Trial of Memantine for Cognitive Impairment in Multiple Sclerosis
Double Blind Placebo Controlled Pilot Trial of Memantine for Cognitive Impairment in Multiple Sclerosis
What it found
The main measure did not show a significant benefit.
“The differences between the groups on the change on the PASAT (placebo-memantine = 0.0 correct responses, 95% CI 3.4, 3.4; p = 0.9) and on CVLT-II LDFR (placebo-memantine =-0.6 words, 95% CI -2.1, 0.8; p = 0.4) as well as on the other cognitive tests were not significant.”Read by software from the paper's abstract
mean difference (placebo-memantine), CVLT-II LDFR -0.6 (95% CI -2.1–0.8)
p = ASAT p = 0.9; CVLT-II LDFR p = 0.4
Read by software from the paper's abstract
What was tested
Treatment tested
- Memantine
What it measured
Main measures
Change in the Paced Auditory Serial Addition Test and the California Verbal Learning Test II (multivariate end-point) after 15 weeks of treatment.
Other measures (11)
Controlled Oral Word Association Test
Stroop Color and Word Test
Symbol Digit Modalities Test
Thinking and memoryDelis-Kaplan Executive Function System
Perceived Deficit Questionnaire
Multiple Sclerosis Screening Neuropsychological Questionnaire
Modified Neuropsychiatric Inventory
Fatigue Severity Scale
FatigueModified Fatigue Impact Scale
FatigueMS Quality of Life Inventory
Quality of life (reported by participants)
Who could take part
Relapsing and progressive · 18 to 65
Show the full criteria
Inclusion criteria
1. A diagnosis of multiple sclerosis as defined by the McDonald criteria. Patients with relapsing-remitting, secondary progressive, and primary progressive forms of MS are eligible. 2. Age between 18 and 65 years. 3. Demonstrated cognitive dysfunction at screening defined as a score worse than 1.0 standard deviations below the mean on the PASAT or the CVLT-II.
Exclusion criteria
1. A history of major depression, psychosis, or a score > 19 on the Beck's Depression Inventory. 2. Corrected binocular visual acuity worse than 20/50; any impairment of binocular color vision. 3. Patients that do not speak English as a primary language (fluency may impact performance). 4. A clinically significant MS exacerbation within 30 days of the screening 5. Pregnancy 6. Renal insufficiency. 7. History of seizures. 8. Patients using acetazolamide (Diamox, Ak-sol, Storzolamide), dichlorphenamide (Daranide), methazolamide (Neptazane) or topiramate (Topamax), dextromethorphan (Robitussin DM and other cold remedies), or amantadine (Symmetrel). 9. Use of medical marijuana in the prior six months. 10. History of alcohol abuse or illicit drug use in the prior six months.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
This study is designed to determine whether memantine is an effective treatment for memory and cognitive problems associated with multiple sclerosis when compared to placebo.
Papers
Results
Memantine for cognitive impairment in multiple sclerosis: a randomized placebo-controlled trial.Mult Scler · 2010
The differences between the groups on the change on the PASAT (placebo-memantine = 0.0 correct responses, 95% CI 3.4, 3.4; p = 0.9) and on CVLT-II LDFR (placebo-memantine =-0.6 words, 95% CI -2.1, 0.8; p = 0.4) as well as on the other cognitive tests were not significant.
Read by software from the paper's abstract
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History
Started
Apr 2004
Main results due
Jan 2009
Finished
Jan 2009