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

NCT02283918 | Completed

• 1 other identifier: 999MS005
• Study Type: observational
• Target: 467
• Locations: 3 countries
• Sites: 8

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

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

Eligibility Criteria

• Age: 25 Years - 58 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.
• Must be in good health as determined by the Investigator, based on medical history, physical examination, and Screening evaluations.
• Must be a native language speaker of the country where the study is being conducted.

You may not qualify if:

• 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.
• 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.
• 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) \[WHO 2010\].
• History of developmental disorders.

Sponsors & Collaborators

• Biogen: lead

Study Sites (8)

Research Site

Thornton, Colorado, 80233, United States

Location

Research site

Decatur, Georgia, 30033, United States

Location

Research Site

Latham, New York, 12110, United States

Location

Research Site

Akron, Ohio, 44320, United States

Location

Research site

Marseille, Bouches-du-Rhône, 13385, France

Location

Research site

Bordeaux, Gironde, 33076, France

Location

Research site

Milan, Milano, 20162, Italy

Location

Research site

Roma, Roma, 179, Italy

Location

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2014
• First Posted: November 5, 2014
• Study Start: November 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: October 5, 2015

Record last verified: 2015-10

Locations

IT (2); US (4); FR (2)