University of Basel, Division of Cognitive Neuroscience
Basel, 4055, Switzerland
NCT Number: NCT02904109
The purpose of this study is to investigate the effects of the eNOS activating agent triflusal on episodic memory and cognitive functions in participants under chronic stress.
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Notify Me18 year–40 year
All sexes
Interventional
Phase 2
Basel, 4055, Switzerland
Randomised, placebo controlled, double blind, cross-over design
Primary study outcome is:
Performance in a verbal memory task.
Main secondary outcomes are: Performance in working memory and cognitive tasks and influence on mood, depression and anxiety and subjective memory impairment.
Once daily oral administration of 600 mg triflusal and placebo mannitol for 8 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
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Once daily oral administration of 600 mg triflusal Disgren® for 8 days.
Other names: Disgren®
Once daily oral administration of placebo mannitol for 8 days.
Other names: mannitol
Time frame: Timepoint 1:45 minutes after first medication. Timepoint 1:45 minutes after last medication.
Verbal task as described in ( de Quervain, Henke et al. 2003). Number of correctly remembered words is counted.
Time frame: Timepoint 1:45 minutes after first medication. Timepoint 1:45 minutes after last medication.
Working memory as assessed by digit span task. Number of correctly remembered digitsis counted.
Time frame: Timepoint 1:45 minutes after first medication. Timepoint 1:45 minutes after last medication.
Episodic memory is assessed by the visual/spatial and verbal memory test VVM (Building und roadmap) (Quiske 2000). Number of correct answers is counted
Time frame: Timepoint 1:45 minutes after first medication. Timepoint 1:45 minutes after last medication.
A memory game consisting of 12 pictures will be used to assess episodic memory.Total score is calculated by summing the correctly located pictures after 3 rounds of the game
Time frame: 20 min before last medication of each placebo and verum
a two part questionnaire (MIQ) consisting of a 10-item Rasch modeled Memory self-efficacy scale (Zelinski and Gilewski 2004) extended by 6 items as second part.Total score is calculated by summing the answers of each part.
Time frame: Timepoint 1:45 minutes after first medication. Timepoint 1:45 minutes after last medication.
Mood state as assessed by self-rating instrument MDBF. Total score is calculated by summing the answers of nine items.
Time frame: Timepoint 1:45 minutes after first medication. Timepoint 1:45 minutes after last medication.
Depressive symptoms as assessed by self-rating instrument MADRS. Total score is calculated by summing the answers of nine items.
Time frame: Timepoint 1:45 minutes after first medication. Timepoint 1:45 minutes after last medication.
Anxiety symptoms as assessed by self-rating instrument STAI-G from X1 (state). Total score is calculated by summing the answers.
Prof. Dominique de Quervain, MD
Other
Randomized Placebo Controlled Phase II Cross Over Study on the Influence of Triflusal on Cognitive Functions in Subjects Under Chronic Stress
Acronym: Tricross-Basel
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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