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Memantine - Communication Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00624026
Recruitment Status : Completed
First Posted : February 26, 2008
Last Update Posted : November 1, 2011
Sponsor:
Information provided by (Responsible Party):
Merz Pharmaceuticals GmbH

Tracking Information
First Submitted Date  ICMJE February 14, 2008
First Posted Date  ICMJE February 26, 2008
Last Update Posted Date November 1, 2011
Study Start Date  ICMJE November 2007
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 14, 2008)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00624026 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Memantine - Communication Study
Official Title  ICMJE Prospective, Single-arm, Multicenter, Open-label Study to Investigate the Efficacy and Tolerability of the Once Daily (OD) Memantine Treatment
Brief Summary The study objective is to evaluate the effects of memantine treatment on communication abilities and other cognitive abilities in moderate to severe DAT patients.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Alzheimer's Disease
Intervention  ICMJE Drug: Memantine-HCl
20 mg per day (once daily)
Study Arms  ICMJE Experimental: 1
Intervention: Drug: Memantine-HCl
Publications * Schulz JB, Rainer M, Klünemann HH, Kurz A, Wolf S, Sternberg K, Tennigkeit F. Sustained effects of once-daily memantine treatment on cognition and functional communication skills in patients with moderate to severe Alzheimer's disease: results of a 16-week open-label trial. J Alzheimers Dis. 2011;25(3):463-75. doi: 10.3233/JAD-2011-101929.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 8, 2008)
107
Original Estimated Enrollment  ICMJE
 (submitted: February 14, 2008)
119
Actual Study Completion Date  ICMJE December 2008
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00624026
Other Study ID Numbers  ICMJE MRZ 90001-0608/1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Merz Pharmaceuticals GmbH
Study Sponsor  ICMJE Merz Pharmaceuticals GmbH
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Joerg B. Schulz, MD PhD Center of Neurological Medicine, Goettingen, Germany
PRS Account Merz Pharmaceuticals GmbH
Verification Date October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP