UPA Perpustakaan Universitas Jember

Disease modification and Neuroprotection in neurodegenerative disorders

Jeffrey Cummings - Personal Name

Background: Disease modifying therapies (DMTs) are urgently needed for neurodegenerative diseases (NDD) such
as Alzheimer’s disease (AD) and many other disorders characterized by protein aggregation and neurodegeneration.
Despite advances in understanding the neurobiology of NDD, there are no approved DMTs.
Discussion: Defining disease-modification is critical to drug-development programs. A DMT is an intervention that
produces an enduring change in the trajectory of clinical decline of an NDD by impacting the disease processes
leading to nerve cell death. A DMT is neuroprotective, and neuroprotection will result in disease modification.
Disease modification can be demonstrated in clinical trials by a drug-placebo difference in clinical outcomes
supported by a drug-placebo difference on biomarkers reflective of the fundamental pathophysiology of the NDD.
Alternatively, disease modification can be supported by findings on a staggered start or delayed withdrawal clinical
trial design. Collecting multiple biomarkers is necessary to support a comprehensive view of disease modification.
Conclusion: Disease modification is established by demonstrating an enduring change in the clinical trajectory of
an NDD based on intervention in the fundamental pathophysiology of the disease leading to nerve cell death.
Supporting data are collected in clinical trials. Effectively defining a DMT will assist in NDD drug development programs.

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Alzheimer’s disease
Frontotemporal dementia
Progressive supranuclear palsy
Corticobasal degeneration
Amyotropic lateral sclerosis
Multiple system atrophy
Disease modification
Disease modifying therapy

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Background: Disease modifying therapies (DMTs) are urgently needed for neurodegenerative diseases (NDD) such as Alzheimer’s disease (AD) and many other disorders characterized by protein aggregation and neurodegeneration. Despite advances in understanding

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UPA Perpustakaan Universitas Jember

NPP. 3509212D1000001

Disease modification and Neuroprotection in neurodegenerative disorders

Jeffrey Cummings - Personal Name

Series Title

Call Number

Publisher

Collation

Language

ISBN/ISSN

Classification

Content Type

Media Type

Carrier Type

Edition

Subject(s)

Specific Detail Info

Statement of Responsibility

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