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| ID | Type | Description | Link |
|---|---|---|---|
| ZonMw (the Netherlands) | Other Grant/Funding Number | 95110091 | |
| 2011-002070-23 | EudraCT Number |
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| Name | Class |
|---|---|
| ZonMw: The Netherlands Organisation for Health Research and Development | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| roflumilast 100ug | Experimental |
| |
| roflumilast 300ug | Experimental |
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| roflumilast1000ug | Experimental |
| |
| placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| roflumilast (EU: Daxas, USA: Daliresp) | Drug | Acute intervention: 1 time each dose on different days. Capsulated |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jos H. Prickaerts, PhD | Maastricht University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maastricht University, Faculty of Psychology and Neuroscience | Maastricht | Limburg | 6200 MD | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29098341 | Result | 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. | |
| 29241652 | Result | 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. |
| Label | URL |
|---|---|
| Published sensory gating data | View source |
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| ID | Term |
|---|---|
| D003704 | Dementia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
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| ID | Term |
|---|---|
| C424423 | Roflumilast |
| D058988 | Phosphodiesterase 4 Inhibitors |
| ID | Term |
|---|---|
| D010726 | Phosphodiesterase Inhibitors |
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
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| Placebo | Drug | Acute intervention: single administration, capsulated form. |
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| roflumilast | Drug | Acute intervention: 1 time each dose (100ug, 300ug, 1000ug, placebo). Capsulated. |
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| D001523 | Mental Disorders |
| D020164 | Chemical Actions and Uses |