scholarly journals THE CASE FOR USING ACTIGRAPHY GENERATED SLEEP AND ACTIVITY ENDPOINTS IN ALZHEIMER’S DISEASE CLINICAL TRIALS

2016 ◽  
pp. 1-4
Author(s):  
M. Mc Carthy ◽  
W. Muehlhausen ◽  
P. Schüler
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Clinical Trials ◽  
Drug Development ◽  
Outcome Measures ◽  
Patient Population ◽  
Daily Activities ◽  
Site Staff ◽  
Consumer Devices ◽  
Relevant Outcome

More and more people in the industrialised world use wearables and smartphones to monitor their health and fitness. These devices are often used in combination with special apps to monitor and document daily activities and sleep. It would appear to be a logical step to assess the relevance of these devices in drug development trials. In contrast to the consumer devices, the technology used in clinical trials needs to be validated and compliant with the relevant regulations. Even under these complex requirements, wearables offer a number of new opportunities to objectively capture clinically relevant outcome measures –potentially with lower burden for patients and site staff. As an example, we describe the use in Alzheimer’s disease drug development studies. This is an indication where there have been a number of failures, in part due to the difficulties this patient population has in reliably completing existing tools. In addition rater scales add complexity due to inter- and intra-rater variability.

P4-066: Alzheimer's disease biomarkers as outcome measures for clinical trials

2013 ◽  
Vol 9 ◽  
pp. P727-P728
Author(s):  
Anna Caroli ◽  
Annapaola Prestia ◽  
Sara Wade ◽  
Kewei Chen ◽  
Napatkamon Ayutyanont ◽  
...  
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Clinical Trials ◽  
Outcome Measures ◽  
Disease Biomarkers

scholarly journals [P-151]: Associative and item memory as outcome measures for Alzheimer's disease clinical trials: A pilot study

2005 ◽  
Vol 1 ◽  
pp. S58-S58
Author(s):  
Andrew E. Budson ◽  
Hyemi Chong ◽  
Lisa M. Sardinha ◽  
Sibyl Salisbury ◽  
Dorene M. Rentz ◽  
...  
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Clinical Trials ◽  
Pilot Study ◽  
Outcome Measures ◽  
Item Memory

Statistical analysis, trial design and duration in Alzheimer's disease clinical trials: a review

2011 ◽  
Vol 24 (5) ◽  
pp. 689-697 ◽  
Author(s):  
P. A. Thompson ◽  
D. E. Wright ◽  
C. E. Counsell ◽  
J. Zajicek
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Clinical Trials ◽  
Statistical Analysis ◽  
Statistical Methods ◽  
Outcome Measures ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Primary Outcome Measure ◽  
Primary Analysis

ABSTRACTBackground: The social and economic burden of Alzheimer's disease (AD) and its increasing prevalence has led to much work on new treatment strategies and clinical trials. The search for surrogate markers of disease progression continues but traditional parallel group trial designs that use well-established, but often insensitive, clinical outcome measures predominate.Methods: We performed a systematic search across the Cochrane Library and PubMed abstracts published between January 2004 and August 2009. Information regarding the clinical trial methodology, outcome measures, intervention type and primary statistical analysis techniques was extracted and categorized, according to a standard protocol.Results: We identified 149 papers describing results from clinical trials in AD containing sufficient detail for our purposes. The largest proportion (38%) presented results of trials based on tests of cognition as the primary outcome measure. The primary analysis in most papers (85%) was a univariate significance test of a single primary outcome measure.Conclusions: The majority of trials reported a comparison of baseline and end-point assessment over relatively short patient follow-up periods, using univariate statistical methods to compare differences between intervention and control groups in the primary analysis. There is considerable scope to introduce newer statistical methods and trial designs in treatment evaluations in AD.

Clinical Trials in Dementia

2006 ◽  
Vol 2 (1) ◽  
pp. 39-78
Author(s):  
Encarnita Raya-Ampil ◽  
Jeffrey L. Cummings
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Clinical Trials ◽  
Patient Population ◽  
Trial Methodology ◽  
Screening Criteria ◽  
Profound Impact

ABSTRACTDementia, particularly Alzheimer's disease (AD), is increasing by patient population included in clinical trials. The methodology for trials of AD patients have been defined in terms of outcomes, standard measures and analytic techniques. Trial methodology is evolving with experience as new potential therapies become available. Screening criteria, instrumentation choices, duration of trials and analytic strategies may have a profound impact on the conclusions that can be derived from trials. The components of AD trials are reviewed in detail in this chapter.

IS ALZHEIMER’S DISEASE DRUG DEVELOPMENT BROKEN? WHAT MUST BE IMPROVED

2014 ◽  
pp. 1-6
Author(s):  
P.-J. Ousset ◽  
J. Cummings ◽  
J. Delrieu ◽  
V. Legrand ◽  
N. Prins ◽  
...  
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Clinical Trials ◽  
Drug Development ◽  
Drop Out ◽  
New Drugs ◽  
Trial Duration ◽  
Surrogate Outcomes ◽  
Technical Requirements ◽  
Number Of Patients

During the decade from 2002 to 2012, 99.6% of the 244 agents tested for efficacy in slowing the progression of Alzheimer’s’ disease (AD) failed to achieve their primary endpoints. At a CTAD symposium on November 14, 2013, in San Diego, USA, an international group of AD researchers met to discuss the evolution of trials over the past 10 years and proposed a number of changes intended to streamline and enhance the efficiency of clinical trials. Approximately 1,031 AD trials were conducted between 2000 and 2012. The number of patients per trial site tended to decrease over time necessitating a larger number of sites. The use of biomarkers for enrichment purposes, or as measures of target engagement or surrogate outcomes, results in higher screen failure and drop-out rates, adding to trial duration and/or costs. Present disease modifying AD trials ask for increasing logistical and technical requirements, necessitating the creation of highly specialized trial facilities and limiting the participation of smaller sites. Due to heavy administrative and regulatory task, only about 13% of the team's time is used for the essential recruitment. Proposals and perspectives: Strategies suggested to improve the efficiency of recruitment include establishing “ready to go cohorts” in advance of trials using biomarkers and clinical measures. Simplification and harmonization of administrative procedures, including harmonization of certification procedures, are urgently needed. Alternative approaches, such as using the Internet to screen volunteers for possible inclusion needs to be evaluated. The AD drug development enterprise from discovery through clinical trials requires re-examination and re-organization if new drugs are to be delivered to patients in a timely way.

Disease-Modifying Therapies for Alzheimer’s Disease

2013 ◽  
pp. 854-871
Author(s):  
Joshua D. Grill ◽  
Jeffrey Cummings
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Clinical Trials ◽  
Medical Research ◽  
Cause Of Death ◽  
Outcome Measures ◽  
Societal Impact ◽  
Safety And Efficacy ◽  
Disease Modifying Therapies ◽  
Disease Modifying

Alzheimer’s disease (AD) is growing in frequency rapidly and represents an area of urgent need in medical research. Now the sixth leading cause of death, AD is expected to triple in prevalence in coming decades. Key to averting the personal and international toll of AD will be clinical trials to examine the safety and efficacy of potentially disease-slowing therapies. These studies face a variety of challenges, including imperfect outcome measures, unvalidated surrogate biomarkers, and often slow and challenging recruitment. Nevertheless, a large number of promising potential therapies are in development. If successful and started early enough, these treatments could reduce the societal impact of AD. In this chapter, we provide an overview of the methodologies and designs of AD trials of potential disease-modifying therapies, the challenges these studies meet, and the targets and potential treatments that are currently in development.

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