Study of Memantine in Assessment of Selected Measures of Volumetric Magnetic Resonance Imaging (MRI) and Cognition in Moderate AD (Alzheimer's Disease)

NCT ID: NCT00334906

Last Updated: 2008-01-07

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

PHASE4

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Brief Summary

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The purpose of this study is to characterize the progression of disease using volumetric MRI techniques and cognitive outcome measures in patients with moderate dementia of the Alzheimer's type treated with open-label memantine.

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

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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memantine HCl

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Ambulatory male or female patients at least 50 years of age (females at least 2 years postmenopausal)
* A diagnosis of probable AD \[according to the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Associations (NINCDS-ADRDA) criteria\] of moderate severity \[Mini-Mental State Examination score between 15 and 20, inclusive\]
* On a stable dose of Food and Drug Administration (FDA)-approved acetylcholinesterase inhibitor

Exclusion Criteria

* Current Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (DSM-IV) Axis I disorder other than AD
* Previous imaging results not consistent with the diagnosis of AD
* Modified Hachinski Ischemia Score greater than 4
* Evidence of other neurologic disorders
* Inability to participate in MRI testing
* No clinically significant systemic disease
* A known or suspected history of alcohol or drug abuse in the past 10 years
* Taking excluded medication
* Previous treatment with commercial memantine
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Forest Laboratories

INDUSTRY

Sponsor Role lead

Locations

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Forest Laboratories

Jersey City, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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MEM-MD-15

Identifier Type: -

Identifier Source: org_study_id

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