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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00627848
Recruitment Status : Completed
First Posted : March 3, 2008
Last Update Posted : October 28, 2011
Information provided by (Responsible Party):
Hilkka Soininen, 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.

Condition or disease Intervention/treatment Phase
Alzheimer' Disease Drug: rivastigmine Not Applicable

Study Type : Interventional  (Clinical Trial)
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 : March 2007
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

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.

Primary Outcome Measures :
  1. FMRI response in face recognition task [ Time Frame: at baseline and at 1 mo ]

Secondary Outcome Measures :
  1. treatment response measured by ADAS-cog [ Time Frame: at 6 month and 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 85 Years   (Adult, Senior)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00627848

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

Responsible Party: Hilkka Soininen, Professor, Kuopio University Hospital Identifier: NCT00627848     History of Changes
Other Study ID Numbers: KUH5772749
First Posted: March 3, 2008    Key Record Dates
Last Update Posted: October 28, 2011
Last Verified: October 2011

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

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