Clinical Effectiveness of 10 cm2 Rivastigmine Patch in Patients With Alzheimer's Disease - Tabular View

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Clinical Effectiveness of 10 cm2 Rivastigmine Patch in Patients With Alzheimer's Disease (ADEPT)

This study is currently recruiting participants.

Study NCT00561392. Last updated on June 6, 2008. Information provided by Novartis

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Clinical Effectiveness of 10 cm2 Rivastigmine Patch in Patients With Alzheimer's Disease

Official Title ^†

A 24 Week, Multicenter, Open, Evaluation of the Clinical Effectiveness of the Once-Daily 10 cm² Rivastigmine Patch Formulation in Patients With Probable Alzheimer's Disease (MMSE10-26)

Brief Summary

This study will evaluate the safety and efficacy of 10 cm2 Rivastigmine Patch in patients with Alzheimer Disease (MMSE 10-26). Primary objective is the percentage of patients who stay on the target size of 10 cm2 for at least 8 weeks. This proportion will then be compared to historic data with the percentage of patients who could reach Rivastigmine capsule target dose of 12 mg and stay on it at least 8 weeks, in previous Rivastigmine trials.

Detailed Description

Study Phase

Phase IV

Study Type ^†

Interventional

Study Design ^†

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment

Primary Outcome Measure ^†

Percentage of patients who can reach Rivastigmine target patch size 10 cm² (and stay on it for at least 8 weeks).

Secondary Outcome Measure ^†

Cognitive and global outcome of the patients: Mini-Mental-State-Examination (Screening, after 4, 8 and 24 weeks)
Clinical Global Impression of Change (after 4, 8 and 24 weeks)
Trail Making Test A (Baseline, after 4, 8 and 24 weeks)
Activities of Daily living (Baseline, after 4, 8 and 24 weeks)
Safety/tolerability data (AEs and SAEs)
Patient compliance with the patch (drug accounting)
Caregiver preference and satisfaction with the patch
Caregiver burden (mini-Zarit score, Baseline, after 4, 8 and 24 weeks)

Condition ^†

Alzheimer's Disease

Intervention ^†

Drug: Rivastigmine

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Recruiting

Enrollment ^†

200

Start Date ^†

October 2007

Completion Date

July 2008

Eligibility Criteria ^†

Inclusion Criteria:

Males, and females not of child-bearing potential (surgically sterile or at least one year postmenopausal) of at least 50 years of age;
Probable Alzheimer's disease according to the NINCDS-ADRDA (National Institute of Neurological and Communicative Diseases and Stroke/Alzheimer's Disease and Related Disorders Association) and DSMIV (Diagnostic and Statistical Manual of Mental Disorders) criteria;
MMSE (Mini Mental State Examination) score of > 10 and < 26;
Patients initiating therapy for the first time with a cholinesterase inhibitor (patients prescribed both Rivastigmine and memantine are allowed);
Patients who failed to benefit from previous cholinesterase inhibitor treatment

Exclusion Criteria:

Patients not treated according to the product monograph for Rivastigmine capsules;
patients involved in a clinical trial;
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);

Other protocol-defined exclusion criteria may apply.

Gender

Both

Ages

50 Years and older

Accepts Healthy Volunteers

Contacts ^††

Contact: Novartis

+41 61 324 1111

Location Countries ^†

Germany

Administrative Information Fields

NCT ID ^†

NCT00561392

Organization ID

CENA713DDE15

Secondary IDs ^††

Study Sponsor ^†

Novartis

Collaborators ^††

Investigators ^†

Principal Investigator:

Novartis

Information Provided By

Novartis

Verification Date

June 2008

First Received Date ^†

November 19, 2007

Last Updated Date

June 6, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.