Clinical trial NCT02283918: Observational Study to Establish Patient-Matched Population Norms for the Multiple Sclerosis Cognition Assessment Battery
Official title: Study to Establish Patient-Matched Population Norms for the MS-COG
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2014-11-05
Enrollment: 467
Sex: ALL
Minimum age (years): 25
Maximum age (years): 58
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This is a multinational, multicenter study that will be conducted in healthy adult volunteers to establish normative values for the MS-COG. A total of 150 to 200 participants in each of the 3 countries will be enrolled. The study sample will include healthy participants who are matched in age and level of education to the general MS patient population for the respective country and/or region.

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 States (US), France, and Italy.


Eligibility criteria: 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.

Primary outcomes:
measure: Selective Reminding Test (SRT) Score
timeFrame: Day 1
measure: Brief Visuospatial Memory Test-Revised (BVMT-R) Score
timeFrame: Day 1
measure: 2- second and 3-second Paced Auditory Serial Addition Test (PASAT) Score
timeFrame: Day 1
measure: Symbol Digit Modalities Test (SDMT) Score
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Thornton
country: United States
facility: Research Site
state: Colorado
city: Decatur
country: United States
facility: Research site
state: Georgia
city: Latham
country: United States
facility: Research Site
state: New York
city: Akron
country: United States
facility: Research Site
state: Ohio
city: Marseille Cedex 5
country: France
facility: Research site
state: Bouches-du-Rhône
city: Bordeaux
country: France
facility: Research site
state: Gironde
city: Milano
country: Italy
facility: Research site
city: Roma
country: Italy
facility: Research site
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: