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Completed

NCT Number: NCT03545126

Human CNS Tau Kinetics in Tauopathies

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.

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Key information

Conditions

Progressive Supranuclear Palsy (PSP) Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Corticobasal Degeneration Corticobasal Degeneration (CBD) Cranial Nerve Diseases Dementia Eye Diseases Frontotemporal Dementia Frontotemporal Dementia (FTD MAPT Mutation) Frontotemporal Lobar Degeneration Mental Disorders Metabolic Diseases Movement Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Neurologic Manifestations Nutritional and Metabolic Diseases Ocular Motility Disorders Ophthalmoplegia Paralysis Pathological Conditions, Signs and Symptoms Proteostasis Deficiencies Signs and Symptoms Supranuclear Palsy, Progressive TDP-43 Proteinopathies Tauopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Washington University in St. Louis School of Medicine

St Louis, Missouri, 63110, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

13C6 Leucine

Other

Recruited participants will be given 13C6-labeled leucine through intravenous infusion (4mg/kg/hr for 16hrs)

Primary outcomes

  1. Tau Fractional Turnover Rate (FTR)

    Time frame: 6 months

    Calculated by using CSF tau labeling and plasma free leucine.

Secondary outcomes

  1. CSF Tau Absolute Concentration

    Time frame: 6 months

    Measured using labeled and unlabeled tau protein isoforms that will be immunoprecipitated and analyzed by mass spectrometry.

  2. Tau Production Rate

    Time frame: 6 months

    Measured by FTR multiplied by CSF tau concentration.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • Association of Frontotemporal Degeneration
  • Tau Consortium

Registry information

Acronym: TANGLES

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Jun 4, 2018
Registry last updated
Apr 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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