Rivastigmine in Mild Alzheimer's Disease, FMRI Study

Effect of Rivastigmine on FMRI in Mild Alzheimer's Disease

Sponsors

Lead Sponsor: Kuopio University Hospital

Source Kuopio University Hospital
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.

Overall Status Completed
Start Date March 2007
Completion Date December 2008
Primary Completion Date December 2008
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
FMRI response in face recognition task at baseline and at 1 mo
Secondary Outcome
Measure Time Frame
treatment response measured by ADAS-cog at 6 month and 1 year
Enrollment 20
Condition
Intervention

Intervention Type: Drug

Intervention Name: rivastigmine

Description: 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.

Eligibility

Criteria:

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: All

Minimum Age: 55 Years

Maximum Age: 85 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Hilkka Soininen Principal Investigator Kuopio University Hospital
Location
Facility: Kuopio University Hospital
Location Countries

Finland

Verification Date

October 2011

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Kuopio University Hospital

Investigator Full Name: Hilkka Soininen

Investigator Title: Professor

Keywords
Has Expanded Access No
Condition Browse
Acronym ADFRMI
Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

Primary Purpose: Basic Science

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov