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Safety and Tolerability of Rivastigmine With Add-on Memantine in Patients With Probable Alzheimer's Disease

NCT ID: NCT00305903

Last Updated: 2007-12-21

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

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2007-08-31

Brief Summary

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This is a prospective, 26-week, open-label, single-arm multi-center pilot study. Eligible patients will receive open-label treatment with rivastigmine capsules plus memantine tablets as add on therapy. This study is designed to evaluate the safety and tolerability of add on therapy with memantine to rivastigmine capsules in patients with probable AD (MMSE 10-20)

Detailed Description

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Conditions

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Alzheimer's Disease

Keywords

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Dementia, Alzheimer's, Rivastigmine, Memantine

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

* Have a diagnosis of probable Alzheimer's disease;
* Have an MMSE score between 10 and 20;
* Must be able to swallow capsule/tablet;
* Must have a caregiver who is able to attend all study visits;

Exclusion Criteria

* Have an advanced, severe, progressive, or unstable disease of any type that may interfere with efficacy and safety assessments or put the patient at special risk;
* Have a current diagnosis of active, uncontrolled seizure disorder;
* Have a history within the past year or current diagnosis of cerebrovascular disease
* Have a current diagnosis of severe or unstable cardiovascular disease;
* Had a myocardial infarction (MI) within the last six months;
* Have specific respiratory, digestive, renal, or endocrine disorders;
* Have had previous treatment with rivastigmine or memantine;
Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Principal Investigators

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Novartis

Role: STUDY_CHAIR

862-778-8300

Locations

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Paterson, New Jersey, United States

Site Status

Countries

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United States

References

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Sadowsky CH, Dengiz A, Meng X, Olin JT; US38 Study Group. Switching from oral donepezil to rivastigmine transdermal patch in Alzheimer's disease: 20-week extension phase results. Prim Care Companion J Clin Psychiatry. 2010;12(5):PCC.09m00852. doi: 10.4088/PCC.09m00852oli.

Reference Type DERIVED
PMID: 21274364 (View on PubMed)

Other Identifiers

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CENA713BUS32

Identifier Type: -

Identifier Source: org_study_id