NCT01433666

Brief Summary

The aim of the current project is to validate PDE4 inhibitors as a target for cognition enhancers (proof-of-concept) using a translational behaviour-EEG approach. The project will demonstrate whether memory, but also attention, information processing or executive function improves with the PDE4 inhibitor roflumilast in healthy humans.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2011

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

June 27, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 14, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

January 2, 2020

Status Verified

September 1, 2013

Enrollment Period

10 months

First QC Date

June 27, 2011

Last Update Submit

December 30, 2019

Conditions

Dementia

Outcome Measures

Primary Outcomes (1)

  • Number of words remembered on Verbal learning task

    30 monosyllable words will be displayed on a computer screen. Immediately after the presentation and after 45 minutes, subjects will be asked to report as much words as they remember. In addition, a recognition trial is conducted. Here, 30 words will be presented; 15 new words and 15 from the original list. Subjects have to indicate whether the word is old or new.

    1hr after drug intake

Study Arms (4)

roflumilast 100ug

EXPERIMENTAL
Drug: roflumilast (EU: Daxas, USA: Daliresp)Drug: roflumilast

roflumilast 300ug

EXPERIMENTAL
Drug: roflumilast (EU: Daxas, USA: Daliresp)Drug: roflumilast

roflumilast1000ug

EXPERIMENTAL
Drug: roflumilast (EU: Daxas, USA: Daliresp)Drug: roflumilast

placebo

PLACEBO COMPARATOR
Drug: PlaceboDrug: roflumilast

Interventions

roflumilast (EU: Daxas, USA: Daliresp)DRUG

Acute intervention: 1 time each dose on different days. Capsulated

roflumilast 100ugroflumilast 300ugroflumilast1000ug
PlaceboDRUG

Acute intervention: single administration, capsulated form.

placebo
roflumilastDRUG

Acute intervention: 1 time each dose (100ug, 300ug, 1000ug, placebo). Capsulated.

Also known as: Daxas, Daliresp, PDE4-inhibitor
placeboroflumilast 100ugroflumilast 300ugroflumilast1000ug

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • to 35 years of age

You may not qualify if:

  • Body mass index between 18.5 and 30
  • Willingness to sign an informed consent.
  • Positive evaluation on the memory screening
  • History of cardiac, hepatic, renal, pulmonary, neurological, gastrointestinal, haematological, or psychiatric illness
  • First-degree relative with psychiatric disorder (in particular major depressive disorder and suicidality)
  • Excessive drinking (\>20 glasses of alcohol containing beverages per week)
  • Pregnancy or lactation
  • Use of chronic medication other than oral contraceptives
  • Use of recreational drugs in the 2 weeks preceding participation
  • Smoking
  • Orthostatic hypotension
  • Lactose intolerance
  • Sensory or motor deficits which could reasonably be expected to affect test performance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University, Faculty of Psychology and Neuroscience

Maastricht, Limburg, 6200 MD, Netherlands

Location

Related Publications (2)

  • Heckman PRA, Van Duinen MA, Blokland A, Uz T, Prickaerts J, Sambeth A. Acute administration of roflumilast enhances sensory gating in healthy young humans in a randomized trial. Psychopharmacology (Berl). 2018 Jan;235(1):301-308. doi: 10.1007/s00213-017-4770-y. Epub 2017 Nov 3.

    PMID: 29098341RESULT

  • Van Duinen MA, Sambeth A, Heckman PRA, Smit S, Tsai M, Lahu G, Uz T, Blokland A, Prickaerts J. Acute administration of roflumilast enhances immediate recall of verbal word memory in healthy young adults. Neuropharmacology. 2018 Mar 15;131:31-38. doi: 10.1016/j.neuropharm.2017.12.019. Epub 2017 Dec 11.

    PMID: 29241652RESULT

Related Links

MeSH Terms

Conditions

Dementia

Interventions

RoflumilastPhosphodiesterase 4 Inhibitors

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Phosphodiesterase InhibitorsEnzyme InhibitorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and Uses

Study Officials

  • Jos H. Prickaerts, PhD

    Maastricht University

    STUDY DIRECTOR

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

Study Record Dates

First Submitted

June 27, 2011

First Posted

September 14, 2011

Study Start

September 1, 2011

Primary Completion

July 1, 2012

Study Completion

September 1, 2013

Last Updated

January 2, 2020

Record last verified: 2013-09

Locations

NL(1)