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: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assessment of treatment response and correlation of new scale against ADAScog, SIB, NPI, DAD. [ Time Frame: at a post baseline visit ] [ Designated as safety issue: No ]

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
Genders Eligible for Study:   Both
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.
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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
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Austria: Federal Office for Safety in Health Care

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Mental Disorders
Nervous System Diseases
Neurocognitive Disorders
Neurodegenerative Diseases
Anti-Dyskinesia Agents
Antiparkinson Agents
Dopamine Agents
Excitatory Amino Acid Agents
Excitatory Amino Acid Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs processed this record on May 26, 2016