Memantine and Validation of a New Alzheimer's Disease Scale

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

487 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2009-11-30

Brief Summary

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To validate a new Alzheimer's Disease scale against other rating tools in subjects with dementia of Alzheimer's type, treated with memantine.

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Detailed Description

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Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Memantine

Group Type OTHER

memantine

Intervention Type DRUG

memantine tablets, OD, 12 weeks

Interventions

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memantine

memantine tablets, OD, 12 weeks

Intervention Type DRUG

Other Intervention Names

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Axura

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of probable Alzheimer's disease consistent with NINCDS-ADRDA criteria or with DSM IV TR criteria for Dementia of Alzheimer's type.
* Signed informed consent prior to the initiation of any study specific procedures.
* Sight and hearing (a hearing aid is permitted) are sufficiently good to allow the undertaking of study-related procedures and psychometric tests.

Exclusion Criteria

* Evidence of clinically significant and active pulmonary, gastrointestinal, renal, hepatic, endocrine or cardiovascular system disease.
* Intake of any medication that is contra-indicated in combination with memantine.
* History of severe drug allergy, or hypersensitivity, or patients with known hypersensitivity to ingredients of memantine or lactose.
* Known or suspected history of alcoholism or drug abuse within the past 2 years.
* Current or previous treatment with memantine or participation in an investigational study with memantine.

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No