Trial · NCT00235716
A Randomized, Clinical Trial of Vitamin E and Memantine in Alzheimer's Disease
NCT00235716, Phase 3, Completed, US Department of Veterans Affairs; results first posted 2014-01-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Randomized, Clinical Trial of Vitamin E and Memantine in Alzheimer's Disease. Trials, record NCT00235716. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00235716
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Randomized, Clinical Trial of Vitamin E and Memantine in Alzheimer's Disease
- NCT number
- NCT00235716
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 613 participants, actual
- Lead sponsor
- US Department of Veterans Affairs
- Conditions
- Alzheimer's Disease
- Interventions
- dl-alpha-tocopherol, Memantine, dl-alpha-tocopherol, Memantine, Placebo
- First posted
- 2005-10-10
- Last updated
- 2014-07-23
- Results first posted
- 2014-01-29
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS/ADL) Inventory Change From Baseline | 6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline | The primary outcome of the study was the Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS/ADL) Inventory. The ADCS/ADL Inventory is designed to assess functional abilities to perform activities of daily living in Alzheimer patients with a broad range of dementia severity. The total score ranges from 0 to 78 with higher scores indicating greater abilities. Outcome analysis is average least square means change from baseline. |
| Primary | Mini-Mental State Examination Change From Baseline | 6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline | The Mini-Mental State Examination (MMSE) briefly and objectively assess cognitive status in psychiatric patients with cognitive impairment. The MMSE questions are grouped into seven categories, each representing a different cognitive domain. The MMSE yields a total score that ranges from 0 for a patient who gives no correct response to a score of 30 for a patient who makes no errors. Outcome analysis is average least square means change from baseline. |
| Primary | Alzheimer's Disease Assessment Scale - Cognitive (ADAS-cog) Change From Baseline | 6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline | The Alzheimer's Disease Assessment Scale (ADAS) is a 21-item scale designed to assess the severity of cognitive and non-cognitive behavioral impairments in patients with Alzheimer's disease. The cognitive portion of the scale (ADAS-cog) consists of 11 items to assess memory, language, and praxis functions. The ADAS-cog total score ranges from 0 (no errors) to 70 (severe cognitive impairment). Outcome analysis is average least square means change from baseline. |
| Primary | Neuropsychiatric Inventory Change From Baseline | 6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline | The Neuropsychiatric Inventory (NPI) assesses psychological and behavioral problems in patients with dementia. For each of twelve domains, there are four scores: frequency, severity, total frequency x severity, and caregiver distress. The frequency x severity total scores from each domain are summed for an overall total score that ranges from 0 to 144. The total caregiver distress scores are also summed for an overall total caregiver distress score that ranges from 0 to 60. The secondary endpoint for the trial will be the overall frequency times severity total score. Outcome analysis is average least square means change from baseline. |
| Primary | Caregiver Activity Survey Change From Baseline | 6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline | The Caregiver Activity Survey (CAS) was developed to measure the time caregivers spend aiding Alzheimer patients with their day-to-day activities. The CAS consists of six items that ask for an estimate in hours and minutes of the time that the caregiver spent during the previous 24 hours performing these particular activities. The six CAS items are as follows: 1) communication with the person, 2) using transportation, 3) dressing, 4) eating, 5) looking after one's appearance, and 6) supervising the person. The more caregiving hours the worse the patient's functioning level. Outcome analysis is average least square means change from baseline. |
| Secondary | Dependence Scale: Time to Event Analysis (Increase of of One Dependence Level) | Every 6 months to a maximum of 4 years | The Dependence Scale assesses the level of assistance needed by patients with Alzheimer's disease for activities of daily living. The scale yields six levels of dependence: no assistance required (Level 0); requires occasional reminders (Level 1); requires frequent reminders and/or help with household chores (Level 2); needs daily supervision (Level 3); needs to be dressed, toileted or fed (Level 4); needs to be transferred, diapered or tube fed (Level 5). |
| Other | All-cause Mortality | up to 4 years | Survival analysis of death from any cause. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS/ADL) Inventory Change From Baseline | 6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline | Intention-to-treat analysis that includes all participants with baseline and at least one follow-up measurement. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Dependence Scale: Time to Event Analysis (Increase of of One Dependence Level) | Every 6 months to a maximum of 4 years | Intention-to-treat analysis that includes all participants with baseline and at least one follow-up measurement. | participants | NUMBER |
| PRIMARY | Mini-Mental State Examination Change From Baseline | 6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline | Intention-to-treat analysis that includes all participants with baseline and at least one follow-up measurement. | units on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Alzheimer's Disease Assessment Scale - Cognitive (ADAS-cog) Change From Baseline | 6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline | Intention-to-treat analysis that includes all participants with baseline and at least one follow-up measurement. | units on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Neuropsychiatric Inventory Change From Baseline | 6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline | Intention-to-treat analysis that includes all participants with baseline and at least one follow-up measurement. | units on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Caregiver Activity Survey Change From Baseline | 6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline | Intention-to-treat analysis that includes all participants with baseline and at least one follow-up measurement. | hours per day | LEAST_SQUARES_MEAN |
| OTHER_PRE_SPECIFIED | All-cause Mortality | up to 4 years | Intention-to-treat analysis that includes all randomized participants. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group188
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS/ADL) Inventory Change From Baseline | Vitamin E | 6 months minus baseline | -1.72 | Standard Error 0.95 | units on a scale |
| Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS/ADL) Inventory Change From Baseline | Memantine | 6 months minus baseline | -2.40 | Standard Error 0.94 | units on a scale |
| Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS/ADL) Inventory Change From Baseline | Vitamin E + Memantine | 6 months minus baseline | -2.78 | Standard Error 0.96 | units on a scale |
| Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS/ADL) Inventory Change From Baseline | Placebo | 6 months minus baseline | -4.52 | Standard Error 0.95 | units on a scale |
| Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS/ADL) Inventory Change From Baseline | Vitamin E | 12 months minus baseline | -4.29 | Standard Error 1.20 | units on a scale |
| Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS/ADL) Inventory Change From Baseline | Memantine | 12 months minus baseline | -6.99 | Standard Error 1.21 | units on a scale |
| Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS/ADL) Inventory Change From Baseline | Vitamin E + Memantine | 12 months minus baseline | -6.60 | Standard Error 1.21 | units on a scale |
| Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS/ADL) Inventory Change From Baseline | Placebo | 12 months minus baseline | -8.11 | Standard Error 1.23 | units on a scale |
| Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS/ADL) Inventory Change From Baseline | Vitamin E | 18 months minus baseline | -8.01 | Standard Error 1.40 | units on a scale |
| Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS/ADL) Inventory Change From Baseline | Memantine | 18 months minus baseline | -9.32 | Standard Error 1.42 | units on a scale |
1 to 10 of 188Source ClinicalTrials.gov
See all 188 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Vitamin E | 152 | |
| Overall Study | STARTED | Memantine (Namenda) | 155 | |
| Overall Study | STARTED | Vitamin E + Memantine | 154 | |
| Overall Study | STARTED | Placebo | 152 | |
| Overall Study | COMPLETED | Vitamin E | 90 | |
| Overall Study | COMPLETED | Memantine (Namenda) | 88 | |
| Overall Study | COMPLETED | Vitamin E + Memantine | 89 | |
| Overall Study | COMPLETED | Placebo | 90 | |
| Overall Study | NOT COMPLETED | Vitamin E | 62 | |
| Overall Study | NOT COMPLETED | Memantine (Namenda) | 67 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events2,200
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 | Anaemia | Blood and lymphatic system disorders | Vitamin E | 0 | 152 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Memantine | 1 | 155 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Vitamin E + Memantine | 0 | 154 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 0 | 152 | 0 |
| other | Anaemia macrocytic | Blood and lymphatic system disorders | Vitamin E | 0 | 152 | 0 |
| other | Anaemia macrocytic | Blood and lymphatic system disorders | Memantine | 1 | 155 | 1 |
| other | Anaemia macrocytic | Blood and lymphatic system disorders | Vitamin E + Memantine | 0 | 154 | 0 |
| other | Anaemia macrocytic | Blood and lymphatic system disorders | Placebo | 0 | 152 | 0 |
| other | Haemorrhagic disorder | Blood and lymphatic system disorders | Vitamin E | 0 | 152 | 0 |
| other | Haemorrhagic disorder | Blood and lymphatic system disorders | Memantine | 0 | 155 | 0 |
1 to 10 of 2,200Source ClinicalTrials.gov
See all 2,200 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Vitamin E | ||
| Total, all-cause mortality | Memantine | ||
| Total, all-cause mortality | Vitamin E + Memantine | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Vitamin E | 91 | 152 |
| Total, other adverse events | Memantine | 97 | 155 |
| Total, other adverse events | Vitamin E + Memantine | 90 | 154 |
| Total, other adverse events | Placebo | 89 | 152 |
| Total, serious adverse events | Vitamin E | 82 | 152 |
| Total, serious adverse events | Memantine | 84 | 155 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
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
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