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NCT02811627 · ClinicalTrials.gov registry record · Early Phase 1
Predicting Treatment Response to Memantine in Autism Using Magnetic Resonance Spectroscopy
A Early Phase 1 study, sponsored by University of Missouri-Columbia.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 10
- Enrollment target
NCT02811627 is a Early Phase 1 study that has completed, run by University of Missouri-Columbia. The registered enrollment target is 10 participants.
The verdict
NCT02811627, a Early Phase 1 study, has completed, sponsored by University of Missouri-Columbia.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
Memantine, an N-methyl-D-aspartate receptor antagonist, has been explored as a possible therapeutic agent that reduces the excitatory (glutamate) - inhibitory (gamma amino-butyric acid, GABA) imbalance in autism pathology and improves social and communication deficits. While some studies have shown positive results, a large clinical trial failed to show benefit possibly because different subsets of autism responded differently to the treatment. The investigator proposes a pilot, exploratory, clinical follow-on study using proton magnetic resonance spectroscopy (1H-MRS) to determine whether baseline glutamate/GABA levels in certain regions of the brain may help predict treatment response to Memantine in autistic subjects. At study onset, subjects will be assessed on the behavioral scales such as the Aberrant Behavior Checklist and Clinical Global Impressions scale, followed by MRS imaging. Memantine treatment will be started post imaging. Assessment measures will be repeated at week 12 during treatment. Glutamate and GABA levels in brain regions will be correlated to improvements on assessment measures. Expected results include higher glutamate and/or lower GABA levels in the anterior cingulate cortex at baseline in responders to memantine. If the hypotheses are confirmed, it will provide evidence of a relevant neural biomarker to predict treatment response to memantine with important implications for clinical care including improving individualization of treatments.
Interventions
- DEVICE Magnetic Resonance Imaging
- DRUG Memantine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2016-06 |
| Est. Completion | 2021-04 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02811627
The ClinicalTrials.gov registry entry for NCT02811627 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Missouri-Columbia, which has 291 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Magnetic Resonance Imaging is the first listed.
NCT02811627 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02811627 about?
NCT02811627 is a clinical study titled "Predicting Treatment Response to Memantine in Autism Using Magnetic Resonance Spectroscopy". Memantine, an N-methyl-D-aspartate receptor antagonist, has been explored as a possible therapeutic agent that reduces the excitatory (glutamate) - inhibitory (gamma amino-butyric acid, GABA) imbalance in autism pathology and improves social and communication deficits. While some studies have shown ...
What is the current status of trial NCT02811627?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 10 participants. The study started on 2016-06. Estimated completion is 2021-04.
What interventions are being tested in trial NCT02811627?
The interventions under investigation include: Magnetic Resonance Imaging (DEVICE), Memantine (DRUG).
Who is sponsoring clinical trial NCT02811627?
This trial is sponsored by University of Missouri-Columbia, which has 291 total clinical trials registered on ClinicalTrials.gov.
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