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

This study is ongoing, but not recruiting participants.
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: January 28, 2014
Last verified: January 2014
  Purpose

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


Condition Intervention Phase
Alzheimer's Disease
Drug: Active Comparator
Drug: ENA713
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 101
Study Start Date: July 2012
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 step 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.
Active Comparator: 3 step 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.

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01614886

Locations
Japan
Novartis Investigative Site
Anjo-city, Aichi, Japan, 446-8510
Novartis Investigative Site
Toon-city, Ehime, Japan, 791-0295
Novartis Investigative Site
Fukuoka-city, Fukuoka, Japan, 814-0180
Novartis Investigative Site
Miyoshi-city, Hiroshima, Japan, 728-0013
Novartis Investigative Site
Kamakura-city, Kanagawa, Japan, 247-8533
Novartis Investigative Site
Kawasaki-city, Kanagawa, Japan, 216-8511
Novartis Investigative Site
Sagamihara-city, Kanagawa, Japan, 252-5188
Novartis Investigative Site
Yokohama, Kanagawa, Japan, 241-0811
Novartis Investigative Site
Kochi-city, Kochi, Japan, 780-0842
Novartis Investigative Site
Koshi-city, Kumamoto, Japan, 861-1116
Novartis Investigative Site
Kumamoto City, Kumamoto, Japan, 860-8556
Novartis Investigative Site
Kyoto-city, Kyoto, Japan, 600-8558
Novartis Investigative Site
Sendai-city, Miyagi, Japan, 982-8523
Novartis Investigative Site
Kitamorokata-gun, Miyazaki, Japan, 889-1911
Novartis Investigative Site
Azumino-city, Nagano, Japan, 399-8204
Novartis Investigative Site
Kurashiki-city, Okayama, Japan, 710-0826
Novartis Investigative Site
Suita-city, Osaka, Japan, 565-0874
Novartis Investigative Site
Suita-city, Osaka, Japan, 565-0871
Novartis Investigative Site
Kanzaki-gun, Saga, Japan, 842-0192
Novartis Investigative Site
Kasukabe-city, Saitama, Japan, 344-0036
Novartis Investigative Site
Kawaguchi-city, Saitama, Japan, 333-0832
Novartis Investigative Site
Koshigaya-city, Saitama, Japan, 343-0032
Novartis Investigative Site
Hachioji-city, Tokyo, Japan, 193-0998
Novartis Investigative Site
Musashino-city, Tokyo, Japan, 180-8610
Novartis Investigative Site
Tachikawa-city, Tokyo, Japan, 190-8531
Sponsors and Collaborators
Novartis Pharmaceuticals
Ono Pharmaceutical Co. Ltd
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01614886     History of Changes
Other Study ID Numbers: CENA713D1303
Study First Received: June 6, 2012
Last Updated: January 28, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency (PMDA)

Keywords provided by Novartis:
Rivastigmine, Alzheimer's disease, Transdermal patch

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Rivastigmine
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuroprotective Agents
Protective Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 15, 2014