An Efficacy and Safety Study of Galantamine for the Treatment of Patients With Alzheimer's Disease.
Placebo-Controlled, Double-Blind Study of Galantamine (R113675) in the Treatment of Alzheimer's Disease.
1 other identifier
interventional
398
0 countries
N/A
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, and to investigate the dose-response.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 alzheimer-disease
Started Apr 2001
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2004
CompletedFirst Submitted
Initial submission to the registry
March 10, 2006
CompletedFirst Posted
Study publicly available on registry
March 13, 2006
CompletedMay 17, 2011
January 1, 2011
March 10, 2006
May 16, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline to the end of the study in the Alzheimer's Disease Assessment Scale - Japan cognitive subscale (ADAS-J cog) and the Clinician's Interview-Based Impression of Change plus - Japan (CIBIC plus-J)
Secondary Outcomes (1)
Change from baseline to the end of the study in CIBIC plus-J subscales (Disability Assessment for Dementia [DAD], Behavioral Pathology in Alzheimer's Disease Rating Scale [Behave-AD], the Mental Function Impairment Scale [MENFIS ]).
Interventions
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
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Pharmaceutical K.K. Clinical Trial
Janssen Pharmaceutical K.K.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 10, 2006
First Posted
March 13, 2006
Study Start
April 1, 2001
Study Completion
February 1, 2004
Last Updated
May 17, 2011
Record last verified: 2011-01