Memantine - Communication Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merz Pharmaceuticals GmbH
ClinicalTrials.gov Identifier:
NCT00624026
First received: February 14, 2008
Last updated: October 31, 2011
Last verified: October 2011
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

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)

  Eligibility

Ages Eligible for Study:   50 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00624026

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

Publications:
Responsible Party: Merz Pharmaceuticals GmbH
ClinicalTrials.gov Identifier: NCT00624026     History of Changes
Other Study ID Numbers: MRZ 90001-0608/1
Study First Received: February 14, 2008
Last Updated: October 31, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Austria: Austrian Agency for Health and Nutrition Security, Section Pharm. Med.

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
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents

ClinicalTrials.gov processed this record on September 22, 2014