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AGL101 (formerly AD-529) is a proprietary, low-dose, once-daily, extended-release oral formulation of levetiracetam developed by AgeneBio. It is specifically designed to address hippocampal overactivity, a key pathophysiological feature of amnestic mild cognitive impairment (aMCI) that precedes and drives the progression to Alzheimer's dementia. Unlike standard doses of levetiracetam used to treat epilepsy, AGL101 utilizes a significantly lower dose (approximately 220 mg) to normalize neuronal activity in the CA3 region of the hippocampus. The drug's mechanism of action involves binding to the synaptic vesicle protein 2A (SV2A), which modulates neurotransmitter release and reduces the aberrant excitatory signaling associated with cognitive decline. AGL101 is currently being evaluated in the Phase 3 HOPE4MCI clinical trial, making it a leading candidate for therapeutic intervention in the early stages of the Alzheimer's continuum.
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