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Evaluation of Efficacy and Safety of Galantamine in Patients With Dementia of Alzheimer's Type Who Failed to Benefit From Donepezil

Primary Purpose

Alzheimer's Disease

Status
Completed
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
Galantamine
Sponsored by
Janssen Pharmaceutical K.K.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring Alzheimer's disease, Dementia, Galantamine, Donepezil

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Have diagnosis of probable Alzheimer's disease (AD) in accordance with the diagnostic criteria of NINCDS-ADRDA study group
  • Have an MMSE score of 10 to 22 inclusive at screening
  • Have taken donepezil stably at 5 mg/day for more than 6 months before screening
  • Have progression (worsening) of impaired cognitive function 6 months or longer before screening
  • Be considered medically stable by the investigator on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening
  • Be medically stable on the basis of clinical laboratory tests performed at screening

Exclusion Criteria:

  • Has any concurrent neurodegenerative diseases manifesting dementia other than Dementia of Alzheimer's type
  • Has suspected impaired cognitive function due to a variety of causes
  • Has significant health disorders or diseases according to the investigators' detailed criteria
  • Has had major surgery within 52 weeks of screening, or will not have fully recovered from surgery, or planned surgery during the time the subject is expected to participate in the study
  • Is a woman who is pregnant, or breast-feeding, or planning to become pregnant or is a man who plans to father a child while enrolled in this study
  • Has a history of severe drug allergy or severe drug hypersensitivity
  • Has a history of drug or alcohol abuse
  • Used another investigational drug within 90 days of screening
  • Used anti-dementia drugs marketed or being developed other than donepezil or medications containing the same active ingredients within 6 months of screening
  • Is considered as ineligible by the investigator

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Galantamine

Arm Description

Outcomes

Primary Outcome Measures

The Change from Baseline in Alzheimer's Disease Assessment Scale - Japan cognitive subscale (ADAS-J cog) Score at Week 24
The ADAS-J cog scale assesses memory, language and behavior and is composed of 11 tasks: word recall, spoken language ability, auditory comprehension, word finding difficulty in spontaneous speech, following commands, object and finger naming, constructional praxis, ideational praxis, orientation, word recognition, and recalling test instructions. The perfect total score is 70 points, and as the score becomes higher, the degree of impairment becomes severer.

Secondary Outcome Measures

The Clinical Global Impression of Change (CGI-C) at Week 24
CGI-C is employed to evaluate the patient's global clinical improvement according to the rater's impression from 1 (Very much improved) to 7 (Very much worse).
Proportion of Responders at Week 24
Proportion of responders whose ADAS-J cog score at endpoint decreased from baseline.

Full Information

First Posted
November 3, 2011
Last Updated
March 24, 2014
Sponsor
Janssen Pharmaceutical K.K.
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1. Study Identification

Unique Protocol Identification Number
NCT01478633
Brief Title
Evaluation of Efficacy and Safety of Galantamine in Patients With Dementia of Alzheimer's Type Who Failed to Benefit From Donepezil
Official Title
Evaluation of Efficacy and Safety of Galantamine in Subjects With Dementia of Alzheimer's Type Who Failed to Benefit From Donepezil
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Pharmaceutical K.K.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficacy and safety of galantamine in patients who failed to benefit from donepezil (patients switching from donepezil). In clinical practice, it is expected that galantamine will be used in patients switching from donepezil due to the insufficient efficacy of donepezil.
Detailed Description
This is a nonrandomized (study drug is intentionally assigned), open-label (all people involved know the identity of the intervention), single-arm (one group of patients receiving the same treatment), multi-centered study of galantamine in patients with Alzheimer's disease (AD). Galantamine has been approved for treatment of mild to moderate dementia of AD. Galantamine is available as film-coated tablet in 68 countries including the United States and Europe, and is also available as oral syrup and extended-release capsule in 65 counties. In Japan, galantamine was approved in January 2011 and is available in three dosage forms of film-coated tablet, oral disintegrant tablet, and oral syrup. The target population is patients with mild to moderate dementia of Alzheimer's type (ie, Mini-Mental State Examination [MMSE] ranging from 10 to 22) who failed to benefit from donepezil. Patients must have diagnosis of probable AD according to the diagnostic criteria National Institute of Neurological and Communicative Diseases and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) study group. To ensure that at least 100 subjects complete the study, 125 subjects will be enrolled. The treatment group is to receive flexible dosing of 16 mg/day or 24 mg/day. Patients will receive the study treatment for 24 weeks in accordance with the dosing regimen specified in the protocol.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
Alzheimer's disease, Dementia, Galantamine, Donepezil

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
102 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Galantamine
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Galantamine
Intervention Description
8 mg/day (4 mg twice daily) for 4 weeks, followed by 16 mg/day (8 mg twice daily) for an additional 4 weeks, followed by dose at 16 mg or increased to 24 mg (with the option of decreasing back to 16 mg) for the remainder of the study (to week 24)
Primary Outcome Measure Information:
Title
The Change from Baseline in Alzheimer's Disease Assessment Scale - Japan cognitive subscale (ADAS-J cog) Score at Week 24
Description
The ADAS-J cog scale assesses memory, language and behavior and is composed of 11 tasks: word recall, spoken language ability, auditory comprehension, word finding difficulty in spontaneous speech, following commands, object and finger naming, constructional praxis, ideational praxis, orientation, word recognition, and recalling test instructions. The perfect total score is 70 points, and as the score becomes higher, the degree of impairment becomes severer.
Time Frame
at Week 24
Secondary Outcome Measure Information:
Title
The Clinical Global Impression of Change (CGI-C) at Week 24
Description
CGI-C is employed to evaluate the patient's global clinical improvement according to the rater's impression from 1 (Very much improved) to 7 (Very much worse).
Time Frame
at Week 24
Title
Proportion of Responders at Week 24
Description
Proportion of responders whose ADAS-J cog score at endpoint decreased from baseline.
Time Frame
at Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Have diagnosis of probable Alzheimer's disease (AD) in accordance with the diagnostic criteria of NINCDS-ADRDA study group Have an MMSE score of 10 to 22 inclusive at screening Have taken donepezil stably at 5 mg/day for more than 6 months before screening Have progression (worsening) of impaired cognitive function 6 months or longer before screening Be considered medically stable by the investigator on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening Be medically stable on the basis of clinical laboratory tests performed at screening Exclusion Criteria: Has any concurrent neurodegenerative diseases manifesting dementia other than Dementia of Alzheimer's type Has suspected impaired cognitive function due to a variety of causes Has significant health disorders or diseases according to the investigators' detailed criteria Has had major surgery within 52 weeks of screening, or will not have fully recovered from surgery, or planned surgery during the time the subject is expected to participate in the study Is a woman who is pregnant, or breast-feeding, or planning to become pregnant or is a man who plans to father a child while enrolled in this study Has a history of severe drug allergy or severe drug hypersensitivity Has a history of drug or alcohol abuse Used another investigational drug within 90 days of screening Used anti-dementia drugs marketed or being developed other than donepezil or medications containing the same active ingredients within 6 months of screening Is considered as ineligible by the investigator
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Pharmaceutical K. K., Japan Clinical Trial
Organizational Affiliation
Janssen Pharmaceutical K.K.
Official's Role
Study Director
Facility Information:
City
Akita
Country
Japan
City
Izunokuni
Country
Japan
City
Kochi N/A
Country
Japan
City
Kumamoto
Country
Japan
City
Osaka
Country
Japan
City
Saitama N/A
Country
Japan
City
Takatsuki
Country
Japan
City
Tokyo
Country
Japan
City
Uji
Country
Japan
City
Urayasu
Country
Japan
City
Yokohama
Country
Japan

12. IPD Sharing Statement

Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=3298&filename=JNS023-JPN-02_CSR.pdf
Description
Evaluation of Efficacy and Safety of Galantamine in Patients With Dementia of Alzheimer's Type Who Failed to Benefit From Donepezil

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Evaluation of Efficacy and Safety of Galantamine in Patients With Dementia of Alzheimer's Type Who Failed to Benefit From Donepezil

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