Section C contains data collected from the cognitive tests administered during ASPREE. These were the Modified Mini-Mental State Examination (3MS), Controlled Oral Word Association Test (COWAT), Hopkins Verbal Learning Test (HVLT-R), the Symbol-Digit Modalities Test (SDMT) and Color Trails.
C.1 3MS examination
This section contains data collected from the 3MS (1). The 3MS Examination is a validated questionnaire that is widely used to screen cognitive function. The assessment includes the same items as the Mini-Mental State Examination along with four additional items. It offers a brief assessment of the person’s cognitive function including orientation to time and place, recall, and simple language skills.
Timing of Data Collection
The 3MS was performed at Visit 1, which occurred prior to randomisation during the screening process, at odd year annual visits during the ASPREE Clinical Trial and Bridge period, at the Milestone Visit and annually during ASPREE-XT.
Summary of Data Dictionary
This section contains continuous and discrete data. Individual scores have been provided for each question on the 3MS as well as the raw overall 3MS score and predicted score adjusted for age and level of education. A 3MS reassessment was required following a 3MS score below 78 or a 10.15 drop below the expected score accompanied with a CES-D 10 score of eight or higher. Reassessment was carried out three months later. A commentary code of 3 has been applied to indicate when a field is not applicable to the participant. For example, where data was not collected because the 3MS was not scheduled to be performed. Variables collected annually have been named sequentially to represent the timing of and sequential manner of data collection.
In response to the practical limitations experienced during the global COVID-19 pandemic, in which in-person visits were temporarily ceased, study workflows were adapted to enable collection of cognitive data at annual visits conducted via phone call. This included modified 3MS, COWAT and HVLT-R assessments. This change was introduced in April 2020 in Australia, and in July 2020 in the US, for all participants who usually attended annual visits in person. The change was also introduced for participants in both countries who usually completed annual visits via phone call in November 2020. When conducted via phone call, the overall maximum possible score for the 3MS was reduced from 100 to 74, as questions 7, 11, 12, 13 and 14 could not be conducted due to the requirement of physical input from the participant. As a result, the 3MS trigger for further dementia assessment was reduced to a score below 54, and participants could no longer trigger due to a 10.15 drop from their predicted 3MS score when the 3MS was administered by phone. Any 3MS reassessments for phone-call triggers were conducted via phone call (again with a reduced overall maximum possible score of 74 and a score below 54 as a trigger). Where the 3MS was administered via phone call, the overall score has been provided in a variable called “OverallScore_Phone”.
C.2 Longitudinal COWAT, HVLT-R, SDMT and Color Trails
This section contains data relating to participant cognitive function collected from the COWAT (2), HVLT-R (3), the SDMT (4) and Color Trails (5). These tests were used to assess the presence of mild cognitive impairment.
The COWAT is a measure of executive function and verbal fluency where participants are asked to generate as many words as possible beginning with the letter F. The HVLT-R is used to assess immediate and delayed recall and delayed recognition and has been widely used in previous studies of cognitive impairment. The SDMT is a non-language based test used to assess executive functioning, specifically of processing speed and activation as well as complex visual scanning. Color Trails is a language-free tool used to assess sustained attention in adults.
Timing of Data Collection
The COWAT, HVLT-R and SDMT were performed at Visit 2, which occurred prior to randomisation during the screening process, at odd year annual visits during the ASPREE Clinical Trial and Bridge period, the Milestone Visit and annually from the second ASPREE-XT annual visit (XT02). During the ASPREE Clinical Trial and Bridge period, the Color Trails assessment was conducted during in-person dementia assessment visits and this data was not included in the ASPREE Longitudinal Data Set (Version 3). During ASPREE-XT, the Color Trails assessment was conducted every year from the XT02 visit onward and these data have been included in Section C2 of the ASPREE-XT Longitudinal Data Set (XT04).
Summary of Data Dictionary
This section contains discrete data only. An overall score for the COWAT and SDMT have been provided for baseline and each annual visit. Scores have been provided for HVLT-R trials one to four as well as the number of true positives and false positives for baseline and each annual visit. A commentary code of 3 has been applied to indicate when a field is not applicable to the participant. For example, where data was not collected because the test was not scheduled to be performed. Variables collected annually have been named sequentially to represent the timing of and sequential manner of data collection.
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