scholarly journals BIOMARKER AND CLINICAL TRIAL DESIGN SUPPORT FOR DISEASE-MODIFYING THERAPIES: REPORT OF A SURVEY OF THE EU/US: ALZHEIMER’S DISEASE TASK FORCE

2018 ◽  
pp. 1-7
Author(s):  
J. Cummings ◽  
N. Fox ◽  
B. Vellas ◽  
P. Aisen ◽  
G. Shan
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Clinical Trial ◽  
Trial Design ◽  
Task Force ◽  
Clinical Trial Design ◽  
Disease Modification ◽  
Disease Modifying Therapies ◽  
Disease Modifying ◽  
The Eu

BACKGROUND: Disease-modifying therapies are urgently needed for the treatment of Alzheimer’s disease (AD). The European Union/United States (EU/US) Task Force represents a broad range of stakeholders including biopharma industry personnel, academicians, and regulatory authorities. OBJECTIVES: The EU/US Task Force represents a community of knowledgeable individuals who can inform views of evidence supporting disease modification and the development of disease-modifying therapies (DMTs). We queried their attitudes toward clinical trial design and biomarkers in support of DMTs. DESIGN/SETTING/PARTICIANTS: A survey of members of the EU/US Alzheimer’s Disease Task Force was conducted. Ninety-three members (87%) responded. The details were analyzed to understand what clinical trial design and biomarker data support disease modification. MEASUREMENTS/RESULTS/CONCLUSIONS: Task Force members favored the parallel group design compared to delayed start or staggered withdrawal clinical trial designs to support disease modification. Amyloid biomarkers were regarded as providing mild support for disease modification while tau biomarkers were regarded as providing moderate support. Combinations of biomarkers, particularly combinations of tau and neurodegeneration, were regarded as providing moderate to marked support for disease modification and combinations of all three classes of biomarkers were regarded by a majority as providing marked support for disease modification. Task Force members considered that evidence derived from clinical trials and biomarkers supports clinical meaningfulness of an intervention, and when combined with a single clinical trial outcome, nearly all regarded the clinical trial design or biomarker evidence as supportive of disease modification. A minority considered biomarker evidence by itself as indicative of disease modification in prevention trials. Levels of evidence (A,B,C) were constructed based on these observations. CONCLUSION: The survey indicates the view of knowledgeable stakeholders regarding evidence derived from clinical trial design and biomarkers in support of disease modification. Results of this survey can assist in designing clinical trials of DMTs.

scholarly journals CSF Biomarkers of Alzheimer’s Disease: Impact on Disease Concept, Diagnosis, and Clinical Trial Design

2014 ◽  
Vol 2014 ◽  
pp. 1-14 ◽  
Author(s):  
Anne M. Fagan
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Clinical Trial ◽  
Diagnostic Criteria ◽  
Trial Design ◽  
Health Care Systems ◽  
Clinical Trial Design ◽  
Disease Diagnosis ◽  
Csf Biomarkers ◽  
Disease Modifying

Data from clinicopathologic and biomarker studies have converged to support the view of Alzheimer’s disease (AD) as a continuum, with pathology developing decades prior to the onset of cognitive symptoms which culminate as dementia at the end stage of the disease. This concept is impacting disease nomenclature, diagnostic criteria, prognostic potential, and clinical trial design. Revisions to diagnostic criteria to incorporate biomarker results have recently been proposed in order to increase the confidence of AD as the underlying etiology of a clinical impairment and to permit a diagnosis of AD across the disease continuum, eventually perhaps in the asymptomatic period. Individuals in this preclinical stage are receiving intense focus as a targeted population for secondary prevention trials aimed at identifying disease-modifying therapies that have the best chance of preserving normal cognitive function. The goal is to bring validated biomarkers to clinical practice for the purpose of disease diagnosis, prognosis, and evaluation of therapeutic efficacy once disease-modifying treatments become available. Realization of this goal requires worldwide biomarker standardization efforts, consensus among researchers and clinicians regarding the clinical utility of assessing biomarkers in patient care settings, and eventually the endorsement and adoption of such procedures and practices into global health care systems.

P3-037: CLINICAL TRIAL DESIGN FOR A PHASE II, RANDOMIZED, PLACEBO-CONTROLLED TRIAL OF AMX0035 IN ALZHEIMER'S DISEASE

2006 ◽  
Vol 14 (7S_Part_20) ◽  
pp. P1078-P1079
Author(s):  
Kent L. Leslie ◽  
Joshua Cohen ◽  
Justin Klee ◽  
Victoria Williams ◽  
Steven E. Arnold
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Clinical Trial ◽  
Phase Ii ◽  
Trial Design ◽  
Controlled Trial ◽  
Clinical Trial Design

Evaluation of Interventions in Alzheimer's Disease

1996 ◽  
Vol 8 (S1) ◽  
pp. 17-20 ◽  
Author(s):  
Cornelia Beck
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Clinical Trial ◽  
Behavioral Problems ◽  
Trial Design ◽  
Clinical Trial Design ◽  
Delivery Of Care ◽  
Organization Of Care

To address the development of studies for behavioral problems in patients with Alzheimer's disease (AD), a framework is used that includes the patient, the caregiver (formal or informal), the patient-caregiver interaction, the environment, the organization of care within institutions, and systems for the delivery of care to patients and caregivers. Within each of these components, there will be indicated the areas that are ready for testing using a clinical trial design and the areas that need further study using less controlled designs. Finally, recommendations will be made that address all components of the framework.

scholarly journals A IS FOR AMYLOID

2020 ◽  
pp. 1-2
Author(s):  
D.J. Selkoe
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Infectious Diseases ◽  
Task Force ◽  
Modern Medicine ◽  
Disease Modifying ◽  
The Brain ◽  
The Eu

In the age of COVID-19, we are reminded that despite the enormous strides modern medicine has made against acute infectious pathogens, we can still be overwhelmed. And in the field of chronic non-infectious diseases of the brain, we, too, have been traveling a long and unpredictable road. For years, there has been a sense of pessimism about the halting march toward disease-modifying treatments for Alzheimer’s disease. But recent events may have begun to part the clouds. In this issue of JPAD, Aisen et al. (1), representing the EU/US CTAD 2019 Task Force, provide a thoughtful perspective on progress in certain anti-amyloid trials and the resultant lessons for our next steps toward success.

A Novel Subject Synchronization Clinical Trial Design for Alzheimer's Disease

2012 ◽  
Vol 31 (3) ◽  
pp. 507-516
Author(s):  
Timothy Schultz ◽  
Eric Yang ◽  
Michael Farnum ◽  
Victor Lobanov ◽  
Rudi Verbeeck ◽  
...  
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Clinical Trial ◽  
Trial Design ◽  
Clinical Trial Design

scholarly journals Can we improve clinical trial design in Alzheimer’s disease? The participants point of view

2021 ◽  
Vol 17 (S9) ◽  
Author(s):  
Lois Ottenhoff ◽  
Everard G.B. Vijverberg ◽  
Leonie N.C. Visser ◽  
Merike Verrijp ◽  
Niels D. Prins ◽  
...  
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Clinical Trial ◽  
Trial Design ◽  
Clinical Trial Design ◽  
Point Of View
Sign in / Sign up

Export Citation Format

Share Document