Back to resultsMemantine - Communication Study
Primary Purpose
Alzheimer's Disease
Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Memantine-HCl
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer's Disease
Eligibility 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.
Sites / Locations
- Central Medical Affairs
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
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
Secondary Outcome Measures
Full Information
NCT ID
NCT00624026
First Posted
February 14, 2008
Last Updated
October 31, 2011
Sponsor
Merz Pharmaceuticals GmbH
1. Study Identification
Unique Protocol Identification Number
NCT00624026
Brief Title
Memantine - Communication Study
Official Title
Prospective, Single-arm, Multicenter, Open-label Study to Investigate the Efficacy and Tolerability of the Once Daily (OD) Memantine Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merz Pharmaceuticals GmbH
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
107 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Memantine-HCl
Intervention Description
20 mg per day (once daily)
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joerg B. Schulz, MD PhD
Organizational Affiliation
Center of Neurological Medicine, Goettingen, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Central Medical Affairs
City
Frankfurt/Main
ZIP/Postal Code
60318
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
21471647
Citation
Schulz JB, Rainer M, Klunemann 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.
Results Reference
result
Learn more about this trial
Memantine - Communication Study
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