Status:
COMPLETED
Memantine - Communication Study
Lead Sponsor:
Merz Pharmaceuticals GmbH
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
50-90 years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
107 Patients enrolled
Trial Details
Trial ID
NCT00624026
Start Date
November 1 2007
End Date
December 1 2008
Last Update
November 1 2011
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Central Medical Affairs
Frankfurt am Main, Germany, 60318