Using Heavy Water to Study Cell Dynamics in Parkinson's Disease

This study is currently recruiting participants.
Verified February 2014 by KineMed
Sponsor:
Collaborator:
Michael J. Fox Foundation for Parkinson's Research
Information provided by (Responsible Party):
Salena Killion, KineMed
ClinicalTrials.gov Identifier:
NCT00990379
First received: October 2, 2009
Last updated: February 6, 2014
Last verified: February 2014

October 2, 2009
February 6, 2014
April 2009
February 2015   (final data collection date for primary outcome measure)
CSF Biomarkers [ Time Frame: 40 days ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00990379 on ClinicalTrials.gov Archive Site
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Using Heavy Water to Study Cell Dynamics in Parkinson's Disease
Cellular and Molecular Kinetics of Cerebrospinal Fluid (CSF) Using Heavy Water Labeling Method: A Study of Healthy Controls, CNS HIV Infection, Parkinson's Disease and Other Neurodegenerative Diseases

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 Heavy water, also called deuterated water or D20, is the same as normal drinking water except the hydrogen atoms have been replaced by deuterium, a naturally occurring isotope of hydrogen.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:

  1. D2O, administered orally, can be used to measure the proliferation rates of CSF T cells (and, eventually, of their major phenotypic subsets).
  2. D2O can be used to assess the turnover and production rates of CNS constituents that are normally or pathologically shed or secreted into the CSF, including (eventually): cargo molecules transported specifically in neurons in the CNS, such as chromogranin-A and -B, neuregulin-1 (specifically the extracellular secreted ectodomain of neuronal differentiation factor (NDF) isoform type α1, α2, β1, and the acetylcholine receptor inducing activity isoform (ARIA), secreted amyloid precursor protein (sAPP), alpha-synuclein; and APP metabolites amyloid beta (Aβ) 41 and 42.
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Observational
Observational Model: Cohort
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Retention:   Samples Without DNA
Description:

plasma

Non-Probability Sample

Healthy controls, HIV positive (on or off ARVs), patients diagnosed with Parkinson's Disease.

All subjects must be 18 years of age or older.

  • Parkinson's Disease
  • HIV Infections
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  • Controls
    Healthy men and women, 18 years of age or older, who have no history of significant medical conditions.
  • HIV positive
    Men and women, 18 years of age or older, who have been diagnosed with HIV infection. Patients may be on or off of ARVs.
  • Parkinson's Disease
    Men and women, 18 years of age or older, who have been diagnosed with Parkinson's Disease.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
45
February 2015
February 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 18 years of age or older
  • healthy controls with no significant medical conditions
  • diagnosed HIV positive patients on or off ARVs
  • diagnosed Parkinson's Disease patients
  • capacity to provide informed consent

Exclusion Criteria:

  • none
Both
18 Years and older
Yes
Contact: Julia Peterson 415-206-3762 petersonj@sfgh.ucsf.edu
Contact: Salena Killion, MPH 510-655-6525 ext 107 skillion@kinemed.com
United States
 
NCT00990379
6076
No
Salena Killion, KineMed
Salena Killion
Michael J. Fox Foundation for Parkinson's Research
Principal Investigator: Richard Price, MD University of California, San Francisco
KineMed
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP