Methods and compositions for improving cognitive function

Inventors

Smith, Gardiner

Assignees

Agenebio Inc

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Publication Number

US-11160785-B2

Patent

Publication Date

2021-11-02

Expiration Date


Abstract

The invention relates to compositions comprising a synaptic vesicle glycoprotein 2A (SV2A) inhibitor in an extended release and an acetylcholinesterase inhibitor (AChEIs). The invention also relates to using such compositions in treating cognitive impairment associated with central nervous system disorders in a subject in need or at risk thereof, including, without limitation, subjects having or at risk for age-related cognitive impairment, Mild Cognitive Impairment (MCI), dementia, Alzheimer's Disease (AD), prodromal AD, post traumatic stress disorder (PTSD), schizophrenia, bipolar disorder, amyotrophic lateral sclerosis (ALS), cancer-therapy-related cognitive impairment, mental retardation, Parkinson's disease (PD), autism, compulsive behavior, and substance addiction.

Core Innovation

The invention relates to a pharmaceutical composition comprising levetiracetam or a pharmaceutically acceptable salt, hydrate, solvate, polymorph, or prodrug thereof in combination with donepezil or a pharmaceutically acceptable salt, hydrate, solvate, polymorph, or prodrug thereof. The levetiracetam component is present in an extended release form, a controlled release form, a prolonged release form, a sustained release form, a delayed release form, or a slow release form, and the donepezil component is not in an extended release form.

The composition further defines levetiracetam in amounts of about 7-350 mg, 0.1-350 mg, 0.7-350 mg, 3-300 mg, 3-150 mg, 3-110 mg, or 7-70 mg, and donepezil in amounts of 0.1-10 mg, 1-10 mg, 2-10 mg, 2-8 mg, or 2-5 mg. The pharmaceutical composition is in a unit dosage form or in separate units packaged together in a single formulation.

Claims Coverage

The document contains one independent claim. It covers a combination pharmaceutical composition specifying release-form constraints for levetiracetam versus donepezil, dosage-amount ranges for both components, and a unit dosage or co-packaged separate-units presentation.

Combination pharmaceutical composition of levetiracetam and donepezil

A pharmaceutical composition comprising levetiracetam or a pharmaceutically acceptable salt, hydrate, solvate, polymorph, or prodrug thereof and donepezil or a pharmaceutically acceptable salt, hydrate, solvate, polymorph, or prodrug thereof.

Release-form assignment for levetiracetam and non-extended-release donepezil

The levetiracetam component is in an extended release form, a controlled release form, a prolonged release form, a sustained release form, a delayed release form, or a slow release form, while the donepezil component is not in an extended release form.

Specified levetiracetam dosage amount ranges

The levetiracetam component is present in an amount of about 7-350 mg, 0.1-350 mg, 0.7-350 mg, 3-300 mg, 3-150 mg, 3-110 mg, or 7-70 mg.

Specified donepezil dosage amount ranges

The donepezil component is present in an amount of 0.1-10 mg, 1-10 mg, 2-10 mg, 2-8 mg, or 2-5 mg.

Unit dosage form or separate units packaged together

The composition is in a unit dosage form or in separate units packaged together in a single formulation.

Overall, the claim coverage is focused on a combination of levetiracetam with donepezil where levetiracetam is defined by an extended, controlled, prolonged, sustained, delayed, or slow release form while donepezil is not extended release, with defined dosage-amount ranges and presentation as a unit dosage or separately packaged units in a single formulation.

Stated Advantages

Not explicitly described in patent.

Documented Applications

Not explicitly described in patent.

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