Memantine - Communication Study

Merz Pharmaceuticals

Status and phase

Completed

Phase 3

Conditions

Alzheimer's Disease

Treatments

Drug: Memantine-HCl

Study type

Interventional

Funder types

Industry

Identifiers

NCT00624026

MRZ 90001-0608/1

Details and patient eligibility

About

The study objective is to evaluate the effects of memantine treatment on communication abilities and other cognitive abilities in moderate to severe DAT patients.

Enrollment

107 patients

Sex

All

Ages

50 to 90 years old

Volunteers

No Healthy Volunteers

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.