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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00731224




Registration number
NCT00731224
Ethics application status
Date submitted
5/08/2008
Date registered
8/08/2008
Date last updated
28/03/2017

Titles & IDs
Public title
Compliance and Tolerability of Rivastigmine Transdermal Patch 10 cm² in Patients With Probable Alzheimer's Disease.
Scientific 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.
Secondary ID [1] 0 0
CENA713DAU01
Universal Trial Number (UTN)
Trial acronym
CARE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer's Disease 0 0
Condition category
Condition code
Neurological 0 0 0 0
Alzheimer's disease
Neurological 0 0 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Rivastigmine transdermal patch

Experimental: 1 -


Treatment: Drugs: Rivastigmine transdermal patch
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of patients who can reach the target rivastigmine patch size of 10 cm2 and stay on it for at least 8 weeks.
Timepoint [1] 0 0
At week 24
Secondary outcome [1] 0 0
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).
Timepoint [1] 0 0
At baseline, wk 12 and wk 24
Secondary outcome [2] 0 0
Patient compliance (drug accounting)
Timepoint [2] 0 0
During 24 weeks

Eligibility
Key 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;
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2011
Sample size
Target
Accrual to date
Final
380
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - East Gosford
Recruitment hospital [2] 0 0
Novartis Investigative Site - Gosford
Recruitment hospital [3] 0 0
Novartis Investigative Site - Hornsby
Recruitment hospital [4] 0 0
Novartis Investigative Site - Randwick
Recruitment hospital [5] 0 0
Novartis Investigative Site - Chemside
Recruitment hospital [6] 0 0
Novartis Investigative Site - Adelaide
Recruitment hospital [7] 0 0
Novartis Investigative Site - Woodville
Recruitment hospital [8] 0 0
Novartis Investigative Site - Ballarat
Recruitment hospital [9] 0 0
Novartis Investigative Site - Fitzroy
Recruitment hospital [10] 0 0
Novartis Investigative Site - Heidelberg
Recruitment hospital [11] 0 0
Novartis Investigative Site - Nedlands
Recruitment postcode(s) [1] 0 0
2250 - East Gosford
Recruitment postcode(s) [2] 0 0
2250 - Gosford
Recruitment postcode(s) [3] 0 0
2077 - Hornsby
Recruitment postcode(s) [4] 0 0
2031 - Randwick
Recruitment postcode(s) [5] 0 0
4032 - Chemside
Recruitment postcode(s) [6] 0 0
5000 - Adelaide
Recruitment postcode(s) [7] 0 0
5011 - Woodville
Recruitment postcode(s) [8] 0 0
3353 - Ballarat
Recruitment postcode(s) [9] 0 0
3065 - Fitzroy
Recruitment postcode(s) [10] 0 0
3081 - Heidelberg
Recruitment postcode(s) [11] 0 0
WA 6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
Korea, Republic of
State/province [1] 0 0
Korea
Country [2] 0 0
Korea, Republic of
State/province [2] 0 0
Seongnam
Country [3] 0 0
Korea, Republic of
State/province [3] 0 0
Seoul
Country [4] 0 0
Malaysia
State/province [4] 0 0
Johor
Country [5] 0 0
Malaysia
State/province [5] 0 0
Negeri Sembilan
Country [6] 0 0
Malaysia
State/province [6] 0 0
Perak
Country [7] 0 0
Malaysia
State/province [7] 0 0
Selangor
Country [8] 0 0
Malaysia
State/province [8] 0 0
Kuala Lumpur
Country [9] 0 0
Thailand
State/province [9] 0 0
Bangkok
Country [10] 0 0
Turkey
State/province [10] 0 0
Altunizade
Country [11] 0 0
Turkey
State/province [11] 0 0
Ankara
Country [12] 0 0
Turkey
State/province [12] 0 0
Antalya
Country [13] 0 0
Turkey
State/province [13] 0 0
Atakum / Samsun
Country [14] 0 0
Turkey
State/province [14] 0 0
Bursa
Country [15] 0 0
Turkey
State/province [15] 0 0
Emek / Ankara
Country [16] 0 0
Turkey
State/province [16] 0 0
Etlik / Ankara
Country [17] 0 0
Turkey
State/province [17] 0 0
Istanbul
Country [18] 0 0
Turkey
State/province [18] 0 0
Izmir
Country [19] 0 0
Turkey
State/province [19] 0 0
Kocaeli
Country [20] 0 0
Turkey
State/province [20] 0 0
Konya
Country [21] 0 0
Turkey
State/province [21] 0 0
Mersin
Country [22] 0 0
Turkey
State/province [22] 0 0
Meselik / Eskisehir
Country [23] 0 0
Turkey
State/province [23] 0 0
Talas / Kayseri
Country [24] 0 0
Turkey
State/province [24] 0 0
Uskudar / Istanbul

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00731224
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00731224