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

Forest Laboratories265 enrolled

Overview

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

265

Conditions

Alzheimer's Disease

Interventions

MemantineDRUG

Memantine 20mg (10mg twice daily) oral administration for 12 weeks

placeboDRUG

Placebo oral administration twice daily for 12 weeks

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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

Locations (25)

Forest Investigative Site

East Gosford, New South Wales, Australia

Outcomes

Primary Outcomes

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.

Time frame: Baseline to Week 12

Secondary Outcomes

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.

Time frame: Baseline to Week 12

Data from ClinicalTrials.gov

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