Cortical Metrics Assessment Outcome Measure Development in Autism With Memantine Treatment
Status:
Withdrawn
Trial end date:
2015-12-01
Target enrollment:
Participant gender:
Summary
Specific Aim 1: Obtain proof of concept evidence that cortical metrics will change in
response to treatment with Memantine extended release (XR)®, an agent that modulates n-methyl
d-asptartate (NMDA) receptor activation, in children with autism spectrum disorders (ASD) who
clinically demonstrate treatment response.
Hypothesis1: Children with ASD who have dramatic clinical response to Memantine XR® will
exhibit changes in their cortical metrics, which will differ less from neurotypical children.
Subjective ratings of improvement will be correlated with the change in cortical metrics.
The completion of these aims will be essential to design a larger federally funded trial to
validate cortical metrics as an outcome measure in a more heterogeneous pediatric ASD sample.
Specifically, the feasibility data obtained may demonstrate the potential for detecting
changes in cortical metrics over time, so that a larger grant could focus on determining how
sensitive and clinically relevant changes in cortical metrics are or may indicate the need to
explore different interventions to use in a validation study. We have chosen to use Memantine
XR® because of its impact on NMDA neurotransmission, its current evaluation in a large
multi-site randomized ASD clinical trial whose initial results are expected shortly, and our
own observations of clinical improvements and good tolerability in the ongoing trial.