Status:
COMPLETED
A Follow-up Study to Assess Safety and Tolerability of Galantamine Treatment in Individuals With Mild Cognitive Impairment
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Cognition Disorder
Nervous System Diseases
Eligibility:
All Genders
50+ years
Phase:
PHASE3
Brief Summary
The purpose of this follow-up study is to assess the long-term safety and tolerability of galantamine in individuals with mild cognitive impairment who participated in a previous study with galantamin...
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
- Completed 24 months of double-blind treatment in 1 of 2 previous studies with galantamine without progressing to dementia (CDR\< 1)
- Able to safely receive open-label galantamine in the opinion of the investigator and treatment is in the individual's best interest
- Regular (at least 3 days a week) visits from a person able to accompany patient to scheduled visits
- Enrolled within 7-30 days after the previous galantamine study
Exclusion
- Individuals who converted to dementia (CDR \> = 1) during 1 of the previous galantamine studies
- Prematurely discontinued 1 of the previous galantamine studies or completed 1 of the previous studies more than 30 days prior to this study
- Current clinically significant cardiovascular disease (including heart surgery, unstable angina, congestive heart failure, fibrillation, valve disease or uncontrolled high blood pressure)
Key Trial Info
Start Date :
May 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2004
Estimated Enrollment :
724 Patients enrolled
Trial Details
Trial ID
NCT00240695
Start Date
May 1 2003
End Date
May 1 2004
Last Update
May 18 2011
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