A Follow-up Study to Assess Safety and Tolerability of Galantamine Treatment in Individuals With Mild Cognitive Impairment

• Status: Completed
• Trial end date: 2004-05-01
• Target enrollment: 0
• Participant gender: All

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 galantamine

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Treatments: Galantamine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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)