Assessing a Patient’s Quality of Life in Alzheimer’s Disease Clinical Trials

miller-davidBy David Miller, MDClinical Vice President at Bracket

Cognitive and Functional outcomes are generally the co-primary endpoints in most symptomatic and disease-modifying clinical trials of Alzheimer’s disease. But Quality of Life (QOL) is an important component in understanding the disease, and measuring it can be difficult.

There are a handful of measures currently used in clinical trials to evaluate QOL. However, like other clinical outcomes in Alzheimer’s disease, there are unique challenges to understand QOL and difficulties to measure its change.

One important consideration is that as the dementia progresses, insight worsens. Therefore, determining when a reported change is real and when it it’s colored by diminished insight can prove challenging.  Often, caregivers are asked to serve as a proxy for the patient. However, this raises the question of when in the illness course the patient’s insight is better (earlier in the course) and when the caregiver’s becomes more reliable.

A recent article in Alzheimer’s & Dementia examined some of the issues relative to these challenges. In this study, the researchers examined a cohort of patients and caregivers and analyzed both patient and caregiver reports of QOL to try and better understand the differences. There were several important results in this study, including this;

Older patient age was associated with overestimation of QOL by caregivers, whereas neuropsychiatric inventory score and caregiver burden were associated with underestimation.

qol-paperAt Bracket, we’ve focused on making sure the QOL outcome measures are implemented in a valid and reliable way. Clear and concise training for investigators and raters on how QOL information should be collected is essential. Distinguishing between patient and proxy versions is important, as is effectively outlining how the sponsor company wants caregivers to provide the information. For example, distinguishing for a caregiver between their own estimate of a patient’s health OR their estimate of how the caregiver thinks a patient would answer on their own, if they could. Generally, the way QOL is handled is specified in the protocol – whether subject and/or proxy –  and is not left up to the rater to decide which way to administer it.

These nuances are important, and are incorporated into Bracket’s customized training programs. Through effective training and remediation efforts, hopefully researchers are better prepared for handling these issues when they arise with their patients in a clinical trial.

FULL CITATION: Assessing Alzheimer’s disease patients’ quality of life: Discrepancies between patient and caregiver perspectives
JOURNAL: Alzheimer’s & Dementia. Volume 12, Issue 4, Pages 427–437
AUTHORS: Sandrine Andrieu, Nicola Coley, Yves Rolland, Christelle Cantet, Catherine Arnaud, Sophie Guyonnet, Fati Nourhashemi, Alain Grand, Bruno Vellas the PLASA group
YEAR: 2016

Bracket to Introduce Next Generation eCOA Platform at 2016 DIA Annual Meeting

Bracket, a leading clinical trial technology and specialty services provider, will launch its next generation clinical outcomes platform, Bracket eCOA℠ 6.0, at the 52nd Annual DIA Meeting held on June 26 – 30, 2016 in Philadelphia, Pennsylvania.  A demonstration of eCOA 6.0, the first electronic Clinical Outcome Assessment product of its kind to fully integrate with RTSM, will be held at DIA Booth #715.

questionnaire-menu-mockup-r2Bracket eCOA 6.0 is a flexible platform for electronic clinical outcomes assessments that is driving digitization in clinical trials. The platform integrates with industry-leading Samsung Galaxy smartphones and tablets, and Microsoft’s Surface Pro Windows tablets to support ePRO, eClinRO and eObsRO, and features fully integrated clinician and patient-facing tools, to ensure the experience is fully harmonized for any user.

“Bracket eCOA combines science and technology to collect patient information through smartphones or tablets, and ultimately achieve higher quality outcomes and efficiency in clinical trials,” said Jeff Kinell, Chief Executive Officer for Bracket. “We are pleased to launch eCOA 6.0 and continue demonstrating our commitment to paper-free clinical trials as we prepare for the mobile revolution.”

The platform’s integration with industry leading Clinical IRT solution, Bracket RTSM, enables subject questionnaires that trigger enrollment eligibility and randomization to kickoff schedule of reported outcomes entries. Its advisory services support scale design, development, licensing and validation, rater training and certification, clinical review and quality assurance, data analytics and compliance tracking.

You can learn more about Bracket eCOA here.

About Bracket

Bracket, with seven offices and more than 500 employees worldwide, is a clinical trial technology and specialty services provider dedicated to helping biopharmaceutical sponsors and contract research organizations increase the power of their clinical research data by leveraging core competencies in Science, Technology, and Service. Bracket eCOA is a flexible platform for electronic clinical outcomes assessments. Bracket RTSM is a best-in-breed, scalable and configurable clinical IRT solution for the life sciences industry. Bracket Rater Training and Quality Assurance improve outcomes through customized training and quality assurance programs.

Alzheimer’s Disease and Clinical Research

butler-adamBy Adam Butler, Sr. Vice President, Strategic Development at Bracket

Alzheimer’s disease is deadly and difficult, and its impact is enormous. Understanding the scope of how the disease affects people is difficult. Every year, the Alzheimer’s Association compiles a report that attempts to quantify the public health impact of the disease, and it’s an essential resource for helping every stakeholder understand the magnitude of the problem.

The 2016 report is now available, and it includes a comprehensive data set that illustrates the prevalence of the disease, includes pertinent information on the caregivers who bear most of the burden of the disease, and describes both the cost of the disease to health care systems, but also how it can impact patients and their families directly.

roundtable summary

The Alzheimer’s Association has been at the forefront of advocating for better care for patients and their caregivers, but also advocating for more and better research into the disease. There are only limited treatments available for patients with the disease, and the R&D track record has been miserable for the last 15 years. Investment in trials investigating new treatments is at an all-time high, and there are encouraging new approaches now being tested.

One of the ways the Alzheimer’s Association has supported this research effort is through the work of the Research Roundtable. Roundtable members “seek to facilitate the development and implementation of new treatments for Alzheimer’s disease by collectively addressing obstacles to research and development, clinical care and public health education.” Bracket is proud to be a member of the Research Roundtable, which meets semi-annually to gather R&D leaders from across academia and industry to organize new approaches to conducting this research. This gives drug developers, who in some cases may be competing with each other to advance treatments, a pre-competitive forum to discuss the science in a way that will be beneficial to everyone. This is a significant accomplishment, and the Roundtable has published dozens of papers and reports on their progress.

Alzheimer’s disease clinical trials are challenging. Bringing patients and their caregivers into a research program is difficult. The progression of the disease requires clinical trials that run for years to try and properly understand how treatments work. Trials fail, repeatedly. In some cases this is because our treatments may not be working. But in some cases, it may be because the outcomes used in these trials are difficult, and the data collected with them is noisy.
alz roundtable blog bda sampleAt Bracket, we have developed over the years a particular expertise in this area. As these trials started becoming larger, and more global, 15 years ago, initial approaches to improving the use of clinical outcomes assessments in these trials were focused on finding experienced sites and training clinical raters extensively. But the limitations of this approach were obvious, and at Bracket we quickly shifted focus to new methods that could help.

ecoa results

Today, Bracket uses an advanced Electronic Clinical Outcomes Assessment tool called the Rater Station to collect patient and caregiver data in clinical trials. In addition, our Blinded Data Analytics and Quality Assurance programs combine the statistical analysis of raw and derived data with rigorous clinical assessment/interpretation of the results in order to identify areas of concern.

The support of collaborative organizations like the Alzheimer’s Association has been essential to how Bracket has evolved over the years. They provide a forum for discussing and evaluating the best approaches to advancing these research efforts, and Bracket is proud to be a supporter.