# US 11,433,126 B2 · Protection from stress, anxiety, neuroinflammation, and cognitive dysfunction

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- Number: US 11,433,126 B2
- Document ID: US11433126B2
- Status: Granted
- Kind: B2
- Application number: 17/125,422
- Filed: 2020-12-17
- Published: 2021-09-09
- Granted: 2022-09-06
- Earliest claimed: 2018-06-19
- Assignees: The Regents of the University of Colorado, a body corporate
- Applicants: The Regents of the University of Colorado, a body corporate
- Inventors: Christopher A. Lowry; Matthew G. Frank; Laura Fonken; Steven F. Maier
- Web page: https://patentgrep.com/patent/US11433126B2

## CPC

- A61K 35/74: Bacteria (therapeutic use of a bacterial protein A61K38/00)
- A61K 39/04: Mycobacterium, e.g. Mycobacterium tuberculosis
- A61K 35/741: Probiotics (probiotic yeast, e.g. saccharomyces A61K36/06)
- C07K 14/35: from Mycobacteriaceae (F)
- A61K 2039/521: {inactivated (killed)}
- A61K 2039/522: {avirulent or attenuated}
- A61K 2039/542: {oral/gastrointestinal}
- A61K 2039/58: {raising an immune response against a target which is not the antigen used for immunisation}
- 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)
- C07K: PEPTIDES (peptides in foodstuffs A23; obtaining protein compositions for foodstuffs, working-up proteins for foodstuffs A23J; preparations for medicinal purposes A61K; peptides containing beta-lactam rings C07D; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, C07D; ergot alkaloids of the cyclic peptide type C07D519/02; macromolecular compounds having statistically distributed amino acid units in their molecules, i.e. when the preparation does not provide for a specific; but for a random sequence of the amino acid units, homopolyamides and block copolyamides derived from amino acids C08G69/00; macromolecular products derived from proteins C08H1/00; preparation of glue or gelatine C09H; single cell proteins, enzymes C12N; genetic engineering processes for obtaining peptides C12N15/00; compositions for measuring or testing processes involving enzymes C12Q; investigation or analysis of biological material G01N33/00)

## Abstract

Methods of treating or preventing stress, anxiety, or postoperative cognitive dysfunction. Also provided are methods of improving resilience in a subject by administering a therapeutically effective amount of isolated Mycobacterium.

## Claims

### Claim 1

A method of inhibiting postoperative cognitive dysfunction (POCD) comprising administering a therapeutically effective amount of an isolated Mycobacterium vaccae to a mammalian subject before or after administering a surgical anesthetic to the subject.

### Claim 2 (depends on 1)

The method of claim 1, wherein the M. vaccae is whole cell M. vaccae.

### Claim 3 (depends on 1)

The method of claim 1, wherein the M. vaccae is non-pathogenic heat-killed M. vaccae.

### Claim 4 (depends on 1)

The method of claim 1, wherein the M. vaccae is strain NCTC 11659.

### Claim 5 (depends on 1)

The method of claim 1, wherein the M. vaccae is in the form of a vaccine composition, optionally comprising an adjuvant.

### Claim 6 (depends on 1)

The method of claim 1, wherein the M. vaccae is formulated for administration via the parenteral, oral, sublingual, nasal, or pulmonary route.

### Claim 7 (depends on 1)

The method of claim 1, wherein the method ameliorates at least one sign or symptom of POCD wherein the sign or symptom is selected from brain death, stroke, neuropsychological impairment comprising a decline in one or more of neuropsychological domains including memory, executive functioning, and speed processing.

### Claim 8

A method of treating or ameliorating the incidence of postoperative cognitive dysfunction (POCD) in a mammalian patient comprising administering a therapeutically effective amount of an isolated M. vaccae to the subject.

### Claim 9 (depends on 8)

The method of claim 8, wherein the M. vaccae is whole cell M. vaccae.

### Claim 10 (depends on 8)

The method of claim 8, wherein the M. vaccae is a non-pathogenic heat-killed M. vaccae.

### Claim 11 (depends on 8)

The method of claim 8, wherein the M. vaccae is strain NCTC 11659.

### Claim 12 (depends on 8)

The method of claim 8, wherein the M. vaccae is in the form of a vaccine composition optionally comprising an adjuvant.

### Claim 13 (depends on 8)

The method of claim 8, wherein the M. vaccae is formulated for administration via the parenteral, oral, sublingual, nasal, or pulmonary route.

### Claim 14 (depends on 8)

The method of claim 8, wherein the method ameliorates at least one sign or symptom of POCD wherein the sign or symptom is selected from brain death, stroke, neuropsychological impairment comprising a decline in one or more of neuropsychological domains including memory, executive functioning, and speed processing.