Nicotinic Receptor Agonists for Treating Diseases of Cognitive Dysfunction

Published by: Decision Resources

Published: Nov. 13, 2007 - 20 Pages

Table of Contents

Executive Summary

Strategic Considerations

Stakeholder Implications

Introduction

Diseases Involving Cognitive Dysfunction That Are Prospective Targets for Nicotinic

Receptor Agonists

Alzheimer’s Disease

Mild Cognitive Impairment

Age-Associated Memory Impairment

Schizophrenia

Attention-Defi cit/Hyperactivity Disorder

Parkinson’s Disease

Biology of Nicotinic Receptors

Functional Studies of Nicotinic Receptors That Are Targets in Improvement of Cognition

Functional Studies of nAChRs Containing the â4 Subunit Using a Subtype-Specifi c Drug

Functional Studies of nAChRs Containing the â2 Subunit Using Genetic Manipulation

A Study of the Role of the á7 nAChR in Attention

Other Studies of the Potential Role of á7 Receptors in Schizophrenia and Alzheimer’s

Disease

Subtype-Specifi c nAChR Agonists in Clinical Development for Cognitive Disorders

Targacept/AstraZeneca’s TC-1734/AZD-3480

CoMentis’s GTS-21

Memory Pharmaceuticals/Roche’s MEM-3454

EnVivo Pharmaceuticals’ á7 Agonist Program

NeuroSearch/Abbott’s Nicotinic Receptor Agonist Program

Outlook

Tables:

1. Prevalence in the Major Markets of Diseases Involving Cognitive Dysfunction That Are Targets for Nicotinic Acetylcholine Receptor Agonists, 2006

2. Properties of Neural Nicotinic Receptor Subtypes That Are Targets in Cognition

3. Select Subtype-Specifi c Nicotinic Receptor Agonists in Development for Cognitive Disorders

Figures:

1. Cognition and Memory

2. Dopamine Pathways

Abstract

• Although the role of neural nicotinic receptors in cognition has been known since the 1980s, development of nAChR subtype-specifi c agonists has proven diffi cult. Why have previous agents failed during early stages of development?
• Several small biopharmaceutical companies have subtype-specifi c nAChRs in clinical development for diseases of cognitive dysfunction. The most advanced of these agents are in Phase II. Which of these companies have agents in Phase II trials, and which Big Pharma companies have partnered with them? When might nAChR agents now in development reach the market?
• Several pharmaceutical companies are expected to enter candidate nAChR agonists for the treatment of cognitive disorders into the clinic from their in-house programs. Which Big Pharma company has already entered its smoking-cessation drug into pilot trials for schizophrenia?
• One disease condition that is a target for nAChR agonists is mild cognitive impairment (MCI), a less severe form of cognitive dysfunction than Alzheimer’s disease. Some types of MCI may be precursors of Alzheimer’s. What methods are researchers using to clarify which types of MCI have a high risk of progression to AD?

• Prospective cognitive dysfunction disease targets for nicotinic receptor agonists: Alzheimer’s disease, mild cognitive impairment, age-associated memory impairment, schizophrenia, attentiondefi cit/hyperactivity disorder, Parkinson’s disease.
• Biology of nicotinic receptors: structure, function, and subtypes of nAChRs; functional studies of nicotinic receptors being targeted in cognition improvement; the role of the á7 nAChR in attention; studies of the á7 nAChR in schizophrenia and Alzheimer’s disease.
• Subtype-specifi c nAChR agonists in clinical development for cognitive disorders: profi les of the leading drug candidates in the nAChR agonist programs of fi ve leading biopharmaceutical companies.
• Outlook: growing corporate interest in nAChR agonists; the push toward proof-of-concept in human clinical trials; lingering concerns about addictive properties of particular subtype-specifi c nAChRs.

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