NCT00804271CompletedPhase 3
Open Label, Single-Arm, Multi-Centre, Study to Validate a New Alzheimer's Disease Scale in Patients With DAT, Treated With Memantine
Merz Pharmaceuticals GmbH1 site in 1 country487 target enrollmentStarted: December 2008Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Merz Pharmaceuticals GmbH
- Enrollment
- 487
- Locations
- 1
- Primary Endpoint
- Validation of new scale regarding content, reliability and responsiveness for DAT symptoms
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Memantine
Other
Intervention: memantine (Drug)
Outcomes
Primary Outcomes
Validation of new scale regarding content, reliability and responsiveness for DAT symptoms
Time Frame: at post baseline visit
Secondary Outcomes
- Assessment of treatment response and correlation of new scale against ADAScog, SIB, NPI, DAD.(at a post baseline visit)
Investigators
Study Sites (1)
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