Status:
TERMINATED
Memantine and Antipsychotics Use
Lead Sponsor:
Merz Pharmaceuticals GmbH
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
50-85 years
Phase:
PHASE4
Brief Summary
To investigate the potential to reduce concomitant antipsychotic medication use in subjects with moderate dementia of Alzheimer's type, treated with memantine.
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 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.
- MRI or CT scan supporting the diagnosis of DAT without indications of any relevant other CNS disorders.
- Patients treated with any acetylcholinesterase inhibitor (AChEI) man be included.
- The patient should have German as a mother-tongue or at least speak the language fluently.
- Exclusion criteria:
- 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.
- Intake of any medication that is contra-indicated in combination with memantine.
- Treatment with depot antipsychotics.
- History of severe drug allergy, or hypersensitivity, or patients with known hypersensitivity to memantine, amantadine or lactose.
- 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.
Exclusion
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00649220
Start Date
July 1 2008
End Date
June 1 2009
Last Update
September 26 2011
Active Locations (1)
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1
Alexianer Hospital
Krefeld, North Rhine-Westphalia, Germany