Memantine (Namenda) Autism Protocol

Memantine (Namenda) Autism Protocol

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What to Expect
This protocol is a structured, measurement-based off-label memantine trial for a subset of ASD patients in whom the clinical picture suggests a higher likelihood of response. It is designed to reduce interpretive noise (placebo effects, regression to the mean, simultaneous medication changes) by standardizing baseline characterization, follow-up structure, and outcome tracking.

It is not intended as a replacement for educational programming, ABA/skills work, psychotherapy, OT, or speech-language interventions.

Pre-enrollment expectations

• Comprehensive diagnostic reassessment at FHW to confirm ASD and clarify comorbid contributors (ADHD/anxiety/mood/sleep/medical), with a baseline functional profile documented before any protocol decisions.

• Baseline standardized measures completed prior to initiation to enable within-patient change detection rather than impression based tracking.

• Feasibility screen to confirm family capacity for time-intensive monitoring and adherence to program requirements (attendance, in-person appointments, real-time data capture, communication of adverse events).

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Initiation and early phase

• Memantine is initiated low and titrated gradually, with adjustments individualized to age/weight, tolerability, and observed clinical signal.

• Families are instructed to prospectively track targeted domains (e.g., overload-driven dysregulation, recovery latency, sleep perturbation, and stress-linked social withdrawal) to reduce recall bias.

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Follow-up structure

• Early visits are intentionally frequent to support safety monitoring and to reduce the chance of missing clinically relevant activation, disequilibrium, or sleep disruption during titration.

• After a working dose is reached, follow-up generally transitions to approximately monthly through the first year for continued measurement-based assessment and risk–benefit review.

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Expected benefit signal (what to watch for)
When benefit occurs, it is typically domain-specific rather than global. The primary clinical signal you would expect to see (if present) includes:

• Increased social engagement – most common

• Reduced intensity/frequency of overload-driven episodes (meltdown/shutdown patterns)

• Shorter recovery time after stressors/transitions

These effects, when present, are typically gradual and emerge over weeks rather than days.

Safety monitoring

• Common tolerability issues may include GI effects, headache, sleep change, or dizziness.

• Clinically important “stop-and-reassess” signals include new/worsening irritability/agitation, increased

• anxiety/overstimulation, persistent sleep disruption, disequilibrium/unsteady gait, confusion, or atypical “spacing out.”

The protocol approach is not to “push through” adverse activation; dose escalation is paused, the plan is adjusted, or the trial is discontinued depending on severity and trajectory.

Medication stewardship during protocol participation
FHW requests centralized medication oversight of all psychiatric medication treatments during active protocol participation to preserve interpretability and patient safety. Concurrent medication changes by outside prescribers will substantially increase confounding risk and reduce the ability to attribute improvement vs adverse effects to the protocol medication.

Discontinuation and post-protocol options

• Families can exit the protocol at any time; discontinuation is typically handled via taper rather than abrupt cessation when clinically appropriate.

• At ~12 months, the team performs a structured risk–benefit reassessment and integrates newly published evidence that may affect continuation decisions. Patients may return to their prior prescriber at any time.