Trial · NCT00857649
Efficacy and Safety of Memantine in Moderate to Severe Alzheimer's Disease
NCT00857649, Phase 3, Terminated, H. Lundbeck A/S; results first posted 2012-01-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Memantine in Moderate to Severe Alzheimer's Disease. Trials, record NCT00857649. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00857649
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Memantine in Moderate to Severe Alzheimer's Disease
- NCT number
- NCT00857649
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 369 participants, actual
- Lead sponsor
- H. Lundbeck A/S
- Conditions
- Alzheimer's Disease
- Interventions
- Memantine, Placebo
- First posted
- 2009-03-06
- Last updated
- 2013-12-05
- Results first posted
- 2012-01-09
- Limitations and caveats
Long recruitment, premature termination, substantial protocol changes; baseline imbalances (concomitant medication and severity of agitation). Variability across sites in reported events frequency (50% of agitation reports from a single site)
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Efficacy of Memantine on Behavioural Symptoms in Outpatients With Moderate to Severe Dementia of the Alzheimer's Type Using the NPI - 12 Items Version Total Score. | Baseline to Week 24 | Change from Baseline in Neuropsychiatric Inventory (NPI) total score. NPI is a validated scale that assesses behavioural disturbances in patients with dementia. The 12 item version consists of 10 behavioural and 2 neurovegetative areas. It provides both a total score as well as scores for a number of sub-scales. The frequency, severity and caregiver distress for each domain are measured. The NPI is based upon responses obtained from the caregiver. The total score is from 0 to 144. A higher score reflects more frequency and severity of the disturbances. |
| Primary | Efficacy of Memantine on Cognition in Outpatients With Moderate to Severe Dementia of the Alzheimer's Type Using the SIB Total Score. | Baseline to Week 24 | Change from Baseline in Severe Impairment Battery (SIB) total score. SIB is a validated scale used to assess cognitive function in patients with moderate to severe dementia. Items are single words or one-step commands combined with gestures. Nine domains are assessed, and the total score is between 0 and 100. A lower total score reflects the loss of cognitive function. |
| Secondary | Efficacy of Memantine on Global Condition Using CIBIC-plus. | Baseline to Week 24 | Clinician's Interview-Based Impression of Change-Plus Version (CIBIC-plus). Improvement evaluated with reference to Baseline. CIBIC-plus is a global rating that is derived through an independent, comprehensive interview with the patient and caregiver by a rater who is barred from knowledge of all other psychometric test scores conducted as part of this protocol as well as from reported safety data. The rating is made on a 7-point scale ranging from "1 = marked improvement" to "7 = marked worsening". A score of "4" indicates no change. |
| Secondary | Efficacy of Memantine on Functioning Using ADCS-ADL - 19 Items Total Score. | Baseline to Week 24 | Change from Baseline on the Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL) 19-item version total score. ADCS-ADL- 19 items version for moderate to severe AD will measure patient's functioning. This battery of ADL questions is used here to measure the functional capabilities of patients with dementia. The inventory is done 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. Total score is from 0 to 54. The higher score, the lower impairment. |
| Secondary | Efficacy of Memantine on Functioning Using CMAI - Long Form Total Score. | Baseline to Week 24 | Change from Baseline on the Cohen-Mansfield Agitation Inventory (CMAI) - Long Form total score. CMAI - Long Form looks specifically at agitated behaviour in patients with cognitive impairment. It is a seven-point rating scale assessing the frequency of up to 29 agitated behaviours, ranging from "1 = Never" to "7 = Several times an hour". Rating is based on responses obtained from interviews with the caregiver. The total score ranges from 29 to 203, with a higher score reflecting more frequent behavioural disturbances. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Efficacy of Memantine on Behavioural Symptoms in Outpatients With Moderate to Severe Dementia of the Alzheimer's Type Using the NPI - 12 Items Version Total Score. | Baseline to Week 24 | Full-analysis Set (FAS) - all randomised patients on current treatment with an acetylcholinesterase inhibitor (AChEI) who took at least one dose of investigational medicinal product (IMP) and had at least one post-baseline assessment on both co-primary efficacy variables.~Last Observation Carried Forward (LOCF). | Scores on a scale | MEAN |
| PRIMARY | Efficacy of Memantine on Cognition in Outpatients With Moderate to Severe Dementia of the Alzheimer's Type Using the SIB Total Score. | Baseline to Week 24 | FAS; LOCF | Scores on a scale | MEAN |
| SECONDARY | Efficacy of Memantine on Global Condition Using CIBIC-plus. | Baseline to Week 24 | FAS; Observed Cases (OC). | Scores on a scale | MEAN |
| SECONDARY | Efficacy of Memantine on Functioning Using ADCS-ADL - 19 Items Total Score. | Baseline to Week 24 | FAS; OC | Scores on a scale | MEAN |
| SECONDARY | Efficacy of Memantine on Functioning Using CMAI - Long Form Total Score. | Baseline to Week 24 | FAS; OC | Scores on a scale | MEAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Efficacy of Memantine on Behavioural Symptoms in Outpatients With Moderate to Severe Dementia of the Alzheimer's Type Using the NPI - 12 Items Version Total Score. | Memantine | -3.90 | Standard Error 1.24 | Scores on a scale | |
| Efficacy of Memantine on Behavioural Symptoms in Outpatients With Moderate to Severe Dementia of the Alzheimer's Type Using the NPI - 12 Items Version Total Score. | Placebo | -5.13 | Standard Error 1.23 | Scores on a scale | |
| Efficacy of Memantine on Cognition in Outpatients With Moderate to Severe Dementia of the Alzheimer's Type Using the SIB Total Score. | Memantine | -2.34 | Standard Error 0.76 | Scores on a scale | |
| Efficacy of Memantine on Cognition in Outpatients With Moderate to Severe Dementia of the Alzheimer's Type Using the SIB Total Score. | Placebo | -1.86 | Standard Error 0.75 | Scores on a scale | |
| Efficacy of Memantine on Global Condition Using CIBIC-plus. | Memantine | 4.68 | Standard Error 0.11 | Scores on a scale | |
| Efficacy of Memantine on Global Condition Using CIBIC-plus. | Placebo | 4.63 | Standard Error 0.11 | Scores on a scale | |
| Efficacy of Memantine on Functioning Using ADCS-ADL - 19 Items Total Score. | Memantine | -4.36 | Standard Error 0.67 | Scores on a scale | |
| Efficacy of Memantine on Functioning Using ADCS-ADL - 19 Items Total Score. | Placebo | -2.56 | Standard Error 0.65 | Scores on a scale | |
| Efficacy of Memantine on Functioning Using CMAI - Long Form Total Score. | Memantine | -0.26 | Standard Error 0.79 | Scores on a scale | |
| Efficacy of Memantine on Functioning Using CMAI - Long Form Total Score. | Placebo | -1.16 | Standard Error 0.79 | Scores 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 | Memantine | 182 | |
| Overall Study | STARTED | Placebo | 187 | |
| Overall Study | COMPLETED | Memantine | 151 | |
| Overall Study | COMPLETED | Placebo | 155 | |
| Overall Study | NOT COMPLETED | Memantine | 31 | |
| Overall Study | NOT COMPLETED | Placebo | 32 |
Source ClinicalTrials.gov
Adverse events92
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 | Nausea | Gastrointestinal disorders | Memantine | 4 | 182 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 11 | 187 | |
| other | Fall | Injury, poisoning and procedural complications | Memantine | 19 | 182 | |
| other | Fall | Injury, poisoning and procedural complications | Placebo | 8 | 187 | |
| other | Weight decreased | Investigations | Memantine | 11 | 182 | |
| other | Weight decreased | Investigations | Placebo | 5 | 187 | |
| other | Somnolence | Nervous system disorders | Memantine | 10 | 182 | |
| other | Somnolence | Nervous system disorders | Placebo | 5 | 187 | |
| other | Agitation | Psychiatric disorders | Memantine | 15 | 182 | |
| other | Agitation | Psychiatric disorders | Placebo | 7 | 187 |
1 to 10 of 92Source ClinicalTrials.gov
See all 92 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Memantine | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Memantine | 51 | 182 |
| Total, other adverse events | Placebo | 35 | 187 |
| Total, serious adverse events | Memantine | 18 | 182 |
| Total, serious adverse events | Placebo | 11 | 187 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23472619 | RESULT |
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 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/NCT00857649
GET https://conductscience.org/api/trials/v1/NCT00857649/events?page=2