Official Title: “A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Efficacy of Memantine on Functional Communication in Patients With Alzheimer's Disease”

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

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: November 2008

Intervention(s) in this Clinical Trial

• Drug: Memantine
  • Memantine oral administration twice daily for 12 weeks
• Drug: placebo
  • Placebo oral administration twice daily for 12 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Memantine oral administration twice daily for 12 weeks
• Placebo Comparator: 2
  • Placebo oral administration twice daily for 12 weeks

Primary Measures

• Functional Linguistic Communication Inventory (FLCI) at Week 12
  • Time Frame: Week 12
    

Secondary Measures

• American Speech-Language-Hearing Association Functional Assessment of Communication Skills for Adults (ASHA FACS) at Week 12
  • Time Frame: Week 12
    

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
• No 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 50 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Forest Laboratories

Overall Clinical Trial Officials and Contacts

F C Potocnik Principal Investigator Unaffiliated  

Information obtained from ClinicalTrials.gov on January 08, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00469456

Study ID Number: MEM-MD-71

ClinicalTrials.gov Identifier: NCT00469456

Health Authority: Australia: Human Research Ethics Committee