TerminatedResults posted

Observational Study Of Donepezil In Routine Clinical Practice

Ecological Perspective On The Efficacy And Tolerability Of Donepezil In A Routine Clinical Practice: A Patient Centered Observational Study

Lead sponsor

Pfizer

Asset

Donepezil

Listed sites

Recruiting sites

Enrollment

370

actual

Study population

Alzheimer’s disease

Key I/E criterion

•mild-to-moderate AD

Primary endpoints

•All Subjects Improved/Stabilized or Worsened for Cognitive Activation in Top•All Subjects Improved/Stabilized or Worsened for Attention in Top Symptom•All Subjects Improved/Stabilized or Worsened for Repetitiveness in Top Symptom

Identifiers

Registered as

SecondaryECO STUDY

NCT IDNCT00843115

Org study IDNRA2500065

Timeline

Milestones

Study start2007-02 (month precision)

Primary completion2008-04actual (month precision)

Study completion2008-04actual (month precision)

Study first posted2009-02-13estimated

Results first posted2009-06-02estimated

Last update posted2014-03-13estimated

Assets

Drug assets

Donepezil

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•DSM-IV criteria for the clinical diagnosis of mild to moderate Alzheimer's Disease with or without other etiologies of dementia

•Mini Mental Status Examination score of 10-26

Exclusion criteria

•Contraindication as stated in the Canadian label for donepezil

•Subjects treated with medication for dementia within 30 days prior to baseline

Endpoints (86)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)

Behavior / neuropsychiatric

Global cognition

Memory

Other clinical outcomes

Executive function / language

Caregiver / quality of life

Global cognition

8 endpoints

Secondary/protocol endpoint

Change From Baseline in Mini-Mental State Examination (MMSE) Total Scores at Week 12

Time frame:baseline, Week 12

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Secondary/protocol endpoint

Last Observation Carried Forward (LOCF) Change From Baseline in Mini-Mental State Examination (MMSE) Total Scores at Week 12

Time frame:baseline, Week 12 LOCF

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Secondary/protocol endpoint

Correlation Between Change From Baseline in Mini-Mental State Examination (MMSE) Score and Change From Baseline in Combined Patient and Caregiver Health Related Quality of Life (Alzheimer's Disease) (HR QoL-AD) Questionnaire Total Score

Time frame:baseline, 12 Weeks

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Secondary/protocol endpoint

Correlation Between LOCF Change From Baseline in Mini-Mental State Examination (MMSE) Score and LOCF Change From Baseline in Combined Patient and Caregiver Health Related Quality of Life (Alzheimer's Disease) (HR QoL-AD) Questionnaire Total Score

Time frame:baseline, Week 12 LOCF

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Secondary/registry result

Change From Baseline in Mini-Mental State Examination (MMSE) Total Scores at Week 12

Time frame:baseline, Week 12

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Posted result

Group	Value (mean), score on scale	Standard deviation
Donepeziln=322 Participants	1.1	2.75

p<0.0001t-test, 2 sided

Change from baseline in total score at Week 12

Secondary/registry result

Last Observation Carried Forward (LOCF) Change From Baseline in Mini-Mental State Examination (MMSE) Total Scores at Week 12

Time frame:baseline, Week 12 LOCF

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Posted result

Group	Value (mean), score on scale	Standard deviation
Donepeziln=322 Participants	1.1	2.79

p<0.0001t-test, 2 sided

Change from baseline in total score at Week 12 Last Observation Carried Forward

Secondary/registry result

Time frame:baseline, 12 Weeks

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Posted result

Group	Value (number), Pearson Product Correlation Coefficient	Reported bounds
Donepeziln=322 Participants	0.33	-

p<0.0001correlation coefficient

Secondary/registry result

Time frame:baseline, Week 12 LOCF

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Posted result

Group	Value (number), Pearson Product Correlation Coefficient	Reported bounds
Donepeziln=322 Participants	0.35	-

p<0.0001correlation coefficient

Memory

8 endpoints

Secondary/protocol endpoint

Change From Baseline in Combined Patient and Caregiver Health Related Quality of Life (Alzheimer's Disease) (HR QoL-AD) Questionnaire Total Scores

Time frame:baseline, 12 Weeks

change from baseline, improvement

Secondary/protocol endpoint

LOCF Change From Baseline in Combined Patient and Caregiver Health Related Quality of Life (Alzheimer's Disease) (HR QoL-AD) Questionnaire Total Scores

Time frame:baseline, 12 Week LOCF

change from baseline, improvement

Secondary/protocol endpoint

Correlation Analysis: Change From Baseline in Combined Patient and Caregiver Quality of Life in Alzheimer's Disease(QoL-AD) Questionnaire Total Score Versus Number of Treatment Emergent Adverse Events (TEAEs)

Time frame:baseline, 12 Weeks

change from baseline, improvement

Secondary/protocol endpoint

Correlation Analysis: LOCF Change From Baseline in Combined Patient and Caregiver Quality of Life in Alzheimer's Disease (QoL-AD) Questionnaire Total Score Versus the Number of Treatment Emergent Adverse Events (TEAEs)

Time frame:baseline, 12 Weeks LOCF

change from baseline, improvement

Secondary/registry result

Change From Baseline in Combined Patient and Caregiver Health Related Quality of Life (Alzheimer's Disease) (HR QoL-AD) Questionnaire Total Scores

Time frame:baseline, 12 Weeks

change from baseline, improvement

Posted result

Group	Value (mean), score on scale	Standard deviation
Donepeziln=322 Participants	1.4	3.36

p<0.0001t-test, 2 sided

Secondary/registry result

LOCF Change From Baseline in Combined Patient and Caregiver Health Related Quality of Life (Alzheimer's Disease) (HR QoL-AD) Questionnaire Total Scores

Time frame:baseline, 12 Week LOCF

change from baseline, improvement

Posted result

Group	Value (mean), score on scale	Standard deviation
Donepeziln=322 Participants	1.4	3.44

p<0.0001t-test, 2 sided

Secondary/registry result

Time frame:baseline, 12 Weeks

change from baseline, improvement

Posted result

Group	Value (number), Pearson Product Correlation Coefficient	Reported bounds
Donepeziln=322 Participants	-0.13	-

p0.0713correlation coefficient

Secondary/registry result

Time frame:baseline, 12 Weeks LOCF

change from baseline, improvement

Posted result

Group	Value (number), Pearson Product Correlation Coefficient	Reported bounds
Donepeziln=322 Participants	-0.15	-

p0.0225Correlation coefficient

Executive function / language

2 endpoints

Primary/protocol endpoint

All Subjects Improved/Stabilized or Worsened for Attention in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment

Time frame:Baseline and Week 12

event count, event

Primary/registry result

All Subjects Improved/Stabilized or Worsened for Attention in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment

Time frame:Baseline and Week 12

event count, event

Posted result

Group	Value (number), Participants	Reported bounds
DonepezilImproved or Stabilizedn=322 Participants	202	-
Worsenedn=322 Participants	31	-
Missing/Not Applicablen=322 Participants	89	-

p<0.0001Binomial test of proportions

Behavior / neuropsychiatric

16 endpoints

Primary/protocol endpoint

All Subjects Improved/Stabilized or Worsened for Agitation in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment

Time frame:Baseline and Week 12

event count, event

Primary/protocol endpoint

All Subjects Improved/Stabilized or Worsened for Mood in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment

Time frame:Baseline and Week 12

event count, event

Primary/protocol endpoint

All Subjects Improved/Stabilized or Worsened for Anxiety in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment

Time frame:Baseline and Week 12

event count, event

Primary/protocol endpoint

All Subjects Improved/Stabilized or Worsened for Apathy in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment

Time frame:Baseline and Week 12

event count, event

Primary/registry result

All Subjects Improved/Stabilized or Worsened for Agitation in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment

Time frame:Baseline and Week 12

event count, event

Posted result

Group	Value (number), participants	Reported bounds
DonepezilImproved or Stabilizedn=322 Participants	157	-
Worsenedn=322 Participants	23	-
Missing/Not Applicablen=322 Participants	142	-

p<0.0001Binomial test of proportions

Primary/registry result

All Subjects Improved/Stabilized or Worsened for Mood in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment

Time frame:Baseline and Week 12

event count, event

Posted result

Group	Value (number), participants	Reported bounds
DonepezilImproved or Stabilizedn=322 Participants	187	-
Worsenedn=322 Participants	38	-
Missing/Not Applicablen=322 Participants	97	-

p<0.0001Binomial test of proportions

Primary/registry result

All Subjects Improved/Stabilized or Worsened for Anxiety in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment

Time frame:Baseline and Week 12

event count, event

Posted result

Group	Value (number), participants	Reported bounds
DonepezilImproved or Stabilizedn=322 Participants	195	-
Worsenedn=322 Participants	37	-
Missing/Not Applicablen=322 Participants	90	-

p<0.0001Binomial test of proportions

Primary/registry result

All Subjects Improved/Stabilized or Worsened for Apathy in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment

Time frame:Baseline and Week 12

event count, event

Posted result

Group	Value (number), participants	Reported bounds
DonepezilImproved or Stabilizedn=322 Participants	187	-
Worsenedn=322 Participants	27	-
Missing/Not Applicablen=322 Participants	108	-

p<0.0001Binomial test of proportions

Secondary/protocol endpoint

Change From Baseline Total Score in EuroQuality of Life-5 Domains (EQoL-5D)

Time frame:baseline, 12 Weeks

change from baseline, improvement

Secondary/protocol endpoint

LOCF Change From Baseline Total Score in EuroQuality of Life-5 Domains (EQoL-5D)

Time frame:baseline, 12 Weeks LOCF

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Subject's Anxiety/Depression at Week 12

Time frame:baseline, Week 12

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Subject's Anxiety/Depression at Week 12 LOCF

Time frame:baseline, Week 12 LOCF

change from baseline, improvement

Secondary/registry result

Change From Baseline Total Score in EuroQuality of Life-5 Domains (EQoL-5D)

Time frame:baseline, 12 Weeks

change from baseline, improvement

Posted result

Group	Value (mean), score on scale	Standard deviation
Donepeziln=322 Participants	0.015	0.1071

p0.0152t-test, 2 sided

Secondary/registry result

LOCF Change From Baseline Total Score in EuroQuality of Life-5 Domains (EQoL-5D)

Time frame:baseline, 12 Weeks LOCF

change from baseline, improvement

Posted result

Group	Value (mean), score on scale	Standard deviation
Donepeziln=322 Participants	0.013	0.1053

p0.0229t-test, 2 sided

Secondary/registry result

Change From Baseline in Subject's Anxiety/Depression at Week 12

Time frame:baseline, Week 12

change from baseline, improvement

Posted result

Group	Value (number), Participants	Reported bounds
DonepezilAny Problemn=322 Participants	158	-
No Problemn=322 Participants	132	-

p0.0131McNemar

Secondary/registry result

Change From Baseline in Subject's Anxiety/Depression at Week 12 LOCF

Time frame:baseline, Week 12 LOCF

change from baseline, improvement

Posted result

Group	Value (number), Participants	Reported bounds
DonepezilAny Problemn=322 Participants	179	-
No Problemn=322 Participants	142	-

p0.0078McNemar

Caregiver / quality of life

2 endpoints

Primary/protocol endpoint

All Subjects Improved/Stabilized or Worsened for Caregiver in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment

Time frame:Baseline and Week 12

event count, event

Primary/registry result

All Subjects Improved/Stabilized or Worsened for Caregiver in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment

Time frame:Baseline and Week 12

event count, event

Posted result

Group	Value (number), participants	Reported bounds
DonepezilImproved or Stabilizedn=322 Participants	213	-
Worsenedn=322 Participants	30	-
Missing/Not Applicablen=322 Participants	79	-

p<0.0001Binomial test of proportions

Other clinical outcomes

4 endpoints

Secondary/protocol endpoint

Change From Baseline in Subject's Mobility at Week 12

Time frame:baseline, 12 Weeks

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Subject's Mobility at Week 12 LOCF

Time frame:Week 12 LOCF

change from baseline, improvement

Secondary/registry result

Change From Baseline in Subject's Mobility at Week 12

Time frame:baseline, 12 Weeks

change from baseline, improvement

Posted result

Group	Value (number), participants	Reported bounds
DonepezilAny Problemn=322 Participants	129	-
No Problemn=322 Participants	161	-

p0.7963McNemar

Secondary/registry result

Change From Baseline in Subject's Mobility at Week 12 LOCF

Time frame:Week 12 LOCF

change from baseline, improvement

Posted result

Group	Value (number), Participants	Reported bounds
DonepezilAny Problemn=322 Participants	147	-
No Problemn=322 Participants	174	-

p1.0000McNemar

Other (unclassified)

46 endpoints

Primary/protocol endpoint/low confidence

All Subjects Improved/Stabilized or Worsened for Cognitive Activation in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment

Time frame:Baseline and Week 12

event count, event

Primary/protocol endpoint/low confidence

All Subjects Improved/Stabilized or Worsened for Repetitiveness in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment

Time frame:Baseline and Week 12

event count, event

Primary/protocol endpoint/low confidence

All Subjects Improved/Stabilized or Worsened for Remembering in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment

Time frame:Baseline and Week 12

event count, event

Primary/protocol endpoint/low confidence

All Subjects Improved/Stabilized or Worsened for Temporal Orientation in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment

Time frame:Baseline and Week 12

event count, event

Primary/protocol endpoint/low confidence

All Subjects Improved/Stabilized or Worsened for Asphasia in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment

Time frame:Baseline and Week 12

event count, event

Primary/protocol endpoint/low confidence

All Subjects Improved/Stabilized or Worsened for Spatial Orientation in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment

Time frame:Baseline and Week 12

event count, event

Primary/protocol endpoint/low confidence

All Subjects Improved/Stabilized or Worsened for Judgment in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment

Time frame:Baseline and Week 12

event count, event

Primary/protocol endpoint/low confidence

All Subjects Improved/Stabilized or Worsened for Insight in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment

Time frame:Baseline and Week 12

event count, event

Primary/protocol endpoint/low confidence

All Subjects Improved/Stabilized or Worsened for Leisure in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment

Time frame:Baseline and Week 12

event count, event

Primary/protocol endpoint/low confidence

All Subjects Improved/Stabilized or Worsened for Domestic Activities in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment

Time frame:Baseline and Week 12

event count, event

Primary/protocol endpoint/low confidence

All Subjects Improved/Stabilized or Worsened for Hygiene in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment

Time frame:Baseline and Week 12

event count, event

Primary/protocol endpoint/low confidence

All Subjects Improved/Stabilized or Worsened for Dressing in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment

Time frame:Baseline and Week 12

event count, event

Primary/protocol endpoint/low confidence

All Subjects Improved/Stabilized or Worsened for Telephoning in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment

Time frame:Baseline and Week 12

event count, event

Primary/protocol endpoint/low confidence

All Subjects Improved/Stabilized or Worsened for Delusions in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment

Time frame:Baseline and Week 12

event count, event

Primary/protocol endpoint/low confidence

All Subjects Improved/Stabilized or Worsened for Severity in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment

Time frame:Baseline and Week 12

event count, event

Primary/registry result/low confidence

All Subjects Improved/Stabilized or Worsened for Cognitive Activation in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment

Time frame:Baseline and Week 12

event count, event

Posted result

Group	Value (number), participants	Reported bounds
DonepezilImproved or Stabilizedn=322 Participants	196	-
Worsenedn=322 Participants	36	-
Missing/Not Applicablen=322 Participants	90	-

p<0.0001Binomial test of proportions

Primary/registry result/low confidence

All Subjects Improved/Stabilized or Worsened for Repetitiveness in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment

Time frame:Baseline and Week 12

event count, event

Posted result

Group	Value (number), Participants	Reported bounds
DonepezilImproved or Stabilizedn=322 Participants	195	-
Worsenedn=322 Participants	32	-
Missing/Not Applicablen=322 Participants	95	-

p<0.0001Binomial test of proportions

Primary/registry result/low confidence

All Subjects Improved/Stabilized or Worsened for Remembering in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment

Time frame:Baseline and Week 12

event count, event

Posted result

Group	Value (number), participants	Reported bounds
DonepezilImproved or Stabilizedn=322 Participants	231	-
Worsenedn=322 Participants	44	-
Missing/Not Applicablen=322 Participants	47	-

p<0.0001Binomial test of proportions

Primary/registry result/low confidence

All Subjects Improved/Stabilized or Worsened for Temporal Orientation in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment

Time frame:Baseline and Week 12

event count, event

Posted result

Group	Value (number), Participants	Reported bounds
DonepezilImproved or Stabilizedn=322 Participants	209	-
Worsenedn=322 Participants	39	-
Missing/Not Applicablen=322 Participants	74	-

p<0.0001Binomial test of proportions

Primary/registry result/low confidence

All Subjects Improved/Stabilized or Worsened for Asphasia in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment

Time frame:Baseline and Week 12

event count, event

Posted result

Group	Value (number), participants	Reported bounds
DonepezilImproved or Stabilizedn=322 Participants	190	-
Worsenedn=322 Participants	28	-
Missing/Not Applicablen=322 Participants	104	-

p<0.0001Binomial test of proportions

Primary/registry result/low confidence

All Subjects Improved/Stabilized or Worsened for Spatial Orientation in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment

Time frame:Baseline and Week 12

event count, event

Posted result

Group	Value (number), participants	Reported bounds
DonepezilImproved or Stabilizedn=322 Participants	201	-
Worsenedn=322 Participants	25	-
Missing/Not Applicablen=322 Participants	96	-

p<0.0001Binomial test of proportions

Primary/registry result/low confidence

All Subjects Improved/Stabilized or Worsened for Judgment in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment

Time frame:Baseline and Week 12

event count, event

Posted result

Group	Value (number), participants	Reported bounds
DonepezilImproved or Stabilizedn=322 Participants	206	-
Worsenedn=322 Participants	30	-
Missing/Not Applicablen=322 Participants	86	-

p<0.0001Binomial test of proportions

Primary/registry result/low confidence

All Subjects Improved/Stabilized or Worsened for Insight in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment

Time frame:Baseline and Week 12

event count, event

Posted result

Group	Value (number), participants	Reported bounds
DonepezilImproved or Stabilizedn=322 Participants	209	-
Worsenedn=322 Participants	34	-
Missing/Not Applicablen=322 Participants	79	-

p<0.0001Binomial test of proportions

Primary/registry result/low confidence

All Subjects Improved/Stabilized or Worsened for Leisure in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment

Time frame:Baseline and Week 12

event count, event

Posted result

Group	Value (number), participants	Reported bounds
DonepezilImproved or Stabilizedn=322 Participants	205	-
Worsenedn=322 Participants	28	-
Missing/Not Applicablen=322 Participants	89	-

p<0.0001Binomial test of proportions

Primary/registry result/low confidence

All Subjects Improved/Stabilized or Worsened for Domestic Activities in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment

Time frame:Baseline and Week 12

event count, event

Posted result

Group	Value (number), participants	Reported bounds
DonepezilImproved or Stabilizedn=322 Participants	198	-
Worsenedn=322 Participants	23	-
Missing/Not Applicablen=322 Participants	101	-

p<0.0001Binomial test of proportions

Primary/registry result/low confidence

All Subjects Improved/Stabilized or Worsened for Hygiene in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment

Time frame:Baseline and Week 12

event count, event

Posted result

Group	Value (number), participants	Reported bounds
DonepezilImproved or Stabilizedn=322 Participants	168	-
Worsenedn=322 Participants	23	-
Missing/Not Applicablen=322 Participants	131	-

p<0.0001Binomial test of proportions

Primary/registry result/low confidence

All Subjects Improved/Stabilized or Worsened for Dressing in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment

Time frame:Baseline and Week 12

event count, event

Posted result

Group	Value (number), participants	Reported bounds
DonepezilImproved or Stabilizedn=322 Participants	152	-
Worsenedn=322 Participants	23	-
Missing/Not Applicablen=322 Participants	147	-

p<0.0001Binomial test of proportions

Primary/registry result/low confidence

All Subjects Improved/Stabilized or Worsened for Telephoning in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment

Time frame:Baseline and Week 12

event count, event

Posted result

Group	Value (number), participants	Reported bounds
DonepezilImproved or Stabilizedn=322 Participants	190	-
Worsenedn=322 Participants	16	-
Missing/Not Applicablen=322 Participants	116	-

p<0.0001Binomial test of proportions

Primary/registry result/low confidence

All Subjects Improved/Stabilized or Worsened for Delusions in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment

Time frame:Baseline and Week 12

event count, event

Posted result

Group	Value (number), participants	Reported bounds
DonepezilImproved or Stabilizedn=322 Participants	139	-
Worsenedn=322 Participants	16	-
Missing/Not Applicablen=322 Participants	167	-

p<0.0001Binomial test of proportions

Primary/registry result/low confidence

All Subjects Improved/Stabilized or Worsened for Severity in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment

Time frame:Baseline and Week 12

event count, event

Posted result

Group	Value (number), participants	Reported bounds
DonepezilImproved or Stabilizedn=322 Participants	233	-
Worsenedn=322 Participants	40	-
Missing/Not Applicablen=322 Participants	49	-

p<0.0001Binomial test of proportions

Secondary/protocol endpoint/low confidence

Change From Baseline in Visual Analog Scale (VAS) of Subject's Overall Health Included in EuroQuality of Life-5 Domains (EQoL-5D)Questionnaire

Time frame:baseline, 12 Weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

LOCF Change From Baseline in Visual Analog Scale (VAS) of Subject's Overall Health Included in EuroQuality of Life-5 Domains (EQoL-5D) Questionnaire

Time frame:baseline, 12 Weeks LOCF

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change From Baseline in Subject's Self-Care at Week 12

Time frame:baseline, Week 12

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change From Baseline in Subject's Self-Care at Week 12 LOCF

Time frame:baseline, 12 Weeks LOCF

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change From Baseline in Subject's Usual Activities at Week 12

Time frame:baseline, Week 12

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change From Baseline in Subject's Usual Activities at Week 12 LOCF

Time frame:baseline, 12 Weeks LOCF

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change From Baseline in Subject's Pain/Discomfort at Week 12

Time frame:baseline, Week 12

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change From Baseline in Subject's Pain/Discomfort at Week 12 LOCF

Time frame:Week 12 LOCF

change from baseline, improvement

Secondary/registry result/low confidence

Change From Baseline in Visual Analog Scale (VAS) of Subject's Overall Health Included in EuroQuality of Life-5 Domains (EQoL-5D)Questionnaire

Time frame:baseline, 12 Weeks

change from baseline, improvement

Posted result

Group	Value (mean), score on scale	Standard deviation
Donepeziln=322 Participants	3.7	10.55

p<0.0001t-test, 2 sided

Secondary/registry result/low confidence

LOCF Change From Baseline in Visual Analog Scale (VAS) of Subject's Overall Health Included in EuroQuality of Life-5 Domains (EQoL-5D) Questionnaire

Time frame:baseline, 12 Weeks LOCF

change from baseline, improvement

Posted result

Group	Value (mean), score on scale	Standard deviation
Donepeziln=322 Participants	3.1	10.91

p<0.0001t-test, 2 sided

Secondary/registry result/low confidence

Change From Baseline in Subject's Self-Care at Week 12

Time frame:baseline, Week 12

change from baseline, improvement

Posted result

Group	Value (number), participants	Reported bounds
DonepezilAny Problemn=322 Participants	122	-
No Problemn=322 Participants	168	-

p0.0719McNemar

Secondary/registry result/low confidence

Change From Baseline in Subject's Self-Care at Week 12 LOCF

Time frame:baseline, 12 Weeks LOCF

change from baseline, improvement

Posted result

Group	Value (number), Participants	Reported bounds
DonepezilAny Problemn=322 Participants	140	-
No Problemn=322 Participants	181	-

p0.1779McNemar

Secondary/registry result/low confidence

Change From Baseline in Subject's Usual Activities at Week 12

Time frame:baseline, Week 12

change from baseline, improvement

Posted result

Group	Value (number), Participants	Reported bounds
DonepezilAny Problemn=322 Participants	181	-
No Problemn=322 Participants	109	-

p1.0000McNemar

Secondary/registry result/low confidence

Change From Baseline in Subject's Usual Activities at Week 12 LOCF

Time frame:baseline, 12 Weeks LOCF

change from baseline, improvement

Posted result

Group	Value (number), Participants	Reported bounds
DonepezilAny Problemn=322 Participants	203	-
No Problemn=322 Participants	118	-

p0.8575McNemar

Secondary/registry result/low confidence

Change From Baseline in Subject's Pain/Discomfort at Week 12

Time frame:baseline, Week 12

change from baseline, improvement

Posted result

Group	Value (number), Participants	Reported bounds
DonepezilAny Problemn=322 Participants	147	-
No Problemn=322 Participants	143	-

p1.0000McNemar

Secondary/registry result/low confidence

Change From Baseline in Subject's Pain/Discomfort at Week 12 LOCF

Time frame:Week 12 LOCF

change from baseline, improvement

Posted result

Group	Value (number), Participants	Reported bounds
DonepezilAny Problemn=322 Participants	162	-
No Problemn=322 Participants	159	-

p1.0000McNemar

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.