Clinical trial NCT00469456: Effect of Memantine on Functional Communication in Patients With Alzheimer's Disease
Official title: A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Efficacy of Memantine on Functional Communication in Patients With Alzheimer's Disease (AD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Alzheimer's Disease
Keywords: memantine
Alzheimer's Disease
communication
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
First posted: 2007-05-04
Enrollment: 265
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in Functional Linguistic Communication Inventory (FLCI) at Week 12
timeFrame: Baseline to Week 12
Secondary outcomes:
measure: 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
timeFrame: Baseline to Week 12
Other outcomes:
Locations:
city: East Gosford
country: Australia
facility: Forest Investigative Site
state: New South Wales
city: Hornsby
country: Australia
facility: Forest Investigative Site
state: New South Wales
city: Kogarah
country: Australia
facility: Forest Investigative Site
state: New South Wales
city: Newcastle
country: Australia
facility: Forest Investigative Site
state: New South Wales
city: Randwick
country: Australia
facility: Forest Investigative Site
state: New South Wales
city: Chermside
country: Australia
facility: Forest Investigative Site
state: Queensland
city: Toowoomba
country: Australia
facility: Forest Investigative Site
state: Queensland
city: Adelaide
country: Australia
facility: Forest Investigative Site
state: South Australia
city: Woodville
country: Australia
facility: Forest Investigative Site
state: South Australia
city: Box Hill
country: Australia
facility: Forest Investigative Site
state: Victoria
city: Frankston
country: Australia
facility: Forest Investigative Site
state: Victoria
city: Heidelberg West
country: Australia
facility: Forest Investigative Site
state: Victoria
city: Kew
country: Australia
facility: Forest Investigative Site
state: Victoria
city: Perth
country: Australia
facility: Forest Investigative Site
state: Western Australia
city: Christchurch
country: New Zealand
facility: Forest Investigative Site
city: North Shore
country: New Zealand
facility: Forest Investigative Site
city: Timaru
country: New Zealand
facility: Forest Investigative Site
city: George
country: South Africa
facility: Forest Investigative Site
state: E. Cape
city: Port Elizabeth
country: South Africa
facility: Forest Investigative Site
state: E. Cape
city: Johannesburg
country: South Africa
facility: Forest Investigative Site
state: Gauteng
city: Johannesburg
country: South Africa
facility: Forest Investigative Site
state: Gauteng
city: Pretoria
country: South Africa
facility: Forest Investigative Site
state: Gauteng
city: Durban
country: South Africa
facility: Forest Investigative Site
state: KZ-Natal
city: Cape Town
country: South Africa
facility: Forest Investigative Site
state: W. Cape
city: Cape Town
country: South Africa
facility: Forest Investigative Site
state: W. Cape
Study officials:
name: F C Potocnik
role: PRINCIPAL_INVESTIGATOR
References: