A Placebo-controlled Trial to Evaluate the Safety and Efficacy of Galantamine in the Treatment of Vascular Dementia

• Status: Completed
• Trial end date: 2003-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a trial to evaluate the safety and effectiveness of galantamine in patients with dementia secondary to blood vessel disease in the brain.

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

Details

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

Criteria

Inclusion Criteria:

• Diagnosed with vascular dementia per NINDS-AIREN criteria

• Radiologic evidence of VaD on MRI

• Clinical evidence of VaD (ie focal signs)

• Onset of dementia between ages 40 and 90 years

• Ability to read, write, communicate, and understand cognitive testing instructions

• No uncontrolled medical conditions

Exclusion Criteria:

• Presence of other diseases or disorders that could cause loss of mental functioning (such as trauma, cancer, infections, mental retardation)

• Current significant cardiovascular disease that could limit the patient's ability to complete the study

• Major psychiatric diseases

• Peptic ulcer or significant urine outflow obstructions

• Seizures

• Other serious diseases

• History of drug or alcohol abuse within the past year