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Memantine and Validation of a New Alzheimer's Disease Scale

This study has been completed.
Information provided by (Responsible Party):
Merz Pharmaceuticals GmbH Identifier:
First received: December 5, 2008
Last updated: February 21, 2013
Last verified: February 2013
To validate a new Alzheimer's Disease scale against other rating tools in subjects with dementia of Alzheimer's type, treated with memantine.

Condition Intervention Phase
Alzheimer's Disease Drug: memantine Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Open Label, Single-Arm, Multi-Centre, Study to Validate a New Alzheimer's Disease Scale in Patients With DAT, Treated With Memantine

Resource links provided by NLM:

Further study details as provided by Merz Pharmaceuticals GmbH:

Primary Outcome Measures:
  • Validation of new scale regarding content, reliability and responsiveness for DAT symptoms [ Time Frame: at post baseline visit ]

Secondary Outcome Measures:
  • Assessment of treatment response and correlation of new scale against ADAScog, SIB, NPI, DAD. [ Time Frame: at a post baseline visit ]

Enrollment: 487
Study Start Date: December 2008
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Memantine Drug: memantine
memantine tablets, OD, 12 weeks
Other Name: Axura


Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00804271

University Clinic Gustav Carus
Dresden, Saxony, Germany, 01307
Sponsors and Collaborators
Merz Pharmaceuticals GmbH
Principal Investigator: Vjera Holthoff, MD University Clinic Gustav Carus Dresden, Germany
  More Information

Responsible Party: Merz Pharmaceuticals GmbH Identifier: NCT00804271     History of Changes
Other Study ID Numbers: MRZ 90001/AD/3001
EudraCT No. 2008-005144-16
Study First Received: December 5, 2008
Last Updated: February 21, 2013

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents processed this record on September 21, 2017