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

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:

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease

Drug Information available for: Rivastigmine Rivastigmine tartrate

U.S. FDA Resources

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

Estimated Enrollment:	200
Study Start Date:	July 2012
Estimated Study Completion Date:	July 2014
Estimated Primary Completion Date:	July 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

Contacts

Contact: Novartis Novartis Pharmaceuticals, +81-3-3797-8748

+81 3 3797 8748

Locations

Japan
Novartis Investigative Site	Recruiting
Anjo-city, Aichi, Japan, 446-8510
Novartis Investigative Site	Recruiting
Toon-city, Ehime, Japan, 791-0295
Novartis Investigative Site	Recruiting
Fukui-city, Fukui, Japan, 910-3623
Novartis Investigative Site	Recruiting
Fukuoka-city, Fukuoka, Japan, 814-0180
Novartis Investigative Site	Recruiting
Miyoshi-city, Hiroshima, Japan, 728-0013
Novartis Investigative Site	Recruiting
Sapporo-city, Hokkaido, Japan, 060-8543
Novartis Investigative Site	Recruiting
Kamakura-city, Kanagawa, Japan, 247-8533
Novartis Investigative Site	Recruiting
Kawasaki-city, Kanagawa, Japan, 216-8511
Novartis Investigative Site	Not yet recruiting
Sagamihara-city, Kanagawa, Japan, 252-5188
Novartis Investigative Site	Not yet recruiting
Yokohama, Kanagawa, Japan, 241-0811
Novartis Investigative Site	Not yet recruiting
Kochi-city, Kochi, Japan, 780-0842
Novartis Investigative Site	Recruiting
Koshi-city, Kumamoto, Japan, 861-1116
Novartis Investigative Site	Recruiting
Kumamoto City, Kumamoto, Japan, 860-0811
Novartis Investigative Site	Recruiting
Kyoto-city, Kyoto, Japan, 600-8558
Novartis Investigative Site	Not yet recruiting
Sendai-city, Miyagi, Japan, 982-8523
Novartis Investigative Site	Recruiting
Kitamorokata-gun, Miyazaki, Japan, 889-1911
Novartis Investigative Site	Recruiting
Azumino-city, Nagano, Japan, 399-8204
Novartis Investigative Site	Recruiting
Suita-city, Osaka, Japan, 565-0874
Novartis Investigative Site	Recruiting
Suita-city, Osaka, Japan, 565-0871
Novartis Investigative Site	Recruiting
Kasukabe-city, Saitama, Japan, 344-0036
Novartis Investigative Site	Not yet recruiting
Kawaguchi-city, Saitama, Japan, 333-0832
Novartis Investigative Site	Recruiting
Koshigaya-city, Saitama, Japan, 343-0032
Novartis Investigative Site	Recruiting
Hachioji-city, Tokyo, Japan, 193-0998
Novartis Investigative Site	Recruiting
Musashino-city, Tokyo, Japan, 180-8610

Sponsors and Collaborators

Novartis Pharmaceuticals

Ono Pharmaceutical Co. Ltd

Investigators

Study Director:

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:	February 7, 2013
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 May 23, 2013