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

Healthy Clinical Trial

Official title:

Study to Establish Patient-Matched Population Norms for the MS-COG

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02283918
• Other study ID #: 999MS005
• Status: Completed
• Phase: N/A
• First received: November 3, 2014
• Last updated: October 1, 2015
• Start date: November 2014
• Est. completion date: August 2015

Study information

• Verified date: October 2015
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics CommitteeUnited States: Institutional Review BoardFrance: Agence Nationale de Sécurité du Médicament et des produits de santé (ANSM)
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 467
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 58 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Healthy

Locations

Country	Name	City	State
France	Research site	Bordeaux	Gironde
France	Research site	Marseille Cedex 5	Bouches-du-Rhône
Italy	Research site	Milano
Italy	Research site	Roma
United States	Research Site	Akron	Ohio
United States	Research site	Decatur	Georgia
United States	Research Site	Latham	New York
United States	Research Site	Thornton	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Countries where clinical trial is conducted

United States,  France,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No