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

NCT01614886 | Completed Phase 3 Results

• 1 other identifier: CENA713D1303
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 50

Brief Summary

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

Conditions

Alzheimer's Disease

Keywords

Rivastigmine, Alzheimer's disease, Transdermal patch

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients With Adverse Events Leading to Study Drug Discontinuation

  The primary variable of this study is the percentage of patients having an AE leading to study drug discontinuation during the 24-week double-blind treatment period.

  Up to 24 weeks

Secondary Outcomes (4)

• Change From Baseline in the Alzheimer's Disease Assessment Scale - Japan Cognitive Subscale (ADAS-J Cog)

  Baseline, 8,16, and 24 weeks

• Change From Baseline in Mini-Mental State Examination (MMSE)

  Baseline and 24 weeks

• 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

  4, 8, 12,16, 20 and 24 weeks

• The Percentage of Treatment Retention.

  Up to 24 weeks

Study Arms (2)

1 step

EXPERIMENTAL

Drug: Active Comparator

3 step

ACTIVE COMPARATOR

Drug: ENA713

Interventions

Active Comparator DRUG

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.

1 step

ENA713 DRUG

-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.

3 step

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead
• Ono Pharmaceutical Co. Ltd: collaborator

Study Sites (50)

Novartis Investigative Site

Anjo, Aichi-ken, 446-8510, Japan

Location

Novartis Investigative Site

Ōbu, Aichi-ken, 474-8511, Japan

Location

Novartis Investigative Site

Seto, Aichi-ken, 489-8642, Japan

Location

Novartis Investigative Site

Toyoake, Aichi-ken, 470-1168, Japan

Location

Novartis Investigative Site

Akita, Akita, 010-0874, Japan

Location

Novartis Investigative Site

Chiba, Chiba, 260-8712, Japan

Location

Novartis Investigative Site

Tōon, Ehime, 791-0295, Japan

Location

Novartis Investigative Site

Fukuoka, Fukuoka, 814-0180, Japan

Location

Novartis Investigative Site

Fujioka, Gunma, 375-0017, Japan

Location

Novartis Investigative Site

Hiroshima, Hiroshima, 734-8530, Japan

Location

Novartis Investigative Site

Miyoshi, Hiroshima, 728-0013, Japan

Location

Novartis Investigative Site

Kasama, Ibaraki, 309-1793, Japan

Location

Novartis Investigative Site

Kamakura, Kanagawa, 247-8533, Japan

Location

Novartis Investigative Site

Kawasaki, Kanagawa, 212-0016, Japan

Location

Novartis Investigative Site

Kawasaki, Kanagawa, 216-8511, Japan

Location

Novartis Investigative Site

Sagamihara, Kanagawa, 252-5188, Japan

Location

Novartis Investigative Site

Yokohama, Kanagawa, 241-0811, Japan

Location

Novartis Investigative Site

Kochi, Kochi, 780-0842, Japan

Location

Novartis Investigative Site

Kochi, Kochi, 780-8037, Japan

Location

Novartis Investigative Site

Kōshi, Kumamoto, 861-1116, Japan

Location

Novartis Investigative Site

Kumamoto, Kumamoto, 860-8556, Japan

Location

Novartis Investigative Site

Kumamoto, Kumamoto, 861-8002, Japan

Location

Novartis Investigative Site

Kyoto, Kyoto, 600-8558, Japan

Location

Novartis Investigative Site

Kyoto, Kyoto, 607-8411, Japan

Location

Novartis Investigative Site

Kyoto, Kyoto, 616-8255, Japan

Location

Novartis Investigative Site

Sendai, Miyagi, 982-8523, Japan

Location

Novartis Investigative Site

Kitamorokata-gun, Miyazaki, 889-1911, Japan

Location

Novartis Investigative Site

Azumino, Nagano, 399-8204, Japan

Location

Novartis Investigative Site

Matsumoto, Nagano, 399-8701, Japan

Location

Novartis Investigative Site

Nagaoka, Niigata, 940-2302, Japan

Location

Novartis Investigative Site

Kurashiki, Okayama-ken, 710-0826, Japan

Location

Novartis Investigative Site

Okayama, Okayama-ken, 700-8607, Japan

Location

Novartis Investigative Site

Sakai, Osaka, 590-0018, Japan

Location

Novartis Investigative Site

Suita, Osaka, 565-0871, Japan

Location

Novartis Investigative Site

Suita, Osaka, 565-0874, Japan

Location

Novartis Investigative Site

Kanzaki-gun, Saga-ken, 842-0192, Japan

Location

Novartis Investigative Site

Kasukabe, Saitama, 344-0036, Japan

Location

Novartis Investigative Site

Kawaguchi, Saitama, 333-0832, Japan

Location

Novartis Investigative Site

Koshigaya, Saitama, 343-0032, Japan

Location

Novartis Investigative Site

Saitama, Saitama, 338-0003, Japan

Location

Novartis Investigative Site

Shizuoka, Shizuoka, 420-8688, Japan

Location

Novartis Investigative Site

Shizuoka, Shizuoka, 424-8636, Japan

Location

Novartis Investigative Site

Tokushima, Tokushima, 770-8503, Japan

Location

Novartis Investigative Site

Bunkyo-ku, Tokyo, 113-8603, Japan

Location

Novartis Investigative Site

Hachiōji, Tokyo, 193-0998, Japan

Location

Novartis Investigative Site

Koto-ku, Tokyo, 136-0075, Japan

Location

Novartis Investigative Site

Musashino, Tokyo, 180-8610, Japan

Location

Novartis Investigative Site

Ōta-ku, Tokyo, 143-0016, Japan

Location

Novartis Investigative Site

Tachikawa, Tokyo, 190-8531, Japan

Location

Novartis Investigative Site

Shimonoseki, Yamaguchi, 752-8510, Japan

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Rivastigmine

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenylcarbamates; Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2012
• First Posted: June 8, 2012
• Study Start: July 1, 2012
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: August 1, 2016
• Results First Posted: May 12, 2015

Record last verified: 2015-06

Locations

JP (50)