Clinical trial NCT00857233: Safety and Tolerability of Memantine in Moderate to Severe Alzheimer's Disease
Official title: An Open-label Extension Study Examining the Safety and Tolerability of Memantine in Patients With Moderate to Severe Dementia of the Alzheimer's Type Having Completed Study 10158
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Alzheimer's Disease
Keywords: Alzheimer's Disease
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2009-03-06
Enrollment: 297
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Patients With Adverse Events (AEs)
timeFrame: Baseline to Week 24
measure: Percentage of Patients Who Withdrew Due to Intolerance to Treatment
timeFrame: Baseline to Week 24
Secondary outcomes:
measure: Long-term Efficacy of Memantine on Behavioural Symptoms Using the Neuropsychiatric Inventory (NPI) - 12 Items Version Total Score.
timeFrame: Baseline and Week 24
measure: Long-term Efficacy of Memantine on Cognition Using the Severe Impairment Battery (SIB) Total Score.
timeFrame: Baseline and Week 24
measure: Long-term Efficacy of Memantine on Global Condition Using the Clinician's Interview-Based Impression of Change-Plus Version (CIBIC-plus).
timeFrame: Week 24
measure: Long-term Efficacy of Memantine on Functioning Using the Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL) 19-item Version Total Score
timeFrame: Baseline and Week 24
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: CA019
state: Alberta
city: Kelowna
country: Canada
facility: CA033
state: British Columbia
city: Kelowna
country: Canada
facility: CA043
state: British Columbia
city: Penticton
country: Canada
facility: CA042
state: British Columbia
city: Winnipeg
country: Canada
facility: CA034
state: Manitoba
city: St. John
country: Canada
facility: CA022
state: New Brunswick
city: Pictou
country: Canada
facility: CA045
state: Nova Scotia
city: Burlington
country: Canada
facility: CA032
state: Ontario
city: Orangeville
country: Canada
facility: CA029
state: Ontario
city: Ottawa
country: Canada
facility: CA004
state: Ontario
city: Peterborough
country: Canada
facility: CA038
state: Ontario
city: Toronto
country: Canada
facility: CA009
state: Ontario
city: Beauport
country: Canada
facility: CA005
state: Quebec
city: Greenfield Park
country: Canada
facility: CA023
state: Quebec
city: Montreal
country: Canada
facility: CA013
state: Quebec
city: Sherbrooke
country: Canada
facility: CA012
state: Quebec
city: Vanier
country: Canada
facility: CA030
state: Quebec
city: Verdun
country: Canada
facility: CA017
state: Quebec
city: Regina
country: Canada
facility: CA015
state: Saskatchewan
city: Saskatoon
country: Canada
facility: CA040
state: Saskatchewan
city: Chatham
country: Canada
facility: CA044
city: Kentville
country: Canada
facility: CA007
city: Kentville
country: Canada
facility: CA046
city: Kingston
country: Canada
facility: CA001
city: London
country: Canada
facility: CA003
city: London
country: Canada
facility: CA002
city: Moncton
country: Canada
facility: CA016
city: Montreal
country: Canada
facility: CA024
city: Montreal
country: Canada
facility: CA014
city: Montreal
country: Canada
facility: CA011
city: Sherbrooke
country: Canada
facility: CA031
city: Toronto
country: Canada
facility: CA006
city: Windsor
country: Canada
facility: CA037
Study officials:
affiliation: LundbeckClinicalTrials@lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References: