Randomized, Double-blind Study to Evaluate the Tolerability of 2 Different Titration Methods of Rivastigmine Patch in AD Patients (MMSE 10-20)
NCT ID: NCT01614886
Last Updated: 2016-08-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
216 participants
INTERVENTIONAL
2012-07-31
2014-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1 step
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.
3 step
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.
Interventions
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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.
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 Criteria
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Inclusion Criteria
* A clinical diagnosis of probable AD according to NINCDS/ADRDA criteria
* An MMSE score of ≥ 10 and ≤ 20 at baseline
Exclusion Criteria
* 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
50 Years
85 Years
ALL
No
Sponsors
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Ono Pharmaceutical Co. Ltd
INDUSTRY
Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Anjo, Aichi-ken, Japan
Novartis Investigative Site
Ōbu, Aichi-ken, Japan
Novartis Investigative Site
Seto, Aichi-ken, Japan
Novartis Investigative Site
Toyoake, Aichi-ken, Japan
Novartis Investigative Site
Akita, Akita, Japan
Novartis Investigative Site
Chiba, Chiba, Japan
Novartis Investigative Site
Tōon, Ehime, Japan
Novartis Investigative Site
Fukuoka, Fukuoka, Japan
Novartis Investigative Site
Fujioka, Gunma, Japan
Novartis Investigative Site
Hiroshima, Hiroshima, Japan
Novartis Investigative Site
Miyoshi, Hiroshima, Japan
Novartis Investigative Site
Kasama, Ibaraki, Japan
Novartis Investigative Site
Kamakura, Kanagawa, Japan
Novartis Investigative Site
Kawasaki, Kanagawa, Japan
Novartis Investigative Site
Kawasaki, Kanagawa, Japan
Novartis Investigative Site
Sagamihara, Kanagawa, Japan
Novartis Investigative Site
Yokohama, Kanagawa, Japan
Novartis Investigative Site
Kochi, Kochi, Japan
Novartis Investigative Site
Kochi, Kochi, Japan
Novartis Investigative Site
Kōshi, Kumamoto, Japan
Novartis Investigative Site
Kumamoto, Kumamoto, Japan
Novartis Investigative Site
Kumamoto, Kumamoto, Japan
Novartis Investigative Site
Kyoto, Kyoto, Japan
Novartis Investigative Site
Kyoto, Kyoto, Japan
Novartis Investigative Site
Kyoto, Kyoto, Japan
Novartis Investigative Site
Sendai, Miyagi, Japan
Novartis Investigative Site
Kitamorokata-gun, Miyazaki, Japan
Novartis Investigative Site
Azumino, Nagano, Japan
Novartis Investigative Site
Matsumoto, Nagano, Japan
Novartis Investigative Site
Nagaoka, Niigata, Japan
Novartis Investigative Site
Kurashiki, Okayama-ken, Japan
Novartis Investigative Site
Okayama, Okayama-ken, Japan
Novartis Investigative Site
Sakai, Osaka, Japan
Novartis Investigative Site
Suita, Osaka, Japan
Novartis Investigative Site
Suita, Osaka, Japan
Novartis Investigative Site
Kanzaki-gun, Saga-ken, Japan
Novartis Investigative Site
Kasukabe, Saitama, Japan
Novartis Investigative Site
Kawaguchi, Saitama, Japan
Novartis Investigative Site
Koshigaya, Saitama, Japan
Novartis Investigative Site
Saitama, Saitama, Japan
Novartis Investigative Site
Shizuoka, Shizuoka, Japan
Novartis Investigative Site
Shizuoka, Shizuoka, Japan
Novartis Investigative Site
Tokushima, Tokushima, Japan
Novartis Investigative Site
Bunkyo-ku, Tokyo, Japan
Novartis Investigative Site
Hachiōji, Tokyo, Japan
Novartis Investigative Site
Koto-ku, Tokyo, Japan
Novartis Investigative Site
Musashino, Tokyo, Japan
Novartis Investigative Site
Ōta-ku, Tokyo, Japan
Novartis Investigative Site
Tachikawa, Tokyo, Japan
Novartis Investigative Site
Shimonoseki, Yamaguchi, Japan
Countries
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Other Identifiers
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CENA713D1303
Identifier Type: -
Identifier Source: org_study_id
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