Contact information
Type
Scientific
Primary contact
Dr Paul M Matthews
ORCID ID
Contact details
John Radcliffe Hospital
FMRIB Centre
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom
+44 (0)1865 222493
paul@fmrib.ox.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0176079579
Study information
Scientific title
Acronym
Study hypothesis
1. To examine the relationship between magnetic resonance imaging (MRI) indices and the severity of cognitive symptoms (e.g. poor memory and concentration)
2. To evaluate whether Rivastigmine Tartrate has a beneficial effect on the cognitive performance of patients with MS
Ethics approval
Not provided at time of registration
Study design
Randomised placebo controlled crossover group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Multiple sclerosis (MS)
Intervention
Randomised placebo controlled, single dose, crossover trial with MRI and behavioural endpoints.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
1. Behavioural data during performance of the functional imaging task and in the formal cognitive assessment
2. Absolute measures of signal intensity change in regions of interest in the functional scan
3. Lesion load on T1 and T2 weighted MRI scans
4. The percentage of the white matter in the patient that has T1 values greater than normal
Secondary outcome measures
1. Behavioural effect on other tasks within the neuropsychological battery
2. Possible side effects
Overall trial start date
01/11/2000
Overall trial end date
01/11/2003
Reason abandoned
Eligibility
Participant inclusion criteria
12 Healthy people. 24 Patients.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
36
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/11/2000
Recruitment end date
01/11/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
John Radcliffe Hospital
Oxford
OX3 9DU
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Oxford Radcliffe Hospitals NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2003 results in http://www.ncbi.nlm.nih.gov/pubmed/12958082
Publication citations
-
Results
Parry AM, Scott RB, Palace J, Smith S, Matthews PM, Potentially adaptive functional changes in cognitive processing for patients with multiple sclerosis and their acute modulation by rivastigmine., Brain, 2003, 126, Pt 12, 2750-2760, doi: 10.1093/brain/awg284.