Influence of Triflusal on Cognitive Functions in Healthy Subjects

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Randomized Placebo Controlled Phase II Cross Over Study on the Influence of Triflusal on Cognitive Functions in Healthy Participants

Conditions
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Healthy

Intervention / Treatment
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* Drug: Triflusal
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy Male or female Normotensive BMI between 20 and 27 kg/m2 Aged between 18 and 40 years Native or fluent German-speaking Caucasian Female practicing safe contraception Exclusion Criteria: Acute or chronic psychiatric or somatic disorder Any contraindication against aspirin or other NSAIDS History of coagulation disease History of gastrointestinal disease Laboratory exclusion criteria: values of blood count, blood chemistry and coagulation status outside normal range Pathological ECG Pregnancy, breast-feeding

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Verum/Placebo<br>This group will start with triflusal and after washout will receive placebo | Drug: Triflusal<br>* Once daily oral administration of 600 mg triflusal Disgren® for 7 days.<br>* Other names: Disgren®;Drug: Placebo<br>* Once daily oral administration of placebo mannitol for 7 days<br>* Other names: Mannitol;|
| Experimental: Placebo/Verum<br>This group will start with placebo and will receive triflusal after washout. | Drug: Triflusal<br>* Once daily oral administration of 600 mg triflusal Disgren® for 7 days.<br>* Other names: Disgren®;Drug: Placebo<br>* Once daily oral administration of placebo mannitol for 7 days<br>* Other names: Mannitol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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. |