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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hilkka Soininen, Kuopio University Hospital
ClinicalTrials.gov Identifier:
NCT00627848
First received: February 22, 2008
Last updated: October 27, 2011
Last verified: October 2011
History of Changes
  Purpose

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:

U.S. FDA Resources

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.
  Eligibility

Ages Eligible for Study:   55 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00627848

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

No publications provided

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
fmri
face recognition
rivastigmine

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Rivastigmine
Cholinesterase Inhibitors
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuroprotective Agents
Protective Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 17, 2013