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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00990379
Recruitment Status : Unknown
Verified March 2015 by Salena Killion, KineMed.
Recruitment status was:  Active, not recruiting
First Posted : October 6, 2009
Last Update Posted : March 31, 2015
Michael J. Fox Foundation for Parkinson's Research
Information provided by (Responsible Party):
Salena Killion, KineMed

Brief Summary:

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 Heavy water, also called deuterated water or D20, is the same as normal drinking water except the hydrogen atoms have been replaced by deuterium, a naturally occurring isotope of hydrogen.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


  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.

Condition or disease
Parkinson's Disease HIV Infections

Study Type : Observational
Estimated Enrollment : 45 participants
Observational Model: Cohort
Official Title: 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
Study Start Date : April 2009
Estimated Primary Completion Date : February 2016
Estimated Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

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.

Primary Outcome Measures :
  1. CSF Biomarkers [ Time Frame: 40 days ]

Biospecimen Retention:   Samples Without DNA

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

All subjects must be 18 years of age or older.


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:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00990379

United States, California
San Francisco General Hospital
San Francisco, California, United States, 94110
Sponsors and Collaborators
Salena Killion
Michael J. Fox Foundation for Parkinson's Research
Principal Investigator: Richard Price, MD University of California, San Francisco

Responsible Party: Salena Killion, Director of Clinical Studies, KineMed Identifier: NCT00990379     History of Changes
Other Study ID Numbers: 6076
First Posted: October 6, 2009    Key Record Dates
Last Update Posted: March 31, 2015
Last Verified: March 2015

Keywords provided by Salena Killion, KineMed:
brain diseases
spinal fluid
HIV positive

Additional relevant MeSH terms:
Parkinson Disease
HIV Infections
Acquired Immunodeficiency Syndrome
Neurodegenerative Diseases
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Deuterium Oxide
Antineoplastic Agents
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs