Roflumilast and Cognition

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Roflumilast on Cognition in Healthy Adults: a Behaviour-EEG Study

Conditions
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Dementia

Intervention / Treatment
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* Drug: roflumilast (EU: Daxas, USA: Daliresp)
* Drug: Placebo
* Drug: roflumilast


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: roflumilast 100ug<br> | Drug: roflumilast (EU: Daxas, USA: Daliresp)<br>* Acute intervention: 1 time each dose on different days. Capsulated<br>Drug: roflumilast<br>* Acute intervention: 1 time each dose (100ug, 300ug, 1000ug, placebo). Capsulated.<br>* Other names: PDE4-inhibitor;|
| Experimental: roflumilast 300ug<br> | Drug: roflumilast (EU: Daxas, USA: Daliresp)<br>* Acute intervention: 1 time each dose on different days. Capsulated<br>Drug: roflumilast<br>* Acute intervention: 1 time each dose (100ug, 300ug, 1000ug, placebo). Capsulated.<br>* Other names: PDE4-inhibitor;|
| Experimental: roflumilast1000ug<br> | Drug: roflumilast (EU: Daxas, USA: Daliresp)<br>* Acute intervention: 1 time each dose on different days. Capsulated<br>Drug: roflumilast<br>* Acute intervention: 1 time each dose (100ug, 300ug, 1000ug, placebo). Capsulated.<br>* Other names: PDE4-inhibitor;|
| Placebo Comparator: placebo<br> | Drug: Placebo<br>* Acute intervention: single administration, capsulated form.<br>Drug: roflumilast<br>* Acute intervention: 1 time each dose (100ug, 300ug, 1000ug, placebo). Capsulated.<br>* Other names: PDE4-inhibitor;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |