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...
Date First Received: February 22, 2008
Last Updated: April 10, 2008
Verified by: Kuopio University Hospital, February 2008
Clinical Trial Phase: N/A | Start Date: March 2007
Overall Status: Active, not recruiting
Estimated Enrollment: 20
Brief Summary
Official Title: “Effect of Rivastigmine on FMRI in Mild Alzheimer's Disease”
Condition Keyword(s):
Intervention(s):
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 Type: Interventional
Study Design: Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment
Study Primary Completion Date: October 2008
Intervention(s) in this Clinical Trial
- Drug: rivastigmine
- Acute dose 3 mg or placebo. Thereafter 1.5 mg x 2 ad 30 days and thereafter increasing the dose upto 4.5 mg x 2 according to instructions.
Outcome Measures for this Clinical Trial
Primary Measures
- FMRI response in face recognition task
- Time Frame: at baseline and at 1 mo
Safety Issue?: No
- Time Frame: at baseline and at 1 mo
Secondary Measures
- treatment response measured by ADAS-cog
- Time Frame: at 6 month and 1 year
Safety Issue?: No
- Time Frame: at 6 month and 1 year
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 55 Years
Maximum Age for this Clinical Trial: 85 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Kuopio University Hospital
Overall Clinical Trial Officials and Contacts
Hilkka Soininen Principal Investigator Kuopio University Hospital
Additional Information
Information obtained from ClinicalTrials.gov on August 29, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00627848
Study ID Number: KUH5772749
ClinicalTrials.gov Identifier: NCT00627848
Health Authority: Finland: National Agency of Medicines
Clinical Trials Authorship and Review
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
