Roflumilast and Cognition (EEGrofl)

Maastricht University Medical Centre (MUMC)

Status and phase: Completed; Phase 2

Conditions: Dementia

Treatments: Drug: Placebo; Drug: roflumilast; Drug: roflumilast (EU: Daxas, USA: Daliresp)

Study type: Interventional

Funder types: Other

Identifiers

NCT01433666

ZonMw (the Netherlands) (Other Grant/Funding Number)

2011-002070-23 (EudraCT Number)

METC11-3-035

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: All

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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22 participants in 4 patient groups, including a placebo group

roflumilast 100ug

Experimental group

Treatment:

Drug: roflumilast

Drug: roflumilast (EU: Daxas, USA: Daliresp)

roflumilast 300ug

Experimental group

Treatment:

Drug: roflumilast

Drug: roflumilast (EU: Daxas, USA: Daliresp)

roflumilast1000ug

Experimental group

Treatment:

Drug: roflumilast

Drug: roflumilast (EU: Daxas, USA: Daliresp)

placebo

Placebo Comparator group

Treatment:

Drug: roflumilast

Drug: Placebo