Back to resultsRoflumilast and Cognition (EEGrofl)
Primary Purpose
Dementia
Status
Completed
Phase
Phase 2
Locations
Netherlands
Study Type
Interventional
Intervention
roflumilast (EU: Daxas, USA: Daliresp)
Placebo
roflumilast
Sponsored by
About this trial
This is an interventional basic science trial for Dementia
Eligibility Criteria
Inclusion Criteria:
- 18 to 35 years of age
- Healthy (i.e. absence of all exclusion criteria), normal static binocular acuity (corrected or uncorrected),
- Body mass index between 18.5 and 30
- Willingness to sign an informed consent.
- Positive evaluation on the memory screening
Exclusion Criteria:
- 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
Sites / Locations
- Maastricht University, Faculty of Psychology and Neuroscience
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
roflumilast 100ug
roflumilast 300ug
roflumilast1000ug
placebo
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01433666
First Posted
June 27, 2011
Last Updated
December 30, 2019
Sponsor
Maastricht University Medical Center
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT01433666
Brief Title
Roflumilast and Cognition
Acronym
EEGrofl
Official Title
Effects of Roflumilast on Cognition in Healthy Adults: a Behaviour-EEG Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
September 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
roflumilast 100ug
Arm Type
Experimental
Arm Title
roflumilast 300ug
Arm Type
Experimental
Arm Title
roflumilast1000ug
Arm Type
Experimental
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
roflumilast (EU: Daxas, USA: Daliresp)
Intervention Description
Acute intervention: 1 time each dose on different days. Capsulated
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Acute intervention: single administration, capsulated form.
Intervention Type
Drug
Intervention Name(s)
roflumilast
Other Intervention Name(s)
Daxas, Daliresp, PDE4-inhibitor
Intervention Description
Acute intervention: 1 time each dose (100ug, 300ug, 1000ug, placebo). Capsulated.
Primary Outcome Measure Information:
Title
Number of words remembered on Verbal learning task
Description
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.
Time Frame
1hr after drug intake
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
18 to 35 years of age
Healthy (i.e. absence of all exclusion criteria), normal static binocular acuity (corrected or uncorrected),
Body mass index between 18.5 and 30
Willingness to sign an informed consent.
Positive evaluation on the memory screening
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jos H. Prickaerts, PhD
Organizational Affiliation
Maastricht University
Official's Role
Study Director
Facility Information:
Facility Name
Maastricht University, Faculty of Psychology and Neuroscience
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6200 MD
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
29098341
Citation
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.
Results Reference
result
PubMed Identifier
29241652
Citation
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.
Results Reference
result
Links:
URL
https://link.springer.com/article/10.1007%2Fs00213-017-4770-y
Description
Published sensory gating data
Learn more about this trial
Roflumilast and Cognition
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