DementiaPhase 2EEGroflNCT01433666
Roflumilast and Cognition
A Phase 2 study testing roflumilast (EU: Daxas, USA: Daliresp) and roflumilast in people with Dementia, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Dementia
- What is being tested?
- roflumilast (EU: Daxas, USA: Daliresp) and roflumilast
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2011to Sep 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- Smoking
- Orthostatic hypotension
- Lactose intolerance
- Sensory or motor deficits which could reasonably be expected to affect test performance
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University, Faculty of Psychology and Neuroscience
Maastricht, Limburg, 6200 MD
About this study
Official title: Effects of Roflumilast on Cognition in Healthy Adults: a Behaviour-EEG Study
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.
- Conditions
- Dementia
- Being tested
- roflumilast (EU: Daxas, USA: Daliresp), Placebo, roflumilast
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
roflumilast (EU: Daxas, USA: Daliresp)Drug
Acute intervention: 1 time each dose on different days. Capsulated
PlaceboDrug
Acute intervention: single administration, capsulated form.
roflumilastDrug
Also called Daxas, Daliresp, PDE4-inhibitor
Acute intervention: 1 time each dose (100ug, 300ug, 1000ug, placebo). Capsulated.
| Study group | Role | What they receive |
|---|---|---|
| roflumilast 100ug | Experimental | Not described Receives: Drug: roflumilast (EU: Daxas, USA: Daliresp); Drug: roflumilast |
| roflumilast 300ug | Experimental | Not described Receives: Drug: roflumilast (EU: Daxas, USA: Daliresp); Drug: roflumilast |
| roflumilast1000ug | Experimental | Not described Receives: Drug: roflumilast (EU: Daxas, USA: Daliresp); Drug: roflumilast |
| placebo | Placebo comparator | Not described Receives: Drug: Placebo; Drug: roflumilast |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1hr after drug intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionJul 2012
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Responsible party
- Sponsor
- Investigators
- Jos H. Prickaerts, PhD, Study director, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01433666
- Sponsor's protocol ID
- METC11-3-035
- Other IDs
- ZonMw (the Netherlands), 2011-002070-23
- Acronym
- EEGrofl
- Status last verified
- Sep 2013
- First submitted
- 27 Jun 2011
- Last updated
- 2 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 29098341Van 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.
PubMed 29241652
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Roflumilast on Cognition in Healthy Adults: a Behaviour-EEG Study
- ClinicalTrials.gov ID
- NCT01433666
- Acronym / sponsor ID
- EEGrofl / METC11-3-035
- Conditions
- Dementia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- Sep 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 14 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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: Placebo, Drug: roflumilast |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| roflumilast (EU: Daxas, USA: Daliresp)Acute intervention: 1 time each dose on different days. Capsulated | Drug | roflumilast 100ug, roflumilast 300ug, roflumilast1000ug |
| PlaceboAcute intervention: single administration, capsulated form. | Drug | placebo |
| roflumilastAlso: Daxas, Daliresp, PDE4-inhibitorAcute intervention: 1 time each dose (100ug, 300ug, 1000ug, placebo). Capsulated. | Drug | placebo, roflumilast 100ug, roflumilast 300ug, roflumilast1000ug |
Primary outcome
Number of words remembered on Verbal learning task
Time frame: 1hr after drug intake
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2020.
- Results publication: PubMed 29098341Heckman 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 publication: PubMed 29241652Van 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.
- Published sensory gating dataLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jos H. Prickaerts, PhD study director
Maastricht University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing roflumilast (EU: Daxas, USA: Daliresp) and roflumilast in people with Dementia, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of words remembered on Verbal learning task (time frame: 1hr after drug intake). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01433666, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2020.