Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Change in Fluid Cognition Composite from Baseline to 12-weeks |
Subjects completed a battery of computerized cognitive assessments at baseline and 12-weeks, using the NIHToolbox for Assessment of Neurological and Behavioral Function application. The fluid cognition composite score was derived from scores on the Flanker Inhibitory Control and Attention Test, Dimensional Change Card Sort Test, Picture Sequence Memory Test, Pattern Comparison Processing Speed Test, and List Sorting Working Memory test. |
Change from baseline fluid cognition composite score at 12-weeks |
|
| Primary |
Change in Executive Function from Baseline to 12-weeks |
Subjects completed a battery of computerized cognitive assessments at baseline and 12-weeks, using the NIHToolbox for Assessment of Neurological and Behavioral Function application. Executive function was assessed by the Flanker Inhibitory Control and Attention Test and the Dimensional Change Card Sort Test. |
Change from baseline executive function test scores at 12 weeks |
|
| Primary |
Change in Attention from Baseline to 12-weeks |
Subjects completed a battery of computerized cognitive assessments at baseline and 12-weeks, using the NIHToolbox for Assessment of Neurological and Behavioral Function application. Attention was assessed by the Flanker Inhibitory Control and Attention Test. |
Change from baseline attention test scores at 12 weeks |
|
| Primary |
Change in Working Memory from Baseline to 12-weeks |
Subjects completed a battery of computerized cognitive assessments at baseline and 12-weeks, using the NIHToolbox for Assessment of Neurological and Behavioral Function application. Working Memory was assessed by the List Sorting Working Memory test. |
Change from baseline working memory test scores at 12 weeks |
|
| Primary |
Change in Processing Speed from Baseline to 12-weeks |
Subjects completed a battery of computerized cognitive assessments at baseline and 12-weeks, using the NIHToolbox for Assessment of Neurological and Behavioral Function application. Processing Speed was assessed by the Pattern Comparison Processing Speed test. |
Change from baseline processing speed test scores at 12 weeks |
|
| Primary |
Change in Episodic Memory from Baseline to 12-weeks |
Subjects completed a battery of computerized cognitive assessments at baseline and 12-weeks, using the NIHToolbox for Assessment of Neurological and Behavioral Function application. Episodic Memory was assessed by the Picture Sequence Memory test. |
Change in baseline episodic memory score at 12 weeks |
|
| Secondary |
Change in Negative Affect from Baseline to 12-weeks |
Subjects completed a battery of computerized self-reported questionnaires using the NIHToolbox for Assessment of Neurological and Behavioral Function. A Negative Affect summary score was derived from 5 individual assessments of anger affect, anger hostility, sadness, fear affect, and perceived stress. |
Change from baseline negative affect test scores at 12 weeks |
|
| Secondary |
Change in Psychological Wellbeing |
Subjects completed a battery of computerized self-reported questionnaires using the NIHToolbox for Assessment of Neurological and Behavioral Function. A Psychological Wellbeing summary score was derived from 3 individual assessments of life satisfaction, meaning, and positive affect. |
Change from baseline psychological satisfaction test scores at 12 weeks |
|
| Secondary |
Change in Social Satisfaction from Baseline to 12-weeks |
Subjects completed a battery of computerized self-reported questionnaires using the NIHToolbox for Assessment of Neurological and Behavioral Function. A Social Satisfaction summary score was derived from 5 individual assessments of friendship, loneliness, emotional support, instrumental support, and perceived rejection. |
Change from baseline social satisfaction test scores at 12 weeks |
|
| Secondary |
Change in serum interleukin-6 concentration from baseline to 12 weeks |
Serum samples were analyzed to determine concentrations of interleukin-6 (pg/mL). |
Change from baseline serum interleukin-6 concentration at 12 weeks |
|
| Secondary |
Change in serum tumor necrosis factor-alpha concentration from baseline to 12 weeks |
Serum samples were analyzed to determine concentrations of tumor necrosis factor-alpha (pg/mL). |
Change from baseline serum tumor necrosis factor-alpha concentration at 12 weeks |
|
| Secondary |
Change in serum c-reactive protein concentration from baseline to 12 weeks |
Serum samples were analyzed to determine concentrations of c-reactive protein (mg/L). |
Change from baseline serum c-reactive protein concentration at 12 weeks |
|
