Format

Send to

Choose Destination
J Neurol Sci. 2014 May 15;340(1-2):123-9. doi: 10.1016/j.jns.2014.03.009. Epub 2014 Mar 11.

Reliability of a cognitive endpoint for use in a multiple sclerosis pharmaceutical trial.

Author information

1
Psychology Department, Rusk Institute of Rehabilitation Medicine. Electronic address: Derlanger212@gmail.com.
2
PanMedix, Inc.
3
Private Corporation.
4
Neurology Department, SUNY at Buffalo.
5
Ferkauf Graduate School of Psychology, Yeshiva University.
6
Neuropsychology Associates of Fairfax, Georgetown University Department of Neurology.
7
Neurology Clinical Development, Biogen Idec.
8
Research Center, Kessler Foundation.

Abstract

OBJECTIVE:

Determine reliability and basic psychometric properties of a composite cognitive endpoint, MS-COG, for monitoring change in cognitive function in MS drug trials.

BACKGROUND:

50% of MS patients have cognitive impairment that impacts ability to work and quality of life. We selected neuropsychological tests based on sensitivity to MS cognitive impairment, availability of alternate forms, cross-cultural utility, and feasibility for multicenter trials, and assessed the reliability and validity of a composite endpoint, MS-COG.

DESIGN/METHODS:

Administered SRT, BVMT-R, PASAT, and SDMT to 60 MS patients at 4 US centers twice over 45days, along with symptom inventories by patients and informants.

RESULTS:

The MS-COG had test-retest reliability of 0.91. Processing Speed and Memory indices had reliabilities of 0.89 and 0.86, with modest practice effects. Reliability was high for the RR MS and SP MS subgroups as well, with correlations of .90 and .93, respectively for MS-COG. Overall, 42% of subjects obtained MS-COG scores in the impaired range, with SP MS subjects performing 0.8 SD below RR MS subjects. Impairment correlated well (r=0.37 to 0.40) with informant reports but was inconsistent with patient report, with the least reliable assessments by those with greater symptom severity.

CONCLUSIONS:

The MS-COG is a reliable, repeatable measure of MS cognitive functioning that is sensitive to cognitive impairment in SP MS and RR MS patients and feasible for multicenter clinical trials. Further development is warranted.

KEYWORDS:

Assessment; Cognition; Endpoint; Multiple sclerosis; Neuropsychology; Reliability

PMID:
24656433
DOI:
10.1016/j.jns.2014.03.009
[Indexed for MEDLINE]
Free full text

Supplemental Content

Full text links

Icon for Elsevier Science
Loading ...
Support Center