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Working Groups
During the business meeting, we created a new working group to work on the Behavioral Prevention Study. We now have 7 working groups:
- Preclinical trials
- Precision medicine
- Standardization of reporting observational research results to guide clinical trial development for prevention and treatment
- Yoga/meditation focused trials
- Composite scores
- Dementia Risk Reduction/Behavioral Prevention Study (New)
- Educational Workshop creations.
Brief descriptions of each working group and e-mail addresses for each leader are provided at the end of this newsletter. If you are interested in any of these working groups, please contact the working group leaders so that they can include your e-mail address for communications. Participating in working groups is a good way to increase your network and produce tangible outcomes. Working group activities include submitting scientific session proposals for AAIC 2017, writing papers and developing proposals.
Educational Workshop at AAIC 2017 in London: Statistical Methods in Clinical Trials
We are planning a one-day educational workshop on Statistical Methods in Clinical Trials to take place as a pre-conference event at AAIC 2017. The workshop's main aim is to familiarize clinical scientists with modern statistical methods for clinical trials so that they may be able to better participate in the design, conduct and interpretation of Alzheimer-related trials and better evaluate published trials outcomes.
This workshop is supported by ISTAART and the Clinical Trials Methods PIA. We hope this workshop will lead to more cost effective, well-formulated pharmacological and non-pharmacological trials.
Survey
Please take a minute to complete the survey provided here, indicating your interest in possible content areas and also if you would be interested in attending this all day workshop (note: this is to gauge your interest and does not serve as registration).
Upcoming Event
Statistical Methods Conference on Aging & Dementia
October 13, 2016
Baltimore, Maryland, United States
This one-day conference is designed to stimulate discussion and novel ideas on the development of better statistical methods for study design and analysis in aging and dementia research. The conference is sponsored by the National Alzheimer's Coordinating Center and Integrative Analysis of Longitudinal Studies of Aging and Dementia research network and hosted by Johns Hopkins University in Baltimore, MD.
PIA DAY at AAIC 2016
For your reference, below is the 2016 PIA Day scientific session agenda. Thank you to the presenters and audience who helped to make the event successful!
- Introduction: PIA Progress Over the Last Year, Hiroko Dodge, Oregon Health & Science University, Portland, Ore., United States and the University of Michigan, Ann Arbor, Mich., United States
- Opening Remarks: Rethinking Early-Stage Trials: Carts, Horses, Pegs, and Holes, Lon Schneider, University of Southern California, Los Angeles, Calif., United States
- ENRICHMENT
- A Genetics-based Biomarker Risk Algorithm for Cost-Effective Design of Delay of Onset Trials, Daniel Burns, Zinfandel Pharmaceutical, Durham, N.C., United States
- COMPOSITE SCORES
- Optimally Weighted Composite Endpoints For AD Clinical Trials, Nandini Raghaven, Johnson and Johnson, New Brunswick, N.J., United States, Canada
- Instrument Selection and Composite Weighting for Clinical Trials in Cognitively Normal Apoe E4+ Subjects, Mike Donohue, University of Southern California, Los Angeles, Calif., United States
- BEHAVIORAL INTERVENTIONS
- Dementia Risk Reduction Global Initiatives, Kaarin Antsy, Australian National University, Canberra, Australia
- Mind/Body Medicine: Research and Practice, Dharma Singh Khalsa, Alzheimer's Research and Prevention Foundation, Tucson, Ariz., United States
- Multi modal prevention protocols in MAPT study: Challenges and Future directions. University of Toulouse, Sandrine Andrieu, University of Toulouse, Toulouse, France
- Closing Remarks: Lon Schneider, University of Southern California, Los Angeles, Calif., United States
Working Group Descriptions
Reporting Cognitive Assessments in Observational Research to Guide Clinical Trial Development for Prevention and Treatment of Alzheimer's Disease and Associated Disorders
Lead investigators:
Maria Glymour (University of San Francisco)
Holly Posner (Pfizer)
Melodem measurement group
Observational research on determinants of incidence or prognosis of ADAD should provide enough specificity to lay the groundwork for RCTs. Ambiguous or incomplete reporting of cognitive measures in observational research renders the evidence less valuable for choosing outcome measures and selecting appropriate patient populations for RCTs. We discuss essential features of cognitive assessments that should be routinely reported to be of most use to researchers working to develop effective interventions. We briefly explain why omitting these descriptives can result in misleading findings or preclude useful applications of the findings to RCT design.
Composite measures as endpoints for AD and AD-related clinical trials
Lead investigators:
Steve Edland (University of California San Diego)
Michael Donohue (University of Southern California)
Nandini Raghavan (Janssen R&D)
An ultimate goal of the working group may be a co-authored white paper: 1) summarizing composite endpoints, methods for constructing composite endpoints, and the relative strengths, weakness, potential limitations, and potential utility of composite endpoints for AD-related clinical trials; and 2) outlining working guidelines for designing future studies to determine the reliability and validity of composite measures as endpoints for clinical trials.
Methodologies for preclinical trials in Alzheimer's disease
Lead investigators:
Barry Reisberg (New York University Langone Medical Center)
Hiroko Dodge (Oregon Health & Science University / University of Michigan)
RCTs targeted to preclinical subjects face challenges including: (1) interventions and treatments of asymptomatic individuals where cognitive and functional impairment are minimal with broad distribution within the groups studied and large variability in outcomes leads to increasing difficulty to assess treatment effects, (2) uncertainty with respect to the selection of "at risk" samples for trials, (3) the appropriateness of outcomes measures, and (4) discordance between biomarkers and clinical outcomes. How to conduct methodologically sound and efficient trials is vital in order to advance potential, new treatments or prevention approaches. We will examine current trials methods and discuss innovative pharmacological and non-pharmacological clinical trials targeted to pre-symptomatic subjects and their designs.
Methodologies for Precision Medicine
Lead investigator:
Xiao-Hua (Andrew) Zhou (University of Washington)
It is now well known that patients with the same illness and similar symptoms may respond very differently to the same treatment; the same patient may also respond to the same treatment differently over time. Precision medicine is a medical paradigm that aims to tailor the medical treatment to the individual patient according to the individual's unique genetic information, health history, environmental exposure, needs and preferences. An urgent need of precision medicine research is to develop powerful and reliable statistical tools for estimating the optimal treatment regimes. This working group will bring together interested researchers (both methodologists and clinicians) to attach methodological challenges in clinical trials in precision medicine.
Trial Design Workshop Targeted to Clinicians (to be held in conjunction with AAIC 2017)
Lead investigators:
Hong Liu-Seifert (Lilly)
Michael Donahue (University of Southern California)
Hiroko Dodge (Oregon Health & Science University, University of Michigan)
It is important that clinicians have basic understanding of more recent trial approaches, so that they can consider these approaches and consult statisticians appropriately at the early stage of RCT proposal generations. Examples of approaches to be covered include adaptive designs, delayed-start approach, composite trial outcomes.
Yoga and Meditation Intervention
Lead investigator
Dharma Singh Khalsa (Alzheimer's Research and Prevention Foundation)
Kirti Khalsa (Alzheimer’s Research and Prevention Foundation)
Psychological stress is common in the population and there is evidence that it contributes to age-related cognitive decline and dementia. Mind-body medicine interventions are one approach to modify this risk factor, and recent studies suggest a positive benefit on not only stress relief but on enhanced cognition in subjects with SCD and MCI as well. This working group will go over accumulating evidences and new trials in this area.
Dementia Risk Reduction and Behavioral Preventions
Lead investigators:
Kaarin Antsy (The Australian National University)
Hiroko Dodge (Oregon Health & Science University, University of Michigan)
Deborah Barnes (University of California San Francisco)
Ruth Peters (The Australian National University)
Modifiable risk factors have been identified and they could play significant roles in reducing overall dementia incidence in the future. Challenges ahead related to the implementation of dementia risk reduction strategies at the population level. This is hampered by the fact that well-formulated behavioral intervention randomized controlled clinical trials are not as frequently developed as pharmacological trials. This working group will explore dementia risk reduction approaches, obstacles in behavioral interventions and also introduce new trials.
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