Status:
COMPLETED
Observational Study to Establish Patient-Matched Population Norms for the Multiple Sclerosis Cognition Assessment Battery
Lead Sponsor:
Biogen
Conditions:
Healthy
Eligibility:
All Genders
25-58 years
Brief Summary
The primary objective of the study is to develop MS patient-matched healthy population norms for the Multiple Sclerosis Cognition Assessment Battery (MS-COG) that are representative of the United Stat...
Eligibility Criteria
Inclusion
- Key Inclusion Criteria
- Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use confidential health information in accordance with national and local subject privacy regulations.
- Must be in good health as determined by the Investigator, based on medical history, physical examination, and Screening evaluations.
- Must be a native language speaker of the country where the study is being conducted.
- Key Exclusion Criteria:
- Neurological illnesses/conditions, such as motor or vocal tics (including a diagnosis of Tourette's syndrome), head trauma with significant loss of consciousness (\>30 min), cerebral ischemia, carotid artery disease, epilepsy, brain tumor, dementia (including mild cognitive impairment and Alzheimer's disease), chronic meningitis, multiple sclerosis, pernicious anemia, normal-pressure hydrocephalus, HIV infection, Parkinson's disease, and Huntington's disease.
- Medical illnesses/conditions that may affect brain function, such as untreated hypertension (blood pressure \>140/100 mm Hg), cardiac disease, insulin-dependent diabetes mellitus, endocrine disorders, renal disease, glaucoma, and chronic obstructive pulmonary disease.
- Major psychiatric disturbance according to the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (US) Axis I criteria \[American Psychiatric Association 2013\] and the International Statistical Classification of Diseases and Related Health Problems, 10th revision Axis I criteria (Europe) \[WHO 2010\].
- History of developmental disorders.
- Note: Other protocol defined Inclusion/ Exclusion criteria may apply.
Exclusion
Key Trial Info
Start Date :
November 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
467 Patients enrolled
Trial Details
Trial ID
NCT02283918
Start Date
November 1 2014
End Date
August 1 2015
Last Update
October 5 2015
Active Locations (8)
Enter a location and click search to find clinical trials sorted by distance.
1
Research Site
Thornton, Colorado, United States, 80233
2
Research site
Decatur, Georgia, United States, 30033
3
Research Site
Latham, New York, United States, 12110
4
Research Site
Akron, Ohio, United States, 44320