Roflumilast and Cognition

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2013-09-30

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.

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Detailed Description

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Conditions

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Dementia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Acute intervention: single administration, capsulated form.

Intervention Type DRUG

roflumilast

Acute intervention: 1 time each dose (100ug, 300ug, 1000ug, placebo). Capsulated.

Intervention Type DRUG

Other Intervention Names

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Daxas Daliresp PDE4-inhibitor

Eligibility Criteria

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Inclusion Criteria

* 18 to 35 years of age

Exclusion Criteria

* Body mass index between 18.5 and 30
* Willingness to sign an informed consent.
* Positive evaluation on the memory screening

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes