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

This study has been completed.
Information provided by (Responsible Party):
Hilkka Soininen, Kuopio University Hospital
ClinicalTrials.gov Identifier:
First received: February 22, 2008
Last updated: October 27, 2011
Last verified: October 2011
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 Intervention
Alzheimer' Disease
Drug: rivastigmine

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effect of Rivastigmine on FMRI in Mild Alzheimer's Disease

Resource links provided by NLM:

Further study details as provided by Kuopio University Hospital:

Primary Outcome Measures:
  • FMRI response in face recognition task [ Time Frame: at baseline and at 1 mo ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • treatment response measured by ADAS-cog [ Time Frame: at 6 month and 1 year ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: March 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    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.

Ages Eligible for Study:   55 Years to 85 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00627848

Kuopio University Hospital
Kuopio, Finland, 70211
Sponsors and Collaborators
Kuopio University Hospital
Principal Investigator: Hilkka Soininen Kuopio University Hospital
  More Information

Responsible Party: Hilkka Soininen, Professor, Kuopio University Hospital
ClinicalTrials.gov Identifier: NCT00627848     History of Changes
Other Study ID Numbers: KUH5772749 
Study First Received: February 22, 2008
Last Updated: October 27, 2011
Health Authority: Finland: National Agency of Medicines

Keywords provided by Kuopio University Hospital:
Alzheimer's disease
face recognition

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Mental Disorders
Nervous System Diseases
Neurocognitive Disorders
Neurodegenerative Diseases
Cholinergic Agents
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Neuroprotective Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Protective Agents

ClinicalTrials.gov processed this record on May 22, 2016