Alzheimer's DiseasePhase 4NCT00469456
Effect of Memantine on Functional Communication in Patients With Alzheimer's Disease
A Phase 4 study testing Memantine in people with Alzheimer's Disease, run by Forest Laboratories at 25 sites in 3 countries.
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 Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- Memantine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 265 participants
- Where
- 25 sitesin 3 countries
- Study dates
- Apr 2007to Nov 2008
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
25 sites in 3 countries.
25 sites in 3 countries
Australia14 sites
Forest Investigative Site
Adelaide, South Australia, 5000
Forest Investigative Site
Box Hill, Victoria, 3182
Forest Investigative Site
Chermside, Queensland, 4032
Forest Investigative Site
East Gosford, New South Wales, 2250
Forest Investigative Site
Frankston, Victoria, 3199
Forest Investigative Site
Heidelberg West, Victoria, 3081
Forest Investigative Site
Hornsby, New South Wales, 2077
Forest Investigative Site
Kew, Victoria, 3101
Forest Investigative Site
Kogarah, New South Wales, 2217
Forest Investigative Site
Newcastle, New South Wales, 2300
Forest Investigative Site
Perth, Western Australia, 6001
Forest Investigative Site
Randwick, New South Wales, 2031
Forest Investigative Site
Toowoomba, Queensland, 4350
Forest Investigative Site
Woodville, South Australia, 5011
South Africa8 sites
Forest Investigative Site
Cape Town, W. Cape, 7500
Forest Investigative Site
Cape Town, W. Cape, 7530
Forest Investigative Site
Durban, KZ-Natal, 4001
Forest Investigative Site
George, E. Cape, 6529
Forest Investigative Site
Johannesburg, Gauteng, 2052
Forest Investigative Site
Johannesburg, Gauteng, 4001
Forest Investigative Site
Port Elizabeth, E. Cape, 6014
Forest Investigative Site
Pretoria, Gauteng, 0182
New Zealand3 sites
Forest Investigative Site
Christchurch, 8022
Forest Investigative Site
North Shore, 0622
Forest Investigative Site
Timaru, 8022
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Efficacy of Memantine on Functional Communication in Patients With Alzheimer's Disease (AD)
The objective of this study is to evaluate the effect of memantine versus placebo on functional communication in patients with Alzheimer's Disease
- Conditions
- Alzheimer's Disease
- Being tested
- Memantine, placebo
- Keywords
- memantine, Alzheimer's Disease, communication
- Medical subject headings
- Alzheimer Disease, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MemantineDrug
Also called Namenda®
Memantine 20mg (10mg twice daily) oral administration for 12 weeks
placeboDrug
Placebo oral administration twice daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Memantine 20mg (10mg twice daily) oral administration for 12 weeks Receives: Drug: Memantine |
| 2 | Placebo comparator | Placebo oral administration twice daily for 12 weeks Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Week 12
Secondary outcomes (1)
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.
Measured: Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2007 (estimated)
- Study startApr 2007
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 265 participants (actual)
Sponsor and investigators
- Lead sponsor
- Forest Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- F C Potocnik, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00469456
- Sponsor's protocol ID
- MEM-MD-71
- Status last verified
- Dec 2009
- First submitted
- 2 May 2007
- Last updated
- 24 Dec 2009
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Efficacy of Memantine on Functional Communication in Patients With Alzheimer's Disease (AD)
- ClinicalTrials.gov ID
- NCT00469456
- Acronym / sponsor ID
- MEM-MD-71
- Conditions
- Alzheimer's Disease
- Keywords
- memantine, Alzheimer's Disease, communication
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 265 participants (actual)
- Lead sponsor
- Forest LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- Apr 2007
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 4 May 2007 (estimated)
- Results
- Posted 7 Dec 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the effect of memantine versus placebo on functional communication in patients with Alzheimer's Disease
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: MemantineMemantine 20mg (10mg twice daily) oral administration for 12 weeks |
| 2 | Placebo comparator | Drug: placeboPlacebo oral administration twice daily for 12 weeks |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MemantineAlso: Namenda®Memantine 20mg (10mg twice daily) oral administration for 12 weeks | Drug | 1 |
| placeboPlacebo oral administration twice daily for 12 weeks | Drug | 2 |
Primary outcome
Change From Baseline in Functional Linguistic Communication Inventory (FLCI) at Week 12
Time frame: Baseline to 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.
1 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
Time frame: Baseline to Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2009.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Alzheimer's Disease
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Alzheimer's Disease (AD)
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
Alzheimer Disease
RecruitingPhase 3
A Study of Trontinemab in Cognitively Unimpaired Individuals at Risk for Progression to Symptomatic Alzheimer's Disease
Alzheimer's Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
F C Potocnik principal investigator
25 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Memantine in people with Alzheimer's Disease, run by Forest Laboratories at 25 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in Australia, South Africa, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Dec 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Functional Linguistic Communication Inventory (FLCI) at Week 12 (time frame: Baseline to Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2009.