Status:
COMPLETED
A Study of the Safety and Effectiveness of Galantamine in Patients With Alzheimer's Disease
Lead Sponsor:
Janssen-Cilag S.p.A.
Conditions:
Alzheimer Disease
Dementia
Eligibility:
All Genders
50+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the long-term efficacy and safety of galantamine in patients with Alzheimer's disease.
Detailed Description
Dementia is a chronic, progressive brain disease that may involve a number of symptoms, including memory loss and changes in personality, behavior, judgment, attention span, language and thought. The ...
Eligibility Criteria
Inclusion
- Diagnosis of probable Alzheimer's disease according to accepted medical standards
- Patients with mild to moderate impairment of thinking, reasoning, and judgment as defined by a score from 11-24 on the Mini Mental Status Exam (MMSE, a standard assessment tool for Alzheimer's disease) Female patients must be post-menopausal
- Patients and their caregivers must have signed informed consent forms
Exclusion
- Patients with a diagnosis of Parkinson's Disease, Pick's Disease, Huntington's Chorea, Creutzfeld-Jacob disease, Down's syndrome, brain cancer, mental retardation, epilepsy, psychiatric disease, liver, kidney or heart failure, significant heart, lung, digestive, hormone or mental disease or Vitamin B deficiency
- Patients with previous severe head injury or blood clot in the brain
- Patients who are hospitalized, living in nursing homes or residential care facilities
- Patients with brain infections such as abscess, meningitis, encephalitis
- Patients with a history of drug or alcohol abuse
Key Trial Info
Start Date :
August 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2005
Estimated Enrollment :
254 Patients enrolled
Trial Details
Trial ID
NCT00216502
Start Date
August 1 2001
End Date
November 1 2005
Last Update
January 24 2011
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