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

Primary Purpose

Alzheimer's Disease

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
memantine HCl
Sponsored by
Forest Laboratories
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring memantine, Alzheimer's disease, MRI, moderate Alzheimer's disease

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Forest Laboratories

Outcomes

Primary Outcome Measures

Efficacy
Total brain atrophy on MRI

Secondary Outcome Measures

Other measures of brain atrophy on MRI, change from baseline in selected cognitive measures assessing multiple cognitive domains including memory, attention, motor-speed, auditory comprehension, and verbal fluency
Safety

Full Information

First Posted
June 6, 2006
Last Updated
January 3, 2008
Sponsor
Forest Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT00334906
Brief Title
Study of Memantine in Assessment of Selected Measures of Volumetric Magnetic Resonance Imaging (MRI) and Cognition in Moderate AD (Alzheimer's Disease)
Official Title
An Open-Label Exploratory Study With Memantine: Assessment of Selected Measures of Volumetric MRI and Cognition in Patients With Moderate Dementia of the Alzheimer's Type
Study Type
Interventional

2. Study Status

Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Forest Laboratories

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
memantine, Alzheimer's disease, MRI, moderate Alzheimer's disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
75 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
memantine HCl
Primary Outcome Measure Information:
Title
Efficacy
Title
Total brain atrophy on MRI
Secondary Outcome Measure Information:
Title
Other measures of brain atrophy on MRI, change from baseline in selected cognitive measures assessing multiple cognitive domains including memory, attention, motor-speed, auditory comprehension, and verbal fluency
Title
Safety

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Forest Laboratories
City
Jersey City
State/Province
New Jersey
ZIP/Postal Code
07311
Country
United States

12. IPD Sharing Statement

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

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