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Alzheimer's Disease: Clinical Pipelines, R&D Challenges, and Future Directions - Overview

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This publication has been discontinued on September 10, 2014.

Abstract

Overview

Alzheimer's disease is an extraordinarily active realm of research, with nearly 100 products in clinical development and many more at the discovery and preclinical stages. The competition in this arena is fierce, but the company that produces the next innovative compound for Alzheimer's disease will earn a rich return on its investment. This report provides a detailed assessment of Alzheimer's disease and examines:

  • Alzheimer's disease pathology, causes, methods of diagnosis, and epidemiology
  • Current pharmacologic treatment options for Alzheimer's disease
  • The wide range of Alzheimer's disease therapy approaches at the investigational stage
  • The numerous molecular targets being explored for their potential to alter the course of Alzheimer's disease
  • R&D challenges in advancing Alzheimer's disease drugs through the clinical pipeline
  • Future directions in Alzheimer's disease research

Alzheimer's disease, the most common chronic neurodegenerative disease, is a progressive, incurable condition characterized by cognitive impairment. The efficacy of available treatment options is very limited. This, in combination with the huge potential market for Alzheimer's disease - more than 5 million patients in the United States alone suffer from the disease, and this figure is increasing with every decade - has placed Alzheimer's disease prominently in the sights of pharmaceutical companies trying to come up with new and improved drugs.

Developing effective drugs for Alzheimer's disease has been and continues to be challenging. Alzheimer's disease attacks the most complex and least understood region of the human anatomy: the nervous system. Researchers have figured out different aspects of the mechanisms of the disease, but are unsure how the various pieces fit together into pathogenic pathways. As a result, drug development has been slow and painstaking, with numerous incremental advancements and more than a few reversals. Alzheimer's disease research has been stung by the recent setbacks of several novel compounds in late-stage clinical trials. The class of drugs that has suffered the most drastic loss in status since its hopeful entry into the clinic about a decade ago is the gamma-secretase inhibitors, following the failure of the front-running candidate, semagacestat, in Phase III in 2010.

There are a multitude of ideas about interventions that might arrest the course of Alzheimer's disease. Thus, a broad range of molecular targets are being explored. The therapies under evaluation include those aimed at compensating for the loss or dysfunction of neurotransmitters involved in cognition; those that intervene in the process of amyloid-beta production and aggregation; and others that target, for example, tau pathology, neuroprotection, cholesterol and energy homeostasis, and second messenger modulation.

This Insight Pharma Report, Alzheimer's Disease: Clinical Pipelines, R&D Challenges, and Future Directions, provides a detailed assessment of Alzheimer's disease. Following a brief introduction to the disease, Chapter 2 reviews its symptoms and pathology, presumed causes, methods of diagnosis, and epidemiology. Chapter 3 explores available drug therapies for the disease; Chapter 4, the wide range of treatment approaches now at the investigational stage; and Chapter 5, future directions in Alzheimer's disease research.

About the Author

Mark C. Via, an editor at CTB International Publishing, has more than 16 years of experience writing and editing for pharmaceutical trade publications. He holds a BA in history from Williams College.

Table of Contents

Executive Summary

Chapter 1 Introduction

Chapter 2 Alzheimer's Disease: Background and Pathology

  • 2.1. Pathology of Alzheimer's Disease
  • 2.2. Causes of Alzheimer's Disease
  • 2.3. Diagnosis of Alzheimer's Disease
  • 2.4. Epidemiology of Alzheimer's Disease

Chapter 3 Current Pharmacologic Treatment Options

  • 3.1. Cholinesterase InhibitorsAricept (Donepezil HCl)
    • Exelon (Rivastigmine Tartrate)
    • Razadyne (Galantamine HBr)
  • 3.2. NMDA Receptor AntagonistsNamenda (Memantine HCl)
  • 3.3. Other Treatments

Chapter 4 Compounds in Development: The Next Generation of Drugs for AD

  • 4.1. Cholinergic DysfunctionAstraZeneca/Targacept
    • EnVivo Pharmaceuticals
    • Abbott Laboratories
    • Anavex Life Sciences
  • 4.2. Glutamatergic DysfunctionServier/Cortex Pharmaceuticals
    • AC Immune
    • Addex Therapeutics
  • 4.3. Serotonergic DysfunctionNanotherapeutics
    • GlaxoSmithKline
    • Abbott Laboratories
    • Suven Life Sciences
    • Biotie Therapies/Roche
  • 4.4. Histaminergic Dysfunction
  • 4.5. Amyloid Cascade: Inhibiting ProductionBristol Myers-Squibb
    • Chiesi Farmaceutici
    • AC Immune
    • ExonHit Therapeutics
    • Sonexa Therapeutics
    • QR Pharma
    • Eisai
    • Noscira
    • Medisyn Technologies
    • Eli Lilly
    • Roche/Siena Biotech
    • Merck
    • EnVivo Pharmaceuticals
    • High Point Pharmaceuticals
    • Cellzome/Johnson & Johnson
    • NeuroGenetic Pharmaceuticals
    • Cortica Neurosciences
  • 4.6. Amyloid Cascade: Stimulating RemovalPfizer/Johnson & Johnson
    • Eli Lilly
    • Roche/Genentech/AC Immune
    • Novartis/Cytos Biotechnology
    • AFFiRiS/GlaxoSmithKline
    • United Biomedical
    • Merck/Acumen Pharmaceuticals/Merz Pharma
    • BioArctic Neuroscience/Eisai
    • Biogen Idec/Neurimmune Therapeutics
    • Sanofi-Aventis
    • Boehringer Ingelheim/Ablynx
    • Intellect Neurosciences
    • Araclon Biotech
    • ArmaGen Technologies
    • TransTech Pharma
  • 4.7. Amyloid Cascade: Preventing AggregationPrana Biotechnology
    • Bellus Health
    • Elan/Transition Therapeutics/Proteostasis Therapeutics
    • ProteoTech
    • Archer Pharmaceuticals
    • Probiodrug
    • D-Pharm
    • AC Immune
    • NeuroPhage Pharmaceuticals
    • Senexis
  • 4.8. Tau PathologyTauRx Pharmaceuticals
    • Allon Therapeutics
    • Noscira
    • Bristol-Myers Squibb
    • Oligomerix
    • AC Immune
    • Intellect Neurosciences
    • Signum Biosciences/GlaxoSmithKline
  • 4.9. NeuroprotectionNewron Pharmaceuticals
    • Roche/Evotec
  • 4.10. NeurorestorationCeregene
    • NsGene
    • Enkam Pharmaceuticals
  • 4.11. Cholesterol and Energy HomeostasisTakeda Pharmaceutical/Zinfandel Pharmaceuticals
    • Metabolic Solutions Development
    • Resverlogix
  • 4.12. Second Messenger Modulation
  • 4.13. Stem Cell Therapy

Chapter 5 Conclusion: Challenges and Future Directions

References

Company Index

FIGURES

  • Figure 2.1. Amyloid Cascade Mechanism
  • Figure 3.1. Treatment Algorithm for Mild-to-Moderate Alzheimer's Disease
  • Figure 3.2. Treatment Algorithm for Moderate-to-Severe Alzheimer's Disease
  • Figure 3.3. Treatment Algorithm for Severe Alzheimer's Disease

TABLE

  • Table 4.1. Drugs in Clinical Trials for Alzheimer's Disease
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