Alzheimer’s disease therapeutic trials: EU/US task force report on recruitment, retention, and methodology

2012 ◽  
Vol 16 (4) ◽  
pp. 339-345 ◽  
Author(s):  
B. Vellas ◽  
◽  
H. Hampel ◽  
M. E. Rouge-Bugat ◽  
M. Grundman ◽  
...  
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Task Force ◽  
Task Force Report ◽  
Therapeutic Trials

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 EDITORIAL: BLOOD TESTS FOR ALZHEIMER’S DISEASE AND RELATED DISORDERS

2019 ◽  
pp. 1-2
Author(s):  
E.M. Reiman
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Task Force ◽  
Neurofibrillary Tangle ◽  
Neuritic Plaque ◽  
Plaque Burden ◽  
Neurofilament Light ◽  
Task Force Report ◽  
Blood Tests ◽  
Wide Range

This issue of the Journal of Prevention of Alzheimer’s Disease (AD) includes a timely Clinical Trials on AD Task Force Report on promising blood tests for AD and related disorders (1). It highlights the promise of recently developed plasma amyloid-β42/40 (Aβ42/40) measurements for the assessment of neuritic plaque burden (e.g., reference 2), ultrasensitive neurofilament light (NfL) measurements for the assessment of ongoing neuroaxonal injury in a wide range of neurological disorders (3), and their potential roles in evaluation of interventions to treat and prevent the clinical onset of AD. It also considers recently developed plasma total-tau measurements, an indicator of neuronal injury and/or Aβ-mediated tau secretion (4), plasma phospho-tau measurements, a potential indicator of neurofibrillary tangle burden, and the ongoing effort to develop high-dimensional plasma genomic, transcriptomic, metabolomic, lipidomic, and proteomic profiles.

scholarly journals NON-AMYLOID APPROACHES TO DISEASE MODIFICATION FOR ALZHEIMER’S DISEASE: AN EU/US CTAD TASK FORCE REPORT

2020 ◽  
pp. 1-6
Author(s):  
S. Gauthier ◽  
P.S. Aisen ◽  
J. Cummings ◽  
M.J. Detke ◽  
F.M. Longo ◽  
...  
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Task Force ◽  
Neurotrophin Receptor ◽  
General Strategy ◽  
Disease Modification ◽  
Task Force Report ◽  
Receptor Modulation ◽  
Alternative Approaches ◽  
Therapy Strategies

While amyloid-targeting therapies continue to predominate in the Alzheimer’s disease (AD) drug development pipeline, there is increasing recognition that to effectively treat the disease it may be necessary to target other mechanisms and pathways as well. In December 2019, The EU/US CTAD Task Force discussed these alternative approaches to disease modification in AD, focusing on tau-targeting therapies, neurotrophin receptor modulation, anti-microbial strategies, and the innate immune response; as well as vascular approaches, aging, and non-pharmacological approaches such as lifestyle intervention strategies, photobiomodulation and neurostimulation. The Task Force proposed a general strategy to accelerate the development of alternative treatment approaches, which would include increased partnerships and collaborations, improved trial designs, and further exploration of combination therapy strategies.

E.U./U.S. CTAD TASK FORCE ON ALZHEIMER\'S TRIAL POPULATIONS

2014 ◽  
pp. 1-7
Author(s):  
B. Vellas ◽  
C. Sampaio ◽  
R. Bateman ◽  
A. Boxer ◽  
M.C. Carrillo ◽  
...  
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Task Force ◽  
Significant Proportion ◽  
Drug Candidate ◽  
Amyloid Pet ◽  
Non Profit ◽  
Therapeutic Trials ◽  
Moderate Dementia ◽  
Screening And Identification

Successful therapeutic trials require well-targeted populations to demonstrate the effectiveness of a drug candidate. Most trials in the field of Alzheimer’s disease (AD) have been conducted in patients with mild to moderate dementia. However, the advent of amyloid PET imaging has demonstrated that a significant proportion of individuals enrolled in such studies do not have evidence of brain amyloidosis and may in fact not have Alzheimer’s disease. Further, dementia represents an advanced stage of neurodegeneration, perhaps too late for significant benefits of disease-modifying interventions. The successful development of effective disease-slowing therapies requires a study population selected in accordance with the mechanism of the specific intervention. An international task force of investigators from academia, industry, non-profit foundations, and regulatory agencies met in San Diego, California, USA, on November 13, 2013, to address issues related to screening and identification of clinical trial participants, and the ramifications of decisions made in this regard for drug development in AD and other dementias.

scholarly journals NEXT-GENERATION ALZHEIMER’S THERAPEUTICS: LEVERAGING DEEP BIOLOGY

2020 ◽  
pp. 1-2
Author(s):  
F.M. Longo ◽  
S.M. Massa
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Biological Diversity ◽  
Task Force ◽  
Next Generation ◽  
Disease Modification ◽  
Task Force Report ◽  
Field Point

A recent EU/US CTAD Task Force Report focused on non-amyloid approaches to Alzheimer’s disease (AD) modification (1). While the broad range of targets and therapies highlighted is in some ways sobering, several themes and advances in the field point to principles and technologies that are encouraging and will likely accelerate progress. These themes include: the view that amyloid and non-amyloid approaches might ultimately be complementary or synergistic; the biological diversity of approaches; emerging -omics strategies that might help guide such options; and finally, the incorporation of aging biology into perspectives of target prioritization and disease modification.

Prevention trials in Alzheimer's disease: An EU-US task force report

2011 ◽  
Vol 95 (4) ◽  
pp. 594-600 ◽  
Author(s):  
Bruno Vellas ◽  
Paul S. Aisen ◽  
Cristina Sampaio ◽  
Maria Carrillo ◽  
Philip Scheltens ◽  
...  
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Task Force ◽  
Task Force Report ◽  
Prevention Trials

scholarly journals Effects of Light Treatment on Sleep, Cognition, Mood, and Behavior in Alzheimer’s Disease: A Systematic Review

2018 ◽  
Vol 46 (5-6) ◽  
pp. 371-384 ◽  
Author(s):  
Micaela Mitolo ◽  
Caterina Tonon ◽  
Chiara La Morgia ◽  
Claudia Testa ◽  
Valerio Carelli ◽  
...  
Keyword(s):  
Systematic Review ◽  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Task Force ◽  
Critical Evaluation ◽  
Bright Light ◽  
Light Treatment ◽  
Intervention Treatment ◽  
And Behavior ◽  
Bright Light Treatment

Background: Bright light treatment is a therapeutic intervention mainly used to treat sleep and circadian disturbances in Alzheimer’s disease (AD) patients. Recently, a handful of studies also focused on the effect on cognition and behavior. Conflicting findings are reported in the literature, and no definite conclusions have been drawn about its specific therapeutic effect. Summary: The aim of this review is to provide a critical evaluation of available evidence in this field, highlighting the specific characteristics of effective bright light treatment. Eligible studies were required to assess at least one of the following outcome measures: sleep, cognition, mood, and/or behavior (e.g., depression, agitation). A total of 32 articles were included in this systematic review and identified as research intervention studies about light treatment in AD. The quality of the papers was evaluated based on the US Preventive Service Task Force guidelines. Key Messages: Overall, the current literature suggests that the effects of light treatment in AD patients are mixed and may be influenced by several factors, but with a general trend toward a positive effect. Bright light seems to be a promising intervention treatment without significant adverse effects; therefore, further well-designed randomized controlled trials are needed taking into account the highlighted recommendations.

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.

IS A LARGE-SCALE SCREENING FOR ALZHEIMER’S DISEASE POSSIBLE? YES, IN A FEW YEARS

2019 ◽  
pp. 1-2
Author(s):  
F. Ribaldi ◽  
D. Altomare ◽  
G.B. Frisoni
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Large Scale ◽  
Task Force ◽  
Cost Effective ◽  
The European Union ◽  
New Era ◽  
Non Invasive ◽  
Recent Meeting ◽  
Large Scale Screening

Recent evidence on blood-based biomarkers is pointing the way towards a new era of large-scale, feasible, cost-effective and non-invasive screening for Alzheimer’s disease (AD). This was one of the main focuses of the recent meeting of the European Union-North American Clinical Trials in AD (EU/US CTAD) Task Force, which took place in Barcelona in October 24-27, 2018, and convened drug and diagnostics developers from industry and academia in order to define a roadmap for the development and marketing of blood-based biomarkers (1).

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