NCT01529619

Brief Summary

This is a multicenter study to evaluate the efficacy, safety and tolerability of Rivastigmine patch in patients with mild to moderate Alzheimer's disease switched from Cholinesterase Inhibitors.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2012

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 6, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 9, 2012

Completed
21 days until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

November 18, 2016

Status Verified

November 1, 2016

Enrollment Period

1.8 years

First QC Date

February 6, 2012

Last Update Submit

November 16, 2016

Conditions

Alzheimer's Disease

Keywords

RivastigmineAlzheimer's diseaseTransdermal patch

Outcome Measures

Primary Outcomes (1)

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

    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.

    Baseline and Week 24

Secondary Outcomes (6)

  • Adverse Events, Serious Adverse Events, Adverse event leading to discontinuation of study drug

    Week 24

  • Change From Baseline in Disability Assessment for Dementia (DAD)

    Baseline and Week 24

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

    Baseline and Week 24

  • Change From Baseline in Japanese version of the Clinical global impression of change (J-CGIC)

    Week 4, 8, 12, 16, 20, 24

  • Change From Baseline in Modified Crichton Scale

    Baseline and Week 4, 8, 12, 16, 20, 24

  • +1 more secondary outcomes

Study Arms (1)

Rivastigmine 18 mg

EXPERIMENTAL

During the 16-week titration period patients received daily rivastigmine 4.5mg patch for the first 4 weeks, rivastigmine 9mg patch for the next 4 weeks, rivastigmine 13.5mg patch for the next 4 weeks and then rivastigmine 18mg patch for the final 4 weeks. For patients who experienced intolerability, the dose was adjusted downward. Patients then entered the 8-week maintenance period during which time they continued to receive the dose of rivastigmine they were taking at the end of the titration period.

Drug: Rivastigmine transdermal patch

Interventions

Rivastigmine transdermal patchDRUG
Rivastigmine 18 mg

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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 \> or = 10 and \< or = 23
  • Continuous treatment with donepezil ≤ 5 mg/day or galantamine ≤ 24 mg/day for 4 weeks prior to baseline visit
  • Patients having difficulties being treated orally with ChE inhibitors (donepezil or galantamine) as judged by the investigator. Difficulties are defined as:
  • Inadequate compliance with the ChE inhibitors at screening and baseline
  • Presence of caregiver's burden for administering drugs orally at screening and baseline
  • Inadequate treatment (efficacious dose cannot be reached or inadequate compliance) with the ChE inhibitors because of adverse events at screening and baseline
  • Patients with swallowing difficulties at screening and baseline

You may not qualify if:

  • A current DSM-IV diagnosis of major depression
  • Taken rivastigmine in the past
  • A score of \> 5 on the Modified Hachinski Ischemic Scale (MHIS)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Novartis Investigative Site

Nagoya, Aichi-ken, 467-8602, Japan

Location

Novartis Investigative Site

Fukuoka, Fukuoka, 814-0180, Japan

Location

Novartis Investigative Site

Miyoshi, Hiroshima, 728-0013, Japan

Location

Novartis Investigative Site

Ohtake, Hiroshima, 739-0696, Japan

Location

Novartis Investigative Site

Kita-gun, Kagawa-ken, 761-0793, Japan

Location

Novartis Investigative Site

Kamakura, Kanagawa, 247-8533, Japan

Location

Novartis Investigative Site

Kawasaki, Kanagawa, 216-8511, Japan

Location

Novartis Investigative Site

Yokohama, Kanagawa, 241-0811, Japan

Location

Novartis Investigative Site

Kōshi, Kumamoto, 861-1116, Japan

Location

Novartis Investigative Site

Kyoto, Kyoto, 600-8558, Japan

Location

Novartis Investigative Site

Kyoto, Kyoto, 606-0851, Japan

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2012

First Posted

February 9, 2012

Study Start

March 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

November 18, 2016

Record last verified: 2016-11

Locations

JP(11)