A Study to Evaluate the Efficacy and Safety of Galantamine in Patients With Mild Cognitive Impairment

• Status: Completed
• Trial end date: 2003-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy and safety of galantamine treatment in patients with mild cognitive impairment.

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

Details

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

Criteria

Inclusion Criteria:

• Clinical decline of cognitive ability consistent with mild cognitive impairment

• Delayed recall score <= 10 on a New York University paragraph recall test

• Sufficient visual, hearing and communication capabilities and be willing to complete serial standard tests of cognitive function

• Have a consistent informant to accompany them on scheduled visits

• Be able to read, write and fully understand the language of the cognitive scales used in the study

Exclusion Criteria:

• Neurodegenerative disorders such as Parkinson's disease

• Cognitive impairment resulting from acute cerebral trauma, hypoxic cerebral damage, vitamin deficiency states, infections such as meningitis or AIDS, or primary or metastatic cerebral neoplasia

• Epilepsy

• Significant psychiatric disease

• Peptic ulcer disease

• Clinically significant heart, lung, liver or kidney diseases

• Pregnant or nursing women or those without adequate contraception