Memantine and Validation of a New Alzheimer's Disease Scale

• Status: Completed
• Trial end date: 2009-11-01
• Target enrollment: 0
• Participant gender: All

Summary

To validate a new Alzheimer's Disease scale against other rating tools in subjects with dementia of Alzheimer's type, treated with memantine.

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

Details

• Lead Sponsor: Merz Pharmaceuticals GmbH
• Treatments: Memantine

Criteria

Inclusion Criteria:

• Diagnosis of probable Alzheimer's disease consistent with NINCDS-ADRDA criteria or with DSM IV TR criteria for Dementia of Alzheimer's type.

• Signed informed consent prior to the initiation of any study specific procedures.

• Sight and hearing (a hearing aid is permitted) are sufficiently good to allow the undertaking of study-related procedures and psychometric tests.

Exclusion Criteria:

• Evidence of clinically significant and active pulmonary, gastrointestinal, renal, hepatic, endocrine or cardiovascular system disease.

• Intake of any medication that is contra-indicated in combination with memantine.

• History of severe drug allergy, or hypersensitivity, or patients with known hypersensitivity to ingredients of memantine or lactose.

• Known or suspected history of alcoholism or drug abuse within the past 2 years.

• Current or previous treatment with memantine or participation in an investigational study with memantine.