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Use of riluzole prodrugs to treat alzheimer's disease

A technology for Alzheimer's disease and riluzole, which is applied in the field of application of riluzole prodrugs in the treatment of Alzheimer's disease, and can solve problems such as clinical benefits of small effect size

Pending Publication Date: 2021-03-09
BIOHAVEN THERAPEUTICS LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] There are currently approved medicines for the symptomatic treatment of AD, but they have small effect sizes and often limited clinical benefit

Method used

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  • Use of riluzole prodrugs to treat alzheimer's disease
  • Use of riluzole prodrugs to treat alzheimer's disease
  • Use of riluzole prodrugs to treat alzheimer's disease

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0085] Clinical studies were performed using the following parameters. For additional information, see ClinicalTrials.govIdentifier NCT03605667, www.clinicaltrials.gov.

[0086] research description

[0087] Brief overview:

[0088] Preclinical models have shown that riluzole, the active metabolite of BHV-4157, protects against AD-related pathology and cognitive impairment. A titrated dose (to 280 mg) of BHV-4157 or placebo was administered orally once daily. The duration of treatment is 48 weeks. There is also a screening period of up to 42 days and a post-treatment observation period of 4 weeks.

[0089]

[0090] Research design

[0091]

[0092] Groups and Interventions

[0093]

[0094] outcome measures

[0095] Primary Outcome Measures:

[0096] 1. Changes in Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-Cog 11) from Baseline to Week 48 between BHV-4157 Treatment Groups and Placebo [Time Frame: Baseline to Week 48] 48 weeks]

[0097] Alz...

Embodiment 2

[0119] Clinical studies were performed using the following parameters.

[0120] Research Summary

[0121]

[0122]

[0123]

[0124] list of abbreviations

[0125] Aβ β-amyloid

[0126] AchEI acetylcholinesterase inhibitor

[0127] AD Alzheimer's disease

[0128] ADAS-Cog Alzheimer's Disease Assessment Scale-Cognition (subscale)

[0129] ADCS-ADL Alzheimer's Disease Collaborative Study - Activity of Daily Living Record Form

[0130] ADME absorption, distribution, metabolism, excretion

[0131] AICD Automatic Implantable Cardioverter Defibrillator

[0132] AUC area under the curve

[0133] AE adverse events

[0134] AIDS acquired immunodeficiency syndrome

[0135] ALS amyotrophic lateral sclerosis

[0136] ALT alanine aminotransferase

[0137] ApoE apolipoprotein E

[0138] AST aspartate aminotransferase

[0139] BDNF brain-derived neurotrophic factor

[0140] BID twice a day

[0141] BUN blood urea nitrogen

[0142] CDR-SOB Clinical Dementia Scale - To...

Embodiment 3

[0344] Capsules containing 140 mg of troluzole for the studies described in Examples 1 and 2 were prepared in the following proportions.

[0345] Composition of 140mg troluzole capsules

[0346]

[0347] 1 Supplied as a 75:25 mixture of microcrystalline cellulose and dicalcium phosphate anhydrous.

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PUM

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Abstract

Disclosed are methods of treating Alzheimer's Disease by administering to a patient in need thereof a riluzole prodrug such as troriluzole. Pharmaceutical compositions and kits including the riluzoleprodrugs are also disclosed.

Description

technical field [0001] The present invention relates to the use of riluzole prodrug for treating Alzheimer's disease. Background technique [0002] Alzheimer's disease is a progressive, fatal neurodegenerative dementia. It accounts for 80 percent of dementias. According to the Alzheimer's Association, approximately 5.5 million people in the United States were living with the disease in 2016, and that number is expected to rise rapidly in the coming years as the population ages. Glutamate uptake transporters have been reported to be reduced in the postmortem brain tissue of individuals with Alzheimer's disease, and reduced levels of glutamate transporters correlate with cognitive impairment as well as markers of synapse density and neurodegeneration. [0003] The emotional and financial burden of AD on patients, family members, and society is enormous and is expected to grow exponentially as the median age of the population increases. The potential to maintain or even impr...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/428C07D277/82A61P25/28
CPCC07D277/82A61K31/428A61P25/28A61K45/06A61K2300/00A61K9/48
Inventor V·科里克R·伯曼I·库雷希
Owner BIOHAVEN THERAPEUTICS LTD
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