An Efficacy and Safety Study of Galantamine for the Treatment of Patients With Alzheimer's Disease
Placebo-controlled Confirmatory Study of Galantamine (R113675) for Alzheimer's Type Dementia
2 other identifiers
interventional
580
1 country
1
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of two fixed doses (16mg/day and 24mg/day) of galantamine (a drug for treating dementia) versus placebo for the treatment of patients with Alzheimer's disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2007
1 active site
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
Study Start
First participant enrolled
February 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
December 24, 2008
CompletedFirst Posted
Study publicly available on registry
December 25, 2008
CompletedResults Posted
Study results publicly available
July 4, 2012
CompletedApril 17, 2014
March 1, 2014
1.6 years
December 24, 2008
March 13, 2012
March 31, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change From Baseline in the Alzheimer's Disease Assessment Scale - Japan Cognitive Subscale (ADAS-J Cog)
ADAS-J cog is the Japanese version of the cognitive function subscale of the Alzheimer's disease assessment scale (ADAS). This scale is used to detect changes in cognitive function in individuals with Alzheimer disease on the basis of three domains: memory, language and behavior. The minimum score is zero (0) and means well cognitive function. The maximum total score is 70 points, and the larger the score, the more severe the degree of impairment.
Baseline and 24 weeks
Distribution of Clinician's Interview-Based Impression of Change Plus - Japan (CIBIC Plus-J)
CIBIC plus-J is the Japanese version of the Clinician's Interview-based Impression of Change plus the caregiver's input (CIBIC plus). It is a seven-point categorical assessment scale for evaluating the efficacy of antidementia drugs, ranging from "markedly improved" to "markedly worse".
24 weeks
Secondary Outcomes (3)
Change From Baseline in the Disability Assessment for Dementia (DAD)
Baseline and 24 weeks
Change From Baseline in the Behavioral Pathology in Alzheimer's Disease Rating Scale (Behave-AD)
Baseline and 24 weeks
Change From Baseline in the Mental Function Impairment Scale (MENFIS)
Baseline and 24 weeks
Study Arms (3)
Placebo
PLACEBO COMPARATORGalantamine 16 mg/day
EXPERIMENTALGalantamine 24 mg/day
EXPERIMENTALInterventions
Form= tablet, route= oral use. Corresponding placebo tablets confirmed to be indistinguishable from the galantamine tablets will be administered for 24 weeks.
Type= exact number, number= 8, 16, unit= mg/day, form= tablet, route= oral use. Patients will receive 8 mg galantamine daily for the first 4 weeks, and 16 mg galantamine daily for the remaining 20 weeks.
Type= exact number, number= 8, 16, 24, unit= mg/day, form= tablet, route= oral use. Patients will receive 8 mg galantamine daily for the first 4 weeks, then 16 mg galantamine daily for the following 4 weeks, and 24 mg galantamine daily for the remaining 16 weeks.
Eligibility Criteria
You may qualify if:
- Outpatients with a diagnosis of Alzheimer's disease according to the National Institute of Neurological and Communicative Disorders and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria
- Having a Mini-Mental Status Examination (MMSE) score of 10 - 22 inclusive
- Having an Alzheimer's Disease Assessment Scale - Japan cognitive subscale (ADAS-J cog) score of at least 18
- Exhibiting an onset and progression of cognitive dysfunction during at least 6 months prior to the screening period
You may not qualify if:
- Patients with neurodegenerative diseases other than Alzheimer's disease, such as Lewy bodies disease, (dementia due to tiny round structures made of proteins that develop within nerve cells in the brain), Parkinsonism, etc
- Patients with cognitive dysfunction due to cerebral damage resulting from a lack of oxygen, a brain injury, etc
- Patients with multi-infarct dementia (brought on by a series of strokes) or active cerebrovascular disease
- Patients with clinically significant cardiovascular disease
- Patients currently taking drugs such as a cholinesterase inhibitors, which improve cerebral circulation/metabolism
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
Fukuoka, Japan
Related Publications (1)
Lim AWY, Schneider L, Loy C. Galantamine for dementia due to Alzheimer's disease and mild cognitive impairment. Cochrane Database Syst Rev. 2024 Nov 5;11(11):CD001747. doi: 10.1002/14651858.CD001747.pub4.
PMID: 39498781DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director
- Organization
- Janssen Pharm KK Japan
Study Officials
- STUDY DIRECTOR
Janssen Pharmaceutical K.K. Clinical Trial
Janssen Pharmaceutical K.K.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 24, 2008
First Posted
December 25, 2008
Study Start
February 1, 2007
Primary Completion
September 1, 2008
Study Completion
September 1, 2008
Last Updated
April 17, 2014
Results First Posted
July 4, 2012
Record last verified: 2014-03