COMMENTARY: COMBINATION THERAPY FOR ALZHEIMER’S DISEASE: PERSPECTIVES OF THE EU/US CTAD TASK FORCE

2019 ◽  
pp. 1-2
Author(s):  
E. Siemers
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
European Union ◽  
Clinical Trials ◽  
Task Force ◽  
Pharmaceutical Companies ◽  
The European Union ◽  
Combination Therapies ◽  
Regulatory Pathways ◽  
The Eu

In October 2018, the European Union-North American Clinical Trials in Alzheimer’s Disease Task Force (EU/US CTAD Task Force) met to discuss an increasingly important topic, the scientific, regulatory, and logistical challenges to the development of combination therapies for AD. Challenges related to ever-changing scientific knowledge, challenges related to complex regulatory pathways and challenges related to the necessity for pharmaceutical companies to collaborate must all be addressed. These challenges must be met since task Force members unanimously agreed that successful treatment of AD will likely require combination therapies targeting multiple mechanisms and pathways.

COMBINATION THERAPY FOR ALZHEIMER’S DISEASE: PERSPECTIVES OF THE EU/US CTAD TASK FORCE

2019 ◽  
pp. 1-5
Author(s):  
S. Gauthier ◽  
J. Alam ◽  
H. Fillit ◽  
T. Iwatsubo ◽  
H. Liu-Seifert ◽  
...  
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
European Union ◽  
Clinical Trials ◽  
Combination Therapy ◽  
Successful Treatment ◽  
Task Force ◽  
The European Union ◽  
Accelerate Development ◽  
The Eu

Combination therapy is expected to play an important role for the treatment of Alzheimer’s disease (AD). In October 2018, the European Union-North American Clinical Trials in Alzheimer’s Disease Task Force (EU/US CTAD Task Force) met to discuss scientific, regulatory, and logistical challenges to the development of combination therapy for AD and current efforts to address these challenges. Task Force members unanimously agreed that successful treatment of AD will likely require combination therapy approaches that target multiple mechanisms and pathways. They further agreed on the need for global collaboration and sharing of data and resources to accelerate development of such approaches.

scholarly journals THE FUTURE OF ANTI-AMYLOID TRIALS

2020 ◽  
pp. 1-6
Author(s):  
P.S. Aisen ◽  
J. Cummings ◽  
R. Doody ◽  
L. Kramer ◽  
S. Salloway ◽  
...  
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Clinical Trials ◽  
Task Force ◽  
Safety Concern ◽  
Combination Therapies ◽  
Interim Analyses ◽  
New Biomarkers ◽  
Insight Into ◽  
The Eu

The termination of many clinical trials of amyloid-targeting therapies for the treatment of Alzheimer’s disease (AD) has had a major impact on the AD clinical research enterprise. However, positive signals in recent studies have reinvigorated support for the amyloid hypothesis and amyloid-targeting strategies. In December 2019, the EU-US Clinical Trials on Alzheimer’s Disease (CTAD) Task Force met to share learnings from these studies in order to inform future trials and promote the development of effective AD treatments. Critical factors that have emerged in studies of anti-amyloid monoclonal antibody therapies include developing a better understanding of the specific amyloid species targeted by different antibodies, advancing our insight into the mechanism by which those antibodies may reduce pathology, implementing more comprehensive repertoires of biomarkers into trials, and identifying appropriate doses. Studies suggest that Amyloid-Related Imaging Abnormalities – effusion type (ARIA-E) are a manageable safety concern and that caution should be exercised before terminating studies based on interim analyses. The Task Force concluded that opportunities for developing effective treatments include developing new biomarkers, intervening in early stages of disease, and use of combination therapies.

scholarly journals PLASMA BIOMARKERS OF AD EMERGING AS ESSENTIAL TOOLS FOR DRUG DEVELOPMENT: AN EU/US CTAD TASK FORCE REPORT

2019 ◽  
pp. 1-5
Author(s):  
R.J. Bateman ◽  
K. Blennow ◽  
R. Doody ◽  
S. Hendrix ◽  
S. Lovestone ◽  
...  
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Clinical Trials ◽  
Task Force ◽  
Accurate Estimate ◽  
Current Status ◽  
The European Union ◽  
Neurofilament Light ◽  
Stakeholder Collaboration ◽  
Task Force Report

There is an urgent need to develop reliable and sensitive blood-based biomarkers of Alzheimer’s disease (AD) that can be used for screening and to increase the efficiency of clinical trials. The European Union-North American Clinical Trials in Alzheimer’s Disease Task Force (EU/US CTAD Task Force) discussed the current status of blood-based AD biomarker development at its 2018 annual meeting in Barcelona, Spain. Recent improvements in technologies to assess plasma levels of amyloid beta indicate that a single sample of blood could provide an accurate estimate of brain amyloid positivity. Plasma neurofilament light protein appears to provide a good marker of neurodegeneration, although not specific for AD. Plasma tau shows some promising results but weak or no correlation with CSF tau levels, which may reflect rapid clearance of tau in the bloodstream. Blood samples analyzed using -omics and other approaches are also in development and may provide important insight into disease mechanisms as well as biomarker profiles for disease prediction. To advance these technologies, international multidisciplinary, multi-stakeholder collaboration is essential.

scholarly journals Platform Trials to Expedite Drug Development in Alzheimer’s Disease: A Report from the EU/US CTAD Task Force

2021 ◽  
pp. 1-7
Author(s):  
P.S. Aisen ◽  
R.J. Bateman ◽  
M. Carrillo ◽  
R. Doody ◽  
K. Johnson ◽  
...  
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Task Force ◽  
Lessons Learned ◽  
Combination Therapies ◽  
Diverse Range ◽  
Interim Analyses ◽  
Treatment Regimens ◽  
Experimental Therapies ◽  
The Eu

A diverse range of platforms has been established to increase the efficiency and speed of clinical trials for Alzheimer’s disease (AD). These platforms enable parallel assessment of multiple therapeutics, treatment regimens, or participant groups; use uniform protocols and outcome measures; and may allow treatment arms to be added or dropped based on interim analyses of outcomes. The EU/US CTAD Task Force discussed the lessons learned from the Dominantly Inherited Alzheimer’s Network Trials Unit (DIAN-TU) platform trial and the challenges addressed by other platform trials that have launched or are in the planning stages. The landscape of clinical trial platforms in the AD space includes those testing experimental therapies such as DIAN-TU, platforms designed to test multidomain interventions, and those designed to streamline trial recruitment by building trial-ready cohorts. The heterogeneity of the AD patient population, AD drugs, treatment regimens, and analytical methods complicates the design and execution of platform trials, yet Task Force members concluded that platform trials are essential to advance the search for effective AD treatments, including combination therapies.

scholarly journals Drug Closure of a Patent Ductus Arteriosus in an Extremely Low Birth Weight Premature Newborn. A Case Report

2015 ◽  
Vol 124 (4) ◽  
pp. 215-219
Author(s):  
Anna Kaczyńska ◽  
Katarzyna Broczek ◽  
Zofia Sienkiewicz ◽  
Joanna Gotlib
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
European Union ◽  
Ductus Arteriosus ◽  
Extremely Low Birth Weight ◽  
The European Union ◽  
Role Of Government ◽  
Patent Ductus ◽  
The Eu

Abstract The article presents the role of government and non-government organisations in promoting knowledge on Alzheimer's disease in Poland and the European Union. There is a detailed analysis of the EU documents and non-government organisations in promoting knowledge on Alzheimer's disease in Germany, France and Holland. There is a discussion on the National Alzheimer's Plan on the basis of an example of introducing such a plan in Finland. Additionally, the rules of helping people suffering from Alzheimer's disease and their attendants in Poland are presented.

scholarly journals Tau Based Therapeutics: Alternative Approaches in the War on Alzheimer’s Disease

2019 ◽  
pp. 1-2
Author(s):  
M. Grundman
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Clinical Trials ◽  
Task Force ◽  
Meeting Report ◽  
Distant Future ◽  
Alternative Approaches ◽  
The Eu

This issue of The Journal of Prevention of Alzheimer’s Disease highlights EU/US/CTAD TASK FORCE discussions on the topic of tau-based therapeutics that were held in association with the 2018 CTAD meeting. The EU/US/CTAD TASK FORCE meeting report (1) is particularly timely given that a number of tau-based therapies are currently being evaluated in clinical trials and will report their results in the not-too-distant future.

scholarly journals Using Digital Tools to Advance Alzheimer’s Drug Trials During a Pandemic: The EU/US CTAD Task Force

2021 ◽  
pp. 1-7
Author(s):  
J. Kaye ◽  
R. Amariglio ◽  
R. Au ◽  
C. Ballard ◽  
M. Carrillo ◽  
...  
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Clinical Trials ◽  
Task Force ◽  
Digital Technologies ◽  
Digital Data ◽  
Digital Tools ◽  
Functional Changes ◽  
Remote Assessment ◽  
The Eu

The 2020 COVID-19 pandemic has disrupted Alzheimer’s disease (AD) clinical studies worldwide. Digital technologies may help minimize disruptions by enabling remote assessment of subtle cognitive and functional changes over the course of the disease. The EU/US Clinical Trials in Alzheimer’s Disease (CTAD) Task Force met virtually in November 2020 to explore the opportunities and challenges associated with the use of digital technologies in AD clinical research. While recognizing the potential of digital tools to accelerate clinical trials, improve the engagement of diverse populations, capture clinically meaningful data, and lower costs, questions remain regarding the stability, validity, generalizability, and reproducibility of digital data. Substantial concerns also exist regarding regulatory acceptance and privacy. Nonetheless, the Task Force supported further exploration of digital technologies through collaboration and data sharing, noting the need for standardization of digital readouts. They also concluded that while it may be premature to employ remote assessments for trials of novel experimental medications, remote studies of non-invasive, multi-domain approaches may be feasible at this time.

scholarly journals Trends in Hospital Morbidity From Alzheimer’s Disease in the European Union, 2000 to 2014

2018 ◽  
Vol 33 (7) ◽  
pp. 440-449
Author(s):  
Hao Niu ◽  
Ismael Alvarez-Alvarez ◽  
Ines Aguinaga-Ontoso ◽  
Francisco Guillen-Grima
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
European Union ◽  
Public Health Issue ◽  
The European Union ◽  
Men And Women ◽  
Mediterranean Countries ◽  
Eastern European Countries ◽  
Hospital Morbidity ◽  
The Eu

Background: Alzheimer’s disease (AD) has become a concerning public health issue. We aimed to analyze the trends of hospital morbidity from AD in the European Union (EU) in the period 2000 to 2014. Methods: Data from hospital discharges of men and women over 50 years old hospitalized due to AD in the EU were extracted from Eurostat database. We tested for secular trends computing anual percent change, and identified significant changes in the linear slope of the trend. Results: Hospital morbidity from AD showed a 0.8% (95% confidence intervals −2.2 to 0.6) slight declining trend in the EU. In men and women, we recorded a −0.5% and −1.0% decrease in hospital morbidity rates, respectively. Several countries showed changing trends during the study period. Conclusion: Alzheimer’s disease hospital morbidity has slightly declined in the entire EU in the past years. Eastern European countries showed steadily increasing trends, whereas in western and Mediterranean countries the rates decreased or leveled off.

scholarly journals EDITORIAL: IS NOW THE TIME FOR COMBINATION THERAPIES FOR ALZHEIMER DISEASE?

2019 ◽  
pp. 1-2
Author(s):  
J.C. Morris
Keyword(s):  
Clinical Trials ◽  
Alzheimer Disease ◽  
Amyloid Beta ◽  
Task Force ◽  
Human Monoclonal Antibody ◽  
The European Union ◽  
Combination Therapies ◽  
Phase 3 ◽  
Amyloidogenic Peptides ◽  
The Eu

In this issue, Gauthier and colleagues from the European Union-North America Clinical Trials in Alzheimer Disease Task Force (EU/US CTAD Task Force) provide a compelling argument for the implementation of clinical trials in persons with Alzheimer disease (AD) dementia that utilize combinations of experimental anti-Alzheimer therapies (1). The rationale for combination therapy in AD rests on the appreciation that AD pathophysiology is complex and involves many pathogenic pathways (2). The EU/US CTAD Task Force recommends that combination therapies should include therapies that target various aspects of the process wherein amyloid precursor protein undergoes proteolytic cleavage to produce amyloidogenic peptides. That anti-amyloid monotherapy alone is insufficient to provide clinical benefit with AD dementia has been underscored once again by the recent decision of Biogen and Eisai to discontinue Phase 3 studies of aducanumab, a human monoclonal antibody that targets aggregated forms of amyloid-beta, because futility analyses indicated that the trials were unlikely to meet their primary endpoint (3); similarly, Roche has announced discontinuation of trials of crenezumab (4). The EU/US CTAD Task Force nonetheless recommends that therapies that target amyloid-beta should be considered for inclusion in combination clinical trials in AD dementia, given the preponderance of evidence that disruptions in amyloid-beta production, clearance, or processing are very likely to be involved with, or even initiate, AD pathogenesis (5).

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