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Effect of Memantine on Functional Communication in Patients With Alzheimer's Disease

NCT ID: NCT00469456

Last Updated: 2009-12-24

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

265 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2008-11-30

Brief Summary

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The objective of this study is to evaluate the effect of memantine versus placebo on functional communication in patients with Alzheimer's Disease

Detailed Description

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Conditions

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Alzheimer's Disease

Keywords

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memantine Alzheimer's Disease communication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

Memantine 20mg (10mg twice daily) oral administration for 12 weeks

Group Type ACTIVE_COMPARATOR

Memantine

Intervention Type DRUG

Memantine 20mg (10mg twice daily) oral administration for 12 weeks

2

Placebo oral administration twice daily for 12 weeks

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Placebo oral administration twice daily for 12 weeks

Interventions

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Memantine

Memantine 20mg (10mg twice daily) oral administration for 12 weeks

Intervention Type DRUG

placebo

Placebo oral administration twice daily for 12 weeks

Intervention Type DRUG

Other Intervention Names

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Namenda®

Eligibility Criteria

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Inclusion Criteria

* Male and female outpatients, 50 years or older, native English speakers, meeting National Institute of Neurological and Communicative Disorders and Stroke--Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria for probable AD with a Mini Mental State Examination (MMSE) score of 10 to 19 at Screening and Baseline

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
* Clinically significant systemic disease
* A known or suspected history of alcohol or drug abuse in the past 5 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

Responsible Party

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Forest Research Institute, a division of Forest Laboratories, Inc.

Principal Investigators

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F C Potocnik

Role: PRINCIPAL_INVESTIGATOR

Locations

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Forest Investigative Site

East Gosford, New South Wales, Australia

Site Status

Forest Investigative Site

Hornsby, New South Wales, Australia

Site Status

Forest Investigative Site

Kogarah, New South Wales, Australia

Site Status

Forest Investigative Site

Newcastle, New South Wales, Australia

Site Status

Forest Investigative Site

Randwick, New South Wales, Australia

Site Status

Forest Investigative Site

Chermside, Queensland, Australia

Site Status

Forest Investigative Site

Toowoomba, Queensland, Australia

Site Status

Forest Investigative Site

Adelaide, South Australia, Australia

Site Status

Forest Investigative Site

Woodville, South Australia, Australia

Site Status

Forest Investigative Site

Box Hill, Victoria, Australia

Site Status

Forest Investigative Site

Frankston, Victoria, Australia

Site Status

Forest Investigative Site

Heidelberg West, Victoria, Australia

Site Status

Forest Investigative Site

Kew, Victoria, Australia

Site Status

Forest Investigative Site

Perth, Western Australia, Australia

Site Status

Forest Investigative Site

Christchurch, , New Zealand

Site Status

Forest Investigative Site

North Shore, , New Zealand

Site Status

Forest Investigative Site

Timaru, , New Zealand

Site Status

Forest Investigative Site

George, E. Cape, South Africa

Site Status

Forest Investigative Site

Port Elizabeth, E. Cape, South Africa

Site Status

Forest Investigative Site

Johannesburg, Gauteng, South Africa

Site Status

Forest Investigative Site

Johannesburg, Gauteng, South Africa

Site Status

Forest Investigative Site

Pretoria, Gauteng, South Africa

Site Status

Forest Investigative Site

Durban, KZ-Natal, South Africa

Site Status

Forest Investigative Site

Cape Town, W. Cape, South Africa

Site Status

Forest Investigative Site

Cape Town, W. Cape, South Africa

Site Status

Countries

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United States Australia New Zealand South Africa

Other Identifiers

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MEM-MD-71

Identifier Type: -

Identifier Source: org_study_id