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Clinical Effectiveness of 10 cm2 Rivastigmine Patch in Patients With Alzheimer's Disease (ADEPT)
This study is ongoing, but not recruiting participants.
Study NCT00561392   Information provided by Novartis
First Received: November 19, 2007   Last Updated: November 20, 2008   History of Changes

November 19, 2007
November 20, 2008
October 2007
October 2008   (final data collection date for primary outcome measure)
Percentage of patients who can reach Rivastigmine target patch size 10 cm² (and stay on it for at least 8 weeks). [ Time Frame: after 24 weeks ] [ Designated as safety issue: No ]
Percentage of patients who can reach Rivastigmine target patch size 10 cm² (and stay on it for at least 8 weeks).
Complete list of historical versions of study NCT00561392 on ClinicalTrials.gov Archive Site
  • Cognitive and global outcome of the patients: Mini-Mental-State-Examination [ Time Frame: Screening, after 4, 8 and 24 weeks ] [ Designated as safety issue: No ]
  • Clinical Global Impression of Change [ Time Frame: after 4, 8 and 24 weeks ] [ Designated as safety issue: No ]
  • Trail Making Test A [ Time Frame: Baseline, after 4, 8 and 24 weeks ] [ Designated as safety issue: No ]
  • Activities of Daily living [ Time Frame: Baseline, after 4, 8 and 24 weeks ] [ Designated as safety issue: No ]
  • Safety/tolerability data (AEs and SAEs) [ Time Frame: Throughout the trial ] [ Designated as safety issue: Yes ]
  • Patient compliance with the patch (drug accounting) [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
  • Caregiver preference and satisfaction with the patch [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Caregiver burden (mini-Zarit score) [ Time Frame: Baseline, after 4, 8 and 24 weeks ] [ Designated as safety issue: No ]
  • 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)
 
Clinical Effectiveness of 10 cm2 Rivastigmine Patch in Patients With Alzheimer's Disease
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)

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.

 
Phase IV
Interventional
Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Alzheimer's Disease
Drug: Rivastigmine
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
200
 
October 2008   (final data collection date for primary outcome measure)

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.

Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00561392
External Affairs, Novartis
CENA713DDE15
Novartis
 
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP