Evaluating Cerebrospinal Fluid Biomarkers in Alzheimer's, Progressive Supranuclear Palsy Subjects, and Controls
This is an experimental medicine study to evaluate the kinetics of cerebrospinal fluid (CSF) biomarkers in subjects with Alzheimer's disease (AD) or progressive supranuclear palsy (PSP) compared to healthy controls using a heavy water (2H2O) labeling method. This study is exploring the time profile of appearance and disappearance of pulse deuterium-labeled cargo proteins in CSF of subjects with AD and/or PSP, which is different from healthy controls, due to deficits in fast axonal transport.
Progressive Supranuclear Palsy
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Experimental Medicine Study to Evaluate the Kinetics of Cerebrospinal Fluid Biomarkers in Subjects With Alzheimer's Disease and Progressive Supranuclear Palsy Compared to Healthy Subjects Using a Heavy Water Labeling Method|
- Biomarker Measures [ Time Frame: Up to 32 days ] [ Designated as safety issue: No ]o Levels of deuterium-labeled chromogranin B, sAPPα and β-Trace in CSF
- Biomarker Measures [ Time Frame: Up to 32 days ] [ Designated as safety issue: No ]o Body water enrichment of deuterium in saliva and plasma (2H-enrichment(%))
Biospecimen Retention: Samples With DNA
|Study Start Date:||July 2011|
|Estimated Study Completion Date:||July 2013|
|Estimated Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
Elderly Healthy Control (EHV)
No clinically significant deviation from healthy in medical history, physical examination, ECGs, MRI and clinical laboratory determinations for their respective age group.
Progressive Supranuclear Palsy (PSP)
A diagnosis of possible or probable PSP according to clinical criteria of National Institute of Neurologic Diseases and Stroke - the Society for PSP plus a MRI at screening to exclude other potential causes of parkinsonism as well as a mild-to-moderate stage of disease severity according to a score of 1 to 3 in Golbe Staging System.
Alzheimer's Disease (AD)
A diagnosis of probable AD Based on the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association and The Diagnostic and Statistical Manual of Mental Disorders as determined by a mini-mental state examination (MMSE) score of 16 to 26, inclusive.
To compare the time profile of appearance and disappearance in CSF of pulse deuterium-labeled chromogranin B, sAPPα and β-Trace in AD and PSP subjects compared to healthy controls.
- To measure body water enrichment of deuterium in saliva and plasma (2H-enrichment (%))
- To explore the effect of age on the kinetics of deuterium labeling of CSF biomarkers
- To assess intra and inter subject variability of deuterium-labeling of chromogranin B, sAPPα and β-Trace
Subjects will undergo screening evaluations to determine eligibility prior to heavy water (2H20) administration. Eligible subjects will be admitted to the clinical facility on Day -1. On Day 1, subjects will ingest small doses of 2H20 during their inpatient stay. They will also drink 2H20 for 7 more days. Subjects will undergo two lumbar punctures (LPs) for CSF samples. Subjects will return to the study site approximately 7 days after the last LP (or early termination) for a follow-up assessment and discharge.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01348061
|United States, California|
|Glendale, California, United States, 91206|
|United States, New Jersey|
|Memory Enhancement Centers of America Inc.|
|Eatontown, New Jersey, United States, 07724|
|United States, Texas|
|Worldwide Clinical Trials|
|San Antonio, Texas, United States, 78217|
|Study Director:||Marc K Hellerstein, M.D., Ph.D.||KineMed|