A Study of the Safety and Effectiveness of a Flexible Dose of Galantamine Versus Placebo in the Treatment of Patients With Alzheimer's Disease

• Status: Completed
• Trial end date: 1998-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and effectiveness of galantamine (a drug for treating dementia) versus placebo in the treatment of patients with Alzheimer's disease using a flexible dose design.

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

Details

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

Criteria

Inclusion Criteria:

• Outpatients with a diagnosis of Alzheimer's disease according to the National Institute of Neurological and Communicative Disorders and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria (including patients living independently in residential homes for the elderly or day patients)

• have mild to moderate dementia, as evidenced by a, Mini-Mental Status Examination (MMSE) score of 11 - 24, and a score of at least 12 on the cognitive portion of the Alzheimer's Disease Assessment scale (ADAS-cog)

• history of at least 6 months of gradual and progressive cognitive decline

• have a consistent informant to accompany the patient on scheduled visits

Exclusion Criteria:

• Neurogenerative disorders such as Parkinson's disease

• dementia caused by small strokes or cerebrovascular disease

• cognitive impairment resulting from acute cerebral trauma, cerebral damage due to a lack of oxygen, vitamin deficiency, infections such as meningitis or AIDS, significant endocrine or metabolic disease, mental retardation or a brain tumor

• having epilepsy, significant psychiatric disease, active peptic ulcer, clinically significant liver, kidney or lung disorders or heart disease

• Females of child bearing potential without adequate contraception