scholarly journals Enriching the design of Alzheimer's disease clinical trials: Application of the polygenic hazard score and composite outcome measures

2020 ◽  
Vol 6 (1) ◽  
Author(s):  
Sarah J. Banks ◽  
Yuqi Qiu ◽  
Chun Chieh Fan ◽  
Anders M. Dale ◽  
Jingjing Zou ◽  
...  
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Clinical Trials ◽  
Outcome Measures ◽  
Composite Outcome

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.

F4-03-03: VALIDATION OF NOVEL COMPOSITE OUTCOME MEASURES FOR PRE-DEMENTIA ALZHEIMER'S DISEASE

2014 ◽  
Vol 10 ◽  
pp. P244-P244 ◽  
Author(s):  
Nandini Raghavan ◽  
Alette M. Wessels ◽  
David M. Shera ◽  
Enchi Liu ◽  
Gerald Novak ◽  
...  
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Outcome Measures ◽  
Composite Outcome

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.

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.

P2-412: A comparison of hippocampal atrophy algorithms to select outcome measures for clinical trials in mild-to-moderate Alzheimer's disease

2012 ◽  
Vol 8 (4S_Part_11) ◽  
pp. P408-P408
Author(s):  
Leah Burns ◽  
Daniel Rueckert ◽  
Zubin Bhagwagar ◽  
Michael Donohue ◽  
Robin Wolz ◽  
...  
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Clinical Trials ◽  
Outcome Measures ◽  
Hippocampal Atrophy

Utility of Clinical Trial Batteries in the Measurement of Alzheimer's and Huntington's Dementia

1996 ◽  
Vol 8 (3) ◽  
pp. 397-411 ◽  
Author(s):  
Erich Mohr ◽  
Denise Walker ◽  
Christopher Randolph ◽  
Margaret Sampson ◽  
Tilak Mendis
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Outcome Measures ◽  
Rating Scale ◽  
Normal Subjects ◽  
Assessment System ◽  
Disease Assessment ◽  
Mild Dementia

Tests used as outcome measures in clinical trials of antidementia agents are not typically employed as part of diagnostic evaluations, and little information exists as to the sensitivity of these tests in terms of either differentiating demented patients from normal individuals or in distinguishing dementias of various types and etiologies. Sensitivity to mild dementia and sensitivity to impairment of various neuropsychological domains are, however, prerequisites for valid use of an instrument as an outcome measure in this context. The present study was undertaken to directly compare six different tests (three traditional psychometric tests and three clinical trial batteries) in terms of their sensitivity to detect and distinguish between mild dementia in patients with either Alzheimer's disease (n = 15) or Huntington's disease (n = 15), when compared to normal controls (n = 15). Tests included the Mattis Dementia Rating Scale, the Mini-Mental State Examination, the Wechsler Memory Scale-Revised, the Alzheimer's Disease Assessment Scale-Cognitive Subscale, the Computerized Drug Research (CDR) Cognitive Assessment System, and the Repeatable Battery for the Assessment of Dementia (RBAD). All of the tests were roughly equivalent in terms of their ability to discriminate normal subjects from mildly demented patients. Only the CDR and RBAD, however, were able to reliably discriminate between the two patient groups. The results are discussed in terms of the applicability of these tests as outcome measures for clinical trials in dementing disorders.

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