Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00469456




Registration number
NCT00469456
Ethics application status
Date submitted
2/05/2007
Date registered
4/05/2007
Date last updated
24/12/2009

Titles & IDs
Public title
Effect of Memantine on Functional Communication in Patients With Alzheimer's Disease
Scientific title
A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Efficacy of Memantine on Functional Communication in Patients With Alzheimer's Disease (AD)
Secondary ID [1] 0 0
MEM-MD-71
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer's Disease 0 0
Condition category
Condition code
Neurological 0 0 0 0
Alzheimer's disease
Neurological 0 0 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Memantine
Treatment: Drugs - placebo

Active comparator: 1 - Memantine 20mg (10mg twice daily) oral administration for 12 weeks

Placebo comparator: 2 - Placebo oral administration twice daily for 12 weeks


Treatment: Drugs: Memantine
Memantine 20mg (10mg twice daily) oral administration for 12 weeks

Treatment: Drugs: placebo
Placebo oral administration twice daily for 12 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in Functional Linguistic Communication Inventory (FLCI) at Week 12
Timepoint [1] 0 0
Baseline to Week 12
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
Baseline to Week 12

Eligibility
Key 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
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2008
Sample size
Target
Accrual to date
Final
265
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Forest Investigative Site - East Gosford
Recruitment hospital [2] 0 0
Forest Investigative Site - Hornsby
Recruitment hospital [3] 0 0
Forest Investigative Site - Kogarah
Recruitment hospital [4] 0 0
Forest Investigative Site - Newcastle
Recruitment hospital [5] 0 0
Forest Investigative Site - Randwick
Recruitment hospital [6] 0 0
Forest Investigative Site - Chermside
Recruitment hospital [7] 0 0
Forest Investigative Site - Toowoomba
Recruitment hospital [8] 0 0
Forest Investigative Site - Adelaide
Recruitment hospital [9] 0 0
Forest Investigative Site - Woodville
Recruitment hospital [10] 0 0
Forest Investigative Site - Box Hill
Recruitment hospital [11] 0 0
Forest Investigative Site - Frankston
Recruitment hospital [12] 0 0
Forest Investigative Site - Heidelberg West
Recruitment hospital [13] 0 0
Forest Investigative Site - Kew
Recruitment hospital [14] 0 0
Forest Investigative Site - Perth
Recruitment postcode(s) [1] 0 0
2250 - East Gosford
Recruitment postcode(s) [2] 0 0
2077 - Hornsby
Recruitment postcode(s) [3] 0 0
2217 - Kogarah
Recruitment postcode(s) [4] 0 0
2300 - Newcastle
Recruitment postcode(s) [5] 0 0
2031 - Randwick
Recruitment postcode(s) [6] 0 0
4032 - Chermside
Recruitment postcode(s) [7] 0 0
4350 - Toowoomba
Recruitment postcode(s) [8] 0 0
5000 - Adelaide
Recruitment postcode(s) [9] 0 0
5011 - Woodville
Recruitment postcode(s) [10] 0 0
3182 - Box Hill
Recruitment postcode(s) [11] 0 0
3199 - Frankston
Recruitment postcode(s) [12] 0 0
3081 - Heidelberg West
Recruitment postcode(s) [13] 0 0
3101 - Kew
Recruitment postcode(s) [14] 0 0
6001 - Perth
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Christchurch
Country [2] 0 0
New Zealand
State/province [2] 0 0
North Shore
Country [3] 0 0
New Zealand
State/province [3] 0 0
Timaru
Country [4] 0 0
South Africa
State/province [4] 0 0
E. Cape
Country [5] 0 0
South Africa
State/province [5] 0 0
Gauteng
Country [6] 0 0
South Africa
State/province [6] 0 0
KZ-Natal
Country [7] 0 0
South Africa
State/province [7] 0 0
W. Cape

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Forest Laboratories
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
F C Potocnik
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00469456