# US 2020/0338192 A1 · Treatment and prevention of alzheimer's disease (ad)

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- Number: US 2020/0338192 A1
- Document ID: US20200338192A1
- Status: Published application
- Kind: A1
- Application number: 16/821,557
- Filed: 2020-03-17
- Published: 2020-10-29
- Earliest claimed: 2014-04-29
- Assignees: Affiris AG
- Applicants: Affiris AG
- Inventors: Markus MANDLER; Achim SCHNEEBERGER; Frank MATTNER; Walter SCHMIDT
- Web page: https://patentgrep.com/patent/US20200338192A1

## CPC

- A61K 39/39: characterised by the immunostimulating additives, e.g. chemical adjuvants
- A61K 9/0019: {Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner (non-active ingredients are additionally classified in A61K47/00)}
- A61K 33/06: Aluminium, calcium or magnesium; Compounds thereof {, e.g. clay}
- A61K 33/08: Oxides; Hydroxides
- A61K 38/03: Peptides having up to 20 amino acids in an undefined or only partially defined sequence; Derivatives thereof
- A61K 39/0007: {Nervous system antigens; Prions}
- A61K 47/02: Inorganic compounds
- 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 37/04: Immunostimulants
- A61K 2039/54: {characterised by the route of administration}
- A61K 2039/545: {characterised by the dose, timing or administration schedule}
- A61K 2039/55505: {Inorganic adjuvants}
- A61K 2039/6081: {Albumin; Keyhole limpet haemocyanin [KLH]}
- 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

Disclosed is a method for the treatment of AD, wherein an immune stimulating pharmaceutical composition comprising an aluminium salt is administered to a patient having AD or having a risk to develop AD in an effective amount.

## Claims

### Claim 1

A method for treating Alzheimer's Disease (AD) comprising administering an effective amount of at least one immune stimulating pharmaceutical composition comprising an aluminium salt to a patient having AD or having a risk of developing AD.

### Claim 2 (depends on 1)

The method according to claim 1, wherein the aluminium salt has the general formula Mea+Alb3+Anc−.nH2O, wherein
Me+ is Na+, K+, Li+, Rb+, Cs+ or NH4+;
An is PO43, SO42−O(OH)3−, O2 or OH−;
a is 0, 1, 2, or 3;
b is 1 or 2;
c is 1, 2, 3, 4, 5, or 6; and
n is 0 to 48.

### Claim 3 (depends on 1)

The method according to claim 1, wherein the aluminium salt is at least one of aluminium hydroxide, aluminium oxyhydroxide, aluminium phosphate, or aluminium sulphate.

### Claim 4 (depends on 1)

The method according to claim 1, wherein the aluminium salt is administered as the single effective ingredient in said immune stimulating pharmaceutical composition.

### Claim 5 (depends on 1)

The method according to claim 1, wherein the aluminium salt is an aluminium oxyhydroxide suspension.

### Claim 6 (depends on 5)

The method according to claim 5, wherein the aluminium salt is an aluminium oxyhydroxide suspension of European Pharmacopoeia grade aluminium-oxyhydroxide as defined by monograph 1664.

### Claim 7 (depends on 6)

The method according to claim 6, wherein the aluminium salt is Alhydrogel.

### Claim 8 (depends on 1)

The method according to claim 1, wherein the aluminium salt is aluminium oxyhydroxide and is administered in an amount of at least 1.2 mg, given as Al2O3 equivalent, to an AD patient.

### Claim 9 (depends on 1)

The method according to claim 1, wherein the aluminium salt is administered to a patient at least once monthly in an amount of at least 1.5 mg.

### Claim 10 (depends on 1)

The method according to claim 1, wherein the aluminium salt is administered to a patient at least once monthly for a duration of at least three months, in an amount of at least 1.8 mg.

### Claim 11 (depends on 1)

The method according to claim 1, wherein the aluminium salt is administered to a patient at least twice monthly for a duration of at least one month, in an amount of 1.8 to 2.5 mg.

### Claim 12 (depends on 1)

The method according to claim 1, wherein the aluminium salt is aluminium oxyhydroxide and is administered to an AD patient in an amount of 1.2 mg to 5.0 mg.

### Claim 13 (depends on 1)

The method according to claim 1, wherein the aluminium salt is aluminium oxyhydroxide and is administered to an AD patient in an amount of at least 1.5 mg ent.

### Claim 14 (depends on 1)

The method according to claim 1, wherein the aluminium salt is aluminium oxyhydroxide and additionally contains one or more stabilisators, detergents, antioxidants, complexing agents for mono- or divalent metal ions, sugars, sugar alcohols, glycerol, and/or buffer substances.

### Claim 15 (depends on 1)

The method according to claim 1, wherein the aluminium salt is aluminium oxyhydroxide and is administered to a patient in an isotonic suspension.

### Claim 16 (depends on 1)

The method according to claim 1, wherein the aluminium salt is aluminium oxyhydroxide and is administered to an AD patient subcutaneously, intranodally, intradermally, or intramuscularly.

### Claim 17 (depends on 1)

The method according to claim 1, wherein the aluminium salt is aluminium oxyhydroxide and is administered to an AD patient in split doses of 0.8 to 5.0 mg.

### Claim 18 (depends on 1)

The method according to claim 1, wherein the aluminium salt is aluminium oxyhydroxide and is administered to an AD patient at least monthly for at least two years.

### Claim 19 (depends on 1)

The method according to claim 1, wherein the aluminium salt is aluminium oxyhydroxide and is administered to an AD patient by an injection device.

### Claim 20 (depends on 1)

The method according to claim 1, wherein the aluminium salt is aluminium oxyhydroxide and is administered to the AD patient in liquid form in an application volume of 0.1 to 10 ml.

### Claim 21 (depends on 1)

The method according to claim 1 contained in a pharmaceutical preparation, wherein said preparation is devoid of sulphate, nitrate, or chloride anions, wherein said preparation has a heavy metal content of less than 20 ppm and wherein said preparation is a suspension of aluminium oxyhydroxide and has a particle size distribution between 2 μm and approximately 10 μm, said particles being aggregates, composed of smaller fibers of about 2 nm×4.5 nm×10 nm.
