deficiencies
Metabolic Diseases