ES2608846T3 - Uso de ensayos genómicos y compuestos cetogénicos para tratamiento de una función cognitiva reducida - Google Patents

Uso de ensayos genómicos y compuestos cetogénicos para tratamiento de una función cognitiva reducida Download PDF

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ES2608846T3
ES2608846T3 ES08796988.7T ES08796988T ES2608846T3 ES 2608846 T3 ES2608846 T3 ES 2608846T3 ES 08796988 T ES08796988 T ES 08796988T ES 2608846 T3 ES2608846 T3 ES 2608846T3
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Samuel T. Henderson
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Cerecin Inc
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    • A61P25/28—Drugs for disorders of the nervous system 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
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    • C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
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    • C12Q1/6883—Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes for diseases caused by alterations of genetic material
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    • C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
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    • C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q2600/00—Oligonucleotides characterized by their use
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Abstract

Un metodo para seleccionar un paciente para el tratamiento del metabolismo neuronal reducido asociado a enfermedad de Alzheimer (EA), que comprende: a. seleccionar un paciente que tiene un metabolismo neuronal reducido asociado a enfermedad de Alzheimer (EA); b. determinar en el paciente la presencia de al menos uno de los genotipos especificos seleccionados entre el grupo que consiste en: i. heterocigosis para C/T para rs2551101 de Enzima Degradante de Insulina (IDE) en una porcion relevante mostrada por la SEC ID No: 3, y ii. ausencia de homocigosis para C/C de rs2551101 de IDE en una porcion relevante mostrada por la SEC ID No: 3. c. seleccionar un paciente que tiene al menos uno de los genotipos especificos en (b) para tratamiento usando al menos un triglicerido de cadena media (TCM) en una cantidad eficaz para el tratamiento o la prevencion de la reduccion del metabolismo neuronal asociado a enfermedad de Alzheimer

Description

imagen1
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APOE rs448647. No se observaron efectos significativos con este alelo.
rs405509 de APOE. Los sujetos que eran heterocigotos en el sitio rs405509 demostraban un aumento de 3,68 puntos en la puntuación de ADAS-Cog cuando se comparan con el placebo (p = 0,0085). rs769446 de APOE. No se observaron efectos significativos con este alelo.
Tabla 2 Tratamiento por Genotipo
Cambio en ADAS-Cog a Partir de la Medida Inicial el Día 90
Genotipo de Tratamiento* con Anova de 2 vías
Snp
Genotipo N para AC-1202 N para Placebo P-valor
rs449647 de APOE
a 39 38 0,47
Het
17 11 0,14
t
3 3 0,4
rs405509 de APOE
g 11 7 0,48
Het
26 27 0,0085
t
23 18 0,629
rs769446 de APOE
Het 5 6 0,405
t
55 46 0,0951
rs1803274 de BUCHE
a 2 Na
g
40 39 0,541
Het
25 15 0,0133
rs2251101 de IDE
C 9 7 0,079
Het
22 25 0,0068
t
36 24 0,266
rs2229765 de IGF1R
A 5 13 0,00719
G
27 18 0,156
het
34 25 0,826
rs28401726 de IGF1R
C 52 48 0,0578
het
14 5 0,901
G
2 Na
rs16944 de IL1B
C 29 27 0,0145
het
28 17 0,845
T
6 9 0,479
rs1143627 de IL1B
C 6 9 0,479
23
Genotipo de Tratamiento* con Anova de 2 vías
Snp
Genotipo N para AC-1202 N para Placebo Valor de P
het
28 17 0,845
T
29 27 0,0145
rs11669576 de LDLR8
G 59 51 0,025
het
8 5 0,458
rs688 de LDLR13
C 24 22 0,987
het
33 20 0,061
T
7 13 0,061
rs2738447 de LDLR13
A 13 11 0,77
C
18 21 0,037
het
32 22 0,176
rs7259278 de LDLR13
G 44 44 0,0236
het
17 8 0,403
T
2 2 0,974
rs1799898 de LDLR 13
C 40 35 0,045
het
18 15 0,126
T
1 1 0,819
rs662 de PON1
A 28 26 0,12
G
6 7 0,239
het
32 23 0,73
rs2251101 de IDE
c/c 9 7 0,079
otro
58 49 0,0059
fuente del programa de AI: phg Tab 3
imagen22 imagen23 imagen24
ADCSCGIC y MMSE
5 Cuando se comparan AC-1202 y Placebo en la población de ITT usando LOCF, AC-1202 no conducía a una diferencia significativa en la distribución de las puntuaciones de ADCS-CGIC en cualquier estudio.
Tabla 2 Tratamiento por Genotipo: Puntuación de ADCSCGIC el Día 90
Valor de P del Genotipo de Tratamiento* con Anova de 2 vías
Snp
genotipo N para Ketasyn N para Placebo
Apoe4
0 1 29 39 26 31 0,218 0,769
rs449647 de APOE
a het t 39 17 3 38 11 33 0,201 0,604 0,796
24
rs405509 de APOE
g het t 11 26 23 7 27 18 0,6868 0,5660 0,7090
rs769446 de APOE
het t 5 55 6 46 0,441 0,274
rs1803274 de BUCHE
a g het 2 40 25 39 15 Na 0,356 0,574
rs2251101 de IDE
c het t 9 22 36 7 25 24 0,789 0,569 0,259
rs2229765 de IGF1R
a g het 5 27 34 13 18 25 0,350 0,871 0,585
rs28401726 de IGF1R
c het g 52 14 48 5 2 Na 0,299 0,292
rs16944 de IL1B
c het t 29 28 6 27 17 9 0,839 0,492 0,437
rs1143627 de IL1B
c het t 6 28 29 9 17 27 0,437 0,492 0,839
rs11669576 de LDLR8
g het 59 8 51 5 0,538 0,935
rs688 de LDLR13
c het t 24 33 7 22 20 13 0,436 0,662 0,295
rs2738447 de LDLR13
a c het 13 18 32 11 21 22 0,635 0,993 0,147
rs7259278 de LDLR13
g het t 44 17 2 44 8 2 0,288 0,552 1
rs1799898 de LDLR 13
c het t 40 18 1 35 15 1 0,175 0,986 0,321
rs662 de PON1
a g het 28 6 32 26 7 23 0,408 0,975 0,722
rs2251101 de IDE
c/c otro 9 58 7 49 0,494 0,790
fuente del programa de AI: phg Tab 5
imagen25 imagen26
Se encontraron efectos significativos del tratamiento en el cambio a partir de la Medida Inicial en MMSE en Vehículos de rs405509 de APOE y rs662 de PON1.
Tabla 3 Tratamiento por Genotipo: Cambio en MMSE a partir de la Medida Inicial el Día 90
Valor de P del Genotipo de Tratamiento* con Anova de 2 vías
Snp
genotipo N para Ketasyn N para Placebo
Apoe4
0 1 29 39 26 31 0,369 0,704
25
rs449647 de APOE
A het T 39 17 3 38 11 33 0,595 0,424 0,277
rs405509 de APOE
G het T 11 26 23 7 27 18 0,929 0,067 0,037
rs769446 de APOE
het T 5 55 6 46 0,504 0,834
rs1803274 de BUCHE
A G het 2 40 25 39 15 Na 0,892 0,413
rs2251101 de IDE
C het T 9 22 36 7 25 24 0,908 0,206 0,111
rs2229765 de IGF1R
A G het 5 27 34 13 18 25 0,125 0,929 0,844
rs28401726 de IGF1R
C het G 52 14 48 5 2 Na 0,392 0,254
rs16944 de IL1B
C het T 29 28 6 27 17 9 0,846 0,943 0,879
rs1143627 de IL1B
C het T 6 28 29 9 17 27 0,879 0,943 0,846
rs11669576 de LDLR8
G het 59 8 51 5 0,756 0,762
rs688 de LDLR13
C het T 24 33 7 22 20 13 0,240 0,365 0,468
rs2738447 de LDLR13
A C het 13 18 32 11 21 22 0,709 0,265 0,513
rs7259278 de LDLR13
G het T 44 17 2 44 8 2 1 0,903 0,859
rs1799898 de LDLR 13
C het T 40 18 1 35 15 1 0,322 0,145 0,799
rs662 de PON1
A G het 28 6 32 26 7 23 0,085 0,031 0,287
rs2251101 de IDE
c/c otro 9 58 7 49 0,682 0,909
fuente del programa de AI: phg Tab 4
imagen27 imagen28
Sucesos Adversos que se Producen Antes y Después de un Cambio en el Protocolo de Dosificación
Durante los primeros varios meses del estudio, parecía que se retiraría el estudio un número relativamente elevado de sujetos debido a sucesos adversos gastrointestinales, en particular, por diarrea y flatulencia. Después de una evaluación de las razones dadas para la interrupción, se recomendó que la medicación del estudio o el placebo se deberían mezclar con una bebida con alto contenido de proteína (Ensure™) para aumentar la tolerabilidad del producto en investigación. Se informó de esta decisión a los sitios clínicos y posteriormente se les proporcionó un amplio suministro de Ensure para distribución a los sujetos del estudio. Aunque no se recogieron datos específicos
26

Claims (1)

  1. imagen1
    imagen2
ES08796988.7T 2007-07-31 2008-07-31 Uso de ensayos genómicos y compuestos cetogénicos para tratamiento de una función cognitiva reducida Active ES2608846T3 (es)

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US95307407P 2007-07-31 2007-07-31
US953074P 2007-07-31
PCT/US2008/071817 WO2009018478A2 (en) 2007-07-31 2008-07-31 Use of genomic testing and ketogenic compounds for treatment of reduced cognitive function

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ES13167175.2T Active ES2556536T3 (es) 2007-07-31 2008-07-31 Uso de ensayo genómico y compuestos cetogénicos para tratamiento de una función cognitiva reducida
ES13167174.5T Active ES2556537T3 (es) 2007-07-31 2008-07-31 Uso de ensayo genómico y compuestos cetogénicos para tratamiento de una función cognitiva reducida
ES13167176.0T Active ES2556535T3 (es) 2007-07-31 2008-07-31 Uso de ensayo genómico y compuestos cetogénicos para tratamiento de una función cognitiva reducida
ES13167177.8T Active ES2608286T3 (es) 2007-07-31 2008-07-31 Uso de ensayos genómicos y compuestos cetogénicos para tratamiento de una función cognitiva reducida
ES13167178.6T Active ES2556534T3 (es) 2007-07-31 2008-07-31 Uso de ensayo genómico y compuestos cetogénicos para tratamiento de una función cognitiva reducida
ES08796988.7T Active ES2608846T3 (es) 2007-07-31 2008-07-31 Uso de ensayos genómicos y compuestos cetogénicos para tratamiento de una función cognitiva reducida

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ES13167174.5T Active ES2556537T3 (es) 2007-07-31 2008-07-31 Uso de ensayo genómico y compuestos cetogénicos para tratamiento de una función cognitiva reducida
ES13167176.0T Active ES2556535T3 (es) 2007-07-31 2008-07-31 Uso de ensayo genómico y compuestos cetogénicos para tratamiento de una función cognitiva reducida
ES13167177.8T Active ES2608286T3 (es) 2007-07-31 2008-07-31 Uso de ensayos genómicos y compuestos cetogénicos para tratamiento de una función cognitiva reducida
ES13167178.6T Active ES2556534T3 (es) 2007-07-31 2008-07-31 Uso de ensayo genómico y compuestos cetogénicos para tratamiento de una función cognitiva reducida

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US (2) US9175345B2 (es)
EP (6) EP2650381B1 (es)
JP (1) JP5819065B2 (es)
KR (1) KR101335021B1 (es)
CN (1) CN101809443B (es)
AU (1) AU2008282130B2 (es)
CA (3) CA2853992C (es)
ES (6) ES2556536T3 (es)
PT (6) PT2650382E (es)
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PT2650382E (pt) 2007-07-31 2016-01-14 Accera Inc Utilização de testagem genómica e compostos cetogénicos para o tratamento de função cognitiva reduzida
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CA2894456C (en) 2012-12-13 2022-06-28 Baylor Research Institute Triheptanoin for the treatment of glucose transporter 1 deficiency
US9833430B2 (en) 2013-11-14 2017-12-05 The University Of Queensland Neurodegenerative disorders and methods of treatment and diagnosis thereof
CN104305192B (zh) * 2014-10-23 2016-05-04 贡岳松 改善老年痴呆症患者记忆的功能性食品及其制备方法
EP3626830A4 (en) * 2017-05-15 2021-01-27 Infomeditech Co., Ltd. SINGLE NUCLEOTIDE POLYMORPHISM OF AN APOE PROMOTER RELATED TO ALZHEIMER'S MORBUS AND USE OF IT
CN109480284A (zh) * 2018-12-05 2019-03-19 上海欣海生物科技有限公司 一种生酮食品及其制备方法
SG11202109268XA (en) * 2019-03-04 2021-09-29 Cerecin Inc Medium chain triglyceride formulations with improved bioavailiblity and methods related thereto
CN112903885B (zh) * 2019-12-03 2022-05-06 中国科学院大连化学物理研究所 一种筛查糖尿病的联合型代谢标志物的应用及其试剂盒
CN112226504B (zh) * 2020-10-21 2021-06-08 北京市劳动保护科学研究所 BuChE基因SNP位点的用途及新烟碱农药接触人群高TG血症易感性分析检测试剂盒
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