Memantine - Communication Study

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merz Pharmaceuticals GmbH
• Treatments: Memantine

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.