Rivastigmine Monotherapy and Combination Therapy With Memantine in Patients With Moderately Severe Alzheimer's Disease Who Failed to Benefit From Previous Cholinesterase Inhibitor Treatment

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

PHASE4

Total Enrollment

204 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-11-30

Study Completion Date

2005-06-30

Brief Summary

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This is a prospective, multicenter, open-label study. Following screening and baseline assessments, eligible patients will be switched to rivastigmine and will enter the 16 week run-in rivastigmine treatment phase. After completion of assessments at the end of the run-in phase, patients who were not sufficiently stabilized on rivastigmine alone will receive add-on memantine to their rivastigmine treatment; patients who were stabilized on rivastigmine alone will have completed and be discontinued from the study.

Detailed Description

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Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Rivastigmine, memantine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Outpatients who have probable Alzheimer's disease according to the DSMIV criteria
* Patients treated with donepezil (5-10 mg ) or galantamine (16- 24 mg) for at least 6 months
* Patients, in the investigator's clinical judgment, not stabilized on treatment with donepezil or galantamine

Exclusion Criteria

* Patients with evidence of severe or unstable physical illness, i.e., acute and severe asthmatic conditions, severe or unstable cardiovascular disorders, active peptic ulcer disease, hypersensitivity to cholinesterase inhibitors or memantine, clinically significant laboratory abnormalities or any patient with a medical condition which would prohibit them from completing the clinical trial

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thierry Dantoine

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire

Locations

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Département de Gérontologie Clinique

Limoges, Cedex, France

Site Status

Countries

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France

Other Identifiers

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CENA713BFR05

Identifier Type: -

Identifier Source: org_study_id