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

NCT00857233 | Terminated Phase 3 Results

• 1 other identifier: 10252
• Study Type: interventional
• Target: 297
• Locations: 1 country
• Sites: 33

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.

Conditions

Alzheimer's Disease

Keywords

Alzheimer's Disease

Outcome Measures

Primary Outcomes (2)

• Number of Patients With Adverse Events (AEs)

  Overview of AEs

  Baseline to Week 24

• Percentage of Patients Who Withdrew Due to Intolerance to Treatment

  Baseline to Week 24

Secondary Outcomes (4)

• Long-term Efficacy of Memantine on Behavioural Symptoms Using the Neuropsychiatric Inventory (NPI) - 12 Items Version Total Score.

  Baseline and Week 24

• Long-term Efficacy of Memantine on Cognition Using the Severe Impairment Battery (SIB) Total Score.

  Baseline and Week 24

• Long-term Efficacy of Memantine on Global Condition Using the Clinician's Interview-Based Impression of Change-Plus Version (CIBIC-plus).

  Week 24

• 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

  Baseline and Week 24

Study Arms (1)

Memantine

EXPERIMENTAL

Drug: Memantine

Interventions

Memantine DRUG

20 mg oral tablets once daily

Also known as: Ebixa®

Memantine

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Diseases/medication which judged by the investigator could interfere with the assessments of safety, tolerability or efficacy.

Sponsors & Collaborators

• H. Lundbeck A/S: lead

Study Sites (33)

CA019

Edmonton, Alberta, T5G 0B7, Canada

Location

CA033

Kelowna, British Columbia, V1W 4V5, Canada

Location

CA043

Kelowna, British Columbia, V1Y 3G8, Canada

Location

CA042

Penticton, British Columbia, V2A 5C8, Canada

Location

CA034

Winnipeg, Manitoba, R3M 0X9, Canada

Location

CA022

Saint John, New Brunswick, Canada

Location

CA045

Pictou, Nova Scotia, B0K 1H0, Canada

Location

CA032

Burlington, Ontario, L7M 4Y1, Canada

Location

CA029

Orangeville, Ontario, L9W 2E1, Canada

Location

CA004

Ottawa, Ontario, K1N 5C8, Canada

Location

CA038

Peterborough, Ontario, K9H 2P4, Canada

Location

CA009

Toronto, Ontario, M3B 2W7, Canada

Location

CA005

Beauport, Quebec, G1J 2G3, Canada

Location

CA023

Greenfield Park, Quebec, J4V 2J2, Canada

Location

CA013

Montreal, Quebec, H1T 2M4, Canada

Location

CA012

Sherbrooke, Quebec, J1J 3H5, Canada

Location

CA030

Vanier, Quebec, G1M 2R9, Canada

Location

CA017

Verdun, Quebec, H4H 1R3, Canada

Location

CA015

Regina, Saskatchewan, S4T 1A5, Canada

Location

CA040

Saskatoon, Saskatchewan, S7N 0W8, Canada

Location

CA044

Chatham, N7L 1B7, Canada

Location

CA007

Kentville, B4N 4K9, Canada

Location

CA046

Kentville, B4N 4K9, Canada

Location

CA001

Kingston, K7L 2V7, Canada

Location

CA003

London, N6A 4V2, Canada

Location

CA002

London, N6C5J1, Canada

Location

CA016

Moncton, E1C 4B7, Canada

Location

CA024

Montreal, H2X 3J4, Canada

Location

CA014

Montreal, H3T 1E2, Canada

Location

CA011

Montreal, H4H 1R3, Canada

Location

CA031

Sherbrooke, J1J 2B8, Canada

Location

CA006

Toronto, M6M 3Z5, Canada

Location

CA037

Windsor, N8X 5A6, Canada

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Memantine

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Amantadine; Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Limitations and Caveats

Long recruitment, premature termination.

Results Point of Contact

• Title: H. Lundbeck A/S
• Organization: H. Lundbeck A/S

LundbeckClinicalTrials@lundbeck.com

+45 3630 1311

Study Officials

• Email contact via H. Lundbeck A/S

  LundbeckClinicalTrials@lundbeck.com

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2009
• First Posted: March 6, 2009
• Study Start: June 1, 2004
• Primary Completion: July 1, 2010
• Study Completion: October 1, 2010
• Last Updated: August 29, 2012
• Results First Posted: August 29, 2012

Record last verified: 2012-07

Locations

CA (33)