Trial · NCT00469456
Effect of Memantine on Functional Communication in Patients With Alzheimer's Disease
NCT00469456, Phase 4, Completed, Forest Laboratories; results first posted 2009-12-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effect of Memantine on Functional Communication in Patients With Alzheimer's Disease. Trials, record NCT00469456. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00469456
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effect of Memantine on Functional Communication in Patients With Alzheimer's Disease
- NCT number
- NCT00469456
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 265 participants, actual
- Lead sponsor
- Forest Laboratories
- Conditions
- Alzheimer's Disease
- Interventions
- Memantine, placebo
- First posted
- 2007-05-04
- Last updated
- 2009-12-24
- Results first posted
- 2009-12-07
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Functional Linguistic Communication Inventory (FLCI) at Week 12 | 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. |
| 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 | 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. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Functional Linguistic Communication Inventory (FLCI) at Week 12 | Baseline to Week 12 | 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. | Units on a scale | LEAST_SQUARES_MEAN |
| 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 | The secondary efficacy analysis was based on the ITT Population. The last-observation-carried-forward approach was used to impute missing post-Baseline values. | Units on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Functional Linguistic Communication Inventory (FLCI) at Week 12 | Placebo | -0.6 | Standard Error 0.59 | Units on a scale | |
| Change From Baseline in Functional Linguistic Communication Inventory (FLCI) at Week 12 | Memantine | 0.7 | Standard Error 0.57 | Units on a scale | |
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 | Placebo | -5.3 | Standard Error 2.06 | Units on a scale | |
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 | Memantine | 0.5 | Standard Error 1.99 | Units on a scale |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 129 | |
| Overall Study | STARTED | Memantine | 135 | |
| Overall Study | COMPLETED | Placebo | 120 | |
| Overall Study | COMPLETED | Memantine | 131 | |
| Overall Study | NOT COMPLETED | Placebo | 9 | |
| Overall Study | NOT COMPLETED | Memantine | 4 |
Source ClinicalTrials.gov
Adverse events36
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Dizziness | Nervous system disorders | Placebo | 2 | 129 | |
| other | Dizziness | Nervous system disorders | Memantine | 7 | 135 | |
| serious | Syncope | Nervous system disorders | Placebo | 2 | 129 | |
| serious | Syncope | Nervous system disorders | Memantine | 0 | 135 | |
| serious | Urinary Tract Infection | Infections and infestations | Placebo | 2 | 129 | |
| serious | Urinary Tract Infection | Infections and infestations | Memantine | 0 | 135 | |
| serious | Abdominal Pain | Gastrointestinal disorders | Placebo | 0 | 129 | |
| serious | Abdominal Pain | Gastrointestinal disorders | Memantine | 1 | 135 | |
| serious | Angina Unstable | Cardiac disorders | Placebo | 0 | 129 | |
| serious | Angina Unstable | Cardiac disorders | Memantine | 1 | 135 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Memantine | ||
| Total, other adverse events | Placebo | 2 | 129 |
| Total, other adverse events | Memantine | 7 | 135 |
| Total, serious adverse events | Placebo | 13 | 129 |
| Total, serious adverse events | Memantine | 4 | 135 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Memantine vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00469456
GET https://conductscience.org/api/trials/v1/NCT00469456/events?page=2