Trial · NCT00889603
Non-Interventional Study With Aricept® Evess
NCT00889603, Completed, Pfizer; results first posted 2011-03-31
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Non-Interventional Study With Aricept® Evess. Trials, record NCT00889603. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00889603
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Non-Interventional Study With Aricept® Evess
- NCT number
- NCT00889603
- Status
- Completed
- Enrollment
- 370 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Alzheimer's Disease, Vascular Dementia
- Interventions
- Aricept® Evess
- First posted
- 2009-04-29
- Last updated
- 2011-03-31
- Results first posted
- 2011-03-31
- Limitations and caveats
FAQ Change from baseline not analyzed, a note to file was issued stating it was removed from protocol but erroneously remained in statistical analysis section. Patient Domain of Benefit, Week 24 LOCF not analyzed; endpoint only collected at Week 24.
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Mini Mental State Examination (MMSE) Total at Week 24 Last Observation Carried Forward (LOCF) | Baseline and Week 24 | MMSE measured general cognitive functioning: orientation, memory, attention, calculation, language, visuospatial functions. Total score derived from sub-scores; total ranged from 0 - 30, higher score indicated better cognitive state. Change: mean score at Week 24 LOCF minus mean score at baseline. |
| Secondary | Change From Baseline in MMSE Total | Baseline, Week 8, 16, and 24 | MMSE measured general cognitive functioning: orientation, memory, attention, calculation, language, visuospatial functions. Total score derived from sub-scores; total ranged from 0 - 30, higher score indicated better cognitive state. Change: least squares (LS) mean score at observation minus LS mean score at baseline. Changes from baseline at each week were controlled for baseline MMSE. |
| Secondary | Change From Baseline in Functional Activity Questionnaire (FAQ) | Baseline and Week 24 | Participants completed the FAQ for physical function. Overall scores could have ranged from 0 (independent) to 30 (dependent) where lower scores represented an improvement in physical function. Change from baseline was to be calculated as baseline scores minus week 24 scores. |
| Secondary | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 8 | Week 8 | CGI-I: 7-point Investigator-rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement was defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected. |
| Secondary | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 16 | Week 16 | CGI-I: 7-point Investigator-rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement was defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected. |
| Secondary | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 24 | Week 24 | CGI-I: 7-point Investigator-rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement was defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected. |
| Secondary | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 24 LOCF | Week 24 | CGI-I: 7-point Investigator-rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement was defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected. |
| Secondary | Number of Participants in Each Patient Domain of Benefit | Week 24 | Participants asked to indicate if the cognition, functionality, and/or behavior domain were most benefited/improved after treatment (dichotomous yes/no endpoints where checking the CRF box next to each domain indicated 'yes' and leaving a box blank indicated 'no'). |
| Other | Number of Participants With Treatment Tolerability | Week 24 | Overall Evaluation of Tolerability at Week 24; 1=Very good, 2=Good, 3=Moderate, 4=Poor |
| Other | Number of Participants Receiving Other Medications | Baseline and Week 24 | Information collected and recorded by investigator in accordance with existing medical records. World Health Organization- Drug (WHO-Drug) coding dictionary applied. |
Source ClinicalTrials.gov
Outcomes10
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 Mini Mental State Examination (MMSE) Total at Week 24 Last Observation Carried Forward (LOCF) | Baseline and Week 24 | Full Analysis Set (FAS): all participants who received at least 1 dose of Donepezil and had at least 1 postbaseline efficacy evaluation. LOCF was used. N=number of participants with evaluable data. | Scores on a scale | MEAN |
| SECONDARY | Change From Baseline in MMSE Total | Baseline, Week 8, 16, and 24 | FAS. N=number of participants with evaluable data. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Functional Activity Questionnaire (FAQ) | Baseline and Week 24 | FAS. Data not analyzed | Scores on a scale | MEAN |
| SECONDARY | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 8 | Week 8 | FAS. N=number of participants with evaluable data. | Participants | NUMBER |
| SECONDARY | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 16 | Week 16 | FAS. N=number of participants with evaluable data. | Participants | NUMBER |
| SECONDARY | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 24 | Week 24 | FAS. N=number of participants with evaluable data. | Participants | NUMBER |
| SECONDARY | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 24 LOCF | Week 24 | FAS; LOCF. N=number of participants with evaluable data. | Participants | NUMBER |
| SECONDARY | Number of Participants in Each Patient Domain of Benefit | Week 24 | Safety population: all participants who received at least 1 dose of study drug. N=number of participants with evaluable data. Week 24 LOCF not reported as data only collected at Week 24. | Participants | NUMBER |
| OTHER_PRE_SPECIFIED | Number of Participants With Treatment Tolerability | Week 24 | Safety population; N=number of particpants with evaluable data. | Participants | NUMBER |
| OTHER_PRE_SPECIFIED | Number of Participants Receiving Other Medications | Baseline and Week 24 | Safety population | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group39
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 Mini Mental State Examination (MMSE) Total at Week 24 Last Observation Carried Forward (LOCF) | Donepezil | 1.92 | Standard Error 0.14 | Scores on a scale | |
| Change From Baseline in MMSE Total | Donepezil | Week 8 (N=348) | 0.92 | Standard Error 0.09 | Scores on a scale |
| Change From Baseline in MMSE Total | Donepezil | Week 16 (N=340) | 1.56 | Standard Error 0.12 | Scores on a scale |
| Change From Baseline in MMSE Total | Donepezil | Week 24 (N=327) | 1.97 | Standard Error 0.14 | Scores on a scale |
| Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 8 | Donepezil | Very much improved | 5 | Participants | |
| Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 8 | Donepezil | Much improved | 68 | Participants | |
| Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 8 | Donepezil | Minimally improved | 194 | Participants | |
| Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 8 | Donepezil | No change | 74 | Participants | |
| Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 8 | Donepezil | Minimally worse | 8 | Participants | |
| Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 8 | Donepezil | Much worse | 2 | Participants |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Donepezil | 370 | |
| Overall Study | COMPLETED | Donepezil | 333 | |
| Overall Study | NOT COMPLETED | Donepezil | 37 |
Source ClinicalTrials.gov
Adverse events39
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 | Tinnitus | Ear and labyrinth disorders | Donepezil | 1 | 370 | |
| other | Diarrhoea | Gastrointestinal disorders | Donepezil | 2 | 370 | |
| other | Dry mouth | Gastrointestinal disorders | Donepezil | 1 | 370 | |
| other | Nausea | Gastrointestinal disorders | Donepezil | 11 | 370 | |
| other | Vomiting | Gastrointestinal disorders | Donepezil | 2 | 370 | |
| other | Irritability | General disorders | Donepezil | 1 | 370 | |
| other | Weight decreased | Investigations | Donepezil | 1 | 370 | |
| other | Myalgia | Musculoskeletal and connective tissue disorders | Donepezil | 1 | 370 | |
| other | Aphasia | Nervous system disorders | Donepezil | 1 | 370 | |
| other | Cerebral disorder | Nervous system disorders | Donepezil | 1 | 370 |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Donepezil | ||
| Total, other adverse events | Donepezil | 52 | 370 |
| Total, serious adverse events | Donepezil | 12 | 370 |
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/NCT00889603
GET https://conductscience.org/api/trials/v1/NCT00889603/results?page=2