Memantine and Validation of a New Alzheimer's Disease Scale
Information source: Merz Pharmaceuticals GmbH
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Alzheimer's Disease
Intervention: memantine (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Merz Pharmaceuticals GmbH Official(s) and/or principal investigator(s): Vjera Holthoff, MD, Principal Investigator, Affiliation: University Clinic Gustav Carus Dresden, Germany
Summary
To validate a new Alzheimer's Disease scale against other rating tools in subjects with
dementia of Alzheimer's type, treated with memantine.
Clinical Details
Official title: Open Label, Single-Arm, Multi-Centre, Study to Validate a New Alzheimer's Disease Scale in Patients With DAT, Treated With Memantine
Study design: Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label
Primary outcome: Validation of new scale regarding content, reliability and responsiveness for DAT symptoms
Secondary outcome: Assessment of treatment response and correlation of new scale against ADAScog, SIB, NPI, DAD.
Eligibility
Minimum age: 50 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
University Clinic Gustav Carus, Dresden, Saxony 01307, Germany
Additional Information
Starting date: December 2008
Last updated: February 21, 2013
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