Roflumilast and Cognition

• Status: Completed
• Trial end date: 2013-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Maastricht University Medical Center
• Collaborator: ZonMw: The Netherlands Organisation for Health Research and Development
• Treatments: Phosphodiesterase 4 Inhibitors

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