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

Alzheimer's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00469456
• Other study ID #: MEM-MD-71
• Status: Completed
• Phase: Phase 4
• First received: May 2, 2007
• Last updated: December 21, 2009
• Start date: April 2007
• Est. completion date: November 2008

Study information

• Verified date: December 2009
• Source: Forest Laboratories
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics CommitteeAustralia: Department of Health and Ageing Therapeutic Goods AdministrationSouth Africa: National Health Research Ethics CouncilSouth Africa: Medicines Control CouncilNew Zealand: Health Research CouncilNew Zealand: Medsafe
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 265
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• Memantine
Memantine 20mg (10mg twice daily) oral administration for 12 weeks
• placebo
Placebo oral administration twice daily for 12 weeks

Locations

Country	Name	City	State
Australia	Forest Investigative Site	Adelaide	South Australia
Australia	Forest Investigative Site	Box Hill	Victoria
Australia	Forest Investigative Site	Chermside	Queensland
Australia	Forest Investigative Site	East Gosford	New South Wales
Australia	Forest Investigative Site	Frankston	Victoria
Australia	Forest Investigative Site	Heidelberg West	Victoria
Australia	Forest Investigative Site	Hornsby	New South Wales
Australia	Forest Investigative Site	Kew	Victoria
Australia	Forest Investigative Site	Kogarah	New South Wales
Australia	Forest Investigative Site	Newcastle	New South Wales
Australia	Forest Investigative Site	Perth	Western Australia
Australia	Forest Investigative Site	Randwick	New South Wales
Australia	Forest Investigative Site	Toowoomba	Queensland
Australia	Forest Investigative Site	Woodville	South Australia
New Zealand	Forest Investigative Site	Christchurch
New Zealand	Forest Investigative Site	North Shore
New Zealand	Forest Investigative Site	Timaru
South Africa	Forest Investigative Site	Cape Town	W. Cape
South Africa	Forest Investigative Site	Cape Town	W. Cape
South Africa	Forest Investigative Site	Durban	KZ-Natal
South Africa	Forest Investigative Site	George	E. Cape
South Africa	Forest Investigative Site	Johannesburg	Gauteng
South Africa	Forest Investigative Site	Johannesburg	Gauteng
South Africa	Forest Investigative Site	Port Elizabeth	E. Cape
South Africa	Forest Investigative Site	Pretoria	Gauteng

Sponsors (1)

Lead Sponsor	Collaborator
Forest Laboratories

Countries where clinical trial is conducted

Australia,  New Zealand,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Functional Linguistic Communication Inventory (FLCI) at Week 12		Baseline to Week 12	No
Secondary	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	No