Safety and Tolerability of Memantine in Moderate to Severe Alzheimer's Disease

NCT ID: NCT00857233

Last Updated: 2012-08-29

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

PHASE3

Total Enrollment

297 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2010-10-31

Brief Summary

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The primary objective of the study was to examine the safety and tolerability of memantine in outpatients with moderate to severe Alzheimer's Disease.

Detailed Description

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Memantine is a moderate affinity, uncompetitive N-methyl-D-aspartate (NMDA) receptor antagonist. Pre-clinical studies have demonstrated that memantine can decrease the neuronal toxicity associated with excessive glutamate release and calcium overload in neurons. Results from clinical trials in patients with moderate to severe Alzheimer's Disease (AD) have demonstrated memantine's efficacy and safety by showing positive treatment effects on cognitive, global and functional decline.

The purpose of this 24-week open-label extension study was to collect additional long-term safety and tolerability data on memantine in patients who completed the lead-in double-blind placebo-controlled Study 10158.

In agreement with Health Canada the study was prematurely terminated due to recruitment difficulties in the lead-in Study 10158. Patients ongoing in the study when the decision to terminate was taken were allowed to complete it.

Conditions

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Alzheimer's Disease

Keywords

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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

20 mg oral tablets once daily

Interventions

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Memantine

20 mg oral tablets once daily

Intervention Type DRUG

Other Intervention Names

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Ebixa®

Eligibility Criteria

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Inclusion Criteria

* Ambulatory outpatients with moderate to severe dementia of the Alzheimer's type who have completed the 24-week Study 10158 and who have a knowledgeable and reliable caregiver who will accompany the patient to all clinic visits during the course of the study.

Exclusion Criteria

* Diseases/medication which judged by the investigator could interfere with the assessments of safety, tolerability or efficacy.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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H. Lundbeck A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Email contact via H. Lundbeck A/S

Role: STUDY_DIRECTOR

[email protected]

Locations

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CA019

Edmonton, Alberta, Canada

Site Status

CA033

Kelowna, British Columbia, Canada

Site Status

CA043

Kelowna, British Columbia, Canada

Site Status

CA042

Penticton, British Columbia, Canada

Site Status

CA034

Winnipeg, Manitoba, Canada

Site Status

CA022

Saint John, New Brunswick, Canada

Site Status

CA045

Pictou, Nova Scotia, Canada

Site Status

CA032

Burlington, Ontario, Canada

Site Status

CA029

Orangeville, Ontario, Canada

Site Status

CA004

Ottawa, Ontario, Canada

Site Status

CA038

Peterborough, Ontario, Canada

Site Status

CA009

Toronto, Ontario, Canada

Site Status

CA005

Beauport, Quebec, Canada

Site Status

CA023

Greenfield Park, Quebec, Canada

Site Status

CA013

Montreal, Quebec, Canada

Site Status

CA012

Sherbrooke, Quebec, Canada

Site Status

CA030

Vanier, Quebec, Canada

Site Status

CA017

Verdun, Quebec, Canada

Site Status

CA015

Regina, Saskatchewan, Canada

Site Status

CA040

Saskatoon, Saskatchewan, Canada

Site Status

CA044

Chatham, , Canada

Site Status

CA007

Kentville, , Canada

Site Status

CA046

Kentville, , Canada

Site Status

CA001

Kingston, , Canada

Site Status

CA003

London, , Canada

Site Status

CA002

London, , Canada

Site Status

CA016

Moncton, , Canada

Site Status

CA024

Montreal, , Canada

Site Status

CA014

Montreal, , Canada

Site Status

CA011

Montreal, , Canada

Site Status

CA031

Sherbrooke, , Canada

Site Status

CA006

Toronto, , Canada

Site Status

CA037

Windsor, , Canada

Site Status

Countries

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Canada

Other Identifiers

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10252

Identifier Type: -

Identifier Source: org_study_id