Observational Study to Establish Patient-Matched Population Norms for the Multiple Sclerosis Cognition Assessment Battery

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.

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.