NCT02321852

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2 healthy

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 2, 2014

Completed
20 days until next milestone

First Posted

Study publicly available on registry

December 22, 2014

Completed
10 days until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

November 10, 2015

Status Verified

November 1, 2015

Enrollment Period

10 months

First QC Date

December 2, 2014

Last Update Submit

November 9, 2015

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (6)

  • Change in performance in working memory task between placebo and verum at two different time points.

    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.

    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.

    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.

    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.

    Timepoint 1:45 minutes after first medication. Timepoint 2: 24 h after last medication.

  • +1 more secondary outcomes

Study Arms (2)

Verum/Placebo

EXPERIMENTAL

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

Drug: TriflusalDrug: Placebo

Placebo/Verum

EXPERIMENTAL

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

Drug: TriflusalDrug: Placebo

Interventions

TriflusalDRUG

Once daily oral administration of 600 mg triflusal Disgren® for 7 days.

Also known as: Disgren®
Placebo/VerumVerum/Placebo
PlaceboDRUG

Once daily oral administration of placebo mannitol for 7 days

Also known as: Mannitol
Placebo/VerumVerum/Placebo

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Acute or chronic psychiatric or somatic disorder
  • Any contraindication against aspirin or other NSAIDS
  • History of coagulation disease
  • History of gastrointestinal disease
  • Pathological ECG
  • Pregnancy, breast-feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Basel, Division of Cognitive Neuroscience

Basel, Basel, 4055, Switzerland

Location

MeSH Terms

Interventions

triflusalMannitol

Intervention Hierarchy (Ancestors)

Sugar AlcoholsAlcoholsOrganic ChemicalsCarbohydrates

Study Officials

  • Dominique De Quervain, MD

    Division of Cognitive Neuroscience University of Basel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

December 2, 2014

First Posted

December 22, 2014

Study Start

January 1, 2015

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

November 10, 2015

Record last verified: 2015-11

Locations

CH(1)