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

NCT02021682 | Completed DMC

• 2 other identifiers: In Vivo metabolism of ABetaR01NS065667
• Study Type: observational
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer's Disease

Keywords

Aβ; ABeta; ABeta kinetics; Alzheimer's Disease; Alzheimer's; amyloid beta; biomarker; dementia; PET/PIB

Outcome Measures

Primary Outcomes (1)

• Analysis of SILK blood and CSF Aβ isoforms

  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.

  Sample collection 24 - 96 hours post labeling

Secondary Outcomes (8)

• Age

  Sample collection 24-96 hours post labeling

• CSF tau/ptau

  Sample collection 24-96 hours post labeling

• PET/Fluoro-D-glucose (FDG) scan findings.

  Sample collection 24-96 hours post labeling

• ApoE

  Sample collection 24-96 hours post labeling

• Mutation status

  Sample collection 24-96 hours post labeling

Other Outcomes (2)

• novel CSF biomarkers

  Sample collection 24-96 hours post labeling

• novel imaging protocols

  Sample collection 24-96 hours post labeling

Study Arms (2)

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 .

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults from the Alzheimer's Disease Research Center and Memory and Aging Project at Washington University.

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Washington University School of Medicine: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

Washington University in St. Louis

St Louis, Missouri, 63110, United States

Location

Related Publications (2)

• Mawuenyega KG, Sigurdson W, Ovod V, Munsell L, Kasten T, Morris JC, Yarasheski KE, Bateman RJ. Decreased clearance of CNS beta-amyloid in Alzheimer's disease. Science. 2010 Dec 24;330(6012):1774. doi: 10.1126/science.1197623. Epub 2010 Dec 9.

  PMID: 21148344 BACKGROUND

• Potter R, Patterson BW, Elbert DL, Ovod V, Kasten T, Sigurdson W, Mawuenyega K, Blazey T, Goate A, Chott R, Yarasheski KE, Holtzman DM, Morris JC, Benzinger TL, Bateman RJ. Increased in vivo amyloid-beta42 production, exchange, and loss in presenilin mutation carriers. Sci Transl Med. 2013 Jun 12;5(189):189ra77. doi: 10.1126/scitranslmed.3005615.

  PMID: 23761040 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma and cerebro spinal fluid

MeSH Terms

Conditions

Alzheimer Disease; Plaque, Amyloid; Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Randall J Bateman, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2013
• First Posted: December 27, 2013
• Study Start: December 1, 2013
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: December 5, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)