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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01047579

Acronym

BETTER

Enrollment

Registered

2010-01-13

Start date

2010-04-30

Completion date

2012-01-31

Last updated

2017-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease

Keywords

Alzheimer's Disease, Rivastigmine transdermal, caregiver preference

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.

Interventions

DRUGRivastigmine transdermal

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

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/

Design outcomes

Primary

Measure	Time frame
Caregiver questionnaire	12 weeks

Secondary

Measure	Time frame
Safety and Tolerability. Safety assessments include vital signs and adverse events (AEs)	every visit

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026