Memantine and Validation of a New Alzheimer's Disease Scale

Merz Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Alzheimer's Disease

Treatments: Drug: memantine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00804271

MRZ 90001/AD/3001

EudraCT No. 2008-005144-16

Details and patient eligibility

About

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

Enrollment: 487 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

487 participants in 1 patient group

Memantine

Other group

Treatment:

Drug: memantine