ADFRMI: Rivastigmine in Mild Alzheimer's Disease, FMRI Study

• Sponsor: Kuopio University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT00627848
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Duration (Months): 21.1
• Patients Per Site Per Month: 0.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Alzheimer' Disease	Drug: rivastigmine	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: Effect of Rivastigmine on FMRI in Mild Alzheimer's Disease
• Study Start Date: Mar 1, 2007
• Actual Primary Completion Date: Dec 1, 2008
• Actual Study Completion Date: Dec 1, 2008

Outcome Measures

Primary Outcome Measures

1. FMRI response in face recognition task [at baseline and at 1 mo]

Secondary Outcome Measures

1. treatment response measured by ADAS-cog [at 6 month and 1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 55 Years to 85 Years
• Sexes Eligible for Study: 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kuopio University Hospital	Kuopio		Finland	70211

Sponsors and Collaborators

• Kuopio University Hospital

Investigators

• Principal Investigator: Hilkka Soininen, Kuopio University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hilkka Soininen, Professor, Kuopio University Hospital
• ClinicalTrials.gov Identifier: NCT00627848
• Other Study ID Numbers: KUH5772749
• First Posted: Mar 3, 2008
• Last Update Posted: Oct 28, 2011
• Last Verified: Oct 1, 2011

• Keywords provided by Hilkka Soininen, Professor, Kuopio University Hospital: Alzheimer's disease; fmri; face recognition; rivastigmine
• Additional relevant MeSH terms: Alzheimer Disease; Rivastigmine

Study Results

No Results Posted as of Oct 28, 2011