Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Other |
Brain volume |
Regional gray matter volume assessed with structural Magnetic Resonance Imaging |
16 weeks |
|
Other |
White matter tract integrity |
Tract integrity assessed with Diffusion Tensor Imaging |
16 weeks |
|
Other |
NIH EXAMINER Verbal Fluency 1 |
The construct for this test is Phonemic Fluency. The unit is total number of words beginning with the letter 'F' produced in 60 seconds. The value range is variable but is typically 0-36. A higher score is better. There are two sub-scales: 1) Total Repetitions; and 2) Total Rule Violations. The value range is variable for either sub-scale. A higher value for either sub-scale is worse. |
16 weeks |
|
Other |
NIH EXAMINER Verbal Fluency 2 |
The construct for this test is Phonemic Fluency. The unit is total number of words produced beginning with the letter 'L' produced in 60 seconds. The value range is variable but is typically 0-30. A higher score is better. |
16 weeks |
|
Other |
NIH EXAMINER Categorical Fluency 1 |
The construct for this test is Categorical Fluency. The unit is total number of words produced related to animals in 60 seconds. The value range is variable but is typically 0-40. A higher score is better. |
16 weeks |
|
Other |
NIH EXAMINER Categorical Fluency 2 |
The construct for this test is Categorical Fluency. The unit is total number of words produced related to vegetables in 60 seconds. The value range is variable but is typically 0-30. A higher score is better. |
16 weeks |
|
Other |
NIH EXAMINER Insight |
The construct for this test is Insight. The unit, in terms of % (0-100) is how well the participant thought they performed on the Fluency tasks relative to the population. We derive a sub-score that calculates the discrepancy between the stated % and the participant's actual % along the distribution. A larger discrepancy between %'s indicates worse performance. |
16 weeks |
|
Other |
NIH EXAMINER Spatial 1-Back Task |
The construct for this test is Working Memory. The unit is the total number of correct responses over 30 trials, regarding if a square on the screen was in that position 1 trial ago. The range is 0-30. A higher score is better. A D-prime performance scale is also automatically computed, based on the difference between the z-transforms of the "hit rate" and the "false positive" rate. The range is typically -0.25 to 3.67. A higher score is better. |
16 weeks |
|
Other |
NIH EXAMINER Spatial 2-Back Task |
The construct for this test is Working Memory. The unit is the total number of correct responses over 90 trials, regarding if a square on the screen was in that position 2 trials ago. The range is 0-90. A higher score is better. A D-prime performance scale is also automatically computed, based on the difference between the z-transforms of the "hit rate" and the "false positive" rate. The range is typically -1.12 to 2.48. A higher score is better. |
16 weeks |
|
Other |
NIH EXAMINER Saccades and Anti-Saccades |
The construct for this test is Inhibition. The unit is the total number of correct eye movements toward or away from a visual stimulus on the screen. The range is 0-40. A higher score is better. |
16 weeks |
|
Other |
NIH EXAMINER Continuous Performance Task |
The construct for this test is Inhibition. The units are the mean % accuracy and reaction time for choosing whether or not a symbol on the screen is the target symbol of interest (i.e., a "star"), which occurs during 100 trials. The accuracy range is 0-100%. The reaction time range is 400-2800 milliseconds. Higher accuracy is better and higher reaction time is worse. A sub-scale, False Alarm Errors, is also created. The unit is the number of times the participant makes the wrong selection during 100 trials. The range is from 0-100. A higher score is worse. |
16 weeks |
|
Other |
NIH EXAMINER Dot Counting |
The construct for this test is Working Memory. The unit is the total number of correct number selections, where a participant selects the number of blue circles shown over 2-7 separate displays for a given trial, with a total of six trials conducted. The range is 0-27. A higher score is better. |
16 weeks |
|
Other |
NIH EXAMINER Set-Shifting |
The construct for this test is Set-Shifting. The unit is the mean % accuracy and reaction time, over 104 trials, for selecting either the proper matching color or shape of a stimulus presented at the top of the screen when given a specific prompt (i.e., "shape" or "color"). The accuracy range is 0-100% and the reaction time range is 400-2800 milliseconds. A higher accuracy % is better and a higher reaction time is worse. A sub-scale is automatically computed that weights median reaction time and accuracy into a composite score. The range is 0-10. A higher number is better. |
16 weeks |
|
Other |
NIH EXAMINER Unstructured Task |
The constructs for this test are Planning and Organizing. The unit is the total number of points that a participant accrues by completing a series of "high point" and "low point" puzzles within 6 minutes. The range is 0-1478. A higher score is better. Several sub-scales are automatically created, where a higher number is better: 1) the number of "high point" puzzles completed with a range of 0-21; 2) the number of low value puzzles completed with a range of 0-51; 3) The number of "high point" puzzles attempted with a range of 0-21; and 4) The number of "low point" puzzles attempted with a range of 0-51. Finally, a weighted composite score is created, where the unit is the value of the equation UTpct*log10(UTTotal+1), where UTpct is % of "high point" completed puzzles and UTTotal is the total number of points earned. The range is 0-2.7. A higher value is better. |
16 weeks |
|
Other |
NIH EXAMINER Flanker |
The construct for this test is Inhibition. The unit is the mean % accuracy and reaction time over 24 trials, where the participant make a selection regarding where a middle arrow is facing amongst several other arrows facing the same way ("congruent") or the opposite way ("incongruent"). The accuracy range is 0-100% and the reaction time range is 500-3000 milliseconds. Higher accuracy is better and higher reaction time is worse. A composite sub-scale of performance is created basically based on log-rescaled median reaction time and accuracy. The range is 0-10. A higher number is better. Other sub-scales include accuracy and reaction time for congruent and incongruent trials. Ranges are variable. Higher accuracy is better and higher reaction time is worse. |
16 weeks |
|
Other |
NIH EXAMINER Social Norms Questionnaire |
The construct for this test is Social Behavior/Cognition. The unit is the total number of correct responses to what would generally constitute proper or improper responses to various situations in mainstream heteronormative White culture in the United States. The range is 0-24. A higher score is better. |
16 weeks |
|
Other |
NIH EXAMINER Behavior Rating Scale |
The construct for this scale is Social Behavior/Cognition. The unit is a total score over 9 behavioral domains (e.g., "agitation") shown by the participant during NIH EXAMINER testing, where each domain is scored on a 1-4 Likert scale of "absent" to "severe" based on operationalized criteria. The range is 0-36. A higher score is worse. |
16 weeks |
|
Other |
Trails A |
The construct for this test is Attention. The unit is elapsed time taken to complete the test. The range is 10-300 seconds. A higher score is worse. |
16 weeks |
|
Other |
Trails B |
The constructs for this test are Attention and Working Memory. The unit is elapsed time taken to complete the test. The range is 10-300 seconds. A higher score is worse. |
16 weeks |
|
Other |
Digit-Span Forward and Backward |
The construct for this test is Working Memory. The unit is the total number of correct responses in remembering a 2-7 number sequence and relating the sequence either forward or backward. The range is 0-28. A higher score is better. |
16 weeks |
|
Other |
Digit Substitution |
The construct for this test is Fluid Intelligence. The unit is the total number of correct symbol-to-number substitutions made over 93 symbol stimuli presented on a piece of paper. The range is 0-93. A higher score is better. |
16 weeks |
|
Other |
Benton Visual Retention Test |
The construct for this test is Visual Memory. The unit is the total number of correctly drawn tableaus, each composed of arbitrary geometric shapes, that are presented to the participant for 10 seconds. The range is 0-10. A higher score is better. |
16 weeks |
|
Other |
Montreal Cognitive Assessment |
The construct for this total score is global cognitive performance over several sub-domains, some of which vary from the Mini-Mental State Examination. The unit is correct performance on a series of sub-domain tasks. The range is 0-30. A higher number is better. |
16 weeks |
|
Other |
Clinical Dementia Rating |
The construct for this Likert-scaled structured interview is global cognition and overall function, where the interview is conducted with the participant and a caretaker/informant. The unit is the sum of six Likert-scaled sub-domains of cognition and function ("CDR-sum of boxes"), where on the Likert-scale a 0 corresponds to cognitively unimpaired, 0.5 suggests Mild Cognitive Impairment, and 1-3 indicate mild to severe dementia. The range is 0-18. A higher score is worse. Six sub-domain scores (Memory, Orientation, Judgment and Problem Solving, Community Affairs, Home and Hobbies, Personal Care) are also tallied. The range is 0-3 for each sub-domain. A higher score is worse. |
16 weeks |
|
Other |
NIH EXAMINER Fluency Factor |
The construct for this factor is Fluency, based on overall performance during 4 NIH EXAMINER Fluency tasks. The unit is a mean Z-Score calculated from 4 separate Z-scores based on the total correct for 4 Fluency NIH EXAMINER tasks. The range is -3 to 3. A higher score is better. |
16 weeks |
|
Other |
NIH EXAMINER Cognitive Control Factor Score |
The construct for this composite score is Inhibition, based on overall performance during the NIH EXAMINER Flanker, Set-Shifting, and Saccade/Anti-Saccade tasks, as well as the total number of dysexecutive errors committed. The unit is a mean Z-score of Z-scored performance for those tests listed and a Z-score of total errors committed. The range is -3 to 3. A higher score is better. |
16 weeks |
|
Other |
NIH EXAMINER Working Memory Factor Score |
The construct for this factor is Working Memory, based on overall performance during NIH EXAMINER tasks including Dot Counting and d-prime scales from the spatial 1- and 2-back tasks. The unit is a mean Z-score based on Z-scored values for total correct in Dot Counting and derived d-prime in each N-back task. The range is -3 to 3. A higher number is better. |
16 weeks |
|
Primary |
Body Weight |
% change in BMI (kg/m2) |
16 weeks |
|
Secondary |
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) |
Insulin resistance measured with fasting glucose and insulin |
16 weeks |
|
Secondary |
Functional Magnetic Resonance Imaging memory task activation |
Regional brain activity induced by a memory task |
16 weeks |
|
Secondary |
Functional Magnetic Resonance Imaging executive function task activation |
Regional brain activity induced by an executive function task |
16 weeks |
|
Secondary |
Cerebral blood flow |
Regional cerebral blood flow assessed using Arterial Spin Labeling |
16 weeks |
|
Secondary |
Neural network functional connectivity |
Degree of network strength in neural networks assessed at rest using Functional Magnetic Resonance Imaging |
16 weeks |
|
Secondary |
Mini-Mental State Examination |
The construct for this total score is global cognitive performance, based on performance over a series of cognitive sub-domains. The unit is correct performance on a series of cognitive sub-domain tasks. The range is 0-30. A higher number is better. |
16 weeks |
|
Secondary |
NIH EXAMINER Dysexecutive Errors Composite Score |
The construct for this composite score is overall impairment in various executive function domains. The unit is the total number of errors committed during several NIH EXAMINER tasks (Continuous Performance Task, Fluency, Flanker, Set Shifting). The range is 0-43. A higher score is worse. |
16 weeks |
|
Secondary |
California Verbal Learning Test |
The construct for this factor is Verbal Memory. There are three sub-scales of main interest with the following units: 1) the total number of correctly recalled items in a 16-item list for a given trial where that list is read, spanning 5 trials ("CVLT Trials 1-5 Total"); 2) the total number of correctly recalled items in the same 16-item list after a 5 minute delay ("CVLT Short Delay"); and 3) the total number of correctly recall items in the same 16-item list after a 20 minute delay ("CVLT Long Delay"). The ranges are 0-80 for CVLT Trials 1-5 Total, 0-16 for CVLT Short Delay, and 0-16 for CVLT Long Delay. A higher number is better. |
16 weeks |
|
Secondary |
Digit Span - Forward and Backward |
This construct probes working memory, a sub-domain of executive function. It requires participants to remember a list of numbers that gradually has more numbers added. |
16 weeks |
|