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

Information source: Forest Laboratories
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Alzheimer's Disease

Intervention: Memantine (Drug); placebo (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Forest Laboratories

Official(s) and/or principal investigator(s):
F C Potocnik, Principal Investigator

Summary

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

Clinical Details

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

Primary outcome: Change From Baseline in Functional Linguistic Communication Inventory (FLCI) at Week 12

Secondary outcome: 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

Eligibility

Minimum age: 50 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

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, 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, Cape Town, W. Cape 7500, South Africa

Forest Investigative Site, Cape Town, W. Cape 7530, South Africa

Forest Investigative Site, Perth, Western Australia 6001, Australia

Additional Information

Starting date: April 2007
Last updated: December 21, 2009

Page last updated: August 23, 2015

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