|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT01433666 |
|
Date of registration:
|
27/06/2011 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Roflumilast and Cognition
EEGrofl |
|
Scientific title:
|
Effects of Roflumilast on Cognition in Healthy Adults: a Behaviour-EEG Study |
|
Date of first enrolment:
|
September 2011 |
|
Target sample size:
|
22 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT01433666 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Basic Science. Masking: Triple (Participant, Investigator, Outcomes Assessor).
|
|
Phase:
|
Phase 2
|
|
|
Countries of recruitment
|
|
Netherlands
| | | | | | | |
|
Contacts
|
|
Name:
|
Jos H. Prickaerts, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Maastricht University |
| | |
|
Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
35 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Dementia
|
|
Intervention(s)
|
|
Drug: roflumilast (EU: Daxas, USA: Daliresp)
|
|
Drug: Placebo
|
|
Drug: roflumilast
|
|
Primary Outcome(s)
|
|
Number of words remembered on Verbal learning task
[Time Frame: 1hr after drug intake]
|
|
Secondary ID(s)
|
|
METC11-3-035
|
|
2011-002070-23
|
|
ZonMw (the Netherlands)
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|