First Patient Enrolled in Phase 3 Trial of Low-Dose Formulation of Levetiracetam for Mild Cognitive Impairment
A first patient has been enrolled in a phase 3 clinical trial of a proprietary low-dose formulation of the antiepileptic drug levetiracetam (AGB101; AgeneBio, Baltimore,MD) for the treatment of amnestic mild cognitive impairment (MCI). In the HOPE4MCI trial (NCT03486938), 830 patients in the US, Canada, and Europe will be randomly assigned to receive 220 mg low-dose levetiracetam or placebo taken as an oral table once daily for an 18-month period.
Low-dose levetiracetam is thought to act by modulating overactivity in the hippocampus that is hypothesized to increase ß-amyloid and tau pathology in the brain. In an earlier phase 2 trial, low-dose levetiracetam was shown to reduce hippocampal overactivity and improve episodic memory impairment in MCI. In this phase 3 trial, cognitive and functional abilities will be measured with the Clinical Dementia Ratins Scale—Sum of Boxes (CDR-SB). Scores on the Mini-Mental State Exam (MMSE) and Functional Activities Questionnaire (FAQ)will also be collected. A subgroup of enrollees will also undergo structural imaging and tau-positron emission tomography (tau-PET) to investigate whether treatment with low-dose levetiracetam is correlated with any neuropathologic changes or neurodegeneration.
"We are very excited to have commenced the next phase of development on this novel approach to addressing the looming global public health crisis presented by Alzheimer's Disease," said Richard Mohs, Principal Investigator on AgeneBio's HOPE4MCI clinical trial. "We have been extremely encouraged by the number of people who have expressed interest in participating in this trial."