Effect of Memantine on Functional Communication in Patients With Alzheimer's Disease
A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Efficacy of Memantine on Functional Communication in Patients With Alzheimer's Disease (AD)
1 other identifier
interventional
265
3 countries
25
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Apr 2007
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2007
CompletedFirst Submitted
Initial submission to the registry
May 2, 2007
CompletedFirst Posted
Study publicly available on registry
May 4, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2008
CompletedResults Posted
Study results publicly available
December 7, 2009
CompletedDecember 24, 2009
December 1, 2009
1.6 years
May 2, 2007
November 3, 2009
December 21, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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
Study Arms (2)
1
ACTIVE COMPARATORMemantine 20mg (10mg twice daily) oral administration for 12 weeks
2
PLACEBO COMPARATORPlacebo oral administration twice daily for 12 weeks
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Forest Investigative Site
East Gosford, New South Wales, 2250, Australia
Forest Investigative Site
Hornsby, New South Wales, 2077, Australia
Forest Investigative Site
Kogarah, New South Wales, 2217, Australia
Forest Investigative Site
Newcastle, New South Wales, 2300, Australia
Forest Investigative Site
Randwick, New South Wales, 2031, Australia
Forest Investigative Site
Chermside, Queensland, 4032, Australia
Forest Investigative Site
Toowoomba, Queensland, 4350, Australia
Forest Investigative Site
Adelaide, South Australia, 5000, Australia
Forest Investigative Site
Woodville, South Australia, 5011, Australia
Forest Investigative Site
Box Hill, Victoria, 3182, Australia
Forest Investigative Site
Frankston, Victoria, 3199, Australia
Forest Investigative Site
Heidelberg West, Victoria, 3081, Australia
Forest Investigative Site
Kew, Victoria, 3101, Australia
Forest Investigative Site
Perth, Western Australia, 6001, Australia
Forest Investigative Site
Christchurch, 8022, New Zealand
Forest Investigative Site
North Shore, 0622, New Zealand
Forest Investigative Site
Timaru, 8022, New Zealand
Forest Investigative Site
George, E. Cape, 6529, South Africa
Forest Investigative Site
Port Elizabeth, E. Cape, 6014, South Africa
Forest Investigative Site
Johannesburg, Gauteng, 2052, South Africa
Forest Investigative Site
Johannesburg, Gauteng, 4001, South Africa
Forest Investigative Site
Pretoria, Gauteng, 0182, South Africa
Forest Investigative Site
Durban, KZ-Natal, 4001, South Africa
Forest Investigative Site
Cape Town, W. Cape, 7500, South Africa
Forest Investigative Site
Cape Town, W. Cape, 7530, South Africa
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Stephen Graham, PhD
- Organization
- Forest Research Institute, a subsidiary of Forest Laboratories Inc.
Study Officials
- PRINCIPAL INVESTIGATOR
F C Potocnik
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 2, 2007
First Posted
May 4, 2007
Study Start
April 1, 2007
Primary Completion
November 1, 2008
Study Completion
November 1, 2008
Last Updated
December 24, 2009
Results First Posted
December 7, 2009
Record last verified: 2009-12