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Memantine - Communication Study

This study has been completed.
Information provided by (Responsible Party):
Merz Pharmaceuticals GmbH Identifier:
First received: February 14, 2008
Last updated: October 31, 2011
Last verified: October 2011
The study objective is to evaluate the effects of memantine treatment on communication abilities and other cognitive abilities in moderate to severe DAT patients.

Condition Intervention Phase
Alzheimer's Disease Drug: Memantine-HCl Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective, Single-arm, Multicenter, Open-label Study to Investigate the Efficacy and Tolerability of the Once Daily (OD) Memantine Treatment

Resource links provided by NLM:

Further study details as provided by Merz Pharmaceuticals GmbH:

Primary Outcome Measures:
  • To assess the efficacy of the memantine OD IR treatment using the Consortium to establish a registry for Alzheimer's Disease (CERAD-NP) total score [ Time Frame: 4 months ]

Enrollment: 107
Study Start Date: November 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Memantine-HCl
20 mg per day (once daily)


Ages Eligible for Study:   50 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male or female outpatient at least 50 years of age and at least 8 years of education.
  • The patient should have German as a mother-tongue or at least speak the language fluently in order to achieve similar scores in verbal tasks.
  • Current diagnosis of probable Alzheimer's disease consistent with NINCDS- ADRDA criteria or with DSM IV TR criteria for Dementia of the Alzheimer's type.
  • Mini Mental State Examination (MMSE) total score is less than 20
  • Patients treated with any acetylcholinesterase inhibitor (AChEI) may be included, when treatment has started at least 6 months prior screening and was stable during the last 3 months.

Exclusion Criteria:

  • Any type of evident aphasia, which may interfere with patient's communication difficulties caused by Alzheimer's disease
  • History of severe drug allergy, or hypersensitivity, or patients with known hypersensitivity to amantadine, lactose.
  • Evidence (including CT/MRI results) of any clinically significant central nervous system disease other than Alzheimer's disease.
  • Modified Hachinski Ischemia score greater than 4 at screening.
  • Current evidence of clinically significant systemic disease
  • Known or suspected history of alcoholism or drug abuse within the past 10 years.
  • 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: NCT00624026

Central Medical Affairs
Frankfurt/Main, Germany, 60318
Sponsors and Collaborators
Merz Pharmaceuticals GmbH
Principal Investigator: Joerg B. Schulz, MD PhD Center of Neurological Medicine, Goettingen, Germany
  More Information

Responsible Party: Merz Pharmaceuticals GmbH Identifier: NCT00624026     History of Changes
Other Study ID Numbers: MRZ 90001-0608/1
Study First Received: February 14, 2008
Last Updated: October 31, 2011

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 August 17, 2017