Predicting Treatment Response to Memantine in Autism Using Magnetic Resonance Spectroscopy

Completed · Early Phase 1

Conditions studied: Autism Spectrum Disorder

In brief

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.

Key facts

Study ID

NCT02811627

Run by

University of Missouri-Columbia

People needed

10

Starts

2016-06-01

Expected to finish

2021-04-01

Last updated by the study team

2021-04-14

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Potential participants will be asked to take part in this study because he/she:
• has autism spectrum disorder
• is starting memantine off label for managing their autism symptoms
• is deemed safe to enter the MR environment using the attached screening form, and
• is capable of lying still for approximately 1.5 hour.

You may not qualify if…

• Subjects would be excluded if:
• they have certain types of metallic implants, risk of exposure to metallic foreign bodies, pacemakers, magnetically sensitive implants that cannot be removed or are not securely attached,
• pregnancy
• claustrophobia
• memantine intolerance
• known hypersensitivity to memantine hydrochloride or
• inability to lie still for approximately 90 minutes.

Where it is running

• University of Missouri — Columbia, Missouri, United States

Full record on ClinicalTrials.gov

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