Memantine and Antipsychotics Use (MemAP)

Merz Pharmaceuticals

Status and phase: Terminated; Phase 4

Conditions: Alzheimer's Disease

Treatments: Drug: Memantine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00649220

2007-004489-41 (EudraCT Number)

MRZ 90001-0716/1

Details and patient eligibility

About

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

Enrollment: 19 patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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19 participants in 1 patient group

Memantine

Experimental group

Treatment:

Drug: Memantine