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Rivastigmine in Mild Alzheimer's Disease, FMRI Study (ADFRMI)

Primary Purpose

Alzheimer' Disease

Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
rivastigmine
Sponsored by
Kuopio University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional basic science trial for Alzheimer' Disease focused on measuring Alzheimer's disease, fmri, face recognition, rivastigmine

Eligibility Criteria

55 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kuopio University Hospital

Outcomes

Primary Outcome Measures

FMRI response in face recognition task

Secondary Outcome Measures

treatment response measured by ADAS-cog

Full Information

First Posted
February 22, 2008
Last Updated
October 27, 2011
Sponsor
Kuopio University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00627848
Brief Title
Rivastigmine in Mild Alzheimer's Disease, FMRI Study
Acronym
ADFRMI
Official Title
Effect of Rivastigmine on FMRI in Mild Alzheimer's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kuopio University Hospital

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer' Disease
Keywords
Alzheimer's disease, fmri, face recognition, rivastigmine

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
rivastigmine
Intervention 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.
Primary Outcome Measure Information:
Title
FMRI response in face recognition task
Time Frame
at baseline and at 1 mo
Secondary Outcome Measure Information:
Title
treatment response measured by ADAS-cog
Time Frame
at 6 month and 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hilkka Soininen
Organizational Affiliation
Kuopio University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kuopio University Hospital
City
Kuopio
ZIP/Postal Code
70211
Country
Finland

12. IPD Sharing Statement

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Rivastigmine in Mild Alzheimer's Disease, FMRI Study

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