Status:
TERMINATED
A Study of Galantamine Used to Treat Patients With Mild to Moderate Alzheimer's Disease
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
45-90 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to compare the effectiveness and safety of 2 years of treatment with galantamine as compared with placebo of patients who have mild to moderately severe Alzheimer's diseas...
Detailed Description
This is a long-term (2-year), randomized (patients will be assigned to treatment by chance), double blind (neither the physician nor the patient will know which treatment is assigned) study of galanta...
Eligibility Criteria
Inclusion
- Outpatients
- diagnosed with mild to moderately-severe, probable or possible AD, established in accordance with the criteria defined by the National Institute of Neurological and Communicative Disorders and Stroke and Alzheimer's Disease Related Disorders Association or the Diagnostic and Statistical Manual, Fourth Edition
- living with or have regular and frequent visits from a responsible caregiver.
Exclusion
- Neurodegenerative disorders other than AD, such as Parkinson's Disease, Frontotemporal Dementia or Huntington's disease
- Any of specified conditions which may contribute to dementia
- any of specified coexisting diseases, including significant cardiovascular disease.
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
2051 Patients enrolled
Trial Details
Trial ID
NCT00679627
Start Date
June 1 2008
End Date
May 1 2012
Last Update
September 19 2013
Active Locations (95)
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1
Hradec Králové, Czechia
2
Mìlník 1, Czechia
3
Olomouc, Czechia
4
Ostrava, Czechia