Human CNS Tau Kinetics in Tauopathies

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Brief Title

Human CNS Tau Kinetics in Tauopathies

Official Title

Human CNS Tau Kinetics in Tauopathies

Brief Summary

      The goal of this study is to characterize tau kinetics and tau aggregation in the human CNS
      and to test the hypothesis that tau kinetics are altered (i.e. increased production,
      decreased clearance, and increased aggregation rate) in tauopathies.
    

Detailed Description

      Tauopathies are neurodegenerative diseases with tau pathology. These tauopathies are the most
      common pathology in neurodegenerative diseases, and they are reaching epidemic proportions.
      The rates of tau kinetics are central to understanding normal and abnormal processing and
      production and clearance of tau kinetics in humans to help understand the causes of tauopathy
      and evaluate tau-targeted therapeutics.

      This study will utilize the Stable Isotope Labeling Kinetics (SILK) method to elucidate tau
      kinetics in vivo in the human central nervous system (CNS) and its alteration in tauopathies.
      A total of ~34 participants from 3 different neurodegenerative diseases: Frontotemporal
      Dementia (FTD), Corticobasal Degeneration (CBD), and Progressive Supranuclear Palsy (PSP),
      will be invited to enroll in the study.

      Participants will be labeled with stable isotopes via 16hr intravenous infusion and CSF
      samples collected during subsequent lumbar puncture visits over ~120 days. CSF will be
      analyzed over time for the quantitation of labeled tau.
    


Study Type

Observational


Primary Outcome

Tau Fractional Turnover Rate (FTR)

Secondary Outcome

 CSF Tau Absolute Concentration

Condition

Progressive Supranuclear Palsy (PSP)

Intervention

13C6 Leucine

Study Arms / Comparison Groups

 Progressive Supranuclear Palsy (PSP)
Description:  N=12 Age: 18 and older Recruited participants will be given 13C6 Leucine through intravenous infusion (4mg/kg/hr for 16hrs), and CSF will be collected five times over 120 days (on approximately days 1-4, 5-10, 11-20, 21-60 and 61-120) after labeling.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

32

Start Date

August 21, 2017

Completion Date

December 31, 2021

Primary Completion Date

August 31, 2021

Eligibility Criteria

        Inclusion Criteria:

          -  Diagnosed with PSP, CBD, or FTD MAPT

        Exclusion Criteria:

          -  Clotting disorder

          -  Active anticoagulation therapy

          -  Active infection

          -  Meningitis

          -  Recent syncope

          -  Current experimental treatment targeting Aβ or medications thought to influence Aβ
             production or clearance rates (benzodiazepines, muscarinic agents, or anti-epileptics)
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Randall Bateman, MD, 314-747-4857, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03545126

Organization ID

201703052


Responsible Party

Sponsor

Study Sponsor

Washington University School of Medicine

Collaborators

 Association of Frontotemporal Degeneration

Study Sponsor

Randall Bateman, MD, Principal Investigator, Washington University in Saint Louis Medical School


Verification Date

November 2020