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Rivastigmine in Mild Alzheimer's Disease, FMRI Study

NCT ID: NCT00627848

Last Updated: 2011-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2008-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Alzheimer' Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

55 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kuopio University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hilkka Soininen

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hilkka Soininen

Role: PRINCIPAL_INVESTIGATOR

Kuopio University Hospital

Locations

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Kuopio University Hospital

Kuopio, , Finland

Site Status

Countries

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Finland

Other Identifiers

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KUH5772749

Identifier Type: -

Identifier Source: org_study_id