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Central Nervous System disorders have an enormous impact on individuals and on society as a whole. The development of better treatments is crucial and is a major focus of pharmaceutical and biotechnology companies. This book explains the complicated process of CNS drug development in a way that is engaging for any interested professional or student. Chapters cover each stage of drug development, from pre-clinical research through all phases of clinical trials, to reporting to the regulatory authorities. Other key issues covered include strategic considerations, regulatory constraints, dissemination of results and ethical considerations. The user-friendly format and style enable readers to find important information quickly and easily. Written and edited by experts from different sectors actively engaged in CNS drug development, this is a unique resource for drug developers, investigators, academics and clinicians.
This chapter focuses on drug development for psychiatric as opposed to other central nervous system (CNS) indications such as neurological conditions, pain, and sleep. It provides an overview of how CNS drug development has evolved over its relatively short history of perhaps 50-100 years as well as to provide some sense of how it might evolve in the not-too-distant future. Chlorpromazine and other phenothiazine molecules were synthesized around the turn of the last century and some were initially used to treat pinworm infestation. However, chlorpromazine over the last 50 years has come to play a pivotal role in the modern era of clinical psychopharmacology. CNS drug development principally focused on serotonin selective reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors SNRIs, atypical antipsychotics, and cholinesterase inhibitors. The current development of drugs for Alzheimer's and other neurodegenerative diseases could be a model for how future CNS drug development might proceed.
In 1906, Alois Alzheimer first described a neurological disorder of the brain associated with global deterioration of cognitive functioning and resulting in severe social impairment. Once thought rare, senile dementia of the Alzheimer’s type is the most commonly acquired progressive brain syndrome. Alzheimer’s disease begins with insidious intellectual and memory loss as the brain becomes shrunken from nerve cell loss and advances over 5 to 15 years to a chronic vegetative state. Progressive cognitive, psychological, and social dysfunction has a profound effect on family and friends. Alzheimer’s disease is associated with significant morbidity, and it may be the fourth leading cause of death in the United States (Katzman 1976). D. K. Kay and colleagues (1964) showed the average survival for demented men to be 2.6 years after the diagnosis of illness, whereas the survival period for nondemented men of the same age was 8.7 years. However, there is great variability in survival statistics from different studies.
Although Alzheimer’s disease is the leading cause of dementia, its etiology remains unknown, and treatment is supportive. The illness is a major problem among the elderly. Approximately 4 percent of the population over the age of 65 is affected, and by age 80, prevalence reaches 20 percent (Brodie 1982). As the elderly population of the United States increases, the number of persons with Alzheimer-type dementia will also increase. Alzheimer’s disease exists in the presenium, but it has been difficult to document a bimodal distribution with regard to age. Even though pathological changes in presenile and senile forms of the illness are similar, there is evidence that early- and late-onset Alzheimer-type dementia differ clinically (Seltzer and Sherwin 1983).
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