ES2556535T3 - Uso de ensayo genómico y compuestos cetogénicos para tratamiento de una función cognitiva reducida - Google Patents
Uso de ensayo genómico y compuestos cetogénicos para tratamiento de una función cognitiva reducida Download PDFInfo
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- A61P25/16—Anti-Parkinson drugs
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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
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- C12Q2600/00—Oligonucleotides characterized by their use
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Abstract
Un método para seleccionar un paciente para tratamiento de función cognitiva reducida relacionada con la enfermedad causada por reducción del metabolismo neuronal asociada con la enfermedad de Alzheimer (EA), método que comprende: a. seleccionar un paciente que tiene reducción de la función cognitiva relacionada con la enfermedad causada por reducción del metabolismo neuronal asociada a la enfermedad de Alzheimer (EA); b. determinar en el paciente la presencia de homocigosis para adenina de rs2229765 de Precursor de Receptor de tipo Insulínico (IGF1 R) en una porción relevante mostrada por la SEC ID Nº: 6; y c. seleccionar un paciente que tiene el genotipo específico en (b) para tratamiento, en el que el tratamiento comprende la administración al paciente de al menos un triglicérido de cadena media (MCT) en una cantidad eficaz para el tratamiento o la prevención de la reducción de la función cognitiva relacionada con la enfermedad por metabolismo neuronal reducido asociado a la enfermedad de Alzheimer.
Description
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 0,147
- 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
- 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
23
- 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
-
imagen21 imagen22 imagen23
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 ADCS-CGIC 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
- 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 0,299 0,292 Na
24
- 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
-
imagen24
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
- 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
25
- 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
-
imagen25
Durante los primeros varios meses del estudio, parecía que se retiraría el estudio un número relativamente elevado
5 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
10 con respecto a que sujetos se adherían a las instrucciones de mezcla de la nueva medicación, Accera tenía razones para creer que Ensure™ llevó a estar disponible para todos los sujetos que estaban en el estudio en es el punto temporal o se inscribieron después del cambio.
Para evaluar si o no este cambio en las instrucciones en vez de la medicación del estudio parecía a aumentar la
15 tolerabilidad del producto, se realizó un análisis de las interrupciones del sujeto antes y después de realizar el cambio.
20 Diez sujetos [9 de 31 (29,0 %) con Tratamiento y 1 de 27 (3,4 %) de placebo] interrumpieron el estudio. durante este periodo de tiempo, algunos sucesos dentro del sistema gastrointestinal fueron la causa principal de retirada del estudio. Dentro del sistema GI, 7 de 31 (22,6 %) sujetos con Tratamiento y 1 de 27 (3,4 %) sujetos con placebo interrumpieron el estudio debido a uno o más sucesos adversos.
Después del cambio de las instrucciones de mezcla de la medicación, la incidencia global de sucesos adversos que conducían a la interrupción del estudio disminuyó ligeramente en el grupo con el Tratamiento de un 29,0 % a un 21,9 %. De forma más notable, la incidencia de sucesos gastrointestinales que causaban la retirada del estudio en el
30 grupo con el Tratamiento disminuyó de un 22,6 % a un 12,5 %.
26
Claims (1)
-
imagen1 imagen2
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
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US95307407P | 2007-07-31 | 2007-07-31 | |
US953074P | 2007-07-31 |
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ES2556535T3 true ES2556535T3 (es) | 2016-01-18 |
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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 |
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 |
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 |
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 |
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 |
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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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 |
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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 |
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 |
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 |
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 |
Country Status (10)
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US (2) | US9175345B2 (es) |
EP (6) | EP2650378B1 (es) |
JP (1) | JP5819065B2 (es) |
KR (1) | KR101335021B1 (es) |
CN (1) | CN101809443B (es) |
AU (1) | AU2008282130B2 (es) |
CA (3) | CA3078084C (es) |
ES (6) | ES2608286T3 (es) |
PT (6) | PT2650382E (es) |
WO (1) | WO2009018478A2 (es) |
Families Citing this family (16)
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US6323237B1 (en) | 1997-03-17 | 2001-11-27 | Btg International Limited | Therapeutic compositions |
US6835750B1 (en) | 2000-05-01 | 2004-12-28 | Accera, Inc. | Use of medium chain triglycerides for the treatment and prevention of alzheimer's disease and other diseases resulting from reduced neuronal metabolism II |
EP1929995A1 (en) | 2006-12-04 | 2008-06-11 | INSERM (Institut National de la Santé et de la Recherche Médicale) | Anaplerotic therapy of Huntington disease and other polyglutamine diseases |
PT2650382E (pt) | 2007-07-31 | 2016-01-14 | Accera Inc | Utilização de testagem genómica e compostos cetogénicos para o tratamento de função cognitiva reduzida |
KR101734152B1 (ko) | 2008-07-03 | 2017-05-11 | 액세라인크 | 신경계 장애의 치료를 위한 아세토아세테이트의 모노글리세리드 및 유도체 |
WO2011082111A1 (en) * | 2009-12-30 | 2011-07-07 | Baylor Research Institute | Anaplerotic therapy for alzheimer's disease and the aging brain |
EP2360280A1 (en) * | 2010-02-24 | 2011-08-24 | Fundació Institut d'Investigació en Ciències de la Salut Germans Trias i Pujol | Genetic marker for the diagnosis of dementia with Lewy bodies |
AU2013358951C1 (en) | 2012-12-13 | 2019-06-27 | 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 |
JP7399465B2 (ja) * | 2017-05-15 | 2023-12-18 | インフォメディテック・カンパニー,リミテッド | アルツハイマー病の危険性と関連するapoeプロモーターの一塩基多型およびその使用 |
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 |
US20220125925A1 (en) * | 2019-03-04 | 2022-04-28 | Cerecin Inc. | Medium chain triglyceride formulations with improved bioavailability 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 |
JP7414693B2 (ja) | 2020-11-09 | 2024-01-16 | 三協立山株式会社 | 建具 |
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