Completed

KAPAA Multi-center, Randomised, Open-label Study to Evaluate Convenience and Safety of Change in the Mode of Administration of Rivastigmine (From Capsules to a Transdermal Patch) in Patients With Alzheimer's Disease

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What is being tested

Rivastigmine patch (4.6 mg/day switch to 9.5 mg/day)

+ Rivastigmine patch (9.5 mg/day)

+ Rivastigmine capsules (6 mg to 12 mg/day)

Drug
Who is being recruted

Alzheimer Disease+6

+ Mental Disorders

+ Brain Diseases

Over 60 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: September 2007
See protocol details

Summary

Principal SponsorNovartis
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2007

Actual date on which the first participant was enrolled.

This study used two doses of rivastigmine transdermal patch (5 cm\^2, 10 cm\^2) to establish the feasibility of 2 switch schedules (with transdermal patch one-step dose titration or without dose titration) from rivastigmine capsules (3 mg bid (bis in die, twice a day), 4,5 mg bid, 6 mg bid) to rivastigmine transdermal patch and to assess safety, tolerability, convenience, and caregivers preferences of rivastigmine transdermal patch versus capsules.

Official TitleA Multi-center, Randomised, Open-label Study to Evaluate Convenience and Safety of Change in the Mode of Administration of Rivastigmine (From Capsules to a Transdermal Patch) in Patients With Alzheimer's Disease
NCT00549601
Principal SponsorNovartis
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

142 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 60 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Alzheimer DiseaseMental DisordersBrain DiseasesCentral Nervous System DiseasesDementiaNervous System DiseasesNeurodegenerative DiseasesNeurocognitive DisordersTauopathies

Criteria

Inclusion Criteria: * Meet DSM-IV (Diagnostic \& Statistical Manual of Mental Disorders, Version IV) criteria for dementia of Alzheimer type and NINCDS-ADRDA (National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association) criteria for probable Alzheimer's disease (AD), have a MMSE (Mini Mental State Examination) score \> 10 and \< 26 * Have received continuous treatment with rivastigmine capsules at least with 3 mg bid (6 mg of total daily dose) for at least 3 months before entering in the study * Cooperative, willing to complete all aspects of the study, and capable of doing so, either alone or with the aid of a responsible caregiver * Have a primary caregiver willing to accept responsibility for supervising the treatment, (eg, application and removal of the patch daily at approximately the same time of day) and assessing the condition of the patient throughout the study. Exclusion Criteria: * A medical or neurological condition other that AD that could explain the patients dementia (eg, Huntington's disease, Parkinson's Disease, abnormal thyroid function test, B12 or folate deficiency, post-traumatic conditions, syphilis) * Current diagnosis of an active skin lesion/disorder that would prevent accurate assessment of the adhesion and potential skin irritation of the patch (e.g., atopic dermatitis, wounded or scratched skin in the area of the patch application) * History of allergy to topical products containing vitamin E * Taken any of the following substances prior to randomization: * succinylcholine-type muscle relaxants during the previous 2 weeks * an investigational drug during the previous 4 weeks Other protocol-defined inclusion/exclusion criteria applied to the study.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Group II

Experimental

Group III

Active Comparator

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Novartis Investigative Site

Barcelona, SpainOpen Novartis Investigative Site in Google Maps
CompletedOne Study Center