Trial · NCT00322153
A Study of the Safety and Efficacy of Memantine in Moderate to Severe Alzheimer's Disease
NCT00322153, Phase 3, Completed, Forest Laboratories; results first posted 2010-09-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of the Safety and Efficacy of Memantine in Moderate to Severe Alzheimer's Disease. Trials, record NCT00322153. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00322153
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of the Safety and Efficacy of Memantine in Moderate to Severe Alzheimer's Disease
- NCT number
- NCT00322153
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 677 participants, actual
- Lead sponsor
- Forest Laboratories
- Conditions
- Dementia of the Alzheimer's Type
- Interventions
- memantine ER, Placebo
- First posted
- 2006-05-05
- Last updated
- 2010-09-16
- Results first posted
- 2010-09-16
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Severe Impairment Battery (SIB) at Week 24 (LOCF) | Baseline to week 24 | The SIB was developed for the evaluation of cognitive function in patients with more advanced dementia, and evaluates the areas of memory, language, praxis, orientation, and attention. The SIB test items consist of simple, one-step commands presented with gestural cues that are repeated if necessary. The test contains 51 items, and the range of possible scores is 0 to 100 (with 0 being the worst result). The SIB has been shown to be a valid and reliable instrument sensitive to longitudinal change. |
| Primary | Clinician's Interview-Based Impression of Change With Caregiver Input (CIBIC-plus) at Week 24 (LOCF) | Week 24 | The CIBIC-Plus is a measure of an overall clinical effect and is based on a comprehensive evaluation at Baseline and later visits of four domains: general (overall clinical status), functional (including activities of daily living), cognitive, and behavioral. A skilled clinician interviews the patient, and includes information supplied by a knowledgeable caregiver. The CIBIC-Plus is a rating of the patient's global status relative to Baseline, ranging from a score of 1, indicating "marked improvement" to a score of 4, indicating "no change" to a score of 7, indicating "marked worsening." |
| Secondary | Change From Baseline in the 19-Item Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL19) Scale at Week 24 (LOCF) | Baseline to week 24 | The ADCS-ADL19 modified inventory consists of 19 items used to measure the functional capabilities of patients with moderate to severe dementia. Each activity-of-daily-living (ADL) item comprises a series of hierarchical subquestions ranging from the highest level of independent performance to complete loss of ability to perform the ADL Inventory. The inventory is performed by interviewing a person in close contact with the patient and covers the most usual and consistent performance of the patient over the preceding 4 weeks. Response range is 0 (total disability) to 54 (total independence). |
Source ClinicalTrials.gov
Outcomes3
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 Severe Impairment Battery (SIB) at Week 24 (LOCF) | Baseline to week 24 | Primary efficacy analysis was based on the Intent-to-Treat (ITT) Population. The ITT Population was consisted of all patients in the Safety Population who completed at least one post-Baseline efficacy assessment in SIB or CIBIC-Plus. The last-observation-carried-forward approach was used to impute missing post-Baseline values. | Units on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Clinician's Interview-Based Impression of Change With Caregiver Input (CIBIC-plus) at Week 24 (LOCF) | Week 24 | Primary efficacy analysis was based on the Intent-to-Treat (ITT) Population. The ITT Population was consisted of all patients in the Safety Population who completed at least one post-Baseline efficacy assessment in SIB or CIBIC-Plus. The last-observation-carried-forward approach was used to impute missing post-Baseline values. | Units on a scale | MEAN |
| SECONDARY | Change From Baseline in the 19-Item Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL19) Scale at Week 24 (LOCF) | Baseline to week 24 | 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 group6
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 Severe Impairment Battery (SIB) at Week 24 (LOCF) | Placebo | -0.4 | Standard Error 0.65 | Units on a scale | |
| Change From Baseline in Severe Impairment Battery (SIB) at Week 24 (LOCF) | Memantine ER | 2.2 | Standard Error 0.65 | Units on a scale | |
| Clinician's Interview-Based Impression of Change With Caregiver Input (CIBIC-plus) at Week 24 (LOCF) | Placebo | 4.1 | Standard Error 0.07 | Units on a scale | |
| Clinician's Interview-Based Impression of Change With Caregiver Input (CIBIC-plus) at Week 24 (LOCF) | Memantine ER | 3.8 | Standard Error 0.07 | Units on a scale | |
| Change From Baseline in the 19-Item Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL19) Scale at Week 24 (LOCF) | Placebo | -1.7 | Standard Error 0.44 | Units on a scale | |
| Change From Baseline in the 19-Item Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL19) Scale at Week 24 (LOCF) | Memantine ER | -1.0 | Standard Error 0.44 | Units on a scale |
Source ClinicalTrials.gov
Participant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 335 | |
| Overall Study | STARTED | Memantine ER | 342 | |
| Overall Study | SAFETY POPULATION | Placebo | 335 | |
| Overall Study | SAFETY POPULATION | Memantine ER | 341 | |
| Overall Study | COMPLETED | Placebo | 272 | |
| Overall Study | COMPLETED | Memantine ER | 273 | |
| Overall Study | NOT COMPLETED | Placebo | 63 | |
| Overall Study | NOT COMPLETED | Memantine ER | 69 |
Source ClinicalTrials.gov
Adverse events122
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 | Fall | Injury, poisoning and procedural complications | Placebo | 26 | 335 | |
| other | Fall | Injury, poisoning and procedural complications | Memantine ER | 19 | 341 | |
| other | Urinary tract infection | Infections and infestations | Placebo | 24 | 335 | |
| other | Urinary tract infection | Infections and infestations | Memantine ER | 19 | 341 | |
| other | Headache | Nervous system disorders | Placebo | 17 | 335 | |
| other | Headache | Nervous system disorders | Memantine ER | 19 | 341 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 13 | 335 | |
| other | Diarrhoea | Gastrointestinal disorders | Memantine ER | 17 | 341 | |
| serious | Atrioventricular block complete | Cardiac disorders | Placebo | 0 | 335 | |
| serious | Atrioventricular block complete | Cardiac disorders | Memantine ER | 1 | 341 |
1 to 10 of 122Source ClinicalTrials.gov
See all 122 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 ER | ||
| Total, other adverse events | Placebo | 70 | 335 |
| Total, other adverse events | Memantine ER | 67 | 341 |
| Total, serious adverse events | Placebo | 21 | 335 |
| Total, serious adverse events | Memantine ER | 28 | 341 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 29771687 | DERIVED |
Source PubMed
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 ER 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/NCT00322153
GET https://conductscience.org/api/trials/v1/NCT00322153/events?page=2