Randomized, Double-blind Study to Evaluate the Tolerability of 2 Different Titration Methods of Rivastigmine Patch in AD Patients (MMSE 10-20)

This study has been completed.
Sponsor:
Collaborator:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01614886
First received: June 6, 2012
Last updated: May 21, 2014
Last verified: May 2014

June 6, 2012
May 21, 2014
July 2012
May 2014   (final data collection date for primary outcome measure)
The percentage of patients with adverse events leading to discontinuation [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: Yes ]
Adverse Events: An adverse event is the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug.
Same as current
Complete list of historical versions of study NCT01614886 on ClinicalTrials.gov Archive Site
  • Change From Baseline in ADAS-J cog [ Time Frame: Baseline, 8,16, and 24 weeks ] [ Designated as safety issue: No ]
    The Alzheimer's Disease Assessment Scale - Japan cognitive subscale (ADAS-J cog) was used to measure change in cognitive function. The ADAS-J cog score ranges from 0-70, with higher total scores indicating more impairment. A negative change score indicates improvement from baseline.
  • Change From Baseline in MMSE [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]
    The MMSE is a screening test for cognitive dysfunction. The test consists of five sections (orientation, registration, attention-calculation, recall, and language); the total score can range from 0 to 30, with a higher score indicating better function. A positive change score indicates improvement from baseline.
  • Change From Baseline in J-CGIC [ Time Frame: 4, 8, 12,16, 20 and 24 weeks ] [ Designated as safety issue: No ]
    The J-CGIC is simple 7 grade investigator's impression scale (1. Markedly improved, 2. Improved, 3. Slightly improved, 4. No change, 5. Slightly aggravated, 6. Aggravated, 7. Markedly aggravated).
  • The percentage of patients who complete study [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: Yes ]
    Study Completion is defined as follow -To be received rivastigmine patch 18 mg/day in the last 8 weeks -Not to decrease the dose during the last 8 weeks -To comply with drug application ≥75% during the last 8 weeks
Same as current
Not Provided
Not Provided
 
Randomized, Double-blind Study to Evaluate the Tolerability of 2 Different Titration Methods of Rivastigmine Patch in AD Patients (MMSE 10-20)
A 24-week, Multicenter, Parallel-group, Randomized,Double-blind Study to Evaluate the Tolerability, Safety and Efficacy of 2 Different Titration Methods of Rivastigmine Patch (ENA713D/ONO-2540) in Patients With Mild to Moderate Alzheimer's Disease (MMSE 10-20)

To evaluate the tolerability, safety and efficacy of 3-step titration versus 1-step titration of Rivastigmine patch in the Japanese population.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Alzheimer's Disease
  • Drug: Active Comparator
    1-step titration group begin treatment with a rivastigmine patch 9 mg/day for 4 weeks, followed by a dose increase to 18 mg/day.
  • Drug: ENA713
    -3-step titration group will begin treatment with a rivastigmine patch 4.5 mg/day for 4 weeks, followed by a further dose increase of 4.5 mg/day at 4-week intervals up to the maintenance dose of 18 mg/day.
  • Experimental: 1 step
    Intervention: Drug: Active Comparator
  • Active Comparator: 3 step
    Intervention: Drug: ENA713
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
101
May 2014
May 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • A diagnosis of dementia of the Alzheimer's type according to the DSM-IV criteria
  • A clinical diagnosis of probable AD according to NINCDS/ADRDA criteria
  • An MMSE score of ≥ 10 and ≤ 20 at baseline

Exclusion Criteria:

  • Any medical or neurological conditions other than AD that could explain the patient's dementia
  • A current diagnosis of probable or possible vascular dementia
  • A score of > 5 on the Modified Hachinski Ischemic Scale (MHIS)
  • A current DSM-IV Axis 1 diagnosis that may interfere with the evaluation of the patient's response to study medication.
  • Treated with donepezil or galantamine within last 4 weeks before the efficacy assessment at baseline.
  • an advanced severe progressive or unstable disease of any type that may interfere with efficacy and safety assessments or put the patient's at special risk
  • Other protocol-defined inclusion/exclusion criteria may apply.
Both
50 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01614886
CENA713D1303
No
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Ono Pharmaceutical Co. Ltd
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
May 2014

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