NCT00627848CompletedNot Applicable
Effect of Rivastigmine on FMRI in Mild Alzheimer's Disease
Kuopio University Hospital2 sites in 1 country20 target enrollmentStarted: March 1, 2007Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- FMRI response in face recognition task
Study Overview
Brief Summary
The purpose of the study is to investigate the effect of rivastigmine given as an acute dose compared to placebo and after 1 month chronic dosing on fMRI response during a face recognition task. Furthermore, the aim is to investigate whether fMRI response is correlated with long term treatment effect at 6 months and 12 months.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 55 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Probable Alzheimer's disease according to the NINCDS-ADRDA criteria
- •mild disease, CDR 1
- •the clinician is planning to start anticholinesterase treatment
Exclusion Criteria
- •cognitive impairment for other reason than Alzheimer's disease
- •severe depression
- •other unstable physical disease
- •medal in body prevention MRI examination, claustrophobia
- •cardiac pacemaker
- •other significant neurologic or psychiatric disease
- •contraindication for anticholinesterase treatment
Outcomes
Primary Outcomes
FMRI response in face recognition task
Time Frame: at baseline and at 1 mo
Secondary Outcomes
- treatment response measured by ADAS-cog(at 6 month and 1 year)
Investigators
Hilkka Soininen
Professor
Kuopio University Hospital
Study Sites (2)
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