Aricept in MS
What it found
We found no results in the registry or in papers.
What was tested
Treatment tested
- Donepezil
What it measured
Main measures
We have chosen to analyse auditory and verbal learning as the primary endpoint. This is a sensitive variable to demonstrate mild and moderate cognitive dysfunction. The instrument is Rey Auditor Visual Learning Test (Rey AVLT). Positive effect is regarded as a 20% improvement in test data as Stanine levels or in points. This will show as a statistical significant result at the 95% CI level.
Thinking and memory
Who could take part
MS (type not specified)
Inclusion: Patients with MS in Motala Neurological unit who are18-55 years of age, with only moderate disability due to MS. They should have complaints of cognitive dysfunction and this must be demonstrated in the Cognistat screening instrument as being separate from normal function. The minimental state examination (MSE/MMT) must not be much affected since this will interfere with the patient´s ability to take part in the extensive neuropsychological testing, minmum score must be at 23 points. Exclusion: Age under 18 or more than 55, pregnancy or insufficient protection against pregnancy, MS relapse during the last 30 days prior to inclusion, treatment against depression started during the last month prior to inclusion. Severe relapse during the study if it affects higher functions - vitality, alertness. depression with onset duuring the study. severe disability, scoring more than 6.5 (EDSS according to Kurtzke).
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
As Aricept (Donepezil generic name) has a well proven effect in Alzheimer´s disease and also demonstrates good safety data and few side effects, we plan to test the effect on intellectual functions in multiple sclerosis. A few small studies have been performed but there are non-optimal study solutions in these designs.
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History
Started
Sept 2005
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