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The purpose of this study is to investigate the effects of the eNOS activating agent triflusal on episodic memory and cognitive functions in healthy participants.
Randomised, placebo controlled, double blind, cross-over design
Primary study outcomes are:
Performance in picturial and verbal memory tasks.
Main secondary outcomes are: Performance in working memory and cognitive tasks and influence on mood, depression and anxiety and motivation.
Once daily oral administration of placebo mannitol for 7 days in a cross-over trial with a washout period of at least 14 days between the two periods. Each participant will take triflusal as well as placebo
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Verum/Placebo | Experimental | This group will start with triflusal and after washout will receive placebo |
|
| Placebo/Verum | Experimental | This group will start with placebo and will receive triflusal after washout. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triflusal | Drug | Once daily oral administration of 600 mg triflusal Disgren® for 7 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in performance in episodic memory task as assessed by a picturial memory task between placebo and verum at two different timepoints | Picture task as described in (de Quervain, Kolassa et al. 2007). Number of correctly remembered pictures is counted. | Timepoint 1:45 minutes after first medication. Timepoint 2: 24 h after last medication. |
| Change in performance in episodic memory task as assessed by a verbal memory task between placebo and verum at two different time points. | Verbal task as described in ( de Quervain, Henke et al. 2003). Number of correctly remembered words is counted. | Timepoint 1:45 minutes after first medication. Timepoint 2: 24 h after last medication. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in performance in working memory task between placebo and verum at two different time points. | Working memory as assessed by digit span task. Number of correctly remembered digitsis counted. | Timepoint 1:45 minutes after first medication. Timepoint 2: 24 h after last medication. |
| Change in performance in a cognitive task between placebo and verum at two different time points. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dominique De Quervain, MD | Division of Cognitive Neuroscience University of Basel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Basel, Division of Cognitive Neuroscience | Basel | Basel | 4055 | Switzerland |
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| ID | Term |
|---|---|
| C016167 | triflusal |
| D008353 | Mannitol |
| ID | Term |
|---|---|
| D013402 | Sugar Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D002241 | Carbohydrates |
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| Placebo | Drug | Once daily oral administration of placebo mannitol for 7 days |
|
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Cognitive performance as assessed by BOMAT matrix reasoning task. Number of correct solutions is counted. |
| Timepoint 1:45 minutes after first medication. Timepoint 2: 24 h after last medication. |
| Mood state changes between placebo and verum at two different time points. | Mood state as assessed by self-rating instrument MDBF. Total score is calculated by summing the answers of nine items. | Timepoint 1:45 minutes after first medication. Timepoint 2: 24 h after last medication. |
| Changes in depressive symptoms between placebo and verum at two different time points. | Depressive symptoms as assessed by self-rating instrument MADRS.Total score is calculated by summing the answers of nine items. | Timepoint 1:45 minutes after first medication. Timepoint 2: 24 h after last medication. |
| Change in anxiety symptoms between placebo and verum at two different time points. | Anxiety symptoms as assessed by self-rating instrument STAI-G from X1 (state). Total score is calculated by summing the answers. | Timepoint 1:45 minutes after first medication. Timepoint 2: 24 h after last medication. |
| Change in motivation between placebo and verum at two different time points. | Motivation is assessed by a visual analogue scale ranging between 0 and 10. | Timepoint 1:45 minutes after first medication. Timepoint 2: 24 h after last medication. |