Multiple sclerosis is a devastating inflammation in the central nervous system and it can often give cognitive dysfunction, affecting memory, mental concentration. Lately it has been shown that the cognitive dysfunction has a big impact on life quality. Immunomodulatory medication can only partially limit the bouts but there is no effective cure at the moment. There is little options to treat the effects on higher functions for the moment.
Conditions
Interventions
Trade Name: Aricept 5 mg filmdragerade tabletter
Product Name: Aricept 5 mg
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Donepezil
Concentration unit: mg milligram(s)
Concentration ty
Sponsors
Neurology Unit
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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. ;Secondary Objective: Secondary endpoints are several variables that can measure memory (spatial, visual, artithmetic) and concentration, also life quality. Test instruments are Rey 15 item, Digit span, Consonant trigram, Trail making, judgement of fine line orientation, verbal Fluency: Animals +FAS, Visual Analog Scales regarding emotional status, ADL-function + QoL as measured by MSIS 29, se protocol for detailed descriptions.;Primary end point(s): 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. | — |
Countries
Sweden
Outcome results
None listed