Influence of Triflusal on Cognitive Functions in Healthy Subjects (Tribunal-Basel)

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Triflusal; Drug: Placebo

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 2

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, 4055
    • University of Basel, Division of Cognitive Neuroscience

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Prof. Dominique de Quervain, MD
• Investigators: Principal Investigator: Dominique De Quervain, MD, Division of Cognitive Neuroscience University of Basel

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: December 2, 2014
• First Submitted That Met QC Criteria: December 19, 2014
• First Posted (Estimate): December 22, 2014

Study Record Updates

• Last Update Posted (Estimate): November 10, 2015
• Last Update Submitted That Met QC Criteria: November 9, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Platelet Aggregation Inhibitors; Natriuretic Agents; Diuretics, Osmotic; Diuretics; Mannitol; Triflusal
• Other Study ID Numbers: 2014DR2154