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Global Clinical Trials For Alzheimers Disease

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Global Clinical Trials for Alzheimer s Disease

Global Clinical Trials for Alzheimer s Disease Book
Author : Menghis Bairu,Michael Weiner
Publisher : Academic Press
Release : 2013-08-28
ISBN : 0124115306
Language : En, Es, Fr & De

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Book Description :

Global Clinical Trials for Alzheimer’s Disease is a handy one-stop reference for researchers and physicians planning and conducting global clinical trials in this area. This book addresses important considerations that may arise during the successful design and execution of these trials, including site selection, local regulatory issues, pharmacogenomics, ethical matters and much more. Given the saturation of traditional clinical trial markets and the worldwide progression of Alzheimer’s disease, there is a need to focus on clinical trials in emerging markets and developing countries. This book provides you with a practical approach to recognizing the opportunities and tackling the challenges that are present during the planning and execution of global clinical trials for Alzheimer’s disease. Written by leading experts with hands-on experience in designing and running global Alzheimer’s disease and other neurodegenerative diseases clinical trials A step-by-step guide that provides critical information on the design, conduct and standardization necessary to effectively execute clinical trials and accelerate drug development in this area Includes practical examples, ethical considerations, lessons learned and other valuable tools to aid the planning and implementation of Alzheimer’s disease global clinical trials in emerging markets and developing countries

Global Clinical Trials for Alzheimer s Disease

Global Clinical Trials for Alzheimer   s Disease Book
Author : Hans J. Möbius
Publisher : Elsevier Inc. Chapters
Release : 2013-08-28
ISBN : 0128070420
Language : En, Es, Fr & De

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Book Description :

Regulatory approval of the first rational AD therapeutic tacrine occurred in 1993, followed by the approval of three other, AChEIs, and the NMDA antagonist memantine in 2002 (EMA) and 2003 (FDA) respectively. Since then, despite an enormous research and development effort, the past 10 years have seen a series of failures to translate pathophysiological understanding of dementia into new medicines. This includes a move away from neurotransmission to a focus on underlying pathological processes. The major reason for these failures was probably the continued absence of a unified disease theory of AD and too narrow a focus on the potential aetiologies of this complex disorder. To foster progress and not repeat mistakes of the past it is time to critically analyze the past approach. This chapter serves as a reminder of potential shortcomings in the field across the complete spectrum flow from animal testing through regulatory approval to daily practice.

Global Clinical Trials for Alzheimer s Disease

Global Clinical Trials for Alzheimer   s Disease Book
Author : Michel Grothe,Jens Kurth,Harald Hampel,Bernd J. Krause,Stefan Teipel
Publisher : Elsevier Inc. Chapters
Release : 2013-08-28
ISBN : 0128070447
Language : En, Es, Fr & De

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Book Description :

In-vivo imaging markers of neuronal changes related to Alzheimer’s disease (AD) are ideally suited to be employed as diagnostic markers for early and differential diagnosis of AD as well as for the assessment of neurobiological effects of medical treatments in clinical trials. Novel molecular imaging techniques enable in-vivo detection of cerebral amyloid pathology, whereas magnetic resonance imaging (MRI)-based techniques, such as volumetric MRI and diffusion tensor imaging (DTI), provide structural lesion markers that allow tracking disease progression from preclinical through predementia to clinically manifest stages of AD. However, a widespread clinical use of these imaging biomarkers is hampered by considerable multi-centric variability related to differences in scanner hardware and acquisition protocols, but also by the lack of internationally agreed upon standards for analytic design and employed quantitative metrics. Several strategies for reducing multicenter variability in imaging measures have been proposed, including homogenization of the acquisition settings across scanner platforms, stringent quality assurance procedures, and artifact removal by means of post-acquisition image processing techniques. In addition, selection of appropriate statistical models to account for remaining multicenter variability in the data can further improve the accuracy and reproducibility of study results. The first projects for international standardization of image analysis methods and derived quantitative metrics have emerged recently for volumetric MRI measures. In contrast, the standardization and establishment of DTI-derived measures within a multicenter context are less well developed. Although molecular imaging techniques are already widely used in multicenter settings, sources of variability across sites and appropriate methods to reduce multicenter effects are still not explored in detail. Comparability of neuroimaging measures as AD biomarkers in worldwide clinical settings will finally depend on the establishment of internationally agreed upon standards for image acquisition, quality assurance, and employed quantitative metrics.

Global Clinical Trials for Alzheimer s Disease

Global Clinical Trials for Alzheimer   s Disease Book
Author : Peter Schüler,Klaudius Siegfried,Michael Hüll
Publisher : Elsevier Inc. Chapters
Release : 2013-08-28
ISBN : 0128070412
Language : En, Es, Fr & De

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Book Description :

To date (2013), we have witnessed over 100 years of research on Alzheimer’s disease (AD). In the past century, this gave new and deep insights into its pathophysiology. However, no new treatment with an innovative mode of action has found its way to the patients since the first targeted therapies with cholinergic drugs like Tacrin. So far A-beta and related targets have shown negative results in pivotal Phase III studies, after showing promising trends in Phase II. Thus the question arises as to whether A-beta is the wrong target for disease-modifying treatments, or whether other substantial changes to clinical development plans need to be made, e.g. including patients at risk of developing AD instead of those already experiencing symptoms. Alternative targets and study design options like enrichment strategies, however, do not evolve as an easy alternative solution.

Global Clinical Trials for Alzheimer s Disease

Global Clinical Trials for Alzheimer   s Disease Book
Author : Jeffrey Cummings,Kate Zhong
Publisher : Elsevier Inc. Chapters
Release : 2013-08-28
ISBN : 0128070404
Language : En, Es, Fr & De

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Book Description :

Globalization is increasingly common as a means of more rapidly recruiting patients, shortening clinical trials, abbreviating clinical development cycle times, and preparing for marketing in non-US markets. Globalization refers to the inclusion of trial sites in three or more international regions. Globalization is common and most drug development programs include both US and non-US sites. There has been limited evaluation of the transnational performance of clinical trial instrumentation used in drug development programs. The performance across nations, languages and cultures of the ADAS-Cog, Clinical Dementia Rating, Neuropsychiatric Inventory, quality of life measures, pharmacoeconomic measures, and activities of daily living tools has been inadequately researched. The creation of a library of well-tested and shared instruments would be of value in globalized trials. The approach to diagnosis of Alzheimer’s disease may vary across trial sites and create undesirable heterogeneity within clinical trials. Biological factors such as differences in liver metabolism enzymes, diet, education and head size may all create differences in treatment response in different ethnic settings. Sites across the globe may differ in terms of experience, and institutional review boards may also perform variably with regard to informed consent and human safety. These require vigilance by sponsors performing globalized trials. International efforts such as the Alzheimer’s Disease Neuroimaging Initiative provide data that will help reduce the variance and improve clinical trial quality. Improved understanding of the effects of globalization will enhance clinical trials and speed the development of new medications for patients with AD.

Global Clinical Trials for Alzheimer s Disease

Global Clinical Trials for Alzheimer   s Disease Book
Author : Tal Burt,Lynne Hughes,Amir Kalali,P. Murali Doraiswamy
Publisher : Elsevier Inc. Chapters
Release : 2013-08-28
ISBN : 0128070498
Language : En, Es, Fr & De

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Book Description :

There is considerable interest, both nationally and internationally, in conducting dementia research in India. Motivated by a rapid increase in the aging population and a desire for indigenous, self-sufficient healthcare and medical research, dementia research in India is on course for rapid growth in the coming years. Several challenges will have to be overcome along the way. A solid and general clinical research culture and a supportive healthcare system, both tailored to the specific needs of the dementia field and its vulnerable patient population, will have to be established through careful guidance of government regulators and collaborations with academic, industry and public stakeholders both in and outside India.

Global Clinical Trials for Alzheimer s Disease

Global Clinical Trials for Alzheimer   s Disease Book
Author : H. Michael Arrighi
Publisher : Elsevier Inc. Chapters
Release : 2013-08-28
ISBN : 0128070463
Language : En, Es, Fr & De

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Book Description :

Alzheimer’s disease (AD) confers an additional risk of death. The magnitude of this impact is related to the person’s underlying mortality and current AD stage. When planning clinical trials, estimating the number of deaths prior to study initiation, and periodically during the study as participants are enrolled, assists in providing an informative context, particularly if there are few life events. Additionally, deaths have the potential to introduce a bias, thus, equal follow-up needs to ensure for participants assigned to either active or placebo, particularly if the period of observation for safety events extends beyond the end of the study. During AD clinical trials, patients discontinue for reasons other than death and at substantially high rates, which has the potential to introduce significant bias. Planning and incorporating strategies to improve retention and identify successful techniques should be an integral part of the study process.

Global Clinical Trials for Alzheimer s Disease

Global Clinical Trials for Alzheimer   s Disease Book
Author : Tiia Ngandu,Francesca Mangialasche,Miia Kivipelto
Publisher : Elsevier Inc. Chapters
Release : 2013-08-28
ISBN : 0128070366
Language : En, Es, Fr & De

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Book Description :

Today there are more than 36 million demented persons worldwide. With the aging of populations, the prevalence of dementia and Alzheimer’s disease (AD) is expected to more than triple in the coming 40 years. Besides high age and genetic factors, evidence from observational studies shows that many modifiable vascular and lifestyle-related risk factors at midlife affect the risk of the disease. Control of vascular and metabolic risk factors, healthy diet, and maintenance of AN active lifestyle (physical, mental, and social components) may thus be the key issues on the road to prevent or delay the onset of AD. As the pathologic processes leading to AD may take decades to develop, it is crucial to identify optimal time windows for preventive efforts. Targeting several risk factors simultaneously and long duration of the intervention may be needed for the optimal preventive effect. As many persons are affected, relatively small effects of an integrative intervention on common risk factors may have a huge public health impact. Usage of biomarkers may help in identifying different risk phenotypes and in monitoring effects of the interventions. International collaboration is necessary to initiate future large-scale dementia prevention studies that are needed to formulate evidence-based preventive measures in cognitive decline and dementia.

Global Clinical Trials for Alzheimer s Disease

Global Clinical Trials for Alzheimer   s Disease Book
Author : Roy W. Jones
Publisher : Elsevier Inc. Chapters
Release : 2013-08-28
ISBN : 0128070382
Language : En, Es, Fr & De

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Book Description :

Current drug treatments for Alzheimer’s disease (AD) appear to be symptomatic. There is an increasing priority to find effective and safe disease-modifying and preventive treatment strategies for cognitive decline, AD, and dementia. Recent developments have allowed the identification of possible pathogenic processes and pathways, and potential targets for intervention. Cerebrospinal fluid (CSF) biomarkers of ß-amyloid and tau, and neuroimaging including amyloid PET tracer retention show that the pathogenic process begins many years before symptoms appear. A number of preventive trials have been completed but so far none has demonstrated significant benefits and some were potentially harmful. New preclinical treatment trials are underway in people at the highest risk of developing AD in the following few years. A US National Institutes of Health panel found no evidence of even moderate scientific quality to clearly support the association of any modifiable factors with a reduced risk of cognitive decline or AD. The best current evidence suggests that heart-healthy eating patterns such as the Mediterranean diet may help to protect the brain. Future preventive approaches will need to harness the increased technological advances concerning biomarkers with new hypotheses driven by a better understanding of the relevant risk factors.

Global Clinical Trials for Alzheimer s Disease

Global Clinical Trials for Alzheimer   s Disease Book
Author : Lynne Hughes,Spencer Guthrie
Publisher : Elsevier Inc. Chapters
Release : 2013-08-28
ISBN : 0128070455
Language : En, Es, Fr & De

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Book Description :

This chapter reviews significant recent clinical trials involving potential disease-modifying drugs, including active immunotherapy, passive immunotherapy, γ-secretase inhibitors and modulators, β-secretase inhibitors, and amyloid-beta (Aβ) anti-aggregants. The challenges and opportunities involved in global trials are then discussed, such as variability in diagnosis and patient selection; patient endpoints for both symptomatic therapies and disease-modifying drugs; rater training and global validation of rating scales; competition to recruit the pool of patients available for clinical trials; and emerging logistical concerns related to the use of biomarkers.

Proceedings of 9th International Conference on Alzheimer s Disease Dementia 2017

Proceedings of 9th International Conference on Alzheimer   s Disease   Dementia 2017 Book
Author : ConferenceSeries
Publisher : ConferenceSeries
Release : 2022-01-20
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

October 16-18, 2017 Rome, Italy Key Topics : Managing Dementia, Diagnosis and Symptoms, Imaging Techniques, Pathophysiology and Disease Mechanisms, Geriatrics and Cognitive Disorder, Amyloid Protein in Dementia, Care Practice and Awareness, Therapeutic Targets, Animal Models and Translational Medicine, Vascular Dementia, Alzheimers disease and Dementia, Traumatic brain injury, Dementia with Lewy Bodies, Alzheimers clinical trials and studies,

Encyclopedia of Alzheimer s Disease

Encyclopedia of Alzheimer s Disease Book
Author : Elaine A. Moore,Lisa Moore
Publisher : Unknown
Release : 2003
ISBN : 9781784021917
Language : En, Es, Fr & De

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Book Description :

The second edition contains updated resources, research institution information and a listing of treatment and care facilities in the United States. Additions to the encyclopedia section include advances in Alzheimers disease research, genetics, diagnostic procedures, treatment, alternative medicine, brain plasticity, risk factors, clinical trial information, nursing home safety, and preventive measures. In addition the book describes medical treatments used in other countries and the results of collaborative efforts such as the recent global imaging test initiatives and the Prevent Alzheimers Disease by 2020 Project.

ABC s of Alzheimers Disease

ABC s of Alzheimers Disease Book
Author : Bruce Bauer
Publisher : Covenant Books, Inc.
Release : 2019-05-23
ISBN : 1643009494
Language : En, Es, Fr & De

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Book Description :

ABCs of Alzheimer's Disease: a Shared Reality by Me and My Shadow is a story of Bruce and Ethel's Alzheimer's disease (AD) journey, along with a history of AD from autopsies to PET scan research, including technology and genetic discoveries. The book is a realistic, short, comprehensive, evidence-based, description of Alzheimer's disease (AD). It describes AD research, including clinical trials, a simplified understanding of the brain, and the experiences of patient/caregiver persistence and journey as well as hope for the future research possibilities through worldwide basic science, biology, genetic, mathematics, and technology evolution and discoveries. In addition, it identifies AD issues, uncertainties, and author's comments, along with "outside the box" ideas for governance to provide leadership for the coming Alzheimer's disease tsunami. With the future facing an AD tsunami and potential shortage of care personnel, the book provides potential for education and/or training for candidate patients, caregivers, primary care doctors, nurses, physician assistants, license nurse practitioners, certified nurse assistant, institutional care personnel, in-home health personnel, hospital personnel, educators, and politicians. In addition, this book could be a supplement document for geriatric schooling as well as an enlightening and educating source for political leaders (all three branches of government) and their staffs. The book describes a stage by stage behavior symptoms tied to cognitive measures and Alzheimer Association warning signs, along with suggestions for caregiver, relative to patient's state of decline. The book addresses why clinical trials have been failing and why hope for delay and prevention may be forthcoming as well as the 2011 paradigm shift and current presymptomatic candidacy. Clinical trials adventures, along with a suggestion to eliminate the placebo cohort group are described. So, what does the future hold for Alzheimer's disease-hope, promises, delay, prevention, or cure? These are all wants. What is reality? Moving research targets are being addressed and pursued with evolving knowledge and tools. This evolution will probably make current targets obsolete in twenty years. For reality, you be the judge after reading this book. "Out the box" ideas are provided that require governance action for confronting the coming AD tsunami and associated diversity care.

Alzheimer s Disease

Alzheimer s Disease Book
Author : Harald Hampel,Maria C. Carrillo
Publisher : Karger Medical and Scientific Publishers
Release : 2012
ISBN : 3805598025
Language : En, Es, Fr & De

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Book Description :

How current biomarkers are modernizing the diagnosis of Alzheimer's disease Expanding knowledge on genetic and epigenetic risk factors is rapidly enhancing our understanding of the complex molecular interactions and systems involved in the pathogenesis of Alzheimer's disease. In this publication, leading experts discuss emerging novel conceptual models of the disease along with advances in the development of surrogate markers that will not only improve the accuracy of diagnostic technologies but also improve the prospects of developing disease-modifying interventions. The novel framework of the disease presented here highlights research on biological markers as well as efforts to validate technologies for early and accurate detection. It also introduces notion of a complex systems dysfunction that extends beyond prevailing ideas derived from the amyloid' or tau' hypotheses. This outstanding publication provides researchers, clinicians, students and other professionals interested in neurodegenerative disorders with a comprehensive update on current trends and future directions in therapy development, with special focus on advances in clinical trial designs.

Aluminium and Alzheimer s Disease

Aluminium and Alzheimer s Disease Book
Author : C. Exley
Publisher : Elsevier
Release : 2001-07-03
ISBN : 0080525504
Language : En, Es, Fr & De

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Book Description :

The subject of aluminium and Alzheimer's disease has been plagued with controversy. This controversy has served to obscure much of the scientific research in this field, and subsequently has obscured the possibility that aluminium is a contributory factor in the aetiology of Alzheimer's disease. This book brings together many of the world's leading scientists researching aluminium and life and contains their critical summaries on the known facts about aluminium toxicity in man and to offer an opinion on the implications of this knowledge on a link between aluminium and Alzheimer's disease. The subject areas of the chapters were chosen to reflect the myriad of ways that aluminium is known to impact upon mammalian physiology and function and range from clinical studies, through animal models of disease to the detailed biochemistry of aluminium toxicity. Chapters are also included on epidemiology and other factors involved in the aetiology of Alzheimer's. This is the first time that this subject has been treated in such a comprehensive manner. The research detailed in each chapter, includes the latest research in the field, it has been critically appraised and this appraisal has been used by each author to present an informed opinion of its relevance to aluminium and Alzheimer's disease. The chapters are much more than reviews; they are a statement of the state of the art and of what the future may hold for research in this field. As a whole they show the high quality of research that has been carried out in our efforts to understand the toxicity of aluminium in man and that we are far away from discounting the possibility that aluminium is a contributory factor in the aetiology of Alzheimer's disease.

Early Diagnosis and Intervention in Predementia Alzheimer s Disease An Issue of Medical Clinics

Early Diagnosis and Intervention in Predementia Alzheimer s Disease  An Issue of Medical Clinics  Book
Author : Jose L. Molinuevo,Jeffrey I. Cummings,Bruno Dubois,Philip Scheltens
Publisher : Elsevier Health Sciences
Release : 2013-05-11
ISBN : 1455772038
Language : En, Es, Fr & De

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Book Description :

This issue of Medical Clinics covers the important advances surrounding the early intervention of Alzheimer's Disease. Guest edited by world-renowned experts from around the world, the topics covered will include evaluation of new diagnostic criteria, CSF biomarkers, diagnostic imaging, neurocognitive approaches, breaking clinical trials and more.

Alzheimer s Turning Point

Alzheimer   s Turning Point Book
Author : Jack C. de la Torre
Publisher : Springer
Release : 2016-06-25
ISBN : 3319340573
Language : En, Es, Fr & De

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Book Description :

This compelling text provides an overview of the available technology for early detection and therapeutic management of vascular risk factors to Alzheimer’s before severe cognitive impairment symptoms appear. Chapters bring the reader from the trackless clinical research that has characterized Alzheimer’s progress for the last 20 years, to a nexus of new ideas and concepts that can change our outlook of this dementia. In-depth examinations of various hypotheses, preventive measures, current and prospective treatments are openly and clearly explored. The author discusses in depth his proposal of the vascular hypothesis of Alzheimer's disease which has become a mother-lode for basic and clinical studies and a key approach to the prevention of this dementia.Alzheimer’s Turning Point offers professionals, students and those looking to learn more about this disorder a fresh clinical perspective of this devastating disease.

Finding the Path in Alzheimer s Disease

Finding the Path in Alzheimer   s Disease Book
Author : Sharon Cohen, MD, FRCPC,R. Scott Turner, MD, PhD
Publisher : Integritas Communications
Release : 2020-11-19
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

AD is a common neurodegenerative condition that results in a range of profoundly disabling cognitive, affective, and behavioral symptoms. It affects approximately 5.8 million Americans. Barring significant clinical efforts and medical breakthroughs that prevent or slow disease development, current estimates suggest that by 2050, AD will afflict 14 million patients in the United States. PCPs are on the front lines of early diagnosis of AD, yet many say they feel unprepared and their community lacks adequate specialists in this area. Signs and symptoms of mild cognitive impairment (MCI) and even early AD are often conflated with normal aging, leading to late or missed diagnosis. This is compounded by the lack of a sense of urgency for early, accurate diagnosis because there are no disease-modifying therapies to treat MCI or AD. This eHealth Source activity reviews the pathophysiology of AD, early signs and symptoms, diagnosis first steps, referral patterns, more-complex diagnostic procedures, and existing nonpharmacologic and pharmacologic management strategies. Drs Cohen and Turner provide expert insight into how PCPs can tailor their practice to better care for these patients.

Frontiers in Clinical Drug Research Alzheimer Disorders

Frontiers in Clinical Drug Research   Alzheimer Disorders Book
Author : Atta-ur-Rahman
Publisher : Bentham Science Publishers
Release : 2013-09-13
ISBN : 1608057224
Language : En, Es, Fr & De

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Book Description :

Frontiers in Clinical Drug Research - Alzheimer Disorders is an e-Book series concerned with Alzheimer's disease (AD) that causes dementia, or loss of brain function. The disease affects the parts of the brain that deal with memory, thought, and language. Chapters in each volume focus on (Alzheimer Disorders) drug research with special emphasis on clinical trials, research on drugs in advanced stages of development and cure for Alzheimer’s disease and related disorders. Frontiers in Clinical Drug Research - Alzheimer Disorders will be of particular interest to readers interested in drug therapy this specific neurodegenerative condition and related brain disorders as the series provides relevant reviews written by experts in field of Alzheimers Disease research.

Drug Discovery Approaches for the Treatment of Neurodegenerative Disorders

Drug Discovery Approaches for the Treatment of Neurodegenerative Disorders Book
Author : Adeboye Adejare
Publisher : Academic Press
Release : 2016-09-20
ISBN : 0128028114
Language : En, Es, Fr & De

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Book Description :

Drug Discovery Approaches for the Treatment of Neurodegenerative Disorders: Alzheimer’s Disease examines the drug discovery process for neurodegenerative diseases by focusing specifically on Alzheimer’s Disease and illustrating the paradigm necessary to ensure future research and treatment success. The book explores diagnosis, epidemiology, drug discovery strategies, current therapeutics, and much more to provide a holistic approach to the discovery, development, and treatment of Alzheimer’s Disease. Through its coverage of the latest research in targeted drug design, preclinical studies, and mouse and rat models, the book is a must-have resource for all pharmaceutical scientists, pharmacologists, neuroscientists, and clinical researchers working in this area. It illustrates why these drugs tend to fail at the clinical stage, and examines Alzheimer’s Disease within the overall context of improving the drug discovery process for the treatment of other neurodegenerative disorders. Provides a compilation of chemical considerations required in drug discovery for the treatment of neurodegenerative disorders Examines different classes of compounds currently being used in discovery and development stages Explores in vitro and in vivo models with respect to their ability to translate these models to human conditions Distills the most significant information across multiple areas of Alzheimer’s disease research to provide a single, comprehensive, and balanced resource