1. The BrainHealthRegistry
The BrainHealthRegistry.org: The use of unsupervised online neuropsychological testing to identify older adults in the early stage of cognitive decline for participation in clinical trials
Michael W. Weiner1,2, Rachel Nosheny2 , Philip Insel2, Diana Truran2, Brian Mohlenhoff1,2, Derek Flennikan2, Shannon Finley2, Monica Comacho2, David Bickford1, Brian Harel3, Paul Maruff3 , & R. Scott Mackin1,2
1University of California, San Francisco, 2San Francisco Veterans Affairs Medical Center Veterans Health Research Institute (NCIRE), 3Cogstate, Ltd, Melbourne, Aus
We gratefully acknowledge support for this project from The Rosenberg Alzheimer’s Project, The Ray and Dagmar Dolby Family Fund, Connie and Kevin Shanahan, and The Drew Foundation
RESULTS:
More than 14,000 participants have registered with the BHR by March 9, 2014
The mean age of the sample was 57.3 (sd=14.8) ; range=18-98 years and
55% of respondents are over age 55 (Fig 1)
71% of participants were female
67% of participants had completed a 4-year college degree
42% of participants reported memory concerns
28% of participants reported family history of dementia
Participants reported a range of medical conditions (Fig 2)
Online Cognitive Testing
Results of unsupervised online cognitive assessments showed high levels of
consistency with published normative data for the same tests in supervised
settings (Table 1).
In multivariate regression analyses significant associations of age on poorer
cognitive performance was seen on all tests (p < for all; data not
shown)
IDENTIFICATION OF POTENTIAL CLINICAL TRIAL PARTICIPANTS
Figure 3 shows the number individuals with evidence of cognitive
dysfunction who meet hypothetical criteria for a prodromal Alzheimer’s
disease clinical trial
OBJECTIVES:
The identification and recruitment of older adults in the earliest stage of cognitive decline represents the most challenging inclusion criteria for many clinical trials for Alzheimer’s disease. The BrainHealthRegistry.org (BHR) is an online research registry developed to facilitate neuroscience clinical trials. The purpose of this study is to evaluate the large scale use of online neuropsychological tests as a mechanism to identify older adults with early stage cognitive decline for participation in clinical trials.
BACKGROUND:
The high cost of clinical trials is a major obstacle towards development of effective treatments and preventative interventions for Alzheimer’s disease (AD). In particular, the identification and recruitment of eligible participants represents a significant cost of these clinical trials. Memory complaints and quantified memory deficits represent important characteristics for many clinical trials. As such, many internet-based patient registries have been developed to assemble “trial ready cohorts” to reduce costs and time to completion for clinical trials. However, currently available registries do not capture measures of cognitive functioning. To meet this need, the BrainHealthRegistry.org (BHR) was launched in the San Francisco Bay Area in March 2014.
METHODS:
The BrainHealthRegistry.org functions within the University of California, San Francisco (UCSF) and is IRB approved. After participants register at the BHR website, they can complete a series of questionnaires, including measures of demographics, overall health, medication use, memory complaints, mood status, sleep, diet, and exercise. Participants can also complete the Cogstate Brief Cognitive Assessment battery which consists of 4 tests of attention, working memory, learning, and psychomotor speed. All cognitive tests are completed online with no direct supervision. Evidence of cognitive dysfunction was defined as individuals scoring > 1.0 standard deviations below mean age adjusted performance for each cognitive test.
DISCUSSION:
These preliminary results of an online research registry suggest a very high rate of enrollment in 12 months including a significant proportion of individuals with memory complaints and family history of dementia.. Further, the consistency of online neuropsychological test results with normative data for supervised computer administered measures suggests these approaches may be valid estimates of cognitive functioning. However, validating these online measures of cognition with standard clinical measures is a priority and we have recently initiated a validation study for this purpose. Our data also demonstrates the feasibility of obtaining detailed health information with quantitative measures of cognitive functioning online. Lastly, our results showing the number of individuals meeting commonly used criteria for prodromal AD clinical trials support the feasibility of utilizing this online research registry to identify participants for clinical trials for Alzheimer’s disease.
CONCLUSION:
The use of online research registries, which utilize neuropsychological assessments, has the potential to significantly improve methods for conducting clinical trials for Alzheimer’s disease.
Table 1. Online cognitive test performance from the Brain Health Registry in comparison with normative data from supervised test performance by age group
Figure 2. Medical characteristics of participants
Figure 1: Age distribution of participants