Status:
COMPLETED
A Study of the Safety and Effectiveness of Galantamine Hydrobromide in Patients With Alzheimer's Disease
Lead Sponsor:
Janssen Cilag Pharmaceutica S.A.C.I., Greece
Conditions:
Alzheimer Disease
Eligibility:
All Genders
Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of galantamine hydrobromide in patients with Alzheimer's disease who have not received or have not responded to treatment with med...
Detailed Description
Galantamine hydrobromide is a medication that is approved for the treatment of symptoms of Alzheimer's disease. In accordance with international guidelines, studies are conducted after a drug is marke...
Eligibility Criteria
Inclusion
- Patients with a score of 10-26 on the Mini Mental Status Exam
- Patients who have not yet received treatment for their Alzheimer's disease with a medication similar to galantamine or patients who have been treated with as medication similar to galantamine hydrobromide and who have discontinued that medication due to lack of effectiveness or poor tolerability (adverse events)
Exclusion
- Patients with severely decreased liver or kidney function
- Patients with a digestive system or urinary blockage who are recovering from digestive system or urinary bladder surgery
- Patients with clinically significant unstable or uncontrolled hormonal or mental disease
- Patients who are unable to take the medication either alone or with help from another person who is available during the entire study period
Key Trial Info
Start Date :
June 1 2004
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2005
Estimated Enrollment :
344 Patients enrolled
Trial Details
Trial ID
NCT00297362
Start Date
June 1 2004
End Date
October 1 2005
Last Update
March 26 2012
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