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

Prof. Dominique de Quervain, MD

Status and phase: Completed; Phase 2

Conditions: Healthy

Treatments: Drug: Triflusal; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02321852

2014DR2154

Details and patient eligibility

About

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.

Full 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

Enrollment: 40 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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40 participants in 2 patient groups

Verum/Placebo

Experimental group

Description:

This group will start with triflusal and after washout will receive placebo

Treatment:

Drug: Placebo

Drug: Triflusal

Placebo/Verum

Experimental group

Description:

This group will start with placebo and will receive triflusal after washout.

Treatment:

Drug: Placebo

Drug: Triflusal