# US 11,896,647 B2 · Methods of treating cognitive impairment

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- Number: US 11,896,647 B2
- Document ID: US11896647B2
- Status: Granted
- Kind: B2
- Application number: 16/938,736
- Filed: 2020-07-24
- Published: 2021-04-15
- Granted: 2024-02-13
- Earliest claimed: 2008-08-05
- Assignees: University of South Florida
- Applicants: University of South Florida
- Inventors: Huntington Potter; Gary W. Arendash; Steven Bennett; Timothy Boyd
- Web page: https://patentgrep.com/patent/US11896647B2

## CPC

- A61K 38/193: {Colony stimulating factors [CSF]}
- A61K 38/1709: {from mammals}
- A61K 38/1816: {Erythropoietin [EPO]}
- A61P 25/00: Drugs for disorders of the nervous system
- A61P 25/28: for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

The subject invention concerns materials and methods for treating a person or animal having cognitive impairment. In one embodiment, the method comprises administering an effective amount of one or more inflammatory mediator(s), for example, fms-related tyrosine kinase 3 (Flt3) ligand, interleukin-6 (IL-6), macrophage migration inhibitory factor (MIF), interleukin-1 (IL-1), interleukin-3 (IL-3), erythropoietin (EPO), vascular endothelial growth factor A (VEGF-A), hypoxia-inducible transcription factor (HIF-1alpha), insulin like growth factor-1 (IGF-1), tumor necrosis factor (TNF), granulocyte colony-stimulating factor (G-CSF), granulocyte/macrophage colony-stimulating factor (GM-CSF), macrophage colony-stimulating factor (M-CSF), Stem Cell Factor (SCF), Darbepoetin (ARANESP), and metalloproteinases, to an animal or person in need of treatment.

## Claims

### Claim 1

A method for reducing the level of an amyloid beta (Aβ) peptide in the brain of a person or animal, comprising administering to the person or animal an effective amount of a granulocyte/macrophage colony-stimulating factor (GM-CSF) or sargramostim, or a composition comprising GM-CSF or sargramostim, wherein the level of an AP peptide is reduced in the person or animal relative to the level of AP peptide in the brain of the person or animal prior to administration of the GM-CSF.

### Claim 2 (depends on 1)

The method according to claim 1, wherein said GM-CSF is human GM-CSF.

### Claim 3 (depends on 1)

The method according to claim 1, wherein said GM-CSF comprises the amino acid sequence of SEQ ID NO: 1, or said GM-CSF has greater than 90% sequence identity with the amino acid sequence of SEQ ID NO: 1.

### Claim 4 (depends on 1)

The method of claim 1, wherein administering comprises administration of GM-CSF or sargramostim at a dose of about 0.028 mg/kg of bodyweight of the person or animal.

### Claim 5 (depends on 1)

The method of claim 1, wherein the amyloid beta (Aβ) peptide comprises deposited amyloid beta.

### Claim 6

A method for increasing the synaptic density in the CA1 or CA3 regions of the hippocampus of a person with Alzheimer's disease, comprising administering to the person an effective amount of a granulocyte/macrophage colony-stimulating factor (GM-CSF) or sargramostim, or a composition comprising GM-CSF or sargramostim, whereby the person exhibits increased synaptic density relative to the level of synaptic density in the CA1 or CA3 regions of the hippocampus of the person prior to administration of GM-CSF.

### Claim 7 (depends on 6)

The method of claim 6, wherein administering comprises administration of GM-CSF or sargramostim at a dose of about 0.028 mg/kg of bodyweight of the person with Alzheimer's disease.