CClinicalTrials.gg
Status unknownNCT00990379Updated Mar 31, 2015

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

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

The sponsor has not verified this record recently (last verified Mar 2015), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Cohort
Enrollment
45
Ages
18 Years and older
Sex
All
01

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 Heavy water, also called deuterated water or D20, is the same as normal drinking water except the hydrogen atoms have been replaced by deuterium, a naturally occurring isotope of hydrogen.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

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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Conditions studied

  • Parkinson's Disease
  • HIV Infections

Keywords

  • HIV
  • brain diseases
  • spinal fluid
  • HIV positive
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In context

Infections

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 →

Lead sponsor

This is the only study on the registry with Salena Killion as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Exclusion Criteria:

  • none
05

Study design

Observational model
Cohort
Enrollment
45 participants (estimated)
Biospecimen retention
Samples without dna

Groups and 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.

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What researchers measure

Primary outcomes

  1. CSF Biomarkers

    Time frame: 40 days

07

Study locations

1 site
  • San Francisco General Hospital
    San Francisco, California 94110, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 31, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00990379
Lead sponsor
Salena Killion
Collaborators
Michael J. Fox Foundation for Parkinson's Research
Responsible party
Salena Killion (Director of Clinical Studies, KineMed) — Sponsor-investigator
First posted
Oct 6, 2009
Start date
Apr 2009
Primary completion
Feb 2016 (estimated)
Completion
Feb 2016 (estimated)
Last update
Mar 31, 2015

Study contacts

Richard Price, MD
principal investigator · University of California, San Francisco

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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