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

Completed

• Conditions: Healthy

• Registration Number: NCT02283918
• Lead Sponsor: Biogen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2014-11-03
• Study First Submitted QC: 2014-11-04
• Study First Posted: 2014-11-05
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-01
• Last Update Posted: 2015-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 467

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Selective Reminding Test (SRT) Score	Day 1	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.
Brief Visuospatial Memory Test-Revised (BVMT-R) Score	Day 1	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.
2- second and 3-second Paced Auditory Serial Addition Test (PASAT) Score	Day 1	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.
Symbol Digit Modalities Test (SDMT) Score	Day 1	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).

Trial Locations

Locations (2)

Research Site; 🇺🇸 Akron, Ohio, United States

Research site; 🇮🇹 Roma, Italy