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High dose treatments for Alzheimer's disease

A technology for Alzheimer's and dosage, applied in the direction of disease diagnosis, measuring devices, antibody medical components, etc.

Inactive Publication Date: 2018-09-28
GENENTECH INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

There is a huge unmet need for safe and effective disease-modifying therapeutics for AD

Method used

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  • High dose treatments for Alzheimer's disease
  • High dose treatments for Alzheimer's disease
  • High dose treatments for Alzheimer's disease

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0415] Example 1-Clinical study of the safety and tolerability of crnibizumab (a humanized anti-Aβ monoclonal antibody) administered to patients with mild to moderate Alzheimer's disease

[0416] A randomized, double-blind phase I trial was conducted using a placebo-control to evaluate the humanized monoclonal anti-amyloid beta ("Aβ") antibody crenibizumab in the diagnosis of mild to moderate Alzheimer's Safety, tolerability, and pharmacokinetics in patients with Murray's disease (AD). The study is designed to evaluate doses up to 8 times the dose administered to patients in a phase II clinical trial. Participants included in the study were aged between 50 and 90 at the time of screening, had a Mini Mental State Examination (MMSE) score of 18 to 28 points (inclusive), and a GDS-15 score of less than 6 , 0.5 or 1.0 clinical dementia assessment-global score (CDR-GS), and the diagnosis of mild to moderate Alzheimer's disease based on NINCDS-ADRDA criteria. Participants are also re...

Embodiment 2

[0436] Example 2-Clinical study of crnibizumab (a humanized anti-Aβ monoclonal antibody) in the treatment of pre-treatment to mild Alzheimer's disease

[0437] Research design and goals

[0438] A multicenter, randomized, double-blind, placebo-controlled trial was conducted to confirm that the humanized monoclonal anti-amyloid beta ("Aβ") antibody crenibizumab has a precursor to mild Alz Impact in amyloid-positive patients with Haymer's disease (AD). Participants in this study were aged between 50 and 85 at the time of screening, had a weight between 40kg and 120kg (inclusive), and had evidence of the pathological process of AD, based on cerebrospinal fluid (CSF) amyloid β1- 42 levels of positive amyloid evaluation, as in Measured on the beta-amyloid (1-42) test system or amyloid PET scan. The other inclusion criteria are: (1) Abnormal memory function demonstrated during screening, selective recall test with free and prompt less than or equal to 0.67-immediate recall (FCSRT) pro...

Embodiment 3

[0441] Example 3-Exposure response to crivizumab supports prodrome to 60 mg / kg dose in the treatment of mild Alzheimer's disease

[0442] Methods and goals

[0443] For patients suffering from a more mild form of AD, the phase 2 study of crenibizumab showed consistent treatment benefits at 15 mg / kg intravenous doses, while the low 300 mg q2wk subcutaneous dose level lacked consistent treatment effects between endpoints. It is suggested that higher dose is related to greater efficacy signal. In these two phase 2 studies, crenibizumab is safe and well tolerated, supporting that a complete treatment window has not yet been explored. A disease progression model of mild to moderate AD was established, which simultaneously described the longitudinal changes of the clinical endpoint ADAS-Cog and the sum of CDR sub-items (CDR-SB) of patients in the phase 2 study. The model was extended to describe the impact of key demographic covariates on disease progression and the impact of cranibizu...

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Abstract

Methods of treating Alzheimer's Disease (AD) in patients suffering from early AD, including amyloid positive patients, ApoE4 positive patients, and patients suffering from prodromal or mild AD are provided.

Description

[0001] Cross references to related applications [0002] This application requires U.S. Provisional Patent Application No. 62 / 281,140 filed on January 20, 2016, U.S. Provisional Patent Application No. 62 / 350,105 filed on June 14, 2016, and U.S. Provisional Patent Application No. 62 / 350,105 filed on December 7, 2016 The priority of patent application No. 62 / 430,852 is hereby included in its entirety by reference. Invention field [0003] It provides a method for treating patients suffering from Alzheimer's disease using high-dose antibodies targeting amyloid β. Background of the invention [0004] Alzheimer's disease (AD) is the most common cause of dementia. It is estimated to affect 4.5 million people in the United States and 26.6 million people worldwide (Hebert et al, Arch. Neurol. 2003; 60:1119-22; Brookmeyer et al. al., Alzheimers Dement. 2007; 3:186-91). The pathology of the disease is characterized by the accumulation of extracellular β-amyloid ("Aβ") plaques and intracellu...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07K16/18G01N33/15C07K16/00A61K39/00
CPCG01N33/6854G01N33/6896C12Q1/6883C07K16/18A61K45/06A61K39/3955A61K31/13A61K31/185A61K31/405A61K31/4418A61K31/455A61K31/4745A61K31/519A61P25/28G01N2333/4709G01N2800/2821C12Q2600/156A61K2039/505A61K2039/545C07K16/00A61K9/0019A61K2039/54C07K2317/24C07K2317/34C07K2317/56C07K2317/76
Inventor 吉莉安·史密斯贾尼斯·史密斯杰夫·基什内尔
Owner GENENTECH INC
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