Clinical trial NCT02321852: Influence of Triflusal on Cognitive Functions in Healthy Subjects
Official title: Randomized Placebo Controlled Phase II Cross Over Study on the Influence of Triflusal on Cognitive Functions in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Healthy
Lead sponsor: University of Basel
Sponsor class: OTHER
First posted: 2014-12-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief 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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Change in performance in episodic memory task as assessed by a picturial memory task between placebo and verum at two different timepoints
timeFrame: Timepoint 1:45 minutes after first medication. Timepoint 2: 24 h after last medication.
measure: Change in performance in episodic memory task as assessed by a verbal memory task between placebo and verum at two different time points.
timeFrame: Timepoint 1:45 minutes after first medication. Timepoint 2: 24 h after last medication.
Secondary outcomes:
measure: Change in performance in working memory task between placebo and verum at two different time points.
timeFrame: Timepoint 1:45 minutes after first medication. Timepoint 2: 24 h after last medication.
measure: Change in performance in a cognitive task between placebo and verum at two different time points.
timeFrame: Timepoint 1:45 minutes after first medication. Timepoint 2: 24 h after last medication.
measure: Mood state changes between placebo and verum at two different time points.
timeFrame: Timepoint 1:45 minutes after first medication. Timepoint 2: 24 h after last medication.
measure: Changes in depressive symptoms between placebo and verum at two different time points.
timeFrame: Timepoint 1:45 minutes after first medication. Timepoint 2: 24 h after last medication.
measure: Change in anxiety symptoms between placebo and verum at two different time points.
timeFrame: Timepoint 1:45 minutes after first medication. Timepoint 2: 24 h after last medication.
measure: Change in motivation between placebo and verum at two different time points.
timeFrame: Timepoint 1:45 minutes after first medication. Timepoint 2: 24 h after last medication.
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University of Basel, Division of Cognitive Neuroscience
Study officials:
affiliation: Division of Cognitive Neuroscience University of Basel
name: Dominique De Quervain, MD
role: PRINCIPAL_INVESTIGATOR
References: