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

This study is ongoing, but not recruiting participants.
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: June 4, 2014
Last verified: June 2014
  Purpose

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 Heavy water, also called deuterated water or D20, is the same as normal drinking water except the hydrogen atoms have been replaced by deuterium, a naturally occurring isotope of hydrogen.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

Condition
Parkinson's Disease
HIV Infections

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by KineMed:

Primary Outcome Measures:
  • CSF Biomarkers [ Time Frame: 40 days ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

plasma


Estimated Enrollment: 45
Study Start Date: April 2009
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00990379

Locations
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
Investigators
Principal Investigator: Richard Price, MD University of California, San Francisco
  More Information

No publications provided

Responsible Party: Salena Killion, Director of Clinical Studies, KineMed
ClinicalTrials.gov Identifier: NCT00990379     History of Changes
Other Study ID Numbers: 6076
Study First Received: October 2, 2009
Last Updated: June 4, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by KineMed:
HIV
brain diseases
spinal fluid
HIV positive

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Parkinson Disease
Neurodegenerative Diseases
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
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Deuterium Oxide
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 22, 2014