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

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

A 24-week, Open-label, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of Rivastigmine Patch in Patients With Mild to Moderate Alzheimer's Disease (MMSE 10-23) Switched From Cholinesterase Inhibitors (Donepezil, Galantamine)

NCT01529619•Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

50 - 85 years

Sex

ALL

Healthy Volunteers

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)

Locations (11)

Novartis Investigative Site

Nagoya, Aichi-ken, Japan

Novartis Investigative Site

Fukuoka, Fukuoka, Japan

Novartis Investigative Site

Miyoshi, Hiroshima, Japan

Novartis Investigative Site

Ohtake, Hiroshima, Japan

Novartis Investigative Site

Kita-gun, Kagawa-ken, Japan

Novartis Investigative Site

Kamakura, Kanagawa, Japan

Novartis Investigative Site

Kawasaki, Kanagawa, Japan

Novartis Investigative Site

Yokohama, Kanagawa, Japan

Novartis Investigative Site

Kōshi, Kumamoto, Japan

Novartis Investigative Site

Kyoto, Kyoto, Japan

Key Dates

Start Date

March 1, 2012

Primary Completion Date

December 1, 2013

Completion Date

December 1, 2013

Last Updated

November 18, 2016

Enrollment

ACTUAL participants

Conditions

Alzheimer's Disease

Interventions

Rivastigmine transdermal patch

DRUG

ACP-204 in Adults With Alzheimer's Disease Psychosis

NCT06159673

Alzheimer's Disease Psychosis

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RECRUITING

Lombard Cohort of Brain Health Services

NCT07457138

Subjective Cognitive Decline (SCD)Functional Cognitive Disorder+2 more

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RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 18, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

ACP-204 in Adults With Alzheimer's Disease Psychosis

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