Memantine and Antipsychotics Use

• Status: Terminated
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

Summary

To investigate the potential to reduce concomitant antipsychotic medication use in subjects with moderate dementia of Alzheimer's type, treated with memantine.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merz Pharmaceuticals GmbH
• Treatments: Antipsychotic Agents; Memantine

Criteria

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.