An observational study in Progressive Supranuclear Palsy (PSP), Corticobasal Degeneration (CBD) and Frontotemporal Dementia (FTD MAPT Mutation), sponsored by Washington University School of Medicine. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-13.
Sponsored by Washington University School of Medicine · Observational
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.
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.
171 studies on the registry are indexed under Supranuclear Palsy, Progressive; 51 are open to participants now.
This study's enrollment of 27 is below the median of 200 across 66 observational studies indexed under Supranuclear Palsy, Progressive.
Browse Supranuclear Palsy, Progressive studies →Washington University School of Medicine is the lead sponsor of 1,803 studies on the registry; 271 are open to participants now.
Of its 329 completed or terminated interventional studies of FDA-regulated products, 216 (66%) have results posted.
Counted across the registry records on this site, refreshed daily.
Progressive Supranuclear Palsy (PSP): N=12
Corticobasal Degeneration (CBD): N=8
Frontotemporal Dementia (FTD): MAPT: Family members with or at-risk of tau mutations (e.g. P301L) N=12
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Other: 13C6 Leucine
N=8 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.
Other: 13C6 Leucine
N=12 Family members with or at-risk of tau mutations (e.g. P301L) 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.
Other: 13C6 Leucine
Recruited participants will be given 13C6-labeled leucine through intravenous infusion (4mg/kg/hr for 16hrs)
Tau Fractional Turnover Rate (FTR)
Calculated by using CSF tau labeling and plasma free leucine.
Time frame: 6 months
CSF Tau Absolute Concentration
Measured using labeled and unlabeled tau protein isoforms that will be immunoprecipitated and analyzed by mass spectrometry.
Time frame: 6 months
Tau Production Rate
Measured by FTR multiplied by CSF tau concentration.
Time frame: 6 months
Plan to share: Undecided — Undecided at this time.
No publications or documents are linked to this record.
Ran from Aug 2017 to primary completion in Mar 2022, 54 months.
Of 37 observational studies under Supranuclear Palsy, Progressive, half reached primary completion within 81 months of starting (the median), counting those still running; a quarter within 54. This study's 54 months is below that.
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This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Supranuclear Palsy, Progressive →
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