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

Phase 4

Completed

• Conditions: Alzheimer's Disease
• Interventions: Drug: placebo; Drug: Memantine

• Registration Number: NCT00469456
• Lead Sponsor: Forest Laboratories

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04
• Study First Submitted: 2007-05-02
• Study First Submitted QC: 2007-05-03
• Study First Posted: 2007-05-04
• Primary Completion: 2008-11
• Study Completion: 2008-11
• Results First Submitted: 2009-11-03
• Results First Submitted QC: 2009-11-03
• Status Verified: 2009-12
• Results First Posted: 2009-12-07
• Last Update Submitted: 2009-12-21
• Last Update Posted: 2009-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 265

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	placebo	Placebo oral administration twice daily for 12 weeks
1	Memantine	Memantine 20mg (10mg twice daily) oral administration for 12 weeks

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Functional Linguistic Communication Inventory (FLCI) at Week 12	Baseline to 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.

Secondary Outcome Measures

Name	Time	Method
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	Baseline to 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.

Trial Locations

Locations (1)

Forest Investigative Site; 🇿🇦 Cape Town, W. Cape, South Africa