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

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

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

Conditions
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Alzheimer's Disease

Intervention / Treatment
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* Drug: Memantine
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Memantine 20mg (10mg twice daily) oral administration for 12 weeks | Drug: Memantine<br>* Memantine 20mg (10mg twice daily) oral administration for 12 weeks<br>* Other names: Namenda®;|
| Placebo Comparator: 2<br>Placebo oral administration twice daily for 12 weeks | Drug: placebo<br>* Placebo oral administration twice daily for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Functional Linguistic Communication Inventory (FLCI) at Week 12 | FLCI is a standardized & validated instrument for evaluating functional communication in pts with moderate-to-severe Alzheimer's that can be used to obtain Baseline information & to track patients' capabilities thereafter. The FLCI evaluates 10 areas: greeting and naming, answering questions, writing, sign comprehension, object-to-picture matching, word reading and comprehension, following commands, pantomime, gesture, and conversation. The FLCI total score ranges from 0 to 87, a higher score denotes better functional communication, and takes approximately 30 minutes to complete. | Baseline to Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | The ASHA FACS assesses & measures functional communication skills of adults with speech, language, & cognitive communication disorders. The measure, which comprises 43 items and takes approximately 20 minutes to complete, assesses functional communication in four areas: social communication; communication of basic needs; reading, writing, and number concepts; and daily planning. Total score of subdomains [Social Communication and Communication of Basic Needs] ranges from 0-196. A higher score denotes better communication. | Baseline to Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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memantine, Alzheimer's Disease, communication