Amnestic mild cognitive impairment (aMCI), a condition in which memory is worse than expected for a person's age, is recognized as an early stage of Alzheimer's disease with high risk of progression to dementia. Currently there is no FDA approved therapeutic treatment for aMCI that has shown either the ability to improve the cognitive symptoms of aMCI or the worsening of that condition. AgeneBio, Inc. has advanced a clinical program to 'slow progression in mild cognitive impairment (MCI) due to Alzheimer's disease (AD)' using the first treatment to target hippocampal hyperactivity, which is characteristic of the aMCI stage of the disease and predicts progression in patients, including conversion to a diagnosis of dementia. The company is preparing to launch a Phase 3 trial of AGB101. AGB101 is a novel low dose once-daily formulation of levetiracetam, an atypical antiepileptic drug with a very favorable safety profile, which has demonstrated therapeutic benefit in both animal models and in a proof-of-concept study in aMCI patients. This novel formulation was successfully manufactured for a Phase 1 pharmacokinetic study and demonstrated appropriate exposures for Phase 3. The FDA has reviewed the Phase 3 clinical protocol and the manufacturing plan and supports its implementation. The current application seeks to accelerate the start of an FDA approved Phase 3 program of this repurposed compound to accelerate the manufacture, testing, validation, packaging, and distribution of study medication, and ensure the timely initiation of the Phase 3 trial.