Influence of Triflusal on Cognitive Functions in Healthy Subjects

Healthy Clinical Trial

— Tribunal-Basel  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02321852
• Other study ID #: 2014DR2154
• Status: Completed
• Phase: Phase 2
• First received: December 2, 2014
• Last updated: November 9, 2015
• Start date: January 2015
• Est. completion date: November 2015

Study information

• Verified date: November 2015
• Source: University of Basel
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Triflusal
Once daily oral administration of 600 mg triflusal Disgren® for 7 days.
• Placebo
Once daily oral administration of placebo mannitol for 7 days

Locations

Country	Name	City	State
Switzerland	University of Basel, Division of Cognitive Neuroscience	Basel

Sponsors (1)

Lead Sponsor	Collaborator
Prof. Dominique de Quervain, MD

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Primary	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No