Background: Glatiramer acetate (Copaxone) therapy reduces clinical disease
activity in relapsing-remitting multiple sclerosis (MS).
Objective: To study the effect of glatiramer therapy on neuropsychologic fu
nction as part of a randomized, placebo-controlled, multicenter trial.
Methods: Two hundred forty-eight patients with relapsing-remitting MS and m
ild to moderate disability (Expanded Disability Status Scale score, <5.0) w
ere tested before and 12 and 24 months after randomization to administratio
n of glatiramer acetate, 20 mg/d, or matching placebo. Neuropsychologic tes
ts examined 5 cognitive domains most often disrupted in patients with MS: s
ustained attention, perceptual processing, verbal and visuospatial memory,
and semantic retrieval.
Results: Baseline neuropsychologic test performance was similar in both tre
atment groups and was within normal range, except for impaired semantic ret
rieval. Mean neuropsychologic test scores were higher at 12 and 24 months t
han at baseline, and no differences were detected between treatment groups
over time. No significant interactions were detected between treatment and
either time or baseline impairment.
Conclusions: Our 2-year longitudinal study showed no effect of glatiramer t
herapy on cognitive function in relapsing-remitting MS. Although it is poss
ible that glatiramer therapy has no effect on cognitive function, the lack
of measurable decline in cognitive function in both patient groups for 2 ye
ars limits the opportunity for glatiramer to demonstrate a therapeutic effe
ct by minimizing such decline. Emerging treatments for MS should continue t
o be examined for their effect on cognitive impairment because it can be a
critical determinant of disability. A greater understanding of the natural
history of cognitive decline in MS is essential for a rational design of th
ese drug trials.