Rivastigmine in Mild Alzheimer's Disease, FMRI Study

Alzheimer' Disease Clinical Trial

— ADFRMI  

Official title:

Effect of Rivastigmine on FMRI in Mild Alzheimer's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00627848
• Other study ID #: KUH5772749
• Status: Completed
• Phase: N/A
• First received: February 22, 2008
• Last updated: October 27, 2011
• Start date: March 2007
• Est. completion date: December 2008

Study information

• Verified date: October 2011
• Source: Kuopio University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: National Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer' Disease

Intervention

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.

Locations

Country	Name	City	State
Finland	Kuopio University Hospital	Kuopio

Sponsors (1)

Lead Sponsor	Collaborator
Kuopio University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FMRI response in face recognition task		at baseline and at 1 mo	No
Secondary	treatment response measured by ADAS-cog		at 6 month and 1 year	No