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The objective of this study is to evaluate the effect of memantine versus placebo on functional communication in patients with Alzheimer's Disease
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Memantine 20mg (10mg twice daily) oral administration for 12 weeks |
|
| 2 | Placebo Comparator | Placebo oral administration twice daily for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Memantine | Drug | Memantine 20mg (10mg twice daily) oral administration for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | The ASHA FACS assesses & measures functional communication skills of adults with speech, language, & cognitive communication disorders. The measure, which comprises 43 items and takes approximately 20 minutes to complete, assesses functional communication in four areas: social communication; communication of basic needs; reading, writing, and number concepts; and daily planning. Total score of subdomains [Social Communication and Communication of Basic Needs] ranges from 0-196. A higher score denotes better communication. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| F C Potocnik | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Forest Investigative Site | East Gosford | New South Wales | 2250 | Australia | ||
| Forest Investigative Site |
Study consisted of up to 2 weeks single-blind placebo treatment followed by 12 weeks double-blind treatment. At end of single-blind placebo treatment, patients (pts) meeting entry criteria were randomized (1:1) to 1 of 2 double-blind treatment groups receiving memantine or placebo. Pts not meeting inclusion/exclusion criteria were not randomized.
The recruitment period was from May 24, 2007 to July 29, 2008 at 25 centers in three countries [14 in Australia, 3 in New Zealand, 8 in South Africa].
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Matching placebo, oral administration, twice daily for 12 weeks |
| FG001 | Memantine | Memantine 20mg (10mg twice daily), oral administration for 12 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| placebo | Drug | Placebo oral administration twice daily for 12 weeks |
|
| Baseline to Week 12 |
| 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 |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Matching placebo, oral administration, twice daily for 12 weeks |
| BG001 | Memantine | Memantine 20mg (10mg twice daily), oral administration for 12 weeks |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
| |||||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||
| Sex: Female, Male | One patient was randomized but did not receive study drug. | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Primary efficacy analysis was based on the Intent-to-Treat (ITT) Population. The ITT Population will consist of all patients in the Safety Population who had at least one post-Baseline assessment of the primary efficacy parameter, FLCI. The last-observation-carried-forward approach was used to impute missing post-Baseline values. | Posted | Oct 2009 | Least Squares Mean | Standard Error | Units on a scale | Baseline to Week 12 |
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| 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 | The ASHA FACS assesses & measures functional communication skills of adults with speech, language, & cognitive communication disorders. The measure, which comprises 43 items and takes approximately 20 minutes to complete, assesses functional communication in four areas: social communication; communication of basic needs; reading, writing, and number concepts; and daily planning. Total score of subdomains [Social Communication and Communication of Basic Needs] ranges from 0-196. A higher score denotes better communication. | The secondary efficacy analysis was based on the ITT Population. The last-observation-carried-forward approach was used to impute missing post-Baseline values. | Posted | Nov 2009 | Least Squares Mean | Standard Error | Units on a scale | Baseline to Week 12 |
|
|
Occurring on or after the date of the first dose of double-blind study medication and within 30 days of the date of last dose of double-blind study medication.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Matching placebo, oral administration, twice daily for 12 weeks | 13 | 129 | 2 | 129 | ||
| EG001 | Memantine | Memantine 20mg (10mg twice daily), oral administration for 12 weeks | 4 | 135 | 7 | 135 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Syncope | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Angina Unstable | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Atrioventricular Block First Degree | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Bile Duct Stone | Hepatobiliary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Cerebellar Infarction | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| Femur Fracture | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| Gastric Ulcer | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Gastrointeritis Yersinia | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Hiatus Hernia | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Pneumonia Aspiration | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Squamous Cell Carcinoma of Skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Vestibular Disorder | Ear and labyrinth disorders | MedDRA 10.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
Sponsor can review results communications prior to public release & can embargo communications re: results for 90 days from time submitted to sponsor for review. PI shall not disclose sponsor's confidential info. Upon sponsor's request, PI shall delete any proprietary info & shall not include raw data in pub. On sponsor's request, PI shall delay submission for any pub while sponsor files patent apps. If trial is multi-center, PI agrees that first publication shall be a multi-center pub.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stephen Graham, PhD | Forest Research Institute, a subsidiary of Forest Laboratories Inc. | 201-427-8156 | stephen.graham@frx.com |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D003142 | Communication |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D008559 | Memantine |
| ID | Term |
|---|---|
| D000547 | Amantadine |
| D000218 | Adamantane |
| D001952 | Bridged-Ring Compounds |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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| Title | Measurements |
|---|---|
|
| 75-84 years |
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| >=85 years |
|
| Male |
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| South Africa |
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| New Zealand |
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| Counts |
|---|
| Participants |
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