A Screening Study To Assess The Cognition Status in Healthy Volunteers
NCT ID: NCT01926873
Last Updated: 2016-11-02
Study Results
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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COMPLETED
240 participants
OBSERVATIONAL
2013-08-31
2014-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Healthy volunteers
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Healthy volunteers with a stable chronic disease that is not associated with cognitive deficits (e.g. asthma) and does not require any treatment known to affect cognition have to be discussed with the medical monitor before enrollment
* A body mass index between 18 to 30 kg/m2 inclusive
* Able to participate and willing to give written informed consent and to comply with the study restrictions
* At least second generation resident in the country of origin
Exclusion Criteria
* Family history of psychiatric disorders
* Suspicion or evidence of regular consumption of drugs of abuse or a positive drug test at the screening visit
* Acute or chronic disorder which is not stable or may affect cognition or needs treatment affecting cognition
* Change of smoking behavior or smoking cessation therapy within 30 days before screening visit
* Positive result on hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) 1 and 2
* Systolic blood pressure greater than 140 or less than 90 mm Hg, and diastolic blood pressure greater than 100 or less than 50 mm Hg
* Resting Pulse Rate greater than 100 or less than 45 beats per minute
* Clinically significant abnormalities in laboratory test results or in ECG assessment at screening visit
* Participation in an investigational drug study within 1 month prior to baseline
18 Years
65 Years
ALL
Yes
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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San Diego, California, United States
Atlanta, Georgia, United States
Oak Brook, Illinois, United States
Cedarhurst, New York, United States
Salt Lake City, Utah, United States
Freiburg im Breisgau, , Germany
Mainz, , Germany
Mannheim, , Germany
Schwerin, Mecklenburg-Vorpommern, , Germany
Bialystok, , Poland
Choroszcz, , Poland
Tuszyn, , Poland
Countries
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Other Identifiers
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2013-001261-16
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
BP28865
Identifier Type: -
Identifier Source: org_study_id