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Memantine and Validation of a New Alzheimer's Disease Scale

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merz Pharmaceuticals GmbH
ClinicalTrials.gov Identifier:
NCT00804271
First received: December 5, 2008
Last updated: February 21, 2013
Last verified: February 2013
History of Changes
  Purpose

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:

U.S. FDA Resources

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

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:

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
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
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Memantine
Dopamine Agents
 Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 17, 2013