Trial · NCT00862940
A Clinical Study Evaluating the Effects of Memantine on Brain Atrophy in Patients With Alzheimer's Disease
NCT00862940, Phase 4, Completed, H. Lundbeck A/S; results first posted 2011-06-03
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Clinical Study Evaluating the Effects of Memantine on Brain Atrophy in Patients With Alzheimer's Disease. Trials, record NCT00862940. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00862940
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Clinical Study Evaluating the Effects of Memantine on Brain Atrophy in Patients With Alzheimer's Disease
- NCT number
- NCT00862940
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 277 participants, actual
- Lead sponsor
- H. Lundbeck A/S
- Conditions
- Alzheimer's Disease
- Interventions
- Memantine, Placebo
- First posted
- 2009-03-17
- Last updated
- 2012-09-03
- Other registries' IDs
- eudract:2004-002614-10
- Results first posted
- 2011-06-03
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Total Brain Atrophy Rate Estimated Using Brain Boundary Shift Integral (BBSI) | Baseline to 1 year | Measures direct changes in total brain volume per visit interval (screening to Week 4, 42, or 52 or from Week 4 to Week 42 or 52) |
| Secondary | Changes in Total Hippocampal Volume (HCV) | Baseline to 1 year | Estimated mean changes in total HCV |
| Secondary | Cognitive and Behavioural Outcomes: Controlled Oral Word Association Test (COWAT) Total Score | Baseline to 1 year | Adjusted mean change from baseline on cognitive and behavioural scores. COWAT: Verbal fluency test. The patient was asked to, during 1 minute, generate as many words as possible beginning with three pre-specified letters. The total score was calculated as the sum of acceptable words generated, with higher scores indicating lower cognitive impairment |
| Secondary | Cognitive and Behavioural Outcomes: Mini Mental State Examination (MMSE) Total Score | Baseline to 1 year | Adjusted mean change from baseline on cognitive and behavioural scores. MMSE: Brief, structured examination of mental status that assesses orientation, memory, attention, naming, comprehension, and praxis. The range is 0 to 30, with a lower score indicating a worse mental state |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Total Brain Atrophy Rate Estimated Using Brain Boundary Shift Integral (BBSI) | Baseline to 1 year | FAS-MRI: Full-analysis set for all patients in the all-patients-treated set (APTS) who had at least one valid MRI scan \>=6 months after initiation of investigational medicinal product (IMP). The FAS (full analysis set, efficacy set) replaces the intention-to-treat (ITT) concept used in older terminology. | mL/year | MEAN |
| SECONDARY | Changes in Total Hippocampal Volume (HCV) | Baseline to 1 year | FAS-MRI | mm^3/year | MEAN |
| SECONDARY | Cognitive and Behavioural Outcomes: Controlled Oral Word Association Test (COWAT) Total Score | Baseline to 1 year | FAS, observed cases (OC) | Scale scores | LEAST_SQUARES_MEAN |
| SECONDARY | Cognitive and Behavioural Outcomes: Mini Mental State Examination (MMSE) Total Score | Baseline to 1 year | FAS, OC | Scale scores | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Total Brain Atrophy Rate Estimated Using Brain Boundary Shift Integral (BBSI) | Memantine 10 mg Tablets Twice Daily | 15.24 | Standard Error 0.97 | mL/year | |
| Total Brain Atrophy Rate Estimated Using Brain Boundary Shift Integral (BBSI) | Placebo Tablets Twice Daily | 15.32 | Standard Error 0.91 | mL/year | |
| Changes in Total Hippocampal Volume (HCV) | Memantine 10 mg Tablets Twice Daily | -218 | Standard Deviation 182 | mm^3/year | |
| Changes in Total Hippocampal Volume (HCV) | Placebo Tablets Twice Daily | -220 | Standard Deviation 171 | mm^3/year | |
| Cognitive and Behavioural Outcomes: Controlled Oral Word Association Test (COWAT) Total Score | Memantine 10 mg Tablets Twice Daily | 0.78 | Standard Error 0.71 | Scale scores | |
| Cognitive and Behavioural Outcomes: Controlled Oral Word Association Test (COWAT) Total Score | Placebo Tablets Twice Daily | -0.90 | Standard Error 0.69 | Scale scores | |
| Cognitive and Behavioural Outcomes: Mini Mental State Examination (MMSE) Total Score | Memantine 10 mg Tablets Twice Daily | -0.50 | Standard Error 0.45 | Scale scores | |
| Cognitive and Behavioural Outcomes: Mini Mental State Examination (MMSE) Total Score | Placebo Tablets Twice Daily | -0.74 | Standard Error 0.44 | Scale scores |
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 10 mg Tablets Twice Daily | 133 | |
| Overall Study | STARTED | Placebo Tablets Twice Daily | 144 | |
| Overall Study | COMPLETED | Memantine 10 mg Tablets Twice Daily | 103 | |
| Overall Study | COMPLETED | Placebo Tablets Twice Daily | 114 | |
| Overall Study | NOT COMPLETED | Memantine 10 mg Tablets Twice Daily | 30 | |
| Overall Study | NOT COMPLETED | Placebo Tablets Twice Daily | 30 |
Source ClinicalTrials.gov
Adverse events126
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 | Agitation | Psychiatric disorders | Memantine 10 mg Tablets Twice Daily | 7 | 133 | 7 |
| other | Agitation | Psychiatric disorders | Placebo Tablets Twice Daily | 1 | 144 | 1 |
| other | Diarrhoea | Gastrointestinal disorders | Memantine 10 mg Tablets Twice Daily | 4 | 133 | 5 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo Tablets Twice Daily | 10 | 144 | 11 |
| other | Dizziness | Nervous system disorders | Memantine 10 mg Tablets Twice Daily | 11 | 133 | 11 |
| other | Dizziness | Nervous system disorders | Placebo Tablets Twice Daily | 4 | 144 | 8 |
| other | Fall | Injury, poisoning and procedural complications | Memantine 10 mg Tablets Twice Daily | 8 | 133 | 9 |
| other | Fall | Injury, poisoning and procedural complications | Placebo Tablets Twice Daily | 9 | 144 | 10 |
| other | Headache | Nervous system disorders | Memantine 10 mg Tablets Twice Daily | 9 | 133 | 11 |
| other | Headache | Nervous system disorders | Placebo Tablets Twice Daily | 7 | 144 | 8 |
1 to 10 of 126Source ClinicalTrials.gov
See all 126 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Memantine 10 mg Tablets Twice Daily | ||
| Total, all-cause mortality | Placebo Tablets Twice Daily | ||
| Total, other adverse events | Memantine 10 mg Tablets Twice Daily | 46 | 133 |
| Total, other adverse events | Placebo Tablets Twice Daily | 36 | 144 |
| Total, serious adverse events | Memantine 10 mg Tablets Twice Daily | 17 | 133 |
| Total, serious adverse events | Placebo Tablets Twice Daily | 20 | 144 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 22269160 | 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 10 mg Tablets Twice Daily vs Placebo Tablets Twice Daily: serious adverse events |
Source Trial comparisons
Tests1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as |
|---|---|
| Verbal Fluency | Secondary outcome |
Source ConductCognition
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/NCT00862940
GET https://conductscience.org/api/trials/v1/NCT00862940/events?page=2