Clinical trial NCT01614886: Randomized, Double-blind Study to Evaluate the Tolerability of 2 Different Titration Methods of Rivastigmine Patch in AD Patients (MMSE 10-20)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Alzheimer's Disease
Keywords: Rivastigmine, Alzheimer's disease, Transdermal patch
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: Ono Pharmaceutical Co. Ltd
First posted: 2012-06-08
Enrollment: 216
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Percentage of Patients With Adverse Events Leading to Study Drug Discontinuation
timeFrame: Up to 24 weeks
Secondary outcomes:
measure: Change From Baseline in the Alzheimer's Disease Assessment Scale - Japan Cognitive Subscale (ADAS-J Cog)
timeFrame: Baseline, 8,16, and 24 weeks
measure: Change From Baseline in Mini-Mental State Examination (MMSE)
timeFrame: Baseline and 24 weeks
measure: Number of Participants With Improvement in Japanese Clinical Global Impression of Change (J-CGIC). Patients With "Improvement": a Total of 1. Markedly Improved, 2. Improved, and 3. Slightly
timeFrame: 4, 8, 12,16, 20 and 24 weeks
measure: The Percentage of Treatment Retention.
timeFrame: Up to 24 weeks
Other outcomes:
Locations:
city: Anjo-city
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Obu-city
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Seto-city
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Toyoake-city
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Akita-city
country: Japan
facility: Novartis Investigative Site
state: Akita
city: Chiba-city
country: Japan
facility: Novartis Investigative Site
state: Chiba
city: Toon-city
country: Japan
facility: Novartis Investigative Site
state: Ehime
city: Fukuoka-city
country: Japan
facility: Novartis Investigative Site
state: Fukuoka
city: Fujioka-city
country: Japan
facility: Novartis Investigative Site
state: Gumma
city: Hiroshima-city
country: Japan
facility: Novartis Investigative Site
state: Hiroshima
city: Miyoshi-city
country: Japan
facility: Novartis Investigative Site
state: Hiroshima
city: Kasama-city
country: Japan
facility: Novartis Investigative Site
state: Ibaraki
city: Kamakura-city
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Kawasaki-city
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Kawasaki-city
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Sagamihara-city
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Yokohama
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Kochi-city
country: Japan
facility: Novartis Investigative Site
state: Kochi
city: Kochi-city
country: Japan
facility: Novartis Investigative Site
state: Kochi
city: Koshi-city
country: Japan
facility: Novartis Investigative Site
state: Kumamoto
city: Kumamoto City
country: Japan
facility: Novartis Investigative Site
state: Kumamoto
city: Kumamoto-city
country: Japan
facility: Novartis Investigative Site
state: Kumamoto
city: Kyoto-city
country: Japan
facility: Novartis Investigative Site
state: Kyoto
city: Kyoto-city
country: Japan
facility: Novartis Investigative Site
state: Kyoto
city: Kyoto-city
country: Japan
facility: Novartis Investigative Site
state: Kyoto
city: Sendai-city
country: Japan
facility: Novartis Investigative Site
state: Miyagi
city: Kitamorokata-gun
country: Japan
facility: Novartis Investigative Site
state: Miyazaki
city: Azumino-city
country: Japan
facility: Novartis Investigative Site
state: Nagano
city: Matsumoto-city
country: Japan
facility: Novartis Investigative Site
state: Nagano
city: Nagaoka-city
country: Japan
facility: Novartis Investigative Site
state: Niigata
city: Kurashiki-city
country: Japan
facility: Novartis Investigative Site
state: Okayama
city: Okayama-city
country: Japan
facility: Novartis Investigative Site
state: Okayama
city: Sakai-city
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Suita-city
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Suita-city
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Kanzaki-gun
country: Japan
facility: Novartis Investigative Site
state: Saga
city: Kasukabe-city
country: Japan
facility: Novartis Investigative Site
state: Saitama
city: Kawaguchi-city
country: Japan
facility: Novartis Investigative Site
state: Saitama
city: Koshigaya-city
country: Japan
facility: Novartis Investigative Site
state: Saitama
city: Saitama-city
country: Japan
facility: Novartis Investigative Site
state: Saitama
city: Shizuoka-city
country: Japan
facility: Novartis Investigative Site
state: Shizuoka
city: Shizuoka-city
country: Japan
facility: Novartis Investigative Site
state: Shizuoka
city: Tokushima-city
country: Japan
facility: Novartis Investigative Site
state: Tokushima
city: Bunkyo-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Hachioji-city
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Koto-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Musashino-city
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Ota-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Tachikawa-city
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Shimonoseki-city
country: Japan
facility: Novartis Investigative Site
state: Yamaguchi
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: