A Study of the Safety and Effectiveness of Galantamine in Patients With Alzheimer's Disease

• Status: Completed
• Trial end date: 2005-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the long-term efficacy and safety of galantamine in patients with Alzheimer's disease.

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

Details

• Lead Sponsor: Janssen-Cilag S.p.A.
• Treatments: Galantamine

Criteria

Inclusion Criteria:

• Diagnosis of probable Alzheimer's disease according to accepted medical standards

• Patients with mild to moderate impairment of thinking, reasoning, and judgment as defined by a score from 11-24 on the Mini Mental Status Exam (MMSE, a standard assessment tool for Alzheimer's disease) Female patients must be post-menopausal

• Patients and their caregivers must have signed informed consent forms Exclusion Criteria:

• Patients with a diagnosis of Parkinson's Disease, Pick's Disease, Huntington's Chorea, Creutzfeld-Jacob disease, Down's syndrome, brain cancer, mental retardation, epilepsy, psychiatric disease, liver, kidney or heart failure, significant heart, lung, digestive, hormone or mental disease or Vitamin B deficiency

• Patients with previous severe head injury or blood clot in the brain

• Patients who are hospitalized, living in nursing homes or residential care facilities

• Patients with brain infections such as abscess, meningitis, encephalitis

• Patients with a history of drug or alcohol abuse