Dementia
Conditions
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.
Interventions
DRUGroflumilast (EU: Daxas, USA: Daliresp)
Acute intervention: 1 time each dose on different days. Capsulated
DRUGPlacebo
Acute intervention: single administration, capsulated form.
DRUGroflumilast
Acute intervention: 1 time each dose (100ug, 300ug, 1000ug, placebo). Capsulated.
Sponsors
ZonMw: The Netherlands Organisation for Health Research and Development
Maastricht University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of words remembered on Verbal learning task | 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. |
Countries
Netherlands
Outcome results
None listed