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Memantine and Validation of a New Alzheimer's Disease Scale

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ClinicalTrials.gov Identifier: NCT00804271
Recruitment Status : Completed
First Posted : December 8, 2008
Last Update Posted : February 22, 2013
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: memantine Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 487 participants
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
Study Start Date : December 2008
Actual Primary Completion Date : November 2009
Actual Study Completion Date : November 2009


Arm Intervention/treatment
Memantine Drug: memantine
memantine tablets, OD, 12 weeks
Other Name: Axura



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

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


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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00804271


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

Publications of Results:
Responsible Party: Merz Pharmaceuticals GmbH
ClinicalTrials.gov Identifier: NCT00804271     History of Changes
Other Study ID Numbers: MRZ 90001/AD/3001
EudraCT No. 2008-005144-16
First Posted: December 8, 2008    Key Record Dates
Last Update Posted: February 22, 2013
Last Verified: February 2013

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Memantine
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