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NCT00362843 · ClinicalTrials.gov registry record
Protein Synthesis in the Brain of Patients With Fragile X Syndrome
A clinical trial, sponsored by National Institute of Mental Health (NIMH).
- Completed
- Registry status
- 147
- Enrollment target
NCT00362843: Completed study, sponsored by National Institute of Mental Health (NIMH).
NCT00362843 is a clinical trial that has completed, run by National Institute of Mental Health (NIMH). The registered enrollment target is 147 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00362843 has completed, sponsored by National Institute of Mental Health (NIMH).
- COMPLETED
- Registry status
- 147 participants
- Enrollment target
Study Summary
Biosynthesis of proteins is essential for growth and continued maintenance of the entire neuron including axons, dendrites, and synaptic terminals, and it is clearly one of the important biochemical processes underlying adaptive changes in the nervous system. Studies in experimental animals with the quantitative autoradiographic L \[1 (14)C\]leucine method have demonstrated a number of the physiological and pathological conditions in which changes in regional rates of cerebral protein synthesis (rCPS) occur. We have recently developed the first fully quantitative method for determining rCPS with positron emission tomography (PET). The PET method was adapted from the autoradiographic L \[1 (14)C\]leucine method; it uses L \[1 (11)C\]leucine as the PET tracer, dynamic scanning, and a kinetic modeling approach for quantification. This method was validated in nonhuman primates by comparison of PET measurements with those based on established biochemical and autoradiographic techniques. The objective of the present study is to examine the degree to which changes in rCPS in human subjects can be quantified with the L \[1 (11)C\]leucine PET method. We propose three studies to be carried out sequentially. In Part I we will establish the L-\[1-(11)C\]leucine PET method in human subjects. In Part II we will measure rCPS in normal control subjects in two states: awake and under deep sedation/general anesthesia with propofol. A difference in rCPS between these two states may indicate that we can detect activity-dependent protein synthesis with the PET method. In Part III we will study subjects with fragile X syndrome. This patient group was chosen since the affected gene in fragile X syndrome codes for a protein that is thought to be a negative regulator of message translation. Thus an effect on protein synthesis may be very close to the underlying genetic abnormality in fragile X syndrome. Regionally selective increases in rCPS have been found in studies in a mouse model of
Primary Outcome
regional rates of cerebral protein synthesis
Interventions
- DRUG [15-O]water
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 147 participants |
| Start Date | 2006-08-22 |
| Est. Completion | 2020-05-01 |
What the finished NCT00362843 record still lists
NCT00362843 is an observational study that tracks outcomes without assigning an intervention. The registered 147 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which [15-O]water is the first listed.
NCT00362843 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00362843 about?
NCT00362843 is a clinical study titled "Protein Synthesis in the Brain of Patients With Fragile X Syndrome". Biosynthesis of proteins is essential for growth and continued maintenance of the entire neuron including axons, dendrites, and synaptic terminals, and it is clearly one of the important biochemical processes underlying adaptive changes in the nervous system. Studies in experimental animals with the...
What is the current status of trial NCT00362843?
This trial is currently completed. The enrollment target is 147 participants. The study started on 2006-08-22. Estimated completion is 2020-05-01.
What interventions are being tested in trial NCT00362843?
The interventions under investigation include: [15-O]water (DRUG).
Who is sponsoring clinical trial NCT00362843?
This trial is sponsored by National Institute of Mental Health (NIMH), which has 343 total clinical trials registered on ClinicalTrials.gov.
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