Effect 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...
Brief Summary
Official Title: “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
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
- Study Primary Completion Date: November 2008
Intervention(s) in this Clinical Trial
- Drug: Memantine
- Memantine 20mg (10mg twice daily) oral administration 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 20mg (10mg twice daily) oral administration for 12 weeks
- Placebo Comparator: 2
- Placebo oral administration twice daily for 12 weeks
Outcome Measures for this Clinical Trial
Primary Measures
- Change From Baseline in Functional Linguistic Communication Inventory (FLCI) at Week 12
- Time Frame: Baseline to Week 12
Safety Issue?: No
- Time Frame: Baseline to Week 12
Secondary Measures
- 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
Safety Issue?: No
- Time Frame: Baseline to Week 12
Criteria for Participation in this Clinical Trial
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
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
Clinical Trial Investigator Information
Lead Investigator: Forest Laboratories Industry
Overall Clinical Trial Officials and Contacts
F C Potocnik Principal Investigator
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
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
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00469456
