The “rights” of precision drug development for Alzheimer’s disease

Preliminary Results of a Trial of Atabecestat in Preclinical Alzheimer’s Disease

(2019) David Henley et al.   NEW ENGLAND JOURNAL OF MEDICINE

Targeting Huntingtin Expression in Patients with Huntington’s Disease

(2019) Sarah J. Tabrizi et al.   NEW ENGLAND JOURNAL OF MEDICINE

Randomized Trial of Verubecestat for Prodromal Alzheimer’s Disease

(2019) Michael F. Egan et al.   NEW ENGLAND JOURNAL OF MEDICINE

NIA-AA Research Framework: Toward a biological definition of Alzheimer's disease

(2018) Clifford R. Jack et al.   Alzheimers & Dementia

The National Institute on Aging—Alzheimer's Association Framework on Alzheimer's disease: Application to clinical trials

(2018) Jeffrey Cummings   Alzheimers & Dementia

Regulatory-accepted drug development tools are needed to accelerate innovative CNS disease treatments

(2018) Stephen P. Arnerić et al.   BIOCHEMICAL PHARMACOLOGY

Enrichment Strategies in Pediatric Drug Development: An Analysis of Trials Submitted to the US Food and Drug Administration

(2018) Dionna J. Green et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Impact of a five-dimensional framework on R&D productivity at AstraZeneca

(2018) Paul Morgan et al.   NATURE REVIEWS DRUG DISCOVERY

Assessing Synaptic Density in Alzheimer Disease With Synaptic Vesicle Glycoprotein 2A Positron Emission Tomographic Imaging

(2018) Ming-Kai Chen et al.   JAMA Neurology

Amyloid-β1-15/16 as a Marker for γ-Secretase Inhibition in Alzheimer's Disease

(2018) Erik Portelius et al.   JOURNAL OF ALZHEIMERS DISEASE

Efficacy and Safety of Donepezil, Galantamine, Rivastigmine, and Memantine for the Treatment of Alzheimer's Disease: A Systematic Review and Meta-Analysis

(2018) Chen-Chen Tan et al.   JOURNAL OF ALZHEIMERS DISEASE

Adaptive crossover designs for assessment of symptomatic treatments targeting behaviour in neurodegenerative disease: a phase 2 clinical trial of intranasal oxytocin for frontotemporal dementia (FOXY)

(2018) Elizabeth Finger et al.   Alzheimers Research & Therapy

Current state of Alzheimer’s fluid biomarkers

(2018) José Luis Molinuevo et al.   ACTA NEUROPATHOLOGICA

A Preliminary Study of Clinical Trial Enrollment Decisions Among People With Mild Cognitive Impairment and Their Study Partners

(2018) Chelsea G. Cox et al.   AMERICAN JOURNAL OF GERIATRIC PSYCHIATRY

Trial watch: Burgeoning oncology pipeline raises questions about sustainability

(2018) Jon Moser et al.   NATURE REVIEWS DRUG DISCOVERY

Alzheimer's disease: The right drug, the right time

(2018) Todd E. Golde et al.   SCIENCE

Heterogeneity of Alzheimer’s disease: consequence for drug trials?

(2018) Gayatri Devi et al.   Alzheimers Research & Therapy

Insights into globalization: comparison of patient characteristics and disease progression among geographic regions in a multinational Alzheimer’s disease clinical program

(2018) Jeffrey L. Cummings et al.   Alzheimers Research & Therapy

Safety, tolerability and efficacy of the glutaminyl cyclase inhibitor PQ912 in Alzheimer’s disease: results of a randomized, double-blind, placebo-controlled phase 2a study

(2018) Philip Scheltens et al.   Alzheimers Research & Therapy

Central Review of Amyloid-Related Imaging Abnormalities in Two Phase III Clinical Trials of Bapineuzumab in Mild-To-Moderate Alzheimer’s Disease Patients

(2017) Nzeera Ketter et al.   JOURNAL OF ALZHEIMERS DISEASE

Phases of Hyperconnectivity and Hypoconnectivity in the Default Mode and Salience Networks Track with Amyloid and Tau in Clinically Normal Individuals

(2017) Aaron P. Schultz et al.   JOURNAL OF NEUROSCIENCE

Translatability score revisited: differentiation for distinct disease areas

(2017) Alexandra Wendler et al.   Journal of Translational Medicine

Functional network integrity presages cognitive decline in preclinical Alzheimer disease

(2017) Rachel F. Buckley et al.   NEUROLOGY

Review: Neuropathology and behavioural features of transgenic murine models of Alzheimer's disease

(2017) K. E. Ameen-Ali et al.   NEUROPATHOLOGY AND APPLIED NEUROBIOLOGY

What’s the Regulatory Value of a Target Product Profile?

(2017) Christopher D. Breder et al.   TRENDS IN BIOTECHNOLOGY

A phase III randomized trial of gantenerumab in prodromal Alzheimer’s disease

(2017) Susanne Ostrowitzki et al.   Alzheimers Research & Therapy

APOE-related risk of mild cognitive impairment and dementia for prevention trials: An analysis of four cohorts

(2017) Jing Qian et al.   PLOS MEDICINE

Association of Plasma Neurofilament Light With Neurodegeneration in Patients With Alzheimer Disease

(2017) Niklas Mattsson et al.   JAMA Neurology

Amyloid PET Screening for Enrichment of Early-Stage Alzheimer Disease Clinical Trials

(2016) Jeff Sevigny et al.   ALZHEIMER DISEASE & ASSOCIATED DISORDERS

2016 Alzheimer's disease facts and figures

(2016)   Alzheimers & Dementia

Translational Medicine Guide transforms drug development processes: the recent Merck experience

(2016) Hugues Dolgos et al.   DRUG DISCOVERY TODAY

Compound high-quality criteria: a new vision to guide the development of drugs, current situation

(2016) Serge Mignani et al.   DRUG DISCOVERY TODAY

A Pharmacovigilance Signaling System Based on FDA Regulatory Action and Post-Marketing Adverse Event Reports

(2016) Keith B. Hoffman et al.   DRUG SAFETY

ADCOMS: a composite clinical outcome for prodromal Alzheimer's disease trials

(2016) Jinping Wang et al.   JOURNAL OF NEUROLOGY NEUROSURGERY AND PSYCHIATRY

Induced pluripotent stem cells in Alzheimer’s disease: applications for disease modeling and cell-replacement therapy

(2016) Juan Yang et al.   Molecular Neurodegeneration

3D culture models of Alzheimer’s disease: a road map to a “cure-in-a-dish”

(2016) Se Hoon Choi et al.   Molecular Neurodegeneration

The antibody aducanumab reduces Aβ plaques in Alzheimer’s disease

(2016) Jeff Sevigny et al.   NATURE

Reducing the risk of failure: biomarker-guided trial design

(2016) Michael J. Townsend et al.   NATURE REVIEWS DRUG DISCOVERY

Suspected non-Alzheimer disease pathophysiology — concept and controversy

(2016) Clifford R. Jack et al.   Nature Reviews Neurology

PET Imaging of Tau Deposition in the Aging Human Brain

(2016) Michael Schöll et al.   NEURON

Role of chronic toxicology studies in revealing new toxicities

(2016) Alema Galijatovic-Idrizbegovic et al.   REGULATORY TOXICOLOGY AND PHARMACOLOGY

A path toward understanding neurodegeneration

(2016) K. S. Kosik et al.   SCIENCE

Disciplined approach to drug discovery and early development

(2016) Robert M. Plenge   Science Translational Medicine

The BACE1 inhibitor verubecestat (MK-8931) reduces CNS  -amyloid in animal models and in Alzheimers disease patients

(2016) M. E. Kennedy et al.   Science Translational Medicine

Towards Personalized Intervention for Alzheimer’s Disease

(2016) Xing Peng et al.   GENOMICS PROTEOMICS & BIOINFORMATICS

Relationship between hippocampal atrophy and neuropathology markers: A 7T MRI validation study of the EADC-ADNI Harmonized Hippocampal Segmentation Protocol

(2015) Liana G. Apostolova et al.   Alzheimers & Dementia

Convergent genetic and expression data implicate immunity in Alzheimer's disease

(2015) Lesley Jones et al.   Alzheimers & Dementia

2015 Alzheimer's disease facts and figures

(2015)   Alzheimers & Dementia

Drug and Exercise Treatment of Alzheimer Disease and Mild Cognitive Impairment: A Systematic Review and Meta-Analysis of Effects on Cognition in Randomized Controlled Trials

(2015) Andreas Ströhle et al.   AMERICAN JOURNAL OF GERIATRIC PSYCHIATRY

Tau positron emission tomographic imaging in aging and early Alzheimer disease

(2015) Keith A. Johnson et al.   ANNALS OF NEUROLOGY

Memantine ER/Donepezil: A Review in Alzheimer’s Disease

(2015) Sarah L. Greig   CNS DRUGS

Using registries to recruit subjects for clinical trials

(2015) Meng H. Tan et al.   Contemporary Clinical Trials

Early intervention and long-term outcome with cardiac resynchronization therapy in patients without a history of advanced heart failure symptoms

(2015) Romana Herscovici et al.   EUROPEAN JOURNAL OF HEART FAILURE

The comparative efficacy and safety of cholinesterase inhibitors in patients with mild-to-moderate Alzheimer's disease: a Bayesian network meta-analysis

(2015) Hisanori Kobayashi et al.   INTERNATIONAL JOURNAL OF GERIATRIC PSYCHIATRY

Integration of active pharmaceutical ingredient solid form selection and particle engineering into drug product design

(2015) Martyn David Ticehurst et al.   JOURNAL OF PHARMACY AND PHARMACOLOGY

CAP—advancing the evaluation of preclinical Alzheimer disease treatments

(2015) Eric M. Reiman et al.   Nature Reviews Neurology

Amyloid-β11C-PiB-PET imaging results from 2 randomized bapineuzumab phase 3 AD trials

(2015) Enchi Liu et al.   NEUROLOGY

Fingolimod and CSF neurofilament light chain levels in relapsing-remitting multiple sclerosis

(2015) J. Kuhle et al.   NEUROLOGY

Early Decision-Making in Drug Development: The Potential Role of Pharmaco-EEG and Pharmaco-Sleep

(2015) Frederick J. Wilson et al.   NEUROPSYCHOBIOLOGY

Peripheral and central effects of γ-secretase inhibition by semagacestat in Alzheimer’s disease

(2015) Rachelle S Doody et al.   Alzheimers Research & Therapy

Alzheimer’s disease progression by geographical region in a clinical trial setting

(2015) David B Henley et al.   Alzheimers Research & Therapy

The need for thorough phase II studies in medicines development for Alzheimer’s disease

(2015) Julian A. Gray et al.   Alzheimers Research & Therapy

Fitting the epidemiology and neuropathology of the early stages of Alzheimer’s disease to prevent dementia

(2015) Javier Mar et al.   Alzheimers Research & Therapy

Comparing recruitment, retention, and safety reporting among geographic regions in multinational Alzheimer’s disease clinical trials

(2015) Joshua D Grill et al.   Alzheimers Research & Therapy

Comparison of minipig, dog, monkey and human drug metabolism and disposition

(2015) Lars Dalgaard   JOURNAL OF PHARMACOLOGICAL AND TOXICOLOGICAL METHODS

Cerebrospinal Fluid Markers of Neurodegeneration and Rates of Brain Atrophy in Early Alzheimer Disease

(2015) Rawan Tarawneh et al.   JAMA Neurology

Targeting Prodromal Alzheimer Disease With Avagacestat

(2015) Vladimir Coric et al.   JAMA Neurology

Murine Aβ over-production produces diffuse and compact Alzheimer-type amyloid deposits

(2015) Guilian Xu et al.   Acta Neuropathologica Communications

The future is now: Model-based clinical trial design for Alzheimer's disease

(2015) K Romero et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

An Effective Method to Identify Shared Pathways and Common Factors among Neurodegenerative Diseases

(2015) Ping Li et al.   PLoS One

A comparison of Aβ amyloid pathology staging systems and correlation with clinical diagnosis

(2014) Susana Boluda et al.   ACTA NEUROPATHOLOGICA

An empirically derived composite cognitive test score with improved power to track and evaluate treatments for preclinical Alzheimer's disease

(2014) Jessica B. Langbaum et al.   Alzheimers & Dementia

A critique of the drug discovery and phase 3 clinical programs targeting the amyloid hypothesis for Alzheimer disease

(2014) Eric Karran et al.   ANNALS OF NEUROLOGY

Biological markers of Alzheimer?s disease

(2014) Leonardo Cruz de Souza et al.   ARQUIVOS DE NEURO-PSIQUIATRIA

Disrupted Intrinsic Networks Link Amyloid-β Pathology and Impaired Cognition in Prodromal Alzheimer's Disease

(2014) Kathrin Koch et al.   CEREBRAL CORTEX

Efficacy and safety studies of gantenerumab in patients with Alzheimer’s disease

(2014) Francesco Panza et al.   Expert Review of Neurotherapeutics

Advancing research diagnostic criteria for Alzheimer's disease: the IWG-2 criteria

(2014) Bruno Dubois et al.   LANCET NEUROLOGY

Lessons learned from the fate of AstraZeneca's drug pipeline: a five-dimensional framework

(2014) David Cook et al.   NATURE REVIEWS DRUG DISCOVERY

The Evolution of Preclinical Alzheimer’s Disease: Implications for Prevention Trials

(2014) Reisa Sperling et al.   NEURON

Genetics of Alzheimer’s Disease

(2014) Rita Guerreiro et al.   Neurotherapeutics

Structural connectivity of the default mode network and cognition in Alzheimer׳s disease

(2014) Marina Weiler et al.   PSYCHIATRY RESEARCH-NEUROIMAGING

Parallel Discovery of Alzheimer's Therapeutics

(2014) A. W. Lo et al.   Science Translational Medicine

Alzheimer’s disease drug-development pipeline: few candidates, frequent failures

(2014) Jeffrey L Cummings et al.   Alzheimers Research & Therapy

Effect of Potent γ-Secretase Modulator in Human Neurons Derived From Multiple Presenilin 1–Induced Pluripotent Stem Cell Mutant Carriers

(2014) Qing Liu et al.   JAMA Neurology

Designing drug trials for Alzheimer’s disease: What we have learned from the release of the phase III antibody trials: A report from the EU/US/CTAD Task Force

(2013) Bruno Vellas et al.   Alzheimers & Dementia

Treatment of HER2-positive breast cancer

(2013) Maria Cristina Figueroa-Magalhães et al.   BREAST

Model-Based Drug Development: A Rational Approach to Efficiently Accelerate Drug Development

(2013) P A Milligan et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Model-based drug discovery: implementation and impact

(2013) Sandra A.G. Visser et al.   DRUG DISCOVERY TODAY

Can pharmaco-electroencephalography help improve survival of central nervous system drugs in early clinical development?

(2013) Frederick J. Wilson et al.   DRUG DISCOVERY TODAY

Assessment of Instrumental Activities of Daily Living in Dementia

(2013) Sietske A. M. Sikkes et al.   JOURNAL OF GERIATRIC PSYCHIATRY AND NEUROLOGY

Validating therapeutic targets through human genetics

(2013) Robert M. Plenge et al.   NATURE REVIEWS DRUG DISCOVERY

Monetary Costs of Dementia in the United States

(2013)   NEW ENGLAND JOURNAL OF MEDICINE

Preclinical trials in autosomal dominant AD: Implementation of the DIAN-TU trial

(2013) S.M. Mills et al.   REVUE NEUROLOGIQUE

Increased in Vivo Amyloid- 42 Production, Exchange, and Loss in Presenilin Mutation Carriers

(2013) R. Potter et al.   Science Translational Medicine

Common Alzheimer’s Disease Research Ontology: National Institute on Aging and Alzheimer’s Association Collaborative Project

(2012) Lorenzo M. Refolo et al.   Alzheimers & Dementia

Improving Alzheimer’s disease phase II clinical trials

(2012) Barry D. Greenberg et al.   Alzheimers & Dementia

Increasing the success rate for Alzheimer's disease drug discovery and development

(2012) Robert E Becker et al.   Expert Opinion on Drug Discovery

Going further than Lipinski's rule in drug design

(2012) W Patrick Walters   Expert Opinion on Drug Discovery

Translatability scoring in drug development: eight case studies

(2012) Alexandra Wendler et al.   Journal of Translational Medicine

Animal systems in the development of treatments for Alzheimer's disease: challenges, methods, and implications

(2012) Jonathan J. Sabbagh et al.   NEUROBIOLOGY OF AGING

Amyloid-related imaging abnormalities in amyloid-modifying therapeutic trials: Recommendations from the Alzheimer’s Association Research Roundtable Workgroup

(2011) Reisa A. Sperling et al.   Alzheimers & Dementia

Structure-based druggability assessment—identifying suitable targets for small molecule therapeutics

(2011) Eric B Fauman et al.   CURRENT OPINION IN CHEMICAL BIOLOGY

Target Validation: Linking Target and Chemical Properties to Desired Product Profile

(2011) Paul G. Wyatt et al.   CURRENT TOPICS IN MEDICINAL CHEMISTRY

What makes a good drug target?

(2011) Isabella Gashaw et al.   DRUG DISCOVERY TODAY

What makes a good drug target?

(2011) Isabella Gashaw et al.   DRUG DISCOVERY TODAY

Can the flow of medicines be improved? Fundamental pharmacokinetic and pharmacological principles toward improving Phase II survival

(2011) Paul Morgan et al.   DRUG DISCOVERY TODAY

In VitroPrimary Human and Animal Cell-Based Blood−Brain Barrier Models as a Screening Tool in Drug Discovery

(2011) Olivier Lacombe et al.   MOLECULAR PHARMACEUTICS

Testing the Right Target and Right Drug at the Right Stage

(2011) R. A. Sperling et al.   Science Translational Medicine

Alzheimer’s Prevention Initiative: a proposal to evaluate presymptomatic treatments as quickly as possible

(2010) Eric M Reiman et al.   Biomarkers in Medicine

Proof of Concept: A PhRMA Position Paper With Recommendations for Best Practice

(2010) M E Cartwright et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Revising the definition of Alzheimer's disease: a new lexicon

(2010) Bruno Dubois et al.   LANCET NEUROLOGY

How to improve R&D productivity: the pharmaceutical industry's grand challenge

(2010) Steven M. Paul et al.   NATURE REVIEWS DRUG DISCOVERY

Multiple brain pathologies in dementia are common

(2010) M. Woodward et al.   European Geriatric Medicine

Older Americansʼ Risk-benefit Preferences for Modifying the Course of Alzheimer Disease

(2009) A. Brett Hauber et al.   ALZHEIMER DISEASE & ASSOCIATED DISORDERS

Characteristics and Performance of a Modified Version of the ADCS-CGIC CIBIC+ for Mild Cognitive Impairment Clinical Trials

(2009) Lon S. Schneider et al.   ALZHEIMER DISEASE & ASSOCIATED DISORDERS

The neuropathology of probable Alzheimer disease and mild cognitive impairment

(2009) Julie A. Schneider et al.   ANNALS OF NEUROLOGY

The basics of preclinical drug development for neurodegenerative disease indications

(2009) Karen L Steinmetz et al.   BMC Neurology

Translational Medicine Lessons from Flurizan's Failure in Alzheimer's Disease (AD) Trial: Implication for Future Drug Discovery and Development for AD

(2009) Hong I. Wan et al.   CTS-Clinical and Translational Science

Assessing the translatability of drug projects: what needs to be scored to predict success?

(2009) Martin Wehling   NATURE REVIEWS DRUG DISCOVERY

Developing drugs that can cross the blood-brain barrier: applications to Alzheimer's disease

(2008) William A Banks   BMC NEUROSCIENCE

CSF as a Surrogate for Assessing CNS Exposure: An Industrial Perspective

(2008) Jiunn Lin   CURRENT DRUG METABOLISM

Strategic Approach to Fit-for-Purpose Biomarkers in Drug Development

(2007) John A. Wagner   Annual Review of Pharmacology and Toxicology

Rates of brain atrophy over time in autopsy-proven frontotemporal dementia and Alzheimer disease

(2007) Jennifer L. Whitwell et al.   NEUROIMAGE