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
27
Start Date
August 21, 2017
Completion Date
March 4, 2022
Primary Completion Date
March 4, 2022
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, ,
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
April 2022