BETTER: A 12 Week, Multicenter, Open Label Evaluation of Caregiver Preference, Safety and Tolerability of Exelon® Patch (Rivastigmine Transdermal) in Patients With Alzheimer's Disease

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT01047579

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

10.2

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is designed to evaluate caregiver preference for Exelon® patch (target patch size 10 cm²) treatment in patients with Alzheimer's disease (MMSE 10-26) who were under cholinesterase inhibitor treatment and experienced adverse event/s in a community setting.

Condition or Disease	Intervention/Treatment	Phase
Alzheimer's Disease	Drug: Rivastigmine transdermal	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

51 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

A 12 Week, Multicenter, Open Label Evaluation of Caregiver Preference, Safety and Tolerability of Exelon® Patch (Rivastigmine Transdermal) in Patients With Alzheimer's Disease

Study Start Date :

Apr 1, 2010

Actual Primary Completion Date :

Jan 1, 2012

Actual Study Completion Date :

Jan 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Other: Rivastigmine transdermal	Drug: Rivastigmine transdermal

Arm

Intervention/Treatment

Other: Rivastigmine transdermal

Drug: Rivastigmine transdermal

Outcome Measures

Primary Outcome Measures

Caregiver questionnaire [12 weeks]

Secondary Outcome Measures

Safety and Tolerability. Safety assessments include vital signs and adverse events (AEs) [every visit]

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Probable Alzheimer's disease according to the NINCDS-ADRDA and DSM-IV criteria.
MMSE score of >10 and <26.
Patients who were under ChE inhibitor treatment and experienced adverse events.
Residing with someone in the communities throughout the study or if, living alone, in contact with the responsible caregiver every day, primary caregiver willing to accept responsibility for supervising the treatment and condition of the patient.

Exclusion Criteria:

Involved in other clinical trials or treated by experimental drug within the previous 4 weeks.
Current diagnosis of an active skin lesion that would prevent accurate assessment of the adhesion and potential skin irritation of the patch.
History of allergy to topical products containing any of the constitution of the patches.
Patients with evidence of severe or unstable physical illness, i.e., acute and severe asthmatic conditions, severe or unstable cardiovascular disorders, etc.
Patients with bradycardia (bpm less than 50) or sick sinus syndrome or conduction defects (sino-atrial block, second degree A-V blocks).
Patients with body weight less than 40 kg.

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Locations

	Site	City	Country
1	Novartis Investigative Site	Ashkelon	Israel
2	Novartis Investigational Site	Haifa	Israel
3	Novartis Investigative Site	Holon	Israel
4	Novartis Investigative Site	Ramat Gan	Israel
5	Novartis Investigative Site	Tel Aviv	Israel