Lead Investigator: Andreas Monsch, University of Basel
Title of Proposal Research: Analyses of available cognitive data from 200 healthy, German-speaking individuals to be used to examine potential patients
Vivli Data Request: 6482
Funding Source: The statistical analyses are funded by the University Department of Geriatric Medicine FELIX PLATTER, Basel, Switzerland.
Potential Conflicts of Interest: None
Summary of the Proposed Research:
The number of patients suffering from Alzheimer’s disease and other dementias is rapidly increasing with an estimated number of almost 10 million new patients per year. Early diagnosis is key for early pharmacological and non-pharmacological interventions. Diagnoses of individuals with mild cognitive impairment rely on the appropriate use of valid and reliable neuropsychological tests. Within the AD-4833/TOMM40_302 study a set of tests was chosen to allow for the identification of patients who had initially been cognitively normal but then develop mild cognitive impairment over time. For this set of tests, i.e., the TOMMORROW Neuropsychological Battery, a German language validation and normative study with 198 cognitively healthy subjects and 25 subjects with mild Alzheimer’s disease (aged 65–88 years) has been conducted in Switzerland. In supplementary materials of the paper by Romero et al. (2018), normative data are available according to four age strata (65 to 69 years, 70 to 74 years, 75 to 79 years, and 80 to 88 years), but not according to age as a continuous variable. The number of years of education was only considered if the influence of education had been statistically significant. Although the analyses in the paper by Romero et al. (2018) are extremely helpful and sound, they do not allow for the determination of a standard score where age (as a continuous variable), education (as a continuous variable), and gender (as a categorical variable) are taken into account. In order to establish demographically-adjusted standard score for each of the variable of the TOMMORROW Neuropsychological Battery, a more fine-grained analysis as described by Berres et al (2000, 2008) would be extremely beneficial. Thus, we would like to reanalize the raw data of the German TOMMORROW Neuropsychological Battery of the AD-4833/TOMM40_302 study. The purpose will be to study the specific influence of age, gender, and education and interactions (e.g., age by gender, education by gender) and establish fine-grained demographically-corrected standard scores.
Requested Studies:
A Validation Study to Determine Performance Characteristics and Normative Values for Common Cognitive Instruments Used to Detect Dementia and Lesser Cognitive Impairments in the Elderly
Sponsor: Takeda
Sponsor ID: AD-4833/TOMM40_302
Update: This data request was withdrawn on 7 July 2021 by the researcher.