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Publication Number
US-12144815-B2
Publication Date
2024-11-19
Expiration Date
Abstract
Disclosed herein include methods, compositions, and kits suitable for use in preventing and treating Alzheimer's disease. In some embodiments, methods of delaying or reducing the likelihood of onset of Alzheimer's disease are provided. The method can comprise administering to a subject in need thereof a composition comprising a neurokinin 1 receptor (NK1R) antagonist (e.g., aprepitant).
Core Innovation
The invention relates to methods of treating Alzheimer’s disease by administering to a subject in need thereof a therapeutically effective amount of a composition consisting of aprepitant or a pharmaceutically acceptable salt, solvate, stereoisomer, or prodrug thereof, and one or more excipients, thereby treating Alzheimer’s disease or at least one symptom thereof in the subject. The subject is diagnosed with early stage Alzheimer’s disease, mid-stage Alzheimer’s disease, or late-stage Alzheimer’s disease, and the composition is administered over a period of at least about 6 weeks.
The invention further encompasses treating dementia of the Alzheimer’s type by administering a therapeutically effective amount of the same composition, thereby treating the dementia or at least one symptom thereof in the subject. In this method, the subject is diagnosed with early stage Alzheimer’s disease, mid-stage Alzheimer’s disease, or late-stage Alzheimer’s disease, and the composition is administered over a period of at least about 6 weeks.
The invention also includes delaying progression of Alzheimer’s disease and reversing progression of Alzheimer’s disease, each by administering a therapeutically effective amount of the same aprepitant-containing composition with one or more excipients over a period of at least about 6 weeks. Additionally, mild cognitive impairment associated with Alzheimer’s disease is treated by administering the same aprepitant-containing composition to a subject diagnosed with early stage Alzheimer’s disease, mid-stage Alzheimer’s disease, or late-stage Alzheimer’s disease, with administration over a period of at least about 6 weeks.
Claims Coverage
The provided claim set includes six independent claims covering treating Alzheimer’s disease, treating dementia of the Alzheimer’s type, delaying progression of Alzheimer’s disease, reversing progression of Alzheimer’s disease, treating mild cognitive impairment associated with Alzheimer’s disease, and a kit for specified Alzheimer’s-related indications. Across these claims, the core inventive theme is aprepitant, or a pharmaceutically acceptable form, in a therapeutically effective composition with one or more excipients, with administration over a period of at least about 6 weeks, and, for several methods, an Alzheimer’s stage requirement.
Aprepitant-containing composition with excipients for treating AD in early-, mid-, or late-stage subjects
Administering to a subject in need a therapeutically effective amount of a composition consisting of aprepitant or a pharmaceutically acceptable salt, solvate, stereoisomer, or prodrug thereof, and one or more excipients, thereby treating Alzheimer’s disease or at least one symptom thereof, wherein the subject is diagnosed with early stage Alzheimer’s disease, mid-stage Alzheimer’s disease, or late-stage Alzheimer’s disease.
Administration over at least about 6 weeks for treating AD
Administering the composition over a period of at least about 6 weeks.
Aprepitant-containing composition with excipients for treating dementia of the Alzheimer’s type
Administering to a subject in need a therapeutically effective amount of a composition consisting of aprepitant or a pharmaceutically acceptable salt, solvate, stereoisomer, or prodrug thereof, and one or more excipients, thereby treating the dementia or at least one symptom thereof, wherein the subject is diagnosed with early stage Alzheimer’s disease, mid-stage Alzheimer’s disease, or late-stage Alzheimer’s disease.
Administration over at least about 6 weeks for treating dementia of the Alzheimer’s type
Administering the composition over a period of at least about 6 weeks.
Aprepitant-containing composition with excipients for delaying progression of AD
Administering to a subject in need thereof a therapeutically effective amount of a composition consisting of aprepitant or a pharmaceutically acceptable salt, solvate, stereoisomer, or prodrug thereof, and one or more excipients, thereby delaying the progression of Alzheimer’s disease in the subject or at least one symptom thereof, wherein the subject has Alzheimer’s disease.
Administration over at least about 6 weeks for delaying progression of AD
Administering the composition over a period of at least about 6 weeks.
Aprepitant-containing composition with excipients for reversing progression of AD
Administering to the subject in need thereof a therapeutically effective amount of a composition consisting of aprepitant or a pharmaceutically acceptable salt, solvate, stereoisomer, or prodrug thereof, and one or more excipients, thereby reversing the progression of Alzheimer’s disease in the subject, wherein the subject is diagnosed with early stage Alzheimer’s disease, mid-stage Alzheimer’s disease, or late-stage Alzheimer’s disease.
Administration over at least about 6 weeks for reversing progression of AD
Administering the composition over a period of at least about 6 weeks.
Aprepitant-containing composition with excipients for treating mild cognitive impairment associated with AD
Administering to the subject in need thereof a therapeutically effective amount of a composition consisting of aprepitant or a pharmaceutically acceptable salt, solvate, stereoisomer, or prodrug thereof, and one or more excipients, thereby treating the mild cognitive impairment or at least one symptom thereof in the subject, wherein the subject is diagnosed with early stage Alzheimer’s disease, mid-stage Alzheimer’s disease, or late-stage Alzheimer’s disease.
Administration over at least about 6 weeks for treating mild cognitive impairment associated with AD
Administering the composition over a period of at least about 6 weeks.
Kit with aprepitant-containing composition and label for Alzheimer’s-related indications
A kit comprising a therapeutically effective amount of a composition consisting of aprepitant or a pharmaceutically acceptable salt, solvate, stereoisomer, or prodrug thereof, and one or more excipients, wherein the composition is administered over a period of at least about 6 weeks; and a label indicating at least one of the kit is for delaying progression of Alzheimer’s disease, treating Alzheimer’s disease, treating dementia of Alzheimer’s type, treating mild cognitive impairment associated with Alzheimer’s disease, and reversing progression of Alzheimer’s disease.
Across the independent claims, the inventive coverage centers on using an aprepitant composition with one or more excipients to treat Alzheimer’s disease, dementia of the Alzheimer’s type, mild cognitive impairment associated with Alzheimer’s disease, and to delay or reverse Alzheimer’s disease progression, with explicit administration over a period of at least about 6 weeks and, for several claims, diagnosis stage limitations.
Stated Advantages
Treating Alzheimer’s disease (AD) or at least one symptom thereof.
Treating dementia of the Alzheimer’s type or at least one symptom thereof.
Delaying the progression of AD or at least one symptom thereof.
Reversing the progression of AD.
Treating mild cognitive impairment associated with AD or at least one symptom thereof.
Documented Applications
Treating Alzheimer’s disease (AD) and symptoms in subjects diagnosed with early stage AD, mid-stage AD, or late-stage AD, using an aprepitant-based composition administered for at least about 6 weeks.
Treating dementia of the Alzheimer’s type.
Delaying progression of Alzheimer’s disease (AD) and related symptoms.
Reversing progression of Alzheimer’s disease (AD).
Treating mild cognitive impairment associated with Alzheimer’s disease (AD).
Preclinical application: oral aprepitant administration in an APP/PS1 mouse model reduces brain interstitial fluid Aβ and improves spatial learning/memory in the Morris Water Maze.
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