Trial · NCT00566501
Open-Label Extension Study of 23 mg Donepezil SR in Participants With Moderate to Severe Alzheimer's Disease
NCT00566501, Phase 3, Completed, Eisai Inc.; results first posted 2012-06-19
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ConductScience Library. Open-Label Extension Study of 23 mg Donepezil SR in Participants With Moderate to Severe Alzheimer's Disease. Trials, record NCT00566501. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00566501
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Open-Label Extension Study of 23 mg Donepezil SR in Participants With Moderate to Severe Alzheimer's Disease
- NCT number
- NCT00566501
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 915 participants, actual
- Lead sponsor
- Eisai Inc.
- Conditions
- Alzheimer's Disease
- Interventions
- Donepezil
- First posted
- 2007-12-03
- Last updated
- 2021-11-17
- Other registries' IDs
- eudract:2006-004890-93
- Results first posted
- 2012-06-19
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Events (AEs) | From the enrollment of the study up to 30 days after last dose of the study drug (up to 2 years 3 months) | An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product, whether or not considered related to the investigational product, a change in treatment, or discontinuation of study drug, recurrence of an intermittent medical condition not present pretreatment, an abnormal laboratory test result was considered an AE if the identified laboratory abnormality led to any type of intervention, withdrawal of study drug, or withholding of study drug, whether prescribed in the protocol or not. All AEs in Study 328 (NCT00566501) excluding treatment-emergent signs or symptoms continuing from Study 326 (NCT00478205) were reported. |
| Secondary | Percentage of Participants With at Least 1 Treatment-Emergent Abnormal Laboratory Values (TEAVs): Hematology | From the first dose of study drug up to 2 years 3 months | A TEAV for a laboratory parameter was defined as a value that was clinically significantly outside (above or below) the normal range post-dose, but within the normal range prior to drug administration, or a value that represented a clinically significant exacerbation of an abnormality present prior to drug administration. Abnormal values for hematology parameters were: White Blood cells count: less than or equal to \[\<=\] 2,800/per millimeter (mm) or greater than or equal to \[\>=\] 16,000/mm; Neutrophils: \<=15 percent (%); Hemoglobin: Male (\<=11.5 gram per deciliter \[g/dL\]), Female (\<=9.5 g/dL); Hematocrit: Male (\<=37%), Female (\<=32%); Eosinophils: \>=10%; Platelet Count: \<=75,000/mm or \>=700,000/mm. Percentage of participants with at least 1 abnormal TEAV for hematology was reported. |
| Secondary | Percentage of Participants With at Least 1 TEAVs for Selected Parameters: Clinical Chemistry | From the first dose of study drug up to 2 years 3 months | A TEAV for a laboratory parameter was defined as a value that was clinically significantly outside (above or below) the normal range postdose, but within the normal range prior to drug administration,or a value that represented a clinically significant exacerbation of an abnormality present prior to drug administration.Abnormal values for clinical chemistry parameters were:Sodium:Less than(\<)130 milliequivalents per litre (mEq/L) or greater than(\>)150 mEq/L;Potassium:\<3 mEq/L or \>5.5 mEq/L; Calcium: \<8.4 milligram per deciliter (mg/dL) or \>1.5 mg/dL;Albumin: 50% lower limit of normal (LLN); Alkaline Phosphatase:\>=3\*upper limit of normal (ULN);Aspartate aminotransferase (AST):\>=3\*ULN;Alanine aminotransferase(ALT):\>=3\*ULN;Total Bilirubin:\>=2.0 mg/dL;Chloride:\<90 mEq/L or \>115 mEq/L;Creatinine:\>=2.0 mg/dL;Creatine phosphokinase:\>=3\*ULN;Blood Urea Nitrogen (BUN):\>=30 mg/dL. Percentage of participants with at least 1 abnormal TEAV (selected parameters) for clinical chemistry was reported. |
| Secondary | Change From Baseline in Severe Impairment Battery (SIB) Total Score | At Baseline, Month 3, Month 6, Month 9 and Month 12 | The SIB evaluated the severity of cognitive dysfunction in participants with more advanced dementia. Test questions measured attention, language, orientation, memory, praxis, visuospatial ability, construction, social skills, orienting head to name. Non-verbal responses were allowed, thus decreasing the need for language output. Forty questions were included with a total possible score range of 0-100. Lower scores indicated greater cognitive impairment. |
| Secondary | Change From Baseline in Mini-Mental State Examination (MMSE) Total Score | At Baseline, Month 3, Month 6, Month 9 and Month 12 | MMSE is a 30-point scale that measured orientation to time and place, registration, immediate and delayed recall, attention, language, and drawing. Scores ranged from 0 (most impaired) to 30 (no impairment). Lower score indicated more impairment. |
| Secondary | Change From Baseline in Modified Alzheimer's Disease Cooperative Study Activities of Daily Living Severe Scale (ADCS-ADL) Total Score | At Baseline, Month 3, Month 6, Month 9 and Month 12 | ADCS-ADL is a comprehensive battery of ADL questions used to measure a participant's functional capabilities. The modified ADCS-ADL-severe scale is a 19-item scale that has been validated for the assessment of participants with moderate to severe dementia. It measured the most appropriate basic and instrumental abilities (such as walking, grooming, bathing, and eating) in this participant population. Response to each item was obtained by interview with the caregiver. Ratings reflected caregiver observations about the participant's actual functioning and provided an assessment of change in the functional state of the participant over time. The total score ranged from 0 to 54. Lower scores indicated greater functional impairment. |
| Secondary | Change From Baseline in Quality of Life-Alzheimer's Disease (Qol-AD) Total Score | At Baseline, Month 6 and Month 12 | QoL-AD is a 13-item quality of life instrument developed to specifically assess QoL in participants who have dementia. Each item was scored on a 4-point scale (poor, fair, good, excellent) and a single score was calculated, ranging from 13 (low functioning) to 52 (normal function). Higher score indicated better QoL. The QoL-AD total scores for the participants and caregiver were the sum of the 13 items on each test. |
| Secondary | Change From Baseline in European Quality of Life-5 Dimension (EQ-5D) Total Score | At Baseline, Month 6 and Month 12 | EQ-5D is a health profile questionnaire assessing quality of life along 5 domains. Caregivers rated 5 domains of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) by choosing from 3 answering options (1=no problems; 2=some problems; 3=extreme problems). The EQ-5D Health Utilities Index (HUI) is derived from the five dimensions of the EQ-5D, using country-specific preference weights (tariffs) to summarize how good or bad each health state is on a scale from 1 to 0. HSI total score ranged from 1 (full health) and 0 (worst health/death). |
| Secondary | Change From Baseline in Screen for Caregiver Objective Burden (SCB) Total Score | At Baseline, Month 6 and Month 12 | The SCB is a 25-item instrument that questions caregivers about the occurrence and degree of distress as aspects of the burden of care during the preceding two weeks. It was designed specifically for use with caregivers of Alzheimer's disease participants. Each item was assessed on a 5-point scale ranging from "0" (no occurrence) to "4" (occurrence with severe distress). The objective burden was the sum of the total numbers of (1 2 3 4) in all items. Total score ranged from 0 (low distress) to 100 (high distress). |
| Secondary | Change From Baseline in Screen for Caregiver Subjective Burden (SCB) Total Score | At Baseline, Month 6 and Month 12 | The SCB is a 25-item instrument that questioned caregivers about the occurrence and degree of distress as aspects of the burden of care during the preceding two weeks. It was designed specifically for use with caregivers of Alzheimer's disease participants. Each item was assessed on a 5-point scale ranging from "0" (no occurrence) to "4" (occurrence with severe distress). The subjective burden was the sum of the (total number with score\*score). Total score ranged from 0 (no occurrence) to 100 (occurrence with severe distress). |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Adverse Events (AEs) | From the enrollment of the study up to 30 days after last dose of the study drug (up to 2 years 3 months) | The safety population included all participants who received at least one dose of the study medication during the open-label treatment period and had at least one post-baseline safety assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants With at Least 1 Treatment-Emergent Abnormal Laboratory Values (TEAVs): Hematology | From the first dose of study drug up to 2 years 3 months | The safety population included all participants who received at least one dose of the study medication during the open-label treatment period and had at least one post-baseline safety assessment. Here 'N' (overall number analyzed) are the participants who were evaluable for the outcome measure. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With at Least 1 TEAVs for Selected Parameters: Clinical Chemistry | From the first dose of study drug up to 2 years 3 months | The safety population included all participants who received at least one dose of the study medication during the open-label treatment period and had at least one post-baseline safety assessment. Here 'N' (overall number analyzed) are the participants who were evaluable for the outcome measure. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Severe Impairment Battery (SIB) Total Score | At Baseline, Month 3, Month 6, Month 9 and Month 12 | The Intent-to-treat (ITT) population included all safety participants who have at least one post-baseline efficacy measurement. Here 'N' (overall number of participants analyzed) included all participants who were evaluable for this outcome measure and 'n' (number analyzed) included all participants who were evaluable at specified timepoints for this outcome measure. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in Mini-Mental State Examination (MMSE) Total Score | At Baseline, Month 3, Month 6, Month 9 and Month 12 | The ITT population included all safety participants who have at least one post-baseline efficacy measurement. Here 'N' (overall number of participants analyzed) included all participants who were evaluable for this outcome measure and 'n' (number analyzed) included all participants who were evaluable at specified timepoints for this outcome measure. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in Modified Alzheimer's Disease Cooperative Study Activities of Daily Living Severe Scale (ADCS-ADL) Total Score | At Baseline, Month 3, Month 6, Month 9 and Month 12 | The ITT population included all safety participants who have at least one post-baseline efficacy measurement. Here 'N' (overall number of participants analyzed) included all participants who were evaluable for this outcome measure and 'n' (number analyzed) included all participants who were evaluable at specified timepoints for this outcome measure. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in Quality of Life-Alzheimer's Disease (Qol-AD) Total Score | At Baseline, Month 6 and Month 12 | The ITT population included all safety participants who have at least one post-baseline efficacy measurement. Here 'N' (overall number of participants analyzed) included all participants who were evaluable for this outcome measure and 'n' (number analyzed) included all participants who were evaluable at specified timepoints for this outcome measure. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in European Quality of Life-5 Dimension (EQ-5D) Total Score | At Baseline, Month 6 and Month 12 | The ITT population included all safety participants who have at least one post-baseline efficacy measurement. Here 'N' (overall number of participants analyzed) included all participants who were evaluable for this outcome measure and 'n' (number analyzed) included all participants who were evaluable at specified timepoints for this outcome measure. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in Screen for Caregiver Objective Burden (SCB) Total Score | At Baseline, Month 6 and Month 12 | The ITT population included all safety participants who have at least one post-baseline efficacy measurement. Here 'N' (overall number of participants analyzed) included all participants who were evaluable for this outcome measure and 'n' (number analyzed) included all participants who were evaluable at specified timepoints for this outcome measure. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in Screen for Caregiver Subjective Burden (SCB) Total Score | At Baseline, Month 6 and Month 12 | The ITT population included all safety participants who have at least one post-baseline efficacy measurement. Here 'N' (overall number of participants analyzed) included all participants who were evaluable for this outcome measure and 'n' (number analyzed) included all participants who were evaluable at specified timepoints for this outcome measure. | score on a scale | MEAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group102
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Adverse Events (AEs) | Donepezil SR 23 mg (Donepezil SR 23 mg in Study NCT00478205) | 416 | Participants | ||
| Number of Participants With Adverse Events (AEs) | Donepezil SR 23 mg (Donepezil IR 10 mg in Study NCT00478205) | 259 | Participants | ||
| Percentage of Participants With at Least 1 Treatment-Emergent Abnormal Laboratory Values (TEAVs): Hematology | Donepezil SR 23 mg (Donepezil SR 23 mg in Study NCT00478205) | 9.5 | percentage of participants | ||
| Percentage of Participants With at Least 1 Treatment-Emergent Abnormal Laboratory Values (TEAVs): Hematology | Donepezil SR 23 mg (Donepezil IR 10 mg in Study NCT00478205) | 10.9 | percentage of participants | ||
| Percentage of Participants With at Least 1 TEAVs for Selected Parameters: Clinical Chemistry | Donepezil SR 23 mg (Donepezil SR 23 mg in Study NCT00478205) | 14.3 | percentage of participants | ||
| Percentage of Participants With at Least 1 TEAVs for Selected Parameters: Clinical Chemistry | Donepezil SR 23 mg (Donepezil IR 10 mg in Study NCT00478205) | 13.1 | percentage of participants | ||
| Change From Baseline in Severe Impairment Battery (SIB) Total Score | Donepezil SR 23 mg (Donepezil SR 23 mg in Study NCT00478205) | At Baseline | 78.4 | Standard Deviation 19.05 | score on a scale |
| Change From Baseline in Severe Impairment Battery (SIB) Total Score | Donepezil SR 23 mg (Donepezil IR 10 mg in Study NCT00478205) | At Baseline | 77.2 | Standard Deviation 19.49 | score on a scale |
| Change From Baseline in Severe Impairment Battery (SIB) Total Score | Donepezil SR 23 mg (Donepezil SR 23 mg in Study NCT00478205) | Change at Month 3 | -1.7 | Standard Deviation 7.11 | score on a scale |
| Change From Baseline in Severe Impairment Battery (SIB) Total Score | Donepezil SR 23 mg (Donepezil IR 10 mg in Study NCT00478205) | Change at Month 3 | -0.9 | Standard Deviation 6.55 | score on a scale |
1 to 10 of 102Source ClinicalTrials.gov
See all 102 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Donepezil SR 23 mg (Donepezil SR 23 mg in Study NCT00478205) | 570 | |
| Overall Study | STARTED | Donepezil SR 23 mg (Donepezil IR 10 mg in Study NCT00478205) | 332 | |
| Overall Study | COMPLETED | Donepezil SR 23 mg (Donepezil SR 23 mg in Study NCT00478205) | 423 | |
| Overall Study | COMPLETED | Donepezil SR 23 mg (Donepezil IR 10 mg in Study NCT00478205) | 210 | |
| Overall Study | NOT COMPLETED | Donepezil SR 23 mg (Donepezil SR 23 mg in Study NCT00478205) | 147 | |
| Overall Study | NOT COMPLETED | Donepezil SR 23 mg (Donepezil IR 10 mg in Study NCT00478205) | 122 |
Source ClinicalTrials.gov
Adverse events330
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 | Weight decreased | Investigations | Donepezil SR 23 mg (Donepezil SR 23 mg in Study NCT00478205) | 58 | 570 | |
| other | Weight decreased | Investigations | Donepezil SR 23 mg (Donepezil IR 10 mg in Study NCT00478205) | 43 | 332 | |
| other | Fall | Injury, poisoning and procedural complications | Donepezil SR 23 mg (Donepezil SR 23 mg in Study NCT00478205) | 54 | 570 | |
| other | Fall | Injury, poisoning and procedural complications | Donepezil SR 23 mg (Donepezil IR 10 mg in Study NCT00478205) | 25 | 332 | |
| other | Agitation | Psychiatric disorders | Donepezil SR 23 mg (Donepezil SR 23 mg in Study NCT00478205) | 33 | 570 | |
| other | Agitation | Psychiatric disorders | Donepezil SR 23 mg (Donepezil IR 10 mg in Study NCT00478205) | 28 | 332 | |
| other | Urinary tract infection | Renal and urinary disorders | Donepezil SR 23 mg (Donepezil SR 23 mg in Study NCT00478205) | 33 | 570 | |
| other | Urinary tract infection | Renal and urinary disorders | Donepezil SR 23 mg (Donepezil IR 10 mg in Study NCT00478205) | 20 | 332 | |
| other | Diarrhoea | Gastrointestinal disorders | Donepezil SR 23 mg (Donepezil SR 23 mg in Study NCT00478205) | 20 | 570 | |
| other | Diarrhoea | Gastrointestinal disorders | Donepezil SR 23 mg (Donepezil IR 10 mg in Study NCT00478205) | 19 | 332 |
1 to 10 of 330Source ClinicalTrials.gov
See all 330 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Donepezil SR 23 mg (Donepezil SR 23 mg in Study NCT00478205) | 14 | 570 |
| Total, all-cause mortality | Donepezil SR 23 mg (Donepezil IR 10 mg in Study NCT00478205) | 5 | 332 |
| Total, other adverse events | Donepezil SR 23 mg (Donepezil SR 23 mg in Study NCT00478205) | 415 | 570 |
| Total, other adverse events | Donepezil SR 23 mg (Donepezil IR 10 mg in Study NCT00478205) | 259 | 332 |
| Total, serious adverse events | Donepezil SR 23 mg (Donepezil SR 23 mg in Study NCT00478205) | 80 | 570 |
| Total, serious adverse events | Donepezil SR 23 mg (Donepezil IR 10 mg in Study NCT00478205) | 56 | 332 |
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Donepezil SR 23 mg (Donepezil SR 23 mg in Study NCT00478205) vs Donepezil SR 23 mg (Donepezil IR 10 mg in Study NCT00478205): deaths from any cause | Trial comparisons |
| Donepezil SR 23 mg (Donepezil SR 23 mg in Study NCT00478205) vs Donepezil SR 23 mg (Donepezil IR 10 mg in Study NCT00478205): Number of Participants With Adverse Events (AEs) | Trial comparisons |
| Donepezil SR 23 mg (Donepezil SR 23 mg in Study NCT00478205) vs Donepezil SR 23 mg (Donepezil IR 10 mg in Study NCT00478205): serious adverse events | 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/NCT00566501
GET https://conductscience.org/api/trials/v1/NCT00566501/results?page=2