Observational Study to Establish Patient-Matched Population Norms for the Multiple Sclerosis Cognition Assessment Battery
Status: | Completed |
---|---|
Conditions: | Healthy Studies |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 25 - 58 |
Updated: | 4/21/2016 |
Start Date: | November 2014 |
End Date: | August 2015 |
Study to Establish Patient-Matched Population Norms for the MS-COG
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 States (US), France, and Italy.
for the Multiple Sclerosis Cognition Assessment Battery (MS-COG) that are representative of
the United States (US), France, and Italy.
Key Inclusion Criteria
1. 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.
2. Must be in good health as determined by the Investigator, based on medical history,
physical examination, and Screening evaluations.
3. Must be a native language speaker of the country where the study is being conducted.
Key Exclusion Criteria:
1. 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.
2. 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.
3. 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].
4. History of developmental disorders.
Note: Other protocol defined Inclusion/ Exclusion criteria may apply.
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5
sites
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Marseille Cedex 5, Bouches-du-Rhône 13385
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