Roflumilast and Cognition

Dementia Clinical Trial

— EEGrofl  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01433666
• Other study ID #: METC11-3-035
• Secondary ID: ZonMw (the Nethe
• Status: Completed
• Phase: Phase 2
• Start date: September 2011
• Est. completion date: September 2013

Study information

• Verified date: September 2013
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: September 2013
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Dementia

Intervention

Drug:
• roflumilast (EU: Daxas, USA: Daliresp)
Acute intervention: 1 time each dose on different days. Capsulated
• Placebo
Acute intervention: single administration, capsulated form.
• roflumilast
Acute intervention: 1 time each dose (100ug, 300ug, 1000ug, placebo). Capsulated.

Locations

Country	Name	City	State
Netherlands	Maastricht University, Faculty of Psychology and Neuroscience	Maastricht	Limburg

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

References & Publications (2)

Heckman PRA, Van Duinen MA, Blokland A, Uz T, Prickaerts J, Sambeth A. Acute administration of roflumilast enhances sensory gating in healthy young humans in a randomized trial. Psychopharmacology (Berl). 2018 Jan;235(1):301-308. doi: 10.1007/s00213-017-4 — View Citation

Van Duinen MA, Sambeth A, Heckman PRA, Smit S, Tsai M, Lahu G, Uz T, Blokland A, Prickaerts J. Acute administration of roflumilast enhances immediate recall of verbal word memory in healthy young adults. Neuropharmacology. 2018 Mar 15;131:31-38. doi: 10.1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Published main data
•   Published sensory gating data