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Memantine and Antipsychotics Use

NCT ID: NCT00649220

Last Updated: 2011-09-26

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2009-06-30

Brief Summary

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

Detailed Description

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Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Memantine

Group Type EXPERIMENTAL

Memantine

Intervention Type DRUG

memantine tablets, twice a day (bid), for 20 weeks

Interventions

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Memantine

memantine tablets, twice a day (bid), for 20 weeks

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merz Pharmaceuticals GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Expert

Role: STUDY_DIRECTOR

Merz Pharmaceuticals GmbH

Locations

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Alexianer Hospital

Krefeld, North Rhine-Westphalia, Germany

Site Status

Countries

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Germany

Other Identifiers

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2007-004489-41

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MRZ 90001-0716/1

Identifier Type: -

Identifier Source: org_study_id