Defining Disease Modifying Therapy for Alzheimer's Disease
J Cummings1, N Fox2
1Cleveland Clinic Lou Ruvo Center for Brain Health, Las Vegas, NV, USA.
The Journal of Prevention of Alzheimer'S Disease
|October 27, 2017
Summary
Disease-modifying therapies (DMTs) offer enduring changes in Alzheimer's disease (AD) progression by targeting underlying pathology. Demonstrating DMT efficacy requires robust clinical trial data and biomarkers for drug development.
Area of Science:
- Neuroscience
- Pharmacology
- Clinical Trials
Background:
- Alzheimer's disease (AD) poses a growing challenge, necessitating effective disease-modifying therapies (DMTs).
- A clear definition of DMTs is crucial for advancing drug development in AD.
- Current therapeutic strategies for AD require enhancement with disease-modifying agents.
Purpose of the Study:
- To review the current scientific understanding of disease-modifying therapies (DMTs) for Alzheimer's disease (AD).
- To establish a working definition for DMTs to guide drug development.
- To outline the criteria for demonstrating disease modification in AD clinical trials.
Main Methods:
- Comprehensive literature review on the definition and development of DMTs.
- Analysis of clinical trial designs and biomarker evidence for disease modification.
- Evaluation of scientific evidence supporting neuroprotection and disease modification.
Main Results:
- A disease-modifying therapy (DMT) is defined as an intervention causing enduring change in AD clinical progression by targeting underlying pathophysiological mechanisms.
- Efficacy demonstration relies on clinical trial designs (e.g., staggered start, delayed withdrawal) and biomarkers.
- Multiple data sources, including slope changes in cognitive decline and biomarker evidence, support disease modification, but no single measure is conclusive.
Conclusions:
- Disease modification is characterized by an enduring effect on cellular death pathways in AD.
- Convincing evidence for DMTs requires consistent, robust, and varied data sources.
- The definition of DMTs hinges on their ability to modify the fundamental disease process in Alzheimer's.
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