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CompletedNCT00571064Updated Sep 27, 2018Results posted

The Effectiveness And Safety Of Donepezil Hydrochloride (E2020) In Subjects With Mild To Severe Alzheimer's Disease Residing In An Assisted Living Facility

A Phase 4 interventional study of Donepezil HCl in Mild to Severe Alzheimer's Disease, sponsored by Eisai Inc.. Completed at 36 sites in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2018-09-27.

Sponsored by Eisai Inc. · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
97
Allocation
Not applicable
Ages
50 Years and older
Sex
All
01

Study summary

This is a study to determine the effectiveness and safety of donepezil hydrochloride (E2020) used to treat residents of assisted living facilities diagnosed with mild, moderate, or severe stage Alzheimer's disease.

02

Conditions studied

  • Mild to Severe Alzheimer's Disease
03

In context

Lead sponsor

Eisai Inc. is the lead sponsor of 368 studies on the registry; 7 are open to participants now.

Of its 83 completed or terminated interventional studies of FDA-regulated products, 56 (67%) have results posted.

Browse Eisai Co., Ltd. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age range: Subjects > 50 years of age.
  2. Sex distribution: both men and women. Women must be two (2) years post-menopausal or surgically sterile. Women of child bearing potential (\< 1 year post menopausal) must be practicing effective contraception and have a negative ß-hCG at screening (Women who are breast feeding are excluded).
  3. MMSE scores between 5 and 24 (inclusive).
  4. Subjects must have diagnostic evidence of possible or probable AD either prior to or at the screening visit based on Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) and National Institute of Neurological and Communicative Disorders and Stroke criteria.
  5. CT or MRI within the last 12 months consistent with a diagnosis of AD without any other clinically significant comorbid pathologies found. A copy of the report will be required and will be collected. If there has been a significant change in clinical status suggestive of stroke or other neurological disease in addition to AD with onset between the time of the last CT or MRI and the screening evaluation, the scan should be repeated during screening.
  6. The caregiver/ informant can be a family member or a professional and must have had contact with the subject at least 6 Weeks prior to study entry and spent at minimum 3 days a Week (10 hours per Week) with the subject. For study visit, the subject can be seen at the Assisted Living Facility (ALF) or in the clinic setting of the Investigator. At each visit, the caregiver/informant will provide the information for completion of the safety and efficacy assessments based on knowledge of and time spent with the subject.
  7. Subjects must reside in an ALF.
  8. The subject is expected to complete all procedures scheduled during the screening, baseline, interim, and final visits including all efficacy assessments.
  9. Putative non-prescription/prescription cognitive enhancers (e.g. ginkgo, high-dose vitamin E, lecithin, estrogen, non-steroidal anti-inflammatory drugs [NSAIDs]) will not be excluded but will be discouraged. If a putative cognitive enhancer is present, the dosage must have been stable for at least 3 months prior to the screening visit and should not change during the course of the study.
  10. Subjects with controlled hypertension (sitting diastolic BP \< 95 mmHg), right bundle branch block (complete or partial), and pacemakers may be included in the study.
  11. Subjects with thyroid disease also may be included in the study provided they are euthyroid and stable on treatment for at least 3 months prior to screening.
  12. Subjects with a history of seizure disorder are allowed provided that they are on stable treatment for at least 3 months prior to screening and have not had a seizure within the past 6 months.
  13. Subjects must be able to swallow tablet medication -- no crushing of tablet is allowed.
  14. Health: independent or ambulatory aided (i.e., walker or cane, to wheelchair); vision and hearing (eyeglasses and/or hearing aid permissible) sufficient for compliance with testing procedures.
  15. Subjects must be sufficiently proficient in the language in which the assessments are to be conducted.
  16. Subjects must have clinical laboratory values within normal limits, and within the Eisai (sponsor) guidelines, or abnormalities considered not clinically significant by the investigator and sponsor.

Exclusion criteria

Exclusion Criteria:

  1. Age range: Subjects \< 50 years of age.
  2. MMSE score of ≤4 or ≥25.
  3. Subjects with active or clinically significant conditions affecting absorption, distribution or metabolism of the study medication (e.g., inflammatory bowel disease, gastric or duodenal ulcers or severe lactose intolerance).
  4. Subjects with a known hypersensitivity to piperidine derivatives or cholinesterase inhibitors.
  5. Subjects living in a skilled nursing home or subjects living in an ALF who may be moved to a skilled nursing home during the course of the study. Subjects who transfer from an ALF to a skilled nursing home during this study will be discontinued.
  6. Subjects who have taken the following medications within the last 3 months prior to screening will be not eligible: Aricept, Exelon, Cognex, Razadyne, Metrifonate, Namenda or propentofylline.
  7. Subjects without a reliable caregiver/informant or subjects whose caregiver is unwilling or unable to complete the outcome measures and fulfill the requirements of this study.
  8. Subjects with clinically significant obstructive pulmonary disease or asthma, untreated for > 3 months.
  9. Subjects with recent (\< 2 years) hematologic/ oncologic disorders, not including mild anemia or basal or squamous cell carcinoma of the skin. Subjects with current evidence of malignant neoplasm or recurrent or metastatic disease will be excluded.
  10. Evidence of clinically significant, active gastrointestinal, renal, hepatic, endocrine or cardiovascular system disease.
  11. Subject with a current DSM-lV diagnosis of Major Depressive Disorder (MDD) or any current primary psychiatric diagnosis other than Alzheimer's disease (as per DSM-lV).
  12. Subjects with dementia complicated by other organic disease (DSM 290.30 or 290.11) are excluded; depression or delusions are common in Alzheimer's disease, and subjects with severe symptoms so pronounced that they warrant an alternative, concurrent diagnosis, are excluded.
  13. Subjects with a known or suspected history of alcoholism or drug abuse (within the past 10 years).
  14. Subjects with treated hypothyroidism that have not been on a stable dose of medication for 3 months prior to screening and who do not have normal serum Free T3, Free T4 and TSH at screening.
  15. Subjects with treated vitamin B-12 deficiency who have not been on a stable dose of medication for at least 3 months prior to the study screening visit and who do not have normal serum B-12 levels at screening.
  16. Any subject taking a prohibited medication will be excluded.
  17. Any condition which would make the subject or the caregiver, in the opinion of the investigator, unsuitable for the study.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
97 participants (actual)

Study arms

  • Experimental
    1

    Drug: Donepezil HCl

Interventions

  • DrugDonepezil HCl

    One 5 mg tablet per day (for the first 6 weeks) with a full glass of water. For the last 6 weeks, one 10mg tablet per day with a full glass of water.

    Also known as: Aricept

06

What researchers measure

Primary outcomes

  1. Mini Mental State Examination (MMSE) Total Scores by Visit

    The MMSE was a brief test that assessed the cognitive status of the participant. The 30-point test included items that evaluate orientation to time and place, immediate and delayed recall, attention, language, and construction. The total number of correct responses was obtained. The scores ranged from 0 to 30, with higher scores representing better performance. Summaries and analyses in the Intent-to-Treat (ITT) population were carried out using observed cases at each visit. A Study Endpoint evaluation was performed using the last observation carried forward (LOCF) from the open label treatment phase for each participant. The outcome of the study was based on analyses of the primary efficacy variable at Study Endpoint, which was defined as end of study assessment, using the ITT population with LOCF.

    Time frame: Baseline (Visit 2), Week 6 (Visit 3), Week 12 (Visit 4) or Early Termination (ET) Visit, Week 12 LOCF (Study Endpoint)

  2. Change From Baseline in MMSE Total Score by Visit

    The MMSE was a brief test that assessed the cognitive status of the participant. The 30-point test included items that evaluated orientation to time and place, immediate and delayed recall, attention, language, and construction. The total number of correct responses was obtained. The scores ranged from 0 to 30, with higher scores representing better performance. Summaries and analyses in the ITT population were carried out using observed cases at each visit. A Study Endpoint evaluation was performed using the LOCF from the open label treatment phase for each participant. The outcome of the study was based on analyses of the primary efficacy variable at Study Endpoint, which was defined as end of study assessment, using the ITT population with LOCF. Change from Baseline in MMSE Total Score at Week 6 (Visit 3), Week 12 (Visit 4) or ET Visit, Week 12 LOCF (Study Endpoint) has been reported.

    Time frame: Baseline, Week 6 (Visit 3), Week 12 (Visit 4) or ET Visit, Week 12 LOCF (Study Endpoint)

Secondary outcomes

  1. Caregiver Activity Survey (CAS) Total Time by Visit

    The CAS was a validated tool that measured the time caregivers spent aiding Alzheimer's participants with their day-to-day activities. The CAS recorded time spent on six activities of daily living, communicating with the person, using transportation, dressing, eating, looking after one's appearance, and supervising the person. Caregivers were asked to report the amount of time spent on each activity during a 'typical' caregiving day. Total time for the CAS was calculated as the sum of the sub-item times.

    Time frame: Baseline (Visit 2), Week 6 (Visit 3), Week 12 (Visit 4) or ET Visit, Week 12 LOCF (Study Endpoint)

  2. Change From Baseline in CAS Total Time by Visit

    The CAS was a validated tool that measured the time caregivers spent aiding Alzheimer's participants with their day-to-day activities. The CAS recorded time spent on six activities of daily living, communicating with the person, using transportation, dressing, eating, looking after one's appearance, and supervising the person. Caregivers were asked to report the amount of time spent on each activity during a 'typical' caregiving day. Total time for the CAS was calculated as the sum of the sub-item times. Change from Baseline in CAS Total Time at Week 6 (Visit 3), Week 12 (Visit 4) or ET Visit, Week 12 LOCF (Study Endpoint) has been reported.

    Time frame: Baseline, Week 6 (Visit 3), Week 12 (Visit 4) or ET Visit, Week 12 LOCF (Study Endpoint)

  3. Neuropsychiatric Inventory (NPI-8) Total Score by Visit

    The NPI-8 was an 8-item scale that assessed eight behavioral domains: delusions, hallucinations, agitation, depression, anxiety, apathy, irritability, and aberrant motor behavior. The frequency (0 to 4) and severity (0 to 3) of each domain were assessed; the sub-score for each domain was calculated as the product of the frequency and severity rating. The total score for the NPI was calculated as the sum of the domain sub-score, range from 0 to 96, with higher scores indicating greater behavior disturbances.

    Time frame: Baseline (Visit 2), Week 12 (Visit 4) or ET Visit, Week 12 LOCF (Study Endpoint)

  4. Change From Baseline in NPI-8 Total Score by Visit

    The NPI-8 was an 8-item scale that assessed eight behavioral domains: delusions, hallucinations, agitation, depression, anxiety, apathy, irritability, and aberrant motor behavior. The frequency (0 to 4) and severity (0 to 3) of each domain were assessed; the sub-score for each domain was calculated as the product of the frequency and severity rating. The total score for the NPI was calculated as the sum of the domain sub-score, range from 0 to 96, with higher scores indicating greater behavior disturbances. Change from Baseline in NPI-8 Total Score at Week 12 (Visit 4) or ET Visit, Week 12 LOCF (Study Endpoint) has been reported.

    Time frame: Baseline, Week 12 (Visit 4) or ET Visit, Week 12 LOCF (Study Endpoint)

  5. Alzheimer Disease-related Quality of Life (ADRQL) Total Score by Visit

    The ADRQL was an observer-rated quality of life instrument that measured the following domains: social interaction, awareness of self, feelings and mood, enjoyment of activities, and response to surroundings. The ADRQL was a 47-item questionnaire with five domains: relating to and being around other people (ADRQL-A; 12 items), a person's special identity and important relationships (ADRQL-B; 8 items), different types of behavior (ADRQL-C; 15 items), usual activities (ADRQL-D; 5 items), and behavior in a person's living environment (ADRQL-E; 7 items). Domain sub-scores were summed to yield a total raw score, which was divided by the total possible score and multiplied by 100 to produce the final score. Each subscale score could be calculated in the similar approach. Total score ranges from 0-100 where higher scores reflected a better quality of life.

    Time frame: Baseline (Visit 2), Week 12 (Visit 4) or ET Visit, Week 12 LOCF (Study Endpoint)

  6. Change From Baseline in ADRQL Total Score by Visit

    The ADRQL was an observer-rated quality of life instrument that measured the following domains: social interaction, awareness of self, feelings and mood, enjoyment of activities, and response to surroundings. The ADRQL was a 47-item questionnaire with five domains: relating to and being around other people (ADRQL-A; 12 items), a person's special identity and important relationships (ADRQL-B; 8 items), different types of behavior (ADRQL-C; 15 items), usual activities (ADRQL-D; 5 items), and behavior in a person's living environment (ADRQL-E; 7 items). Domain sub-scores were summed to yield a total raw score, which was divided by the total possible score and multiplied by 100 to produce the final score. Each subscale score could be calculated in the similar approach. Higher scores reflected a better quality of life. Change from Baseline in ADRQL Total Score at Week 12 (Visit 4) or ET Visit, Week 12 LOCF (Study Endpoint) has been reported.

    Time frame: Baseline, Week 12 (Visit 4) or ET Visit, Week 12 LOCF (Study Endpoint)

  7. Disability Assessment in Dementia (DAD) Total Score by Visit

    The DAD was a 10 domain 40-item scale that measured a participant's ability to initiate, plan, organize, and perform both basic and instrumental activities of daily living. These domains were: hygiene (7 items), dressing (5 items), continence (2 items), eating (3 items), meal preparation (3 items), telephoning (4 items), going on an outing (5 items), finance (4 items), medication (2 items), and leisure (5 items). The three responses to the DAD items were "No, Yes, and N/A". A "No" answer scored 0 and a "Yes" answer scored 1. The scoring range was 0-40, with a higher score indicating less disability (better quality of life). If N/A was selected then it was treated as missing. When there were items with missing values, the domain sub-scores and the total score were imputed. Domain sub-scores were summed to yield a total raw score. This was divided by the total possible score and multiplied by 100 to produce the final score. Each subscale score can be calculated in the similar approach.

    Time frame: Baseline (Visit 2), Week 6 (Visit 3), Week 12 (Visit 4) or ET Visit, Week 12 LOCF (Study Endpoint)

  8. Change From Baseline in DAD Total Score by Visit

    The DAD was a 10 domain 40-item scale that measured a participant's ability to initiate, plan, organize, and perform both basic and instrumental activities of daily living. These domains were: hygiene (7 items), dressing (5 items), continence (2 items), eating (3 items), meal preparation (3 items), telephoning (4 items), going on an outing (5 items), finance (4 items), medication (2 items), and leisure (5 items). The three responses to the DAD items were "No, Yes, and N/A". A "No" answer scored 0 and a "Yes" answer scored 1. The scoring range was 0-40, with a higher score indicating less disability (better quality of life). If N/A was selected then it was treated as missing. When there were items with missing values, the domain sub-scores and the total score were imputed. Domain sub-scores were summed to yield a total raw score. This was divided by the total possible score and multiplied by 100 to produce the final score. Each subscale score can be calculated in the similar approach.

    Time frame: Baselinw, Week 6 (Visit 3) and Week 12 (Visit 4) or ET Visit, Week 12 LOCF (Study Endpoint)

07

Results

Posted Mar 12, 2018

Participant flow

Participant flow — Overall Study
MilestoneDonepezil Hydrochloride (HCl)
Started97
Completed76
Not completed21
Withdrew: Adverse event13
Withdrew: Protocol violation4
Withdrew: Withdrawal by subject2
Withdrew: Other2

Outcome measures

PrimaryMini Mental State Examination (MMSE) Total Scores by Visit

The MMSE was a brief test that assessed the cognitive status of the participant. The 30-point test included items that evaluate orientation to time and place, immediate and delayed recall, attention, language, and construction. The total number of correct responses was obtained. The scores ranged from 0 to 30, with higher scores representing better performance. Summaries and analyses in the Intent-to-Treat (ITT) population were carried out using observed cases at each visit. A Study Endpoint evaluation was performed using the last observation carried forward (LOCF) from the open label treatment phase for each participant. The outcome of the study was based on analyses of the primary efficacy variable at Study Endpoint, which was defined as end of study assessment, using the ITT population with LOCF.

Time frame:
Baseline (Visit 2), Week 6 (Visit 3), Week 12 (Visit 4) or Early Termination (ET) Visit, Week 12 LOCF (Study Endpoint)
Reported as:
Mean · Scores on a scale
Mini Mental State Examination (MMSE) Total Scores by Visit
Scores on a scaleDonepezil Hydrochloride (HCl)
Baseline (Visit 2)18.7 ± 5.29
Week 6 (Visit 3)20.8 ± 5.16
Week 12/ET (Visit 4)20.5 ± 5.92
Week 12 LOCF (Study Endpoint)20.5 ± 5.88
SecondaryCaregiver Activity Survey (CAS) Total Time by Visit

The CAS was a validated tool that measured the time caregivers spent aiding Alzheimer's participants with their day-to-day activities. The CAS recorded time spent on six activities of daily living, communicating with the person, using transportation, dressing, eating, looking after one's appearance, and supervising the person. Caregivers were asked to report the amount of time spent on each activity during a 'typical' caregiving day. Total time for the CAS was calculated as the sum of the sub-item times.

Time frame:
Baseline (Visit 2), Week 6 (Visit 3), Week 12 (Visit 4) or ET Visit, Week 12 LOCF (Study Endpoint)
Reported as:
Mean · Hours/day
Caregiver Activity Survey (CAS) Total Time by Visit
Hours/dayDonepezil Hydrochloride (HCl)
Baseline (Visit 2)8.9 ± 8.80
Week 6 (Visit 3)9.0 ± 9.99
Week 12/ET (Visit 4)9.0 ± 9.81
Week 12 LOCF (Study Endpoint)9.3 ± 10.07
SecondaryChange From Baseline in CAS Total Time by Visit

The CAS was a validated tool that measured the time caregivers spent aiding Alzheimer's participants with their day-to-day activities. The CAS recorded time spent on six activities of daily living, communicating with the person, using transportation, dressing, eating, looking after one's appearance, and supervising the person. Caregivers were asked to report the amount of time spent on each activity during a 'typical' caregiving day. Total time for the CAS was calculated as the sum of the sub-item times. Change from Baseline in CAS Total Time at Week 6 (Visit 3), Week 12 (Visit 4) or ET Visit, Week 12 LOCF (Study Endpoint) has been reported.

Time frame:
Baseline, Week 6 (Visit 3), Week 12 (Visit 4) or ET Visit, Week 12 LOCF (Study Endpoint)
Reported as:
Mean · Hours/day
Change From Baseline in CAS Total Time by Visit
Hours/dayDonepezil Hydrochloride (HCl)
Baseline8.9 ± 8.80
Change from Baseline at Week 6 (Visit 3)0.3 ± 6.83
Change from Baseline at Week 12/ET (Visit 4)0.3 ± 5.82
Change from Baseline at Week 12 LOCF0.3 ± 5.78
Statistical analysis
  • Donepezil Hydrochloride (HCl) · t-test, 2 sided · p = 0.6593 (Significance level of 0.05)
  • Donepezil Hydrochloride (HCl) · t-test, 2 sided · p = 0.6048 (Significance level of 0.05)
  • Donepezil Hydrochloride (HCl) · t-test, 2 sided · p = 0.5924 (Significance level of 0.05)
PrimaryChange From Baseline in MMSE Total Score by Visit

The MMSE was a brief test that assessed the cognitive status of the participant. The 30-point test included items that evaluated orientation to time and place, immediate and delayed recall, attention, language, and construction. The total number of correct responses was obtained. The scores ranged from 0 to 30, with higher scores representing better performance. Summaries and analyses in the ITT population were carried out using observed cases at each visit. A Study Endpoint evaluation was performed using the LOCF from the open label treatment phase for each participant. The outcome of the study was based on analyses of the primary efficacy variable at Study Endpoint, which was defined as end of study assessment, using the ITT population with LOCF. Change from Baseline in MMSE Total Score at Week 6 (Visit 3), Week 12 (Visit 4) or ET Visit, Week 12 LOCF (Study Endpoint) has been reported.

Time frame:
Baseline, Week 6 (Visit 3), Week 12 (Visit 4) or ET Visit, Week 12 LOCF (Study Endpoint)
Reported as:
Mean · Scores on a scale
Change From Baseline in MMSE Total Score by Visit
Scores on a scaleDonepezil Hydrochloride (HCl)
Baseline18.7 ± 5.29
Change from Baseline at Week 6 (Visit 3)1.8 ± 2.81
Change from Baseline at Week 12/ET (Visit 4)1.9 ± 2.79
Change from Baseline at Week 12 LOCF1.8 ± 2.81
Statistical analysis
  • Donepezil Hydrochloride (HCl) · t-test, 2 sided · p = <0.0001 (Significance level 0.05)
  • Donepezil Hydrochloride (HCl) · t-test, 2 sided · p = <0.0001 (Significance level of 0.05)
  • Donepezil Hydrochloride (HCl) · t-test, 2 sided · p = <0.0001 (Significance level of 0.05)
SecondaryNeuropsychiatric Inventory (NPI-8) Total Score by Visit

The NPI-8 was an 8-item scale that assessed eight behavioral domains: delusions, hallucinations, agitation, depression, anxiety, apathy, irritability, and aberrant motor behavior. The frequency (0 to 4) and severity (0 to 3) of each domain were assessed; the sub-score for each domain was calculated as the product of the frequency and severity rating. The total score for the NPI was calculated as the sum of the domain sub-score, range from 0 to 96, with higher scores indicating greater behavior disturbances.

Time frame:
Baseline (Visit 2), Week 12 (Visit 4) or ET Visit, Week 12 LOCF (Study Endpoint)
Reported as:
Mean · Scores on a scale
Neuropsychiatric Inventory (NPI-8) Total Score by Visit
Scores on a scaleDonepezil Hydrochloride (HCl)
Visit 2 (Baseline)5.7 ± 9.70
Week 12/ET (Visit 4)3.9 ± 5.73
Week 12 LOCF (Study Endpoint)3.9 ± 5.73
SecondaryChange From Baseline in NPI-8 Total Score by Visit

The NPI-8 was an 8-item scale that assessed eight behavioral domains: delusions, hallucinations, agitation, depression, anxiety, apathy, irritability, and aberrant motor behavior. The frequency (0 to 4) and severity (0 to 3) of each domain were assessed; the sub-score for each domain was calculated as the product of the frequency and severity rating. The total score for the NPI was calculated as the sum of the domain sub-score, range from 0 to 96, with higher scores indicating greater behavior disturbances. Change from Baseline in NPI-8 Total Score at Week 12 (Visit 4) or ET Visit, Week 12 LOCF (Study Endpoint) has been reported.

Time frame:
Baseline, Week 12 (Visit 4) or ET Visit, Week 12 LOCF (Study Endpoint)
Reported as:
Mean · Scores on a scale
Change From Baseline in NPI-8 Total Score by Visit
Scores on a scaleDonepezil Hydrochloride (HCl)
Baseline5.7 ± 9.7
Change from Baseline at Week 12/ET (Visit 4)-1.8 ± 8.39
Change from Baseline at Week 12 LOCF-1.8 ± 8.39
Statistical analysis
  • Donepezil Hydrochloride (HCl) · t-test, 2 sided · p = 0.0431 (Significance level of 0.05)
  • Donepezil Hydrochloride (HCl) · t-test, 2 sided · p = 0.0431 (Significance level of 0.05)
SecondaryAlzheimer Disease-related Quality of Life (ADRQL) Total Score by Visit

The ADRQL was an observer-rated quality of life instrument that measured the following domains: social interaction, awareness of self, feelings and mood, enjoyment of activities, and response to surroundings. The ADRQL was a 47-item questionnaire with five domains: relating to and being around other people (ADRQL-A; 12 items), a person's special identity and important relationships (ADRQL-B; 8 items), different types of behavior (ADRQL-C; 15 items), usual activities (ADRQL-D; 5 items), and behavior in a person's living environment (ADRQL-E; 7 items). Domain sub-scores were summed to yield a total raw score, which was divided by the total possible score and multiplied by 100 to produce the final score. Each subscale score could be calculated in the similar approach. Total score ranges from 0-100 where higher scores reflected a better quality of life.

Time frame:
Baseline (Visit 2), Week 12 (Visit 4) or ET Visit, Week 12 LOCF (Study Endpoint)
Reported as:
Mean · Scores on a scale
Alzheimer Disease-related Quality of Life (ADRQL) Total Score by Visit
Scores on a scaleDonepezil Hydrochloride (HCl)
Baseline (Visit 2)48.7 ± 8.71
Week 12/ET (Visit 4)47.6 ± 7.90
Week 12 LOCF (Study Endpoint)47.6 ± 7.90
SecondaryChange From Baseline in ADRQL Total Score by Visit

The ADRQL was an observer-rated quality of life instrument that measured the following domains: social interaction, awareness of self, feelings and mood, enjoyment of activities, and response to surroundings. The ADRQL was a 47-item questionnaire with five domains: relating to and being around other people (ADRQL-A; 12 items), a person's special identity and important relationships (ADRQL-B; 8 items), different types of behavior (ADRQL-C; 15 items), usual activities (ADRQL-D; 5 items), and behavior in a person's living environment (ADRQL-E; 7 items). Domain sub-scores were summed to yield a total raw score, which was divided by the total possible score and multiplied by 100 to produce the final score. Each subscale score could be calculated in the similar approach. Higher scores reflected a better quality of life. Change from Baseline in ADRQL Total Score at Week 12 (Visit 4) or ET Visit, Week 12 LOCF (Study Endpoint) has been reported.

Time frame:
Baseline, Week 12 (Visit 4) or ET Visit, Week 12 LOCF (Study Endpoint)
Reported as:
Mean · Scores on a scale
Change From Baseline in ADRQL Total Score by Visit
Scores on a scaleDonepezil Hydrochloride (HCl)
Baseline48.7 ± 8.71
Change from Baseline at Week 12/ET (Visit 4)-1.1 ± 6.93
Change from Baseline at Week 12 LOCF-1.1 ± 6.93
Statistical analysis
  • Donepezil Hydrochloride (HCl) · t-test, 2 sided · p = 0.1285 (Significance level of 0.05)
  • Donepezil Hydrochloride (HCl) · t-test, 2 sided · p = 0.1285 (Significance level of 0.05)
SecondaryDisability Assessment in Dementia (DAD) Total Score by Visit

The DAD was a 10 domain 40-item scale that measured a participant's ability to initiate, plan, organize, and perform both basic and instrumental activities of daily living. These domains were: hygiene (7 items), dressing (5 items), continence (2 items), eating (3 items), meal preparation (3 items), telephoning (4 items), going on an outing (5 items), finance (4 items), medication (2 items), and leisure (5 items). The three responses to the DAD items were "No, Yes, and N/A". A "No" answer scored 0 and a "Yes" answer scored 1. The scoring range was 0-40, with a higher score indicating less disability (better quality of life). If N/A was selected then it was treated as missing. When there were items with missing values, the domain sub-scores and the total score were imputed. Domain sub-scores were summed to yield a total raw score. This was divided by the total possible score and multiplied by 100 to produce the final score. Each subscale score can be calculated in the similar approach.

Time frame:
Baseline (Visit 2), Week 6 (Visit 3), Week 12 (Visit 4) or ET Visit, Week 12 LOCF (Study Endpoint)
Reported as:
Mean · Scores on a scale
Disability Assessment in Dementia (DAD) Total Score by Visit
Scores on a scaleDonepezil Hydrochloride (HCl)
Baseline (Visit 2)58.3 ± 26.48
Week 6 (Visit 3)58.4 ± 24.93
Week 12/ET (Visit 4)57.2 ± 25.53
Week 12 LOCF (Study Endpoint)57.2 ± 25.39
SecondaryChange From Baseline in DAD Total Score by Visit

The DAD was a 10 domain 40-item scale that measured a participant's ability to initiate, plan, organize, and perform both basic and instrumental activities of daily living. These domains were: hygiene (7 items), dressing (5 items), continence (2 items), eating (3 items), meal preparation (3 items), telephoning (4 items), going on an outing (5 items), finance (4 items), medication (2 items), and leisure (5 items). The three responses to the DAD items were "No, Yes, and N/A". A "No" answer scored 0 and a "Yes" answer scored 1. The scoring range was 0-40, with a higher score indicating less disability (better quality of life). If N/A was selected then it was treated as missing. When there were items with missing values, the domain sub-scores and the total score were imputed. Domain sub-scores were summed to yield a total raw score. This was divided by the total possible score and multiplied by 100 to produce the final score. Each subscale score can be calculated in the similar approach.

Time frame:
Baselinw, Week 6 (Visit 3) and Week 12 (Visit 4) or ET Visit, Week 12 LOCF (Study Endpoint)
Reported as:
Mean · Scores on a scale
Change From Baseline in DAD Total Score by Visit
Scores on a scaleDonepezil Hydrochloride (HCl)
Baseline58.3 ± 26.48
Change from Baseline at Week 6 (Visit 2)-1.1 ± 8.52
Change from Baseline at Week 12/ET (Visit 4)-1.1 ± 14.38
Change from Baseline at Week 12 LOCF-1.1 ± 14.30
Statistical analysis
  • Donepezil Hydrochloride (HCl) · t-test, 2 sided · p = 0.2327 (Significance level of 0.05)
  • Donepezil Hydrochloride (HCl) · t-test, 2 sided · p = 0.4724 (Significance level of 0.05)
  • Donepezil Hydrochloride (HCl) · t-test, 2 sided · p = 0.4724 (Significance level of 0.05)

Adverse events

Collected over All adverse events (AEs) and serious adverse events (SAEs) were collected from Screening Visit 1 (-21 to -14 days) until Week 12 Visit 4 (Day 84) or early termination. AEs/SAEs were collected for approximately 4 months.. Non-serious events are listed at a 2% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Donepezil Hydrochloride (HCl)2/97 (2.1%)12/97 (12.4%)56/97 (57.7%)
Most frequent serious events
Showing 10 of 20
Most frequent serious events
EventDonepezil Hydrochloride (HCl)
Atrioventricular block completeCardiac disorders1/97
Cardiac arrestCardiac disorders1/97
Abdominal painGastrointestinal disorders1/97
Gastric volvulusGastrointestinal disorders1/97
Intestinal obstructionGastrointestinal disorders1/97
CellulitisInfections and infestations1/97
Septic shockInfections and infestations1/97
Urinary tract infectionInfections and infestations1/97
Hip fractureInjury, poisoning and procedural complications1/97
Spinal compression fractureInjury, poisoning and procedural complications1/97
Most frequent other events
Showing 10 of 18
Most frequent other events
EventDonepezil Hydrochloride (HCl)
NauseaGastrointestinal disorders9/97
DiarrhoeaGastrointestinal disorders8/97
CoughRespiratory, thoracic and mediastinal disorders4/97
Urinary tract infectionInfections and infestations4/97
VomitingGastrointestinal disorders4/97
DizzinessNervous system disorders3/97
HeadacheNervous system disorders3/97
RashSkin and subcutaneous tissue disorders3/97
Back painMusculoskeletal and connective tissue disorders2/97
Decreased appetiteMetabolism and nutrition disorders2/97

Baseline characteristics

Safety population included all enrolled participants who took at least one dose of study medication.

Age, Continuous
Age, Continuous(Years)Donepezil Hydrochloride (HCl)
Mean81.0 ± 10.30
Sex: Female, Male
Sex: Female, Male(Participants)Donepezil Hydrochloride (HCl)
Female65
Male32
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Study locations

36 sites
  • Senior Care
    Birmingham, Alabama 35209, United States
  • 21st Century Neurology
    Phoenix, Arizona 85004, United States
  • Psypharma Clinical Research
    Phoenix, Arizona 85050, United States
  • South Coast Clinical Trials
    Anaheim, California 38204, United States
  • AVI Clinical Research
    Carson, California 90746, United States
  • Margolin Brain Institute
    Fresno, California 93720, United States
  • Sarah Sam Olelewe, MD Inc
    Hawthorne, California 90250, United States
  • Neuropsychiatric Research Center of Orange County
    Santa Ana, California 92701, United States
  • Danbury Clinical Research, LLC
    Danbury, Connecticut 06810, United States
  • Research Center for Clinical Studies
    Norwalk, Connecticut 06851, United States
  • Neuroscience Consultants
    Miami, Florida 33176, United States
  • Galiz Research
    Miami Springs, Florida 33166, United States
  • Universal Clinical research and Technology
    Orlando, Florida 32833, United States
  • Byrd's Alzheimer Institute
    Tampa, Florida 33613, United States
  • Stedman Clinical Trials, LLC
    Tampa, Florida 33613, United States
  • Center for Clinical Trials
    Venice, Florida 34285, United States
  • Rush Alzheimer Disease Center
    Chicago, Illinois 92804, United States
  • Alexian Brothers Neuroscience Institute
    Elk Grove, Illinois 60007, United States
  • Agewell Health Ltd
    Indianapolis, Indiana 46260, United States
  • Venture Resource Group Inc
    Mission, Kansas 66202, United States
  • Four Rivers Clinical Research
    Paducah, Kentucky 42003, United States
  • McLean Hospital Geriatric Psychiatry
    Belmont, Massachusetts 02478, United States
  • Neuroscience Research of the Bershires
    Pittsfield, Massachusetts 01201, United States
  • Horne Research
    Las Vegas, Nevada 89102, United States
  • Bio Behavioral Health
    Toms River, New Jersey 08755, United States
  • University of New Mexico
    Albuquerque, New Mexico 87131, United States
  • Neurological Associates of Albany, PC
    Albany, New York 12208, United States
  • University Of Buffalo
    Buffalo, New York 14215, United States
  • University of Rochester, Monroe Community Hospital
    Rochester, New York 14620, United States
  • Valley Medical Research
    Centerville, Ohio 45959, United States
  • Infinity Research Group
    Oklahoma City, Oklahoma 73103, United States
  • University of Pennsylvania, Section of Geriatric Psychiatry
    Philadelphia, Pennsylvania 19104, United States
  • Rhode Island Mood and Memory Research Institute
    East Providence, Rhode Island 02914, United States
  • CNS Research, INC
    East Providence, Rhode Island 02916, United States
  • Senior Adults Specialty Research
    Austin, Texas 78757, United States
  • Mech Center
    Plano, Texas 75024, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 27, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00571064
Lead sponsor
Eisai Inc.
Collaborators
Pfizer
Responsible party
Sponsor
First posted
Dec 11, 2007
Start date
Jan 2008
Primary completion
Dec 2008
Completion
Apr 22, 2009
Results posted
Mar 12, 2018
Last update
Sep 27, 2018

Study contacts

James Prodafikas, MD
study director · Eisai Inc.
View the source record on ClinicalTrials.gov ↗

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