Memantine and Validation of a New Alzheimer's Disease Scale
- Registration Number
- NCT00804271
- Lead Sponsor
- Merz Pharmaceuticals GmbH
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 487
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Memantine memantine -
- Primary Outcome Measures
Name Time Method Validation of new scale regarding content, reliability and responsiveness for DAT symptoms at post baseline visit
- Secondary Outcome Measures
Name Time Method Assessment of treatment response and correlation of new scale against ADAScog, SIB, NPI, DAD. at a post baseline visit
Trial Locations
- Locations (1)
University Clinic Gustav Carus
🇩🇪Dresden, Saxony, Germany