Compliance and Tolerability of Rivastigmine Transdermal Patch 10 cm² in Patients With Probable Alzheimer's Disease.

NCT ID: NCT00731224

Last Updated: 2017-03-28

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

PHASE4

Total Enrollment

380 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2011-10-31

Brief Summary

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This study will evaluate compliance, tolerability, safety, efficacy and caregiver burden of rivastigmine patch 10 cm² treatment in people with Alzheimer's disease (MMSE 10-26) initiating therapy for the first time with a cholinesterase inhibitor, and in patients who were unresponsive to previous cholinesterase inhibitor treatment in a community setting.

Detailed Description

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Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

Rivastigmine transdermal patch

Intervention Type DRUG

Interventions

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Rivastigmine transdermal patch

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Probable Alzheimer's disease according to the NINCDS-ADRDA (National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association) and DSM-IV (Diagnostic and Statistical Manual of Mental Disorders) criteria;
* MMSE score of ≥10 and ≤ 26;

Exclusion Criteria

* Bradycardia (beats per minute less than 50)
* Body weight less than 40 kg;
* Hypersensitivity to cholinesterase inhibitors.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

East Gosford, New South Wales, Australia

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Gosford, New South Wales, Australia

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Hornsby, New South Wales, Australia

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Randwick, New South Wales, Australia

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Chemside, Queensland, Australia

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Adelaide, South Australia, Australia

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Woodville, South Australia, Australia

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Ballarat, Victoria, Australia

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Fitzroy, Victoria, Australia

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Heidelberg, Victoria, Australia

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Nedlands, , Australia

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Johor Bahru, Johor, Malaysia

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Seremban, Negeri Sembilan, Malaysia

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Ipoh, Perak, Malaysia

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Kuala Lumpur, Selangor, Malaysia

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Kuala Lumpur, , Malaysia

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Seoul, Korea, South Korea

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Bundang, Seongnam, South Korea

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Seoul, , South Korea

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Bangkok, , Thailand

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Bangkok, , Thailand

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Bangkok, , Thailand

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Ankara, Turkey, Turkey (Türkiye)

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Ankara, Turkey, Turkey (Türkiye)

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Bursa, Turkey, Turkey (Türkiye)

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Izmir, Turkey, Turkey (Türkiye)

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Konya, Turkey, Turkey (Türkiye)

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Altunizade, , Turkey (Türkiye)

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Antalya, , Turkey (Türkiye)

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Atakum / Samsun, , Turkey (Türkiye)

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Emek / Ankara, , Turkey (Türkiye)

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Etlik / Ankara, , Turkey (Türkiye)

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Istanbul, , Turkey (Türkiye)

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Istanbul, , Turkey (Türkiye)

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Izmir, , Turkey (Türkiye)

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Kocaeli, , Turkey (Türkiye)

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Mersin, , Turkey (Türkiye)

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Meselik / Eskisehir, , Turkey (Türkiye)

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Talas / Kayseri, , Turkey (Türkiye)

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Uskudar / Istanbul, , Turkey (Türkiye)

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Countries

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Australia Malaysia South Korea Thailand Turkey (Türkiye)

Other Identifiers

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CENA713DAU01

Identifier Type: -

Identifier Source: org_study_id

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