An observational study in Parkinson's Disease and HIV Infections, sponsored by Salena Killion. Status unknown at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-03-31.
Sponsored by Salena Killion · Observational
This pilot study will assess the feasibility of using heavy water as a safe 'tracer' for biomarker studies of diseases of the brain and spinal cord, that, together, are also called the central nervous system (CNS). Heavy water, also called deuterated water or D20, is the same as normal drinking water except the hydrogen atoms have been replaced by deuterium, a naturally occurring isotope of hydrogen. In particular, this study will use heavy water to define: 1) The rate of immune cell proliferation (growth) in the cerebrospinal fluid (CSF) compared to blood. This study will be examining a particular type of immune cell called T lymphocytes. 2) This study will also examine selected molecules generated by nerve cells of the CNS to understand their rate of secretion and turnover in healthy control participants, HIV-1-infected participants and participants with a non-HIV-related neurodegenerative disease such as Parkinson's disease (PD).
This study will involve the administration of heavy water orally for either seven days, 12 days or six weeks. Measurements will be taken by lumbar puncture (LP, also known as a spinal tap). Blood (approximately five tablespoons per visit) will also be obtained at each of the lumbar puncture appointments.
If this method can be used to establish the rates of immune cell turnover and the production rates of neuronal molecules using cerebrospinal fluid, it will provide unique data that is important to understand chronic neurodegenerative conditions, like PD, and to measure responses to targeted therapies.
Hypothesis:
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's planned enrollment of 45 is below the median of 240 across 2,136 observational studies indexed under Infections.
Browse Infections studies →This is the only study on the registry with Salena Killion as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Healthy controls, HIV positive (on or off ARVs), patients diagnosed with Parkinson's Disease.
All subjects must be 18 years of age or older.
Exclusion Criteria:
Healthy men and women, 18 years of age or older, who have no history of significant medical conditions.
Men and women, 18 years of age or older, who have been diagnosed with HIV infection. Patients may be on or off of ARVs.
Men and women, 18 years of age or older, who have been diagnosed with Parkinson's Disease.
CSF Biomarkers
Time frame: 40 days
This study is status unknown, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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