• Cognitive impairment defined as a cognitive neuroscore greater than or equal to 2 at screening.

• Anti-epileptic, mood or behavioral drugs (if on) at stable doses for a minimum of 4 weeks prior to enrollment.

• If present, VNS must be on stable setting for a minimum of 3 months prior to enrollment.

• If on ketogenic or Atkins diet, must be on stable ratio for a minimum of 3 months prior to enrollment.

• Previous subjects who fail at any point to meet continuation criteria and withdraw early may be considered for re-enrollment under new subject ID as long as the above inclusion criteria are met. The determination of whether to re-enroll will be made by the PI and sponsor on a case-by-case basis. Re-enrollment can occur no earlier than 4 weeks after the final, post-weaning follow-up visit under the old subject ID.

• Written informed consent obtained from the patient or the patient's legal representative must be obtained prior to beginning treatment.