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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 | ||
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| Selective Reminding Test (SRT) Score | The SRT measures verbal learning and memory. A participant is read a list of words and then asked to recall as many of the words as possible. Six learning trials are conducted, followed by a delay trial approximately 20 to 40 minutes later. | Day 1 |
| Brief Visuospatial Memory Test-Revised (BVMT-R) Score | The BVMT-R measures visual learning and memory. The stimulus page is presented for 10 seconds, and the participant is then asked to reproduce the designs as accurately as possible and in the same location on the page. Three learning trials are administered, followed by a delay trial approximately 20 to 40 minutes later. Immediately following the delay trial a recognition trial is administered to see whether the participant recognizes the figures that were on the display. | Day 1 |
| 2- second and 3-second Paced Auditory Serial Addition Test (PASAT) Score | The PASAT assesses auditory information processing speed. A random series of numbers from 1 to 9, inclusive, are presented and the participant is instructed to consecutively add pairs of numbers so that each number is added to the one that immediately preceded it. In the 2- and 3- second PASAT, numbers are presented at a rate of 1 every 2 or 3 seconds, respectively. | Day 1 |
| Symbol Digit Modalities Test (SDMT) Score | SDMT is a screening test for cognitive impairment. Participants are given 90 seconds in which to pair specific numbers with given geometric figures using a key. Scores range from 0 to 110 (best). | Day 1 |
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Key Inclusion Criteria
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/ Exclusion criteria may apply.
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Biogen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Thornton | Colorado | 80233 | United States | ||
| Research site |
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| Decatur |
| Georgia |
| 30033 |
| United States |
| Research Site | Latham | New York | 12110 | United States |
| Research Site | Akron | Ohio | 44320 | United States |
| Research site | Marseille | Bouches-du-Rhône | 13385 | France |
| Research site | Bordeaux | Gironde | 33076 | France |
| Research site | Milan | Milano | 20162 | Italy |
| Research site | Roma | Roma | 179 | Italy |