The study is designed as a multi-site, prospective, 15-month longitudinal, cohort study measuring CSF mHTT in participants with early manifest Stage I or Stage II Huntington's Disease (HD).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
95
No study drug was administered in this study
CenExel Rocky Mountain Clinical Research, LLC
Englewood, Colorado, United States
Georgetown University; Research Division, Psychiatry
Change From Baseline in the Following Clinical Endpoints at 3, 9, and 15 Months: cUHDRS, TFC, TMS, SDMT, SWR Test and IS
The reported data are as follows: cUHDRS = composite Unified Huntington's Disease Rating Scale; TFC = Total Functional; Capacity Scale; TMS = Total Motor; Scale; SDMT = Symbol Digit Modalities Test; SWR = Stroop Word Reading; IS = Independence Scale. cUHDRS: score range from -3.06 (worst) to not defined maximum (best); Stroop Word Reading Test: score range not defined, higher scores indicate better cognitive performance; Symbol Digit Modalities Test: score range from 0 (worst) to 110 (best); Total Functional Capacity: score range from 0 (worst) to 13 (best); Total Motor Scale: score range from 0 (best) to 124 (worst). Data at Month 3, 9, and 15 are reported respectively
Time frame: Baseline to 15 Months
Change From Baseline in Biomarkers of Neuronal Injury (CSF NfL and Tau) at 3, 9, and 15 Months
The reported date appreciations are as follows: CSF = Cerebrospinal Fluid; NfL = Neurofilament Light Chain. An overview of percentage change from baseline in geometric means for CSF tau and CSF NfL, and CSF YKL-40 are reported
Time frame: Baseline to 15 Months
Change From Baseline in Brain Atrophy Endpoints (Whole Brain Volume Decline, Caudate Volume Decline) as Determined by Brain MRI, at 3, 9, and 15 Months
Data for Least Square (LS) mean percentage change from baseline to Months 3, 9, and 15 for ventricular volume, caudate volume, and whole brain volume, based on boundary shift integrals (BSIs) are reported
Time frame: Baseline to 15 Months
Within-Participant Change From Baseline in CSF mHTT Levels at 3, 9, and 15 Months
mHTT=Mutant Huntingtin Protein. New stability information has revealed that all samples for this outcome measure were out of stability, leaving no valid data points. Therefore there is no data to report.
Time frame: Baseline to 15 Months
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Washington D.C., District of Columbia, United States
Hereditary Neurological Disease Centre (HNDC)
Wichita, Kansas, United States
John Hopkins University School of Medicine
Baltimore, Maryland, United States
Columbia University
New York, New York, United States
The University of Texas Health Science Center at Houston; McGovern Medical School
Houston, Texas, United States
The University of British Columbia; The Centre for Huntington Disease
Vancouver, British Columbia, Canada
Centre for Movement Disorders (Neuropharm Consulting Inc.)
Markham, Ontario, Canada
Charité - Universitätsmedizin Berlin, Campus Charité Mitte; Klinik für Psychiatrie und Psychotherapi
Berlin, Germany
St. Josef and St. Elisabeth gGmbH ; St. Josef Hospital Bochum; Neurologisches Forschungszentrum
Bochum, Germany
...and 5 more locations
Association of Change From Baseline in Cerebrospinal Fluid (FSF) mHTT With Change From Baseline in Clinical Measure
New stability information has revealed that all samples for this outcome measure were out of stability, leaving no valid data points. Therefore there is no data to report.
Time frame: Baseline to 15 Months
Association of Change From Baseline in Biomarkers of Neuronal Injury
New stability information has revealed that all samples for this outcome measure were out of stability, leaving no valid data points. Therefore there is no data to report.
Time frame: Baseline to 15 Months
Association of Change From Baseline in Brain Atrophy Endpoints, as Determined by Brain MRI
New stability information has revealed that all samples for this outcome measure were out of stability, leaving no valid data points. Therefore there is no data to report.
Time frame: Baseline to 15 Months