# US 2020/0399352 A1 · Methods of treating alzheimer's disease

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- Number: US 2020/0399352 A1
- Document ID: US20200399352A1
- Status: Published application
- Kind: A1
- Application number: 16/782,654
- Filed: 2020-02-05
- Published: 2020-12-24
- Earliest claimed: 2014-02-08
- Assignees: Genentech, Inc.
- Applicants: Genentech, Inc.
- Inventors: William Cho; Michel Friesenhahn; Robert Paul; Michael Ward
- Web page: https://patentgrep.com/patent/US20200399352A1

## CPC

- C07K 16/18: against material from animals or humans
- A61K 31/56: Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- 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
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- A61K 2039/505: {comprising antibodies}
- C07K 2317/24: containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
- C07K 2317/34: Identification of a linear epitope shorter than 20 amino acid residues or of a conformational epitope defined by amino acid residues
- C07K 2317/56: variable (Fv) region, i.e. VH and/or VL
- 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)
- 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

Methods of treating Alzheimer's Disease (AD) in patients suffering from mild to moderate AD, including ApoE4 positive patients and patients suffering from mild AD are provided.

## Claims

### Claim 1

A method of reducing the decline in functional or cognitive capacity in a patient diagnosed with early or mild to moderate Alzheimer's Disease (AD) comprising administering crenezumab to a patient suffering from early or mild to moderate AD.

### Claim at position 2

-6. (canceled)

### Claim 7 (depends on 1)

The method of claim 1, wherein decline in cognitive capacity is assessed by determining the patient's score before and after administration of said antibody using a 12-item Alzheimer's Disease Assessment Scale-Cognition (ADAS-Cog12), 13-item Alzheimer's Disease Assessment Scale-Cognition (ADAS-Cog13), or 14-item Alzheimer's Disease Assessment Scale-Cognition (ADAS-Cog12) test, optionally wherein the reduction in cognitive decline as measured by ADAS-Cog is at least 30%, at least 35%, at least 40%, or at least 45% relative to placebo.

### Claim 8 (depends on 7)

The method of claim 7, wherein the patient is ApoE4 positive.

### Claim 9

(canceled)

### Claim 10

(canceled)

### Claim 11 (depends on 1)

The method of claim 1, wherein the patient has an MMSE score of at least 20, between 20 and 30, between 20 and 26, between 24 and 30, between 21 and 26, between 22 and 26, between 22 and 28, between 23 and 26, between 24 and 26, or between 25 and 26 before initiation of treatment.

### Claim 12

(canceled)

### Claim 13 (depends on 1)

The method of claim 1, wherein the antibody is administered at a dose of 10 mg/kg to 100 mg/kg of patient body weight.

### Claim 14

(canceled)

### Claim 15

(canceled)

### Claim 16

(canceled)

### Claim 17 (depends on 1)

The method of claim 1, wherein the antibody is administered every 2 weeks, every 4 weeks, every month, every two months, or every six months.

### Claim 18

A method of treating early or mild to moderate AD without increasing the risk of an adverse event comprising administering crenezumab to a patient diagnosed with early or mild to moderate AD in an amount that is effective to treat the AD without increasing the risk of a treatment emergent adverse event, wherein the adverse event is selected from: (i) Amyloid-Related Imaging Abnormality-Edema (ARIA-E) and (ii) Amyloid-Related Imaging Abnormality-Hemorrhage (ARIA-H).

### Claim at position 15

-25. (canceled)

### Claim 26 (depends on 18)

The method of claim 18, wherein if a treatment emergent ARIA-E is detected, administration of the antibody is halted and, optionally, treatment for ARIA-E is administered.

### Claim 27 (depends on 26)

The method of claim 26, further comprising resuming administration of said antibody after the ARIA-E is resolved, wherein the antibody is administered at a lower dose than before administration was halted.

### Claim 28 (depends on 18)

The method of claim 18, wherein if one or more new ARIA-Es is detected in the patient during treatment with said antibody, no more antibody is administered, and, optionally, a corticosteroid is administered to the patient.

### Claim 29 (depends on 28)

The method of claim 28, wherein the patient is ApoE4 positive.

### Claim at position 20

-116. (canceled)
