Status:
COMPLETED
Memantine and Validation of a New Alzheimer's Disease Scale
Lead Sponsor:
Merz Pharmaceuticals GmbH
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
50+ years
Phase:
PHASE3
Brief Summary
To validate a new Alzheimer's Disease scale against other rating tools in subjects with dementia of Alzheimer's type, treated with memantine.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
487 Patients enrolled
Trial Details
Trial ID
NCT00804271
Start Date
December 1 2008
End Date
November 1 2009
Last Update
February 22 2013
Active Locations (1)
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1
University Clinic Gustav Carus
Dresden, Saxony, Germany, 01307