# US 2023/0054073 A1 · Compositions, kits, and methods for detecting preclinical alzheimer's disease > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2023/0054073 A1 - Document ID: US20230054073A1 - Status: Published application - Kind: A1 - Application number: 17/882,671 - Filed: 2022-08-08 - Published: 2023-02-23 - Earliest claimed: 2021-08-09 - Assignees: NeuroQuest Inc. - Applicants: Neuroquest Ltd. - Inventors: Xin Huang; Yihan Li; Christopher Fowler; James Doecke; Colin L. Masters; Baijun Gu - Web page: https://patentgrep.com/patent/US20230054073A1 ## CPC - G01N 33/582: {with fluorescent label} - C07K 16/2803: {against the immunoglobulin superfamily} - G01N 33/6896: {Neurological disorders, e.g. Alzheimer's disease} - C07K 2317/30: characterized by aspects of specificity or valency - G01N 2800/2821: Alzheimer - G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q) - 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 Compositions and kits for diagnosing and prognosing Alzheimer's Disease (AD) in a human patient include a binding agent such as a monoclonal antibody for a biomarker conjugated to a detectable moiety such as a fluorophore, wherein the biomarker is chosen from CD163, CD91, CD59, MerTK and other phagocytosis-related molecules. Further compositions and kits employ panels of fluorophore-conjugated monoclonal antibodies for biomarkers including scavenger receptors. Methods for determining the relative expression of biomarkers, diagnosing AD, and determining the efficacy of AD therapeutic candidates such as phagocytosis-promoting agents and scavenger receptor agonists also appear. ## Claims ### Claim 1 A kit comprising: a first binding agent for CD91 conjugated with a first detectable moiety; a second binding agent for CD59 conjugated with a second detectable moiety; and a third binding agent for CD163 conjugated with a third detectable moiety. ### Claim 2 (depends on 1) The kit of claim 1, wherein the first binding agent, second binding agent, and third binding agent are independently chosen from single chain variable fragments, antibody mimetics, antibody fragments, antibodies, monoclonal antibodies, and combinations thereof. ### Claim 3 (depends on 1) The kit of claim 1, wherein the first detectable moiety, second detectable moiety, and third detectable moiety are independently chosen from radioisotopes, stable isotopes, fluorophores, and combinations thereof. ### Claim 4 (depends on 1) The kit of claim 1, wherein the first binding agent for CD91 is a monoclonal antibody for CD91, and the first detectable moiety is a first fluorophore; the second binding agent for CD59 is a monoclonal antibody for CD59, and the second detectable moiety is a second fluorophore; and the third binding agent for CD163 is a monoclonal antibody for CD163, and the third detectable moiety is a third fluorophore. ### Claim 5 (depends on 4) The kit of claim 4, wherein the monoclonal antibody for CD91 is a mouse anti-human IgG monoclonal antibody for CD91; the monoclonal antibody for CD59 is a mouse anti-human IgG monoclonal antibody for CD59; and the monoclonal antibody for CD163 is a mouse anti-human IgG monoclonal antibody for CD163. ### Claim 6 (depends on 5) The kit of claim 5, wherein the first fluorophore is fluorescein isothiocyanate. ### Claim 7 (depends on 5) The kit of claim 5, wherein the second fluorophore is R-phycoerythrin. ### Claim 8 (depends on 5) The kit of claim 5, wherein the third fluorophore is fluorescent dye sold under the trademark Alexa Fluor® 647 (Molecular Probes, Inc., Eugene Oreg.). ### Claim 9 A composition comprising: a first binding agent for CD91 conjugated with a first detectable moiety; a second binding agent for CD59 conjugated with a second detectable moiety; and a third binding agent for CD163 conjugated with a third detectable moiety. ### Claim 10 (depends on 9) The composition of claim 9, wherein the first binding agent, second binding agent, and third binding agent are independently chosen from single chain variable fragments, antibody mimetics, antibody fragments, antibodies, monoclonal antibodies, and combinations thereof. ### Claim 11 (depends on 9) The composition of claim 9, wherein the first detectable moiety, second detectable moiety, and third detectable moiety are independently chosen from radioisotopes, stable isotopes, fluorophores, and combinations thereof. ### Claim 12 (depends on 9) The composition of claim 9, wherein the first binding agent for CD91 is a monoclonal antibody for CD91, and the first detectable moiety is a first fluorophore; the second binding agent for CD59 is a monoclonal antibody for CD59, and the second detectable moiety is a second fluorophore; and the third binding agent for CD163 is a monoclonal antibody for CD163, and the third detectable moiety is a third fluorophore. ### Claim 13 (depends on 12) The composition of claim 12, wherein the monoclonal antibody for CD91 is a mouse anti-human IgG monoclonal antibody for CD91; the monoclonal antibody for CD59 is a mouse anti-human IgG monoclonal antibody for CD59; and the monoclonal antibody for CD163 is a mouse anti-human IgG monoclonal antibody for CD163. ### Claim 14 (depends on 12) The composition of claim 12, wherein the first fluorophore is fluorescein isothiocyanate. ### Claim 15 (depends on 12) The composition of claim 12, wherein the second fluorophore is R-phycoerythrin. ### Claim 16 (depends on 12) The composition of claim 12, wherein the third fluorophore is fluorescent dye sold under the trademark Alexa Fluor® 647 (Molecular Probes, Inc., Eugene Oreg.). ### Claim 17 A method for diagnosing AD in a human patient, comprising: obtaining a blood sample from the human patient; optionally storing the blood sample in ice; optionally testing the blood sample within three hours of obtaining the blood sample; reacting the blood sample with a mouse anti-human IgG monoclonal antibody for CD91 conjugated with a first fluorophore to obtain bound CD91; a mouse anti-human IgG monoclonal antibody for CD59 conjugated with a second fluorophore to obtain bound CD59; a mouse anti-human IgG monoclonal antibody for CD163 conjugated with a third fluorophore to obtain bound CD163; measuring a concentration of bound CD91, a concentration of bound CD59, and a concentration of bound CD163 in the blood sample by fluorescence of the first fluorophore, the second fluorophore, and the third fluorophore; observing an increase in the concentration of bound CD91 relative to a concentration range of CD91 in healthy humans; observing an increase in the concentration of bound CD59 relative to a concentration range of CD59 in healthy humans; observing a decrease in the concentration of bound CD163 relative to a concentration range of CD163 in healthy humans; thereby diagnosing AD in the human patient.