Trial · NCT00857233
Safety and Tolerability of Memantine in Moderate to Severe Alzheimer's Disease
NCT00857233, Phase 3, Terminated, H. Lundbeck A/S; results first posted 2012-08-29
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Tolerability of Memantine in Moderate to Severe Alzheimer's Disease. Trials, record NCT00857233. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00857233
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Tolerability of Memantine in Moderate to Severe Alzheimer's Disease
- NCT number
- NCT00857233
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 297 participants, actual
- Lead sponsor
- H. Lundbeck A/S
- Conditions
- Alzheimer's Disease
- Interventions
- Memantine
- First posted
- 2009-03-06
- Last updated
- 2012-08-29
- Results first posted
- 2012-08-29
- Limitations and caveats
- Long recruitment, premature termination.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients With Adverse Events (AEs) | Baseline to Week 24 | Overview of AEs |
| Primary | Percentage of Patients Who Withdrew Due to Intolerance to Treatment | Baseline to Week 24 | |
| Secondary | Long-term Efficacy of Memantine on Behavioural Symptoms Using the Neuropsychiatric Inventory (NPI) - 12 Items Version Total Score. | Baseline and Week 24 | Change from Baseline in the NPI total score. Analysed by descriptive methods only. 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. |
| Secondary | Long-term Efficacy of Memantine on Cognition Using the Severe Impairment Battery (SIB) Total Score. | Baseline and Week 24 | Change from Baseline in the SIB total score. Analysed by descriptive methods only. 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 | Long-term Efficacy of Memantine on Global Condition Using the Clinician's Interview-Based Impression of Change-Plus Version (CIBIC-plus). | Week 24 | CIBIC-plus. Improvement evaluated with reference to Baseline. Analysed by descriptive methods only. 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 | Long-term Efficacy of Memantine on Functioning Using the Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL) 19-item Version Total Score | Baseline and Week 24 | Change from Baseline on the ADCS-ADL 19-item version total score. Analysed by descriptive methods only. 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. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients With Adverse Events (AEs) | Baseline to Week 24 | Completers from lead-in study 10158 were eligible for this open-label extension study. We analysed the All-patients-treated Set (APTS) - all patients who took at least one dose of investigational medicinal product (IMP) | participants | NUMBER |
| SECONDARY | Long-term Efficacy of Memantine on Behavioural Symptoms Using the Neuropsychiatric Inventory (NPI) - 12 Items Version Total Score. | Baseline and Week 24 | APTS; Observed cases (OC) | Scores on a scale | MEAN |
| SECONDARY | Long-term Efficacy of Memantine on Cognition Using the Severe Impairment Battery (SIB) Total Score. | Baseline and Week 24 | APTS; OC | Scores on a scale | MEAN |
| SECONDARY | Long-term Efficacy of Memantine on Global Condition Using the Clinician's Interview-Based Impression of Change-Plus Version (CIBIC-plus). | Week 24 | APTS; OC | Scores on a scale | MEAN |
| SECONDARY | Long-term Efficacy of Memantine on Functioning Using the Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL) 19-item Version Total Score | Baseline and Week 24 | APTS; OC | Scores on a scale | MEAN |
| PRIMARY | Percentage of Patients Who Withdrew Due to Intolerance to Treatment | Baseline to Week 24 | APTS | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients With Adverse Events (AEs) | Memantine | Patients with AEs | 191 | participants | |
| Number of Patients With Adverse Events (AEs) | Memantine | Patients with serious AEs (SAEs) | 27 | participants | |
| Number of Patients With Adverse Events (AEs) | Memantine | Patients with AEs Leading to Withdrawal | 24 | participants | |
| Number of Patients With Adverse Events (AEs) | Memantine | Patients with Baseline Events | 1 | participants | |
| Long-term Efficacy of Memantine on Behavioural Symptoms Using the Neuropsychiatric Inventory (NPI) - 12 Items Version Total Score. | Memantine | 2.11 | Standard Deviation 16.12 | Scores on a scale | |
| Long-term Efficacy of Memantine on Cognition Using the Severe Impairment Battery (SIB) Total Score. | Memantine | -5.60 | Standard Deviation 9.81 | Scores on a scale | |
| Long-term Efficacy of Memantine on Global Condition Using the Clinician's Interview-Based Impression of Change-Plus Version (CIBIC-plus). | Memantine | 4.75 | Standard Deviation 1.14 | Scores on a scale | |
| Long-term Efficacy of Memantine on Functioning Using the Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL) 19-item Version Total Score | Memantine | -4.16 | Standard Deviation 6.45 | Scores on a scale | |
| Percentage of Patients Who Withdrew Due to Intolerance to Treatment | Memantine | 8.1 | percentage of participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Memantine | 297 | |
| Overall Study | COMPLETED | Memantine | 242 | |
| Overall Study | NOT COMPLETED | Memantine | 55 |
Source ClinicalTrials.gov
Adverse events38
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 | Constipation | Gastrointestinal disorders | Memantine | 9 | 297 | |
| other | Diarrhoea | Gastrointestinal disorders | Memantine | 12 | 297 | |
| other | Nausea | Gastrointestinal disorders | Memantine | 10 | 297 | |
| other | Gait disturbance | General disorders | Memantine | 9 | 297 | |
| other | Fall | Injury, poisoning and procedural complications | Memantine | 15 | 297 | |
| other | Dizziness | Nervous system disorders | Memantine | 15 | 297 | |
| other | Headache | Nervous system disorders | Memantine | 10 | 297 | |
| other | Agitation | Psychiatric disorders | Memantine | 18 | 297 | |
| other | Confusional state | Psychiatric disorders | Memantine | 10 | 297 | |
| serious | Anaemia | Blood and lymphatic system disorders | Memantine | 1 | 297 |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Memantine | ||
| Total, other adverse events | Memantine | 85 | 297 |
| Total, serious adverse events | Memantine | 27 | 297 |
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00857233
GET https://conductscience.org/api/trials/v1/NCT00857233/events?page=2