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

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

467 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-11-30

Study Completion Date

2015-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants with education less than bachelor's degree

Participants are further divided into three sub-groups based on their age group Group 1: Participants aged between 25 to 34 years Group 2: Participants aged between 35 to 44 years Group 3: Participants aged between 45 to 58 years

No interventions assigned to this group

Participants with bachelor's degree or equivalent

Participants are further divided into three sub-groups based on their age group Group 1: Participants aged between 25 to 34 years Group 2: Participants aged between 35 to 44 years Group 3: Participants aged between 45 to 58 years

No interventions assigned to this group

Eligibility Criteria

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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.

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.

Minimum Eligible Age

25 Years

Maximum Eligible Age

58 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes