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Efficacy, Safety and Tolerability of Rivastigmine Patch in Patients With Mild to Moderate Alzheimer's Disease Switched From Cholinesterase Inhibitors

NCT ID: NCT01529619

Last Updated: 2016-11-18

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

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2013-12-31

Brief Summary

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This is a multicenter study to evaluate the efficacy, safety and tolerability of Rivastigmine patch in patients with mild to moderate Alzheimer's disease switched from Cholinesterase Inhibitors.

Detailed Description

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Conditions

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Alzheimer's Disease

Keywords

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Rivastigmine Alzheimer's disease Transdermal patch

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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Rivastigmine 18 mg

During the 16-week titration period patients received daily rivastigmine 4.5mg patch for the first 4 weeks, rivastigmine 9mg patch for the next 4 weeks, rivastigmine 13.5mg patch for the next 4 weeks and then rivastigmine 18mg patch for the final 4 weeks. For patients who experienced intolerability, the dose was adjusted downward. Patients then entered the 8-week maintenance period during which time they continued to receive the dose of rivastigmine they were taking at the end of the titration period.

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

* A diagnosis of dementia of the Alzheimer's type according to the DSM-IV criteria
* A clinical diagnosis of probable AD according to NINCDS/ADRDA criteria
* An MMSE score of \> or = 10 and \< or = 23
* Continuous treatment with donepezil ≤ 5 mg/day or galantamine ≤ 24 mg/day for 4 weeks prior to baseline visit
* Patients having difficulties being treated orally with ChE inhibitors (donepezil or galantamine) as judged by the investigator. Difficulties are defined as:
* Inadequate compliance with the ChE inhibitors at screening and baseline
* Presence of caregiver's burden for administering drugs orally at screening and baseline
* Inadequate treatment (efficacious dose cannot be reached or inadequate compliance) with the ChE inhibitors because of adverse events at screening and baseline
* Patients with swallowing difficulties at screening and baseline

Exclusion Criteria

* A current DSM-IV diagnosis of major depression
* Taken rivastigmine in the past
* A score of \> 5 on the Modified Hachinski Ischemic Scale (MHIS)
Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ono Pharmaceutical Co. Ltd

INDUSTRY

Sponsor Role collaborator

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

Nagoya, Aichi-ken, Japan

Site Status

Novartis Investigative Site

Fukuoka, Fukuoka, Japan

Site Status

Novartis Investigative Site

Miyoshi, Hiroshima, Japan

Site Status

Novartis Investigative Site

Ohtake, Hiroshima, Japan

Site Status

Novartis Investigative Site

Kita-gun, Kagawa-ken, Japan

Site Status

Novartis Investigative Site

Kamakura, Kanagawa, Japan

Site Status

Novartis Investigative Site

Kawasaki, Kanagawa, Japan

Site Status

Novartis Investigative Site

Yokohama, Kanagawa, Japan

Site Status

Novartis Investigative Site

Kōshi, Kumamoto, Japan

Site Status

Novartis Investigative Site

Kyoto, Kyoto, Japan

Site Status

Novartis Investigative Site

Kyoto, Kyoto, Japan

Site Status

Countries

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Japan

Other Identifiers

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CENA713D1403

Identifier Type: -

Identifier Source: org_study_id