Clinical trial NCT00731224: Compliance and Tolerability of Rivastigmine Transdermal Patch 10 cm² in Patients With Probable Alzheimer's Disease.
Official title: A 24-week, Multi-center, Open-label Evaluation of Compliance and Tolerability of the Once-daily 10 cm² Rivastigmine Patch Formulation in Patients With Probable Alzheimer's Disease.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Alzheimer's Disease
Keywords: Alzheimer's disease, rivastigmine, patch
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-08-08
Enrollment: 380
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate compliance, tolerability, safety, efficacy and caregiver burden of rivastigmine patch 10 cm² treatment in people with Alzheimer's disease (MMSE 10-26) initiating therapy for the first time with a cholinesterase inhibitor, and in patients who were unresponsive to previous cholinesterase inhibitor treatment in a community setting.


Eligibility criteria: Inclusion Criteria:

* Probable Alzheimer's disease according to the NINCDS-ADRDA (National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association) and DSM-IV (Diagnostic and Statistical Manual of Mental Disorders) criteria;
* MMSE score of ≥10 and ≤ 26;

Exclusion Criteria:

* Bradycardia (beats per minute less than 50)
* Body weight less than 40 kg;
* Hypersensitivity to cholinesterase inhibitors.

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Proportion of patients who can reach the target rivastigmine patch size of 10 cm2 and stay on it for at least 8 weeks.
timeFrame: At week 24
Secondary outcomes:
measure: Mini-Mental State Examination (MMSE), Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL), Global Deterioration Scale (GDS), caregiver burden (Zarit Burden Interview).
timeFrame: At baseline, wk 12 and wk 24
measure: Patient compliance (drug accounting)
timeFrame: During 24 weeks
Other outcomes:
Locations:
city: East Gosford
country: Australia
facility: Novartis Investigative Site
state: New South Wales
city: Gosford
country: Australia
facility: Novartis Investigative Site
state: New South Wales
city: Hornsby
country: Australia
facility: Novartis Investigative Site
state: New South Wales
city: Randwick
country: Australia
facility: Novartis Investigative Site
state: New South Wales
city: Chemside
country: Australia
facility: Novartis Investigative Site
state: Queensland
city: Adelaide
country: Australia
facility: Novartis Investigative Site
state: South Australia
city: Woodville
country: Australia
facility: Novartis Investigative Site
state: South Australia
city: Ballarat
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Fitzroy
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Heidelberg
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Nedlands
country: Australia
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
state: Korea
city: Bundang
country: Korea, Republic of
facility: Novartis Investigative Site
state: Seongnam
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Johor Bahru
country: Malaysia
facility: Novartis Investigative Site
state: Johor
city: Seremban
country: Malaysia
facility: Novartis Investigative Site
state: Negeri Sembilan
city: Ipoh
country: Malaysia
facility: Novartis Investigative Site
state: Perak
city: Kuala Lumpur
country: Malaysia
facility: Novartis Investigative Site
state: Selangor
city: Kuala Lumpur
country: Malaysia
facility: Novartis Investigative Site
city: Bangkok
country: Thailand
facility: Novartis Investigative Site
city: Bangkok
country: Thailand
facility: Novartis Investigative Site
city: Bangkok
country: Thailand
facility: Novartis Investigative Site
city: Altunizade
country: Turkey
facility: Novartis Investigative Site
city: Ankara
country: Turkey
facility: Novartis Investigative Site
city: Ankara
country: Turkey
facility: Novartis Investigative Site
city: Antalya
country: Turkey
facility: Novartis Investigative Site
city: Atakum / Samsun
country: Turkey
facility: Novartis Investigative Site
city: Bursa
country: Turkey
facility: Novartis Investigative Site
city: Emek / Ankara
country: Turkey
facility: Novartis Investigative Site
city: Etlik / Ankara
country: Turkey
facility: Novartis Investigative Site
city: Istanbul
country: Turkey
facility: Novartis Investigative Site
city: Istanbul
country: Turkey
facility: Novartis Investigative Site
city: Izmir
country: Turkey
facility: Novartis Investigative Site
city: Izmir
country: Turkey
facility: Novartis Investigative Site
city: Kocaeli
country: Turkey
facility: Novartis Investigative Site
city: Konya
country: Turkey
facility: Novartis Investigative Site
city: Mersin
country: Turkey
facility: Novartis Investigative Site
city: Meselik / Eskisehir
country: Turkey
facility: Novartis Investigative Site
city: Talas / Kayseri
country: Turkey
facility: Novartis Investigative Site
city: Uskudar / Istanbul
country: Turkey
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: