Memantine - Communication Study

Phase 3

Completed

• Conditions: Alzheimer's Disease
• Interventions: Drug: Memantine-HCl

• Registration Number: NCT00624026
• Lead Sponsor: Merz Pharmaceuticals GmbH

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2008-02-14
• Study First Submitted QC: 2008-02-14
• Study First Posted: 2008-02-26
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-31
• Last Update Posted: 2011-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 107

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Memantine-HCl	-

Primary Outcome Measures

Name	Time	Method
To assess the efficacy of the memantine OD IR treatment using the Consortium to establish a registry for Alzheimer's Disease (CERAD-NP) total score	4 months

Trial Locations

Locations (1)

Central Medical Affairs; 🇩🇪 Frankfurt/Main, Germany