A Randomized, Double-blind, Flexible Dose, Multicenter Study to Evaluate the Effectiveness and Safety of Galantamine IR in Mild to Moderate Alzheimer's Disease
Primary Purpose
Alzheimer Disease
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Galantamine HBr
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer Disease focused on measuring Alzheimer Disease, galantamine
Eligibility Criteria
Inclusion Criteria:
- Out-patients diagnosed with mild to moderate probable AD. The diagnosis should have been established in accordance with the classification for probable AD of NINCDS-ADRDA
- MMSE score of 10-24 (inclusive) at screening
- Patients who lived with or had regular daily visits from a responsible caregiver
- .Has signed the informed consent form by subject and assent form by care-giver
Exclusion Criteria:
- Patients with neurodegenerative disorders such as Parkinson's disease
- Patients with some conditions possibly resulting in cognitive impairment, e.g. acute cerebral trauma, infection
- Has evidence of multi-infarct dementia or clinically active cerebrovascular disease.
Sites / Locations
Outcomes
Primary Outcome Measures
Primary endpoint (ADAS-cog/11) decreased 5.4 ± 6.4 and 4 .0 ± 7.3 in galantamine and Donepezil group respectively after 16-week treatment from baseline of 22.5 ± 9.3 and 23.3 ± 9.7 respectively, showing the non-inferiority in term of efficacy.
Secondary Outcome Measures
Secondary endpoint is responder rate. It showed 78% responder rate in galantamine group and 58% responder rate in Donepezil group after 16 weeks.
Full Information
NCT ID
NCT00645190
First Posted
March 24, 2008
Last Updated
May 18, 2011
Sponsor
Xian-Janssen Pharmaceutical Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT00645190
Brief Title
A Randomized, Double-blind, Flexible Dose, Multicenter Study to Evaluate the Effectiveness and Safety of Galantamine IR in Mild to Moderate Alzheimer's Disease
Official Title
A Randomized, Double Blind, Active Control, Flexible Dose, Multicenter Study to Evaluate Galantamine HBr in the Treatment of Alzheimer's Disease:Safety and Effectiveness of an Immediate-release Table Formulation.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Xian-Janssen Pharmaceutical Ltd.
4. Oversight
5. Study Description
Brief Summary
The purpose of this randomized, double-blind, active-controlled, flexible dosage, multicenter study is to evaluate the effectiveness and safety of galantamine tablet (16-24mg/day) for 16 weeks in the treatment of mild to moderate Alzheimer's Disease (AD) comparing with Donepezil.
Detailed Description
This is a randomized, double-blind, active-controlled, flexible dosage, multicenter study to evaluate the effectiveness and safety of galantamine tablet in the treatment of mild to moderate AD. The comparator is Donepezil tablet. At least 206 patients were to be randomized in the study. The study consisted of 3 phases: a screening phase, a single-blind run-in phase and a double-blind treatment phase. Screening phase is less than 2 week for eligible assessment; If the patient was taking any anti-dementia drug at screening, he/she had to stop these drugs and enter into the single-blind run-in phase. The patient who did not take any anti-dementia drug can enter into baseline directly. During the single-blind run-in phase, all eligible patients will take placebo twice daily for 4 weeks. Double-blind treatment phase is 16 weeks. At baseline, all patients who are still eligible for inclusion/exclusion criteria will be randomized to either galantamine group or donepezil group at 1:1 ratio, drugs will be taken twice daily by a flexible dose for 16 weeks. Dose will be titrated during the first 9-12 weeks. Dose will be fixed to 16mg/day or 24mg/day based on tolerability of the patient judged by the investigator. The primary effectiveness endpoint is changes in ADAS-cog/11 at week 16 from baseline, secondary endpoint is responder rate in term of ADAS-cog/11. Safety evaluation included adverse events, physical examination, ECG, and safety laboratory tests. Study drug are taken orally twice a day. The treatment duration was 16 weeks. Initial galantamine dose is 8 mg/day, dose was increased to 16mg/day at week 5 and to 24 mg/day at week 9. At week 12, dose was fixed to either 16mg/day or 24mg/day at the discretion of investigators. Initial donepezil dose is 5mg/day, dose was then increased to 10mg/day at week 9. At week 12, dose was fixed to either 5mg/day or 10mg/day at the discretion of investigators.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
Keywords
Alzheimer Disease, galantamine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
215 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Galantamine HBr
Primary Outcome Measure Information:
Title
Primary endpoint (ADAS-cog/11) decreased 5.4 ± 6.4 and 4 .0 ± 7.3 in galantamine and Donepezil group respectively after 16-week treatment from baseline of 22.5 ± 9.3 and 23.3 ± 9.7 respectively, showing the non-inferiority in term of efficacy.
Secondary Outcome Measure Information:
Title
Secondary endpoint is responder rate. It showed 78% responder rate in galantamine group and 58% responder rate in Donepezil group after 16 weeks.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Out-patients diagnosed with mild to moderate probable AD. The diagnosis should have been established in accordance with the classification for probable AD of NINCDS-ADRDA
MMSE score of 10-24 (inclusive) at screening
Patients who lived with or had regular daily visits from a responsible caregiver
.Has signed the informed consent form by subject and assent form by care-giver
Exclusion Criteria:
Patients with neurodegenerative disorders such as Parkinson's disease
Patients with some conditions possibly resulting in cognitive impairment, e.g. acute cerebral trauma, infection
Has evidence of multi-infarct dementia or clinically active cerebrovascular disease.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xian-Janssen Pharmaceutical Ltd. Clinical Trial
Organizational Affiliation
Xian-Janssen Pharmaceutical Ltd.
Official's Role
Study Director
12. IPD Sharing Statement
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=1077&filename=CR005803_CSR.pdf
Description
A randomized, active control, double-blind study to evaluate the effectiveness and safety of galantamine for mild to moderate Alzheimer's Disease
Learn more about this trial
A Randomized, Double-blind, Flexible Dose, Multicenter Study to Evaluate the Effectiveness and Safety of Galantamine IR in Mild to Moderate Alzheimer's Disease
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