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

This study has been completed.
Sponsor:
Information provided by:
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT00469456
First received: May 2, 2007
Last updated: December 21, 2009
Last verified: December 2009
History of Changes

May 2, 2007
December 21, 2009
April 2007
November 2008   (final data collection date for primary outcome measure)
Change From Baseline in Functional Linguistic Communication Inventory (FLCI) at Week 12 [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]
Functional Linguistic Communication Inventory (FLCI) at Week 12 [ Time Frame: Week 12 ]
Complete list of historical versions of study NCT00469456 on ClinicalTrials.gov Archive Site
Change From Baseline in American Speech-Language-Hearing Association Functional Assessment of Communication Skills for Adults (ASHA FACS) [Total Score of Social Communication and Communication of Basic Needs Subscores] at Week 12 [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]
American Speech-Language-Hearing Association Functional Assessment of Communication Skills for Adults (ASHA FACS) at Week 12 [ Time Frame: Week 12 ]
Not Provided
Not Provided
 
Effect of Memantine on Functional Communication in Patients With Alzheimer's Disease
A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Efficacy of Memantine on Functional Communication in Patients With Alzheimer's Disease (AD)

The objective of this study is to evaluate the effect of memantine versus placebo on functional communication in patients with Alzheimer's Disease
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Alzheimer's Disease
  • Drug: Memantine
    Memantine 20mg (10mg twice daily) oral administration for 12 weeks
    Other Name: Namenda®
  • Drug: placebo
    Placebo oral administration twice daily for 12 weeks
  • Active Comparator: 1
    Memantine 20mg (10mg twice daily) oral administration for 12 weeks
    Intervention: Drug: Memantine
  • Placebo Comparator: 2
    Placebo oral administration twice daily for 12 weeks
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
265
November 2008
November 2008   (final data collection date for primary outcome measure)

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
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia,   New Zealand,   South Africa
 
NCT00469456
MEM-MD-71
Not Provided
Stephen Graham, PhD, Sr. Director, Forest Research Institute, a division of Forest Laboratories, Inc.
Forest Laboratories
Not Provided
Principal Investigator: F C Potocnik
Forest Laboratories
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP