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CompletedPhase 3Results posted

Rosiglitazone (Extended Release Tablets) As Monotherapy In Subjects With Mild To Moderate Alzheimer's Disease

A 24-week, Double-blind, Double-dummy, Randomized, Parallel-group Study to Investigate the Effects of Rosiglitazone (Extended Release Tablets), Donepezil, and Placebo as Monotherapy on Cognition and Overall Clinical Response in APOE ε4-stratified Subjects With Mild to Moderate Alzheimer's Disease. (REFLECT-1)

Lead sponsor

GlaxoSmithKline

Asset

Rosiglitazone

Listed sites

138

Recruiting sites

-

Enrollment

862

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 10-23•Study partner/caregiver required

Primary endpoints

•ADAS-Cog•Change From Baseline (W0) in Mean CIBIC+ Global Functioning Total Score at W24

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study ID105640
NCT IDNCT00428090

Timeline

Milestones

Study first posted2007-01-29estimated
Study start2007-02-27
Primary completion2008-09-01actual
Study completion2008-09-05actual
Last update posted2017-05-19actual
Results first posted2017-05-19actual

Assets

Drug assets

Rosiglitazone

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years
Maximum age90 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Clinical diagnosis of probable Alzheimer's Disease (AD).
•MMSE score 10 to 23
•Has not taken an approved AD therapy in last 30 days.
•No previous hypersensitivity/intolerance to AChEIs
•Have a regular caregiver

Exclusion criteria

•Diagnosis of vascular dementia.
•Type I or secondary diabetes mellitus.
•Type II diabetes mellitus treated with insulin, sulfonylurea or glipizide.
•History or evidence of congestive heart failure, clinically significant peripheral edema or anemia.
•History of significant psychiatric illness, major depressive disorder or current depression needing initiation of treatment.

Endpoints (54)

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)
14
Global cognition
12
Caregiver / quality of life
12
Safety / tolerability / PK
8
Function / daily living
4
Behavior / neuropsychiatric
4

Global cognition

12 endpoints
Primary/protocol endpoint

Change From Baseline (W0) in Mean ADAS-Cog Total Score at W24 as a Function of APOE e4 Status in Apolipoprotein epsilon4 (APOE e4) Negative Cohort

Time frame:Baseline (W0) and W24

ADAS-Cog

change from baseline, improvement

Primary/protocol endpoint

Change From Baseline (W0) in Mean ADAS-Cog Total Score at W24 as a Function of APOE e4 Status in All Except e4/e4's Cohort

Time frame:Baseline (W0) and W24

ADAS-Cog

change from baseline, improvement

Primary/protocol endpoint

Change From Baseline (W0) in Mean ADAS-Cog Total Score at W24 as a Function of APOE e4 Status in Full Population Cohort

Time frame:Baseline (W0) and W24

ADAS-Cog

change from baseline, improvement

Primary/registry result

Change From Baseline (W0) in Mean ADAS-Cog Total Score at W24 as a Function of APOE e4 Status in Apolipoprotein epsilon4 (APOE e4) Negative Cohort

Time frame:Baseline (W0) and W24

ADAS-Cog

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), Score on a scaleStandard error
Placebon=63 Participants1.60.78
RSG XR 2 mgn=69 Participants-0.20.67
RSG XR 8 mgn=65 Participants0.60.67
Donepezil 10 mgn=28 Participants0.91.16
Mean Difference (Final Values)-1.895% CI-3.8 - 0.2p0.074Mixed model for repeated measures
Mean Difference (Final Values)-1.095% CI-3.0 - 1.0p0.338Mixed model for repeated measures
Mean Difference (Final Values)-0.795% CI-3.5 - 2.1p0.602Mixed model for repeated measures
Primary/registry result

Change From Baseline (W0) in Mean ADAS-Cog Total Score at W24 as a Function of APOE e4 Status in All Except e4/e4's Cohort

Time frame:Baseline (W0) and W24

ADAS-Cog

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), Score on a scaleStandard error
Placebon=117 Participants1.50.58
RSG XR 2 mgn=115 Participants0.30.54
RSG XR 8 mgn=112 Participants0.70.57
Donepezil 10 mgn=49 Participants-0.10.79
Mean Difference (Final Values)-1.295% CI-2.7 - 0.4p0.131Mixed model for repeated measures
Mean Difference (Final Values)-0.895% CI-2.4 - 0.8p0.315Mixed model for repeated measures
Mean Difference (Final Values)-1.695% CI-3.5 - 0.3p0.105Mixed model for repeated measures
Primary/registry result

Change From Baseline (W0) in Mean ADAS-Cog Total Score at W24 as a Function of APOE e4 Status in Full Population Cohort

Time frame:Baseline (W0) and W24

ADAS-Cog

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), Score on a scaleStandard error
Placebon=131 Participants2.00.56
RSG XR 2 mgn=130 Participants1.20.53
RSG XR 8 mgn=125 Participants1.20.55
Donepezil 10 mgn=56 Participants0.60.74
Mean Difference (Final Values)-0.895% CI-2.2 - 0.6p0.272Mixed model for repeated measures
Mean Difference (Final Values)-0.895% CI-2.2 - 0.7p0.297Mixed model for repeated measures
Mean Difference (Final Values)-1.395% CI-3.1 - 0.4p0.131Mixed model for repeated measures
Secondary/protocol endpoint

Change From Baseline (W0) in Mean ADAS-Cog Total Score at W8, W16, W24

Time frame:Baseline (W0) and up to W24

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline (W0) in Mean Short Term Memory Assessment Total Score (ADAS-Cog Q1 Plus Q7) at W8, W16, W24

Time frame:Baseline (W0) and up to W24

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline (W0) in Mini Mental State Examination (MMSE) Total Score at W24.

Time frame:Baseline (W0) and W24

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Secondary/registry result

Change From Baseline (W0) in Mean ADAS-Cog Total Score at W8, W16, W24

Time frame:Baseline (W0) and up to W24

ADAS-Cog

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), Score on a scaleStandard error
PlaceboADAS-Cog, W8, n=153, 155,147,67n=159 Participants0.40.42
ADAS-Cog, W16, n=143,145,132,62n=159 Participants0.50.46
ADAS-Cog, W24, n=131, 130,125,156n=159 Participants2.00.56
RSG XR 2 mgADAS-Cog, W8, n=153, 155,147,67n=162 Participants-0.50.45
ADAS-Cog, W16, n=143,145,132,62n=162 Participants0.60.49
ADAS-Cog, W24, n=131, 130,125,156n=162 Participants1.20.53
RSG XR 8 mgADAS-Cog, W8, n=153, 155,147,67n=156 Participants0.50.43
ADAS-Cog, W16, n=143,145,132,62n=156 Participants1.30.45
ADAS-Cog, W24, n=131, 130,125,156n=156 Participants1.20.55
Donepezil 10 mgADAS-Cog, W8, n=153, 155,147,67n=76 Participants-0.30.63
ADAS-Cog, W16, n=143,145,132,62n=76 Participants-1.10.80
ADAS-Cog, W24, n=131, 130,125,156n=76 Participants0.60.74
Mean Difference (Final Values)-0.995% CI-2.0 - 0.2p0.116Mixed model for repeated measures
Mean Difference (Final Values)0.195% CI-0.9 - 1.2p0.816Mixed model for repeated measures
Mean Difference (Final Values)-0.795% CI-2.1 - 0.7p0.318Mixed model for repeated measures
Mean Difference (Final Values)0.195% CI-1.1 - 1.3p0.839Mixed model for repeated measures
Mean Difference (Final Values)0.895% CI-0.3 - 2.0p0.165Mixed model for repeated measures
Mean Difference (Final Values)-1.695% CI-3.4 - 0.2p0.073Mixed model for repeated measures
Mean Difference (Final Values)-0.895% CI-2.2 - 0.6p0.272Mixed model for repeated measures
Mean Difference (Final Values)-0.895% CI-2.2 - 0.7p0.297Mixed model for repeated measures
Mean Difference (Final Values)-1.395% CI-3.1 - 0.4p0.131Mixed model for repeated measures
Secondary/registry result

Change From Baseline (W0) in Mean Short Term Memory Assessment Total Score (ADAS-Cog Q1 Plus Q7) at W8, W16, W24

Time frame:Baseline (W0) and up to W24

ADAS-Cog

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), Score on a scaleStandard error
PlaceboADAS-Cog Q1 plus Q7, W8, n=152,155,146,67n=159 Participants0.10.25
ADAS-Cog Q1 plus Q7, W16, n=143,143,130,62n=159 Participants0.10.27
ADAS-Cog Q1 plus Q7, W24, n=131,128,123,56n=159 Participants0.70.27
RSG XR 2 mgADAS-Cog Q1 plus Q7, W8, n=152,155,146,67n=162 Participants-0.10.27
ADAS-Cog Q1 plus Q7, W16, n=143,143,130,62n=162 Participants0.60.26
ADAS-Cog Q1 plus Q7, W24, n=131,128,123,56n=162 Participants0.30.30
RSG XR 8 mgADAS-Cog Q1 plus Q7, W8, n=152,155,146,67n=156 Participants0.50.25
ADAS-Cog Q1 plus Q7, W16, n=143,143,130,62n=156 Participants0.80.24
ADAS-Cog Q1 plus Q7, W24, n=131,128,123,56n=156 Participants0.60.29
Donepezil 10 mgADAS-Cog Q1 plus Q7, W8, n=152,155,146,67n=76 Participants-0.40.40
ADAS-Cog Q1 plus Q7, W16, n=143,143,130,62n=76 Participants-0.60.45
ADAS-Cog Q1 plus Q7, W24, n=131,128,123,56n=76 Participants0.20.43
Mean Difference (Final Values)-0.295% CI-0.8 - 0.5p0.635Mixed model for repeated measures
Mean Difference (Final Values)0.495% CI-0.2 - 1.1p0.194Mixed model for repeated measures
Mean Difference (Final Values)-0.495% CI-1.3 - 0.4p0.325Mixed model for repeated measures
Mean Difference (Final Values)0.695% CI-0.1 - 1.2p0.109Mixed model for repeated measures
Mean Difference (Final Values)0.795% CI0.1 - 1.4p0.032Mixed model for repeated measures
Mean Difference (Final Values)-0.795% CI-1.7 - 0.3p0.189Mixed model for repeated measures
Mean Difference (Final Values)-0.495% CI-1.1 - 0.3p0.288Mixed model for repeated measures
Mean Difference (Final Values)-0.195% CI-0.8 - 0.6p0.819Mixed model for repeated measures
Mean Difference (Final Values)-0.595% CI-1.5 - 0.5p0.306Mixed model for repeated measures
Secondary/registry result

Change From Baseline (W0) in Mini Mental State Examination (MMSE) Total Score at W24.

Time frame:Baseline (W0) and W24

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), Score on a scaleStandard error
Placebon=131 Participants-0.50.27
RSG XR 2 mgn=133 Participants-0.60.27
RSG XR 8 mgn=127 Participants-0.70.28
Donepezil 10 mgn=56 Participants0.40.38
Mean Difference (Final Values)0.095% CI-0.7 - 0.6p0.886ANCOVA
Mean Difference (Final Values)-0.195% CI-0.8 - 0.6p0.710ANCOVA
Mean Difference (Final Values)1.095% CI0.1 - 1.8p0.030ANCOVA

Function / daily living

4 endpoints
Secondary/protocol endpoint

Change From Baseline (W0) in Mean Disability Assessment for Dementia (DAD) Scale Total Score at W8, W16, W24

Time frame:Baseline (W0) and up to W24

change from baseline, improvement

Secondary/protocol endpoint

Time Spent Caring for Basic and Instrumental Activities Resource Utilization in Dementia (RUD) Scale at W12 and W24

Time frame:Baseline (W0) and up to W24

change from baseline, improvement

Secondary/registry result

Change From Baseline (W0) in Mean Disability Assessment for Dementia (DAD) Scale Total Score at W8, W16, W24

Time frame:Baseline (W0) and up to W24

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), Score on a scaleStandard error
PlaceboDAD, W8, n=147,152, 144, 65n=159 Participants-0.80.80
DAD, W16, n=141,143,131,59n=159 Participants-2.60.98
DAD, W24, n=129,133,127,55n=159 Participants-3.70.97
RSG XR 2 mgDAD, W8, n=147,152, 144, 65n=162 Participants-0.60.94
DAD, W16, n=141,143,131,59n=162 Participants-1.71.07
DAD, W24, n=129,133,127,55n=162 Participants-2.41.21
RSG XR 8 mgDAD, W8, n=147,152, 144, 65n=156 Participants-0.30.78
DAD, W16, n=141,143,131,59n=156 Participants-1.71.05
DAD, W24, n=129,133,127,55n=156 Participants-3.81.19
Donepezil 10 mgDAD, W8, n=147,152, 144, 65n=76 Participants0.51.00
DAD, W16, n=141,143,131,59n=76 Participants1.11.40
DAD, W24, n=129,133,127,55n=76 Participants-0.21.81
Mean Difference (Final Values)0.195% CI-2.1 - 2.3p0.919Mixed model for repeated measures
Mean Difference (Final Values)0.595% CI-1.5 - 2.4p0.649Mixed model for repeated measures
Mean Difference (Final Values)1.395% CI-1.1 - 3.6p0.279Mixed model for repeated measures
Mean Difference (Final Values)0.995% CI-1.8 - 3.6p0.498Mixed model for repeated measures
Mean Difference (Final Values)0.995% CI-1.7 - 3.6p0.489Mixed model for repeated measures
Mean Difference (Final Values)3.795% CI0.5 - 7.0p0.024Mixed model for repeated measures
Mean Difference (Final Values)1.395% CI-1.6 - 4.2p0.385Mixed model for repeated measures
Mean Difference (Final Values)-0.195% CI-3.0 - 2.8p0.944Mixed model for repeated measures
Mean Difference (Final Values)3.695% CI-0.4 - 7.5p0.078Mixed model for repeated measures
Secondary/registry result

Time Spent Caring for Basic and Instrumental Activities Resource Utilization in Dementia (RUD) Scale at W12 and W24

Time frame:Baseline (W0) and up to W24

change from baseline, improvement

Posted result

GroupValue (mean), HoursStandard deviation
PlaceboRUD Q1, W12, n=141, 149, 137, 69n=159 Participants2.343.31
RUD Q1, W24, n=128, 133, 127, 55n=159 Participants19.4109.41
RUD Q2, W12, n=141, 149, 137, 62n=159 Participants13.773.94
RUD Q2, W24, n=128, 133, 127, 55n=159 Participants17.175.45
RSG XR 2 mgRUD Q1, W12, n=141, 149, 137, 69n=162 Participants4.581.21
RUD Q1, W24, n=128, 133, 127, 55n=162 Participants-0.658.72
RUD Q2, W12, n=141, 149, 137, 62n=162 Participants9.060.54
RUD Q2, W24, n=128, 133, 127, 55n=162 Participants9.747.96
RSG XR 8 mgRUD Q1, W12, n=141, 149, 137, 69n=156 Participants-9.877.44
RUD Q1, W24, n=128, 133, 127, 55n=156 Participants-2.786.26
RUD Q2, W12, n=141, 149, 137, 62n=156 Participants4.980.97
RUD Q2, W24, n=128, 133, 127, 55n=156 Participants11.6107.52
Donepezil 10 mgRUD Q1, W12, n=141, 149, 137, 69n=76 Participants-5.770.19
RUD Q1, W24, n=128, 133, 127, 55n=76 Participants3.719.26
RUD Q2, W12, n=141, 149, 137, 62n=76 Participants-5.356.50
RUD Q2, W24, n=128, 133, 127, 55n=76 Participants1.161.49

Behavior / neuropsychiatric

4 endpoints
Secondary/protocol endpoint

Change From Baseline (W0) in Mean Neuropsychiatric Inventory (NPI) Total Score at W8, W16, W24

Time frame:Baseline (W0) and up to W24

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline (W0) in Mean European Quality of Life -5 Dimensions Proxy Version (EQ-5D Proxy) Total Score at W12, W24 Assessed by Utility

Time frame:Baseline (W0) and up to W24

change from baseline, improvement

Secondary/registry result

Change From Baseline (W0) in Mean Neuropsychiatric Inventory (NPI) Total Score at W8, W16, W24

Time frame:Baseline (W0) and up to W24

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), Score on a scaleStandard error
PlaceboNPI, W8, n=146,151,144,65n=159 Participants0.20.59
NPI, W16, n=139,142,131,59n=159 Participants-0.10.69
NPI, W24, n=129,133,127,55n=159 Participants1.21.04
RSG XR 2 mgNPI, W8, n=146,151,144,65n=162 Participants0.10.63
NPI, W16, n=139,142,131,59n=162 Participants-0.00.69
NPI, W24, n=129,133,127,55n=162 Participants1.60.74
RSG XR 8 mgNPI, W8, n=146,151,144,65n=156 Participants0.50.81
NPI, W16, n=139,142,131,59n=156 Participants-0.10.90
NPI, W24, n=129,133,127,55n=156 Participants1.11.01
Donepezil 10 mgNPI, W8, n=146,151,144,65n=76 Participants-0.10.87
NPI, W16, n=139,142,131,59n=76 Participants0.50.97
NPI, W24, n=129,133,127,55n=76 Participants-0.61.12
Mean Difference (Final Values)0.095% CI-1.6 - 1.5p0.957Mixed model for repeated measures
Mean Difference (Final Values)0.495% CI-1.4 - 2.2p0.693Mixed model for repeated measures
Mean Difference (Final Values)-0.395% CI-2.2 - 1.7p0.798Mixed model for repeated measures
Mean Difference (Final Values)0.095% CI-1.7 - 1.8p0.958Mixed model for repeated measures
Mean Difference (Final Values)0.095% CI-2.1 - 2.1p0.998Mixed model for repeated measures
Mean Difference (Final Values)0.595% CI-1.7 - 2.8p0.639Mixed model for repeated measures
Mean Difference (Final Values)0.395% CI-2.1 - 2.7p0.797Mixed model for repeated measures
Mean Difference (Final Values)-0.195% CI-2.9 - 2.7p0.942Mixed model for repeated measures
Mean Difference (Final Values)-1.995% CI-4.8 - 1.1p0.213Mixed model for repeated measures
Secondary/registry result

Change From Baseline (W0) in Mean European Quality of Life -5 Dimensions Proxy Version (EQ-5D Proxy) Total Score at W12, W24 Assessed by Utility

Time frame:Baseline (W0) and up to W24

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), Score on a scaleStandard error
PlaceboEQ-5D Proxy Utility, W12, n=141,146, 135, 62n=159 Participants-0.020.017
EQ-5D Proxy Utility, W24, n=128, 130, 125, 55n=159 Participants-0.020.017
RSG XR 2 mgEQ-5D Proxy Utility, W12, n=141,146, 135, 62n=162 Participants0.000.016
EQ-5D Proxy Utility, W24, n=128, 130, 125, 55n=162 Participants0.020.016
RSG XR 8 mgEQ-5D Proxy Utility, W12, n=141,146, 135, 62n=156 Participants0.010.016
EQ-5D Proxy Utility, W24, n=128, 130, 125, 55n=156 Participants-0.020.019
Donepezil 10 mgEQ-5D Proxy Utility, W12, n=141,146, 135, 62n=76 Participants0.010.021
EQ-5D Proxy Utility, W24, n=128, 130, 125, 55n=76 Participants0.000.018
Mean Difference (Final Values)0.0395% CI-0.01 - 0.07p0.199Mixed model for repeated measures
Mean Difference (Final Values)0.0495% CI-0.01 - 0.08p0.094Mixed model for repeated measures
Mean Difference (Final Values)0.0395% CI-0.02 - 0.09p0.187Mixed model for repeated measures
Mean Difference (Final Values)0.0395% CI-0.01 - 0.07p0.134Mixed model for repeated measures
Mean Difference (Final Values)0.0095% CI-0.05 - 0.05p0.958Mixed model for repeated measures
Mean Difference (Final Values)0.0295% CI-0.03 - 0.07p0.374Mixed model for repeated measures

Caregiver / quality of life

12 endpoints
Primary/protocol endpoint

Change From Baseline (W0) in Mean CIBIC+ Global Functioning Total Score at W24 as a Function of APOE e4 Status in APOE4 Negative Cohort

Time frame:Baseline (W0) and W24

change from baseline, improvement

Primary/protocol endpoint

Change From Baseline (W0) in Mean CIBIC+ Global Functioning Total Score at W24 as a Function of APOE e4 Status in All Except e4/e4's Cohort

Time frame:Baseline (W0) and W24

change from baseline, improvement

Primary/protocol endpoint

Change From Baseline (W0) in Mean CIBIC+ Global Functioning Total Score at W24 as a Function of APOE e4 Status in Full Population Cohort

Time frame:Baseline (W0) and W24

change from baseline, improvement

Primary/registry result

Change From Baseline (W0) in Mean CIBIC+ Global Functioning Total Score at W24 as a Function of APOE e4 Status in APOE4 Negative Cohort

Time frame:Baseline (W0) and W24

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), Score on a scaleStandard error
Placebon=63 Participants4.20.14
RSG XR 2 mgn=71 Participants4.20.12
RSG XR 8 mgn=66 Participants4.10.11
Donepezil 10 mgn=28 Participants3.90.22
Mean Difference (Final Values)0.195% CI-0.3 - 0.4p0.663Mixed model for repeated measures
Mean Difference (Final Values)0.095% CI-0.4 - 0.3p0.891Mixed model for repeated measures
Mean Difference (Final Values)-0.295% CI-0.7 - 0.3p0.414Mixed model for repeated measures
Primary/registry result

Change From Baseline (W0) in Mean CIBIC+ Global Functioning Total Score at W24 as a Function of APOE e4 Status in All Except e4/e4's Cohort

Time frame:Baseline (W0) and W24

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), Score on a scaleStandard error
Placebon=117 Participants4.30.10
RSG XR 2 mgn=117 Participants4.30.10
RSG XR 8 mgn=114 Participants4.10.10
Donepezil 10 mgn=49 Participants3.80.17
Mean Difference (Final Values)0.095% CI-0.3 - 0.3p0.913Mixed model for repeated measures
Mean Difference (Final Values)-0.195% CI-0.4 - 0.1p0.276Mixed model for repeated measures
Mean Difference (Final Values)-0.595% CI-0.8 - -0.1p0.025Mixed model for repeated measures
Primary/registry result

Change From Baseline (W0) in Mean CIBIC+ Global Functioning Total Score at W24 as a Function of APOE e4 Status in Full Population Cohort

Time frame:Baseline (W0) and W24

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), Score on a scaleStandard error
Placebon=131 Participants4.30.09
RSG XR 2 mgn=133 Participants4.30.09
RSG XR 8 mgn=127 Participants4.20.10
Donepezil 10 mgn=56 Participants3.80.16
Mean Difference (Final Values)0.095% CI-0.2 - 0.3p0.939Mixed model for repeated measures
Mean Difference (Final Values)-0.195% CI-0.4 - 0.1p0.307Mixed model for repeated measures
Mean Difference (Final Values)-0.595% CI-0.8 - -0.1p0.009Mixed model for repeated measures
Secondary/protocol endpoint

Change From Baseline (W0) in Mean CIBIC+ Global Functioning Total Score at W8, W16, W24

Time frame:Baseline (W0) and up to W24

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline (W0) in Mean European Quality of Life -5 Dimensions Proxy Version (EQ-5D Proxy) Total Score at W12, W24 Assessed by Thermometer (Visual Analog Scale [VAS])

Time frame:Baseline (W0) and up to W24

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline (W0) in Alzheimer's Carer's Quality of Life Instrument (ACQLI) Score at W12 and W24.

Time frame:Baseline (W0) and up to W24

change from baseline, improvement

Secondary/registry result

Change From Baseline (W0) in Mean CIBIC+ Global Functioning Total Score at W8, W16, W24

Time frame:Baseline (W0) and up to W24

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), Score on a scaleStandard error
PlaceboCIBIC+, W8, n=150, 156,147,67n=159 Participants4.10.07
CIBIC+, W16, n=144,145,127,61n=159 Participants4.20.08
CIBIC+, W24, n=131,133, 127, 56n=159 Participants4.30.09
RSG XR 2 mgCIBIC+, W8, n=150, 156,147,67n=162 Participants3.90.08
CIBIC+, W16, n=144,145,127,61n=162 Participants4.00.08
CIBIC+, W24, n=131,133, 127, 56n=162 Participants4.30.09
RSG XR 8 mgCIBIC+, W8, n=150, 156,147,67n=156 Participants4.10.08
CIBIC+, W16, n=144,145,127,61n=156 Participants4.10.09
CIBIC+, W24, n=131,133, 127, 56n=156 Participants4.20.10
Donepezil 10 mgCIBIC+, W8, n=150, 156,147,67n=76 Participants3.90.12
CIBIC+, W16, n=144,145,127,61n=76 Participants3.80.14
CIBIC+, W24, n=131,133, 127, 56n=76 Participants3.80.16
Mean Difference (Final Values)-0.195% CI-0.3 - 0.0p0.133Mixed model for repeated measures
Mean Difference (Final Values)0.095% CI-0.2 - 0.2p0.958Mixed model for repeated measures
Mean Difference (Final Values)-0.295% CI-0.5 - 0.0p0.085Mixed model for repeated measures
Mean Difference (Final Values)-0.295% CI-0.4 - 0.0p0.102Mixed model for repeated measures
Mean Difference (Final Values)-0.195% CI-0.3 - 0.1p0.380Mixed model for repeated measures
Mean Difference (Final Values)-0.495% CI-0.7 - -0.1p0.006Mixed model for repeated measures
Mean Difference (Final Values)0.095% CI-0.2 - 0.3p0.939Mixed model for repeated measures
Mean Difference (Final Values)-0.195% CI-0.4 - 0.1p0.307Mixed model for repeated measures
Mean Difference (Final Values)-0.595% CI-0.8 - -0.1p0.009Mixed model for repeated measures
Secondary/registry result

Change From Baseline (W0) in Mean European Quality of Life -5 Dimensions Proxy Version (EQ-5D Proxy) Total Score at W12, W24 Assessed by Thermometer (Visual Analog Scale [VAS])

Time frame:Baseline (W0) and up to W24

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), Score on a scaleStandard error
PlaceboEQ-5D Proxy Thermometer, W12, n=141, 146, 135, 62n=159 Participants1.41.35
EQ-5D Proxy Thermometer, W24, n=128, 130, 126, 55n=159 Participants1.91.56
RSG XR 2 mgEQ-5D Proxy Thermometer, W12, n=141, 146, 135, 62n=162 Participants0.31.37
EQ-5D Proxy Thermometer, W24, n=128, 130, 126, 55n=162 Participants-0.71.52
RSG XR 8 mgEQ-5D Proxy Thermometer, W12, n=141, 146, 135, 62n=156 Participants1.71.41
EQ-5D Proxy Thermometer, W24, n=128, 130, 126, 55n=156 Participants0.21.71
Donepezil 10 mgEQ-5D Proxy Thermometer, W12, n=141, 146, 135, 62n=76 Participants-2.62.41
EQ-5D Proxy Thermometer, W24, n=128, 130, 126, 55n=76 Participants1.52.40
Mean Difference (Final Values)-1.295% CI-4.6 - 2.2p0.493Mixed model for repeated measures
Mean Difference (Final Values)0.395% CI-3.2 - 3.7p0.883Mixed model for repeated measures
Mean Difference (Final Values)-4.095% CI-9.3 - 1.2p0.130Mixed model for repeated measures
Mean Difference (Final Values)-2.695% CI-6.6 - 1.4p0.198Mixed model for repeated measures
Mean Difference (Final Values)-1.795% CI-5.9 - 2.6p0.441Mixed model for repeated measures
Mean Difference (Final Values)-0.495% CI-5.8 - 5.1p0.898Mixed model for repeated measures
Secondary/registry result

Change From Baseline (W0) in Alzheimer's Carer's Quality of Life Instrument (ACQLI) Score at W12 and W24.

Time frame:Baseline (W0) and up to W24

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), Score on a scaleStandard error
PlaceboACQLI, W12, n=141, 148, 137, 60n=159 Participants0.50.38
ACQLI, W24, n=128, 132, 126, 54n=159 Participants0.60.45
RSG XR 2 mgACQLI, W12, n=141, 148, 137, 60n=162 Participants-0.60.41
ACQLI, W24, n=128, 132, 126, 54n=162 Participants-0.20.49
RSG XR 8 mgACQLI, W12, n=141, 148, 137, 60n=156 Participants-0.10.46
ACQLI, W24, n=128, 132, 126, 54n=156 Participants0.00.54
Donepezil 10 mgACQLI, W12, n=141, 148, 137, 60n=76 Participants0.50.50
ACQLI, W24, n=128, 132, 126, 54n=76 Participants-0.00.69
Mean Difference (Final Values)-1.195% CI-2.1 - -0.1p0.027Mixed model for repeated measures
Mean Difference (Final Values)-0.695% CI-1.6 - 0.5p0.278Mixed model for repeated measures
Mean Difference (Final Values)0.095% CI-1.2 - 1.1p0.993Mixed model for repeated measures
Mean Difference (Final Values)-0.895% CI-2.0 - 0.4p0.196Mixed model for repeated measures
Mean Difference (Final Values)-0.695% CI-1.9 - 0.7p0.353Mixed model for repeated measures
Mean Difference (Final Values)-0.695% CI-2.2 - 0.9p0.427Mixed model for repeated measures

Safety / tolerability / PK

8 endpoints
Secondary/protocol endpoint

Number of Participants With Adverse Events Defined by Severity

Time frame:Up to W24

event count, event

Secondary/protocol endpoint

Number of Participants With Systolic and Diastolic Blood Pressure (SBP and DBP), Heart Rate (HR) and Weight Values of Potential Clinical Concern (PCC) Any Time on Treatment (ATOT).

Time frame:Up to W24

change from baseline, event

Secondary/protocol endpoint

Change From Baseline (W0) in 12-lead Electrocardiogram (ECG)

Time frame:Baseline (W0) and up to W24

change from baseline, event

Secondary/protocol endpoint

Change From Baseline (W0) in Heart Rate (HR) Measured From 12-lead Electrocardiogram (ECG)

Time frame:Baseline (W0) and up to W24

change from baseline, event

Secondary/registry result

Number of Participants With Adverse Events Defined by Severity

Time frame:Up to W24

event count, event

Posted result

GroupValue (number), ParticipantsReported bounds
PlaceboAny AEn=165 Participants62-
Mild AEn=165 Participants32-
Moderate AEn=165 Participants25-
Severe AEn=165 Participants5-
RSG XR 2 mgAny AEn=166 Participants60-
Mild AEn=166 Participants35-
Moderate AEn=166 Participants22-
Severe AEn=166 Participants3-
RSG XR 8 mgAny AEn=165 Participants69-
Mild AEn=165 Participants37-
Moderate AEn=165 Participants30-
Severe AEn=165 Participants2-
Donepezil 10 mgAny AEn=83 Participants42-
Mild AEn=83 Participants22-
Moderate AEn=83 Participants15-
Severe AEn=83 Participants5-
Secondary/registry result

Number of Participants With Systolic and Diastolic Blood Pressure (SBP and DBP), Heart Rate (HR) and Weight Values of Potential Clinical Concern (PCC) Any Time on Treatment (ATOT).

Time frame:Up to W24

change from baseline, event

Posted result

GroupValue (number), ParticipantsReported bounds
PlaceboSBP, >140 or <90n=160 Participants52-
SBP, Increase from Baseline >=40n=160 Participants1-
SBP, Decrease from Baseline >=30n=160 Participants7-
DBP, >90 or <50n=160 Participants17-
DBP, Increase from Baseline >=30n=160 Participants4-
DBP, Decrease from Baseline >=20n=160 Participants8-
HR, >100 or <50n=160 Participants2-
HR, Increase from Baseline >=30n=160 Participants1-
HR, Decrease from Baseline >=30n=160 Participants3-
Weight, Increase from Baseline >=7%n=160 Participants9-
Weight, Decrease from Baseline >=7%n=160 Participants7-
RSG XR 2 mgSBP, >140 or <90n=162 Participants61-
SBP, Increase from Baseline >=40n=162 Participants3-
SBP, Decrease from Baseline >=30n=162 Participants9-
DBP, >90 or <50n=162 Participants16-
DBP, Increase from Baseline >=30n=162 Participants1-
DBP, Decrease from Baseline >=20n=162 Participants12-
HR, >100 or <50n=162 Participants4-
HR, Increase from Baseline >=30n=162 Participants3-
HR, Decrease from Baseline >=30n=162 Participants0-
Weight, Increase from Baseline >=7%n=162 Participants21-
Weight, Decrease from Baseline >=7%n=162 Participants4-
RSG XR 8 mgSBP, >140 or <90n=154 Participants41-
SBP, Increase from Baseline >=40n=154 Participants3-
SBP, Decrease from Baseline >=30n=154 Participants15-
DBP, >90 or <50n=154 Participants13-
DBP, Increase from Baseline >=30n=154 Participants1-
DBP, Decrease from Baseline >=20n=154 Participants25-
HR, >100 or <50n=154 Participants4-
HR, Increase from Baseline >=30n=154 Participants3-
HR, Decrease from Baseline >=30n=154 Participants0-
Weight, Increase from Baseline >=7%n=154 Participants25-
Weight, Decrease from Baseline >=7%n=154 Participants3-
Donepezil 10 mgSBP, >140 or <90n=79 Participants24-
SBP, Increase from Baseline >=40n=79 Participants3-
SBP, Decrease from Baseline >=30n=79 Participants6-
DBP, >90 or <50n=79 Participants8-
DBP, Increase from Baseline >=30n=79 Participants1-
DBP, Decrease from Baseline >=20n=79 Participants8-
HR, >100 or <50n=79 Participants2-
HR, Increase from Baseline >=30n=79 Participants1-
HR, Decrease from Baseline >=30n=79 Participants1-
Weight, Increase from Baseline >=7%n=79 Participants1-
Weight, Decrease from Baseline >=7%n=79 Participants5-
Secondary/registry result

Change From Baseline (W0) in 12-lead Electrocardiogram (ECG)

Time frame:Baseline (W0) and up to W24

change from baseline, event

Posted result

GroupValue (mean), milliseconds (MSEC)Standard deviation
PlaceboPR Interval, n=16,11, 14, 4n=165 Participants2.214.39
QRS Duration, n=17, 11, 14, 5n=165 Participants1.18.28
QT Interval, n=17, 11, 14, 5n=165 Participants5.327.69
QTcB, n=17, 11, 14, 5n=165 Participants10.218.21
QTcF, n=17, 11, 14, 5n=165 Participants8.117.12
RR Intervaln=165 Participants-12.3107.35
RSG XR 2 mgPR Interval, n=16,11, 14, 4n=166 Participants6.930.44
QRS Duration, n=17, 11, 14, 5n=166 Participants0.75.50
QT Interval, n=17, 11, 14, 5n=166 Participants15.625.06
QTcB, n=17, 11, 14, 5n=166 Participants7.122.69
QTcF, n=17, 11, 14, 5n=166 Participants10.021.47
RR Intervaln=166 Participants43.889.52
RSG XR 8 mgPR Interval, n=16,11, 14, 4n=165 Participants6.019.98
QRS Duration, n=17, 11, 14, 5n=165 Participants3.66.14
QT Interval, n=17, 11, 14, 5n=165 Participants19.822.17
QTcB, n=17, 11, 14, 5n=165 Participants20.013.54
QTcF, n=17, 11, 14, 5n=165 Participants20.112.71
RR Intervaln=165 Participants-0.5107.49
Donepezil 10 mgPR Interval, n=16,11, 14, 4n=83 Participants-5.58.50
QRS Duration, n=17, 11, 14, 5n=83 Participants0.99.04
QT Interval, n=17, 11, 14, 5n=83 Participants15.922.57
QTcB, n=17, 11, 14, 5n=83 Participants-0.217.22
QTcF, n=17, 11, 14, 5n=83 Participants4.915.50
RR Intervaln=83 Participants76.5109.43
Secondary/registry result

Change From Baseline (W0) in Heart Rate (HR) Measured From 12-lead Electrocardiogram (ECG)

Time frame:Baseline (W0) and up to W24

change from baseline, event

Posted result

GroupValue (mean), Beats per minuteStandard deviation
Placebon=17 Participants2.112.08
RSG XR 2 mgn=11 Participants-2.87.77
RSG XR 8 mgn=14 Participants-0.38.39
Donepezil 10 mgn=5 Participants-4.79.23

Other (unclassified)

14 endpoints
Secondary/protocol endpoint/low confidence

Change From Baseline (W0) in Glycosylated Hemoglobin (HbA1c) at W24.

Time frame:Baseline (W0) and W24

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change From Baseline (W0) in Body Weight

Time frame:Baseline (W0) and up to W24

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change From Baseline (W0) in Hemoglobin

Time frame:Baseline (W0) and up to W24

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change From Baseline (W0) in Hematocrit

Time frame:Baseline (W0) and Up to W24

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change From Baseline (W0) in Periodic HbA1c Assessment

Time frame:Baseline (W0) and up to W24

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Number of Par. With Hematology Data of Potential Clinical Concern Any Time on Treatment

Time frame:Up to W24

concentration, descriptive

Secondary/protocol endpoint/low confidence

Number of Par. With Clinical Chemistry Values of Potential Clinical Concern Any Time on Treatment

Time frame:Up to W24

event count, event

Secondary/registry result/low confidence

Change From Baseline (W0) in Glycosylated Hemoglobin (HbA1c) at W24.

Time frame:Baseline (W0) and W24

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), Percentage (%)Standard error
Placebon=123 Participants0.10.05
RSG XR 2 mgn=120 Participants0.20.05
RSG XR 8 mgn=117 Participants0.10.05
Donepezil 10 mgn=52 Participants0.10.07
Mean Difference (Final Values)0.195% CI-0.0 - 0.2p0.139ANCOVA
Mean Difference (Final Values)0.095% CI-0.1 - 0.1p0.846ANCOVA
Mean Difference (Final Values)0.095% CI-0.1 - 0.2p0.864ANCOVA
Secondary/registry result/low confidence

Change From Baseline (W0) in Body Weight

Time frame:Baseline (W0) and up to W24

change from baseline, improvement

Posted result

GroupValue (mean), Kilogram (Kg)Standard deviation
PlaceboWeek 4, n=160, 161, 153, 79n=165 Participants0.11.59
Week 8, n=150, 157, 147, 66n=165 Participants-0.02.56
Week 12, n=143, 149, 136, 61n=165 Participants0.02.12
Week 16, n=143, 146, 132, 61n=165 Participants-0.02.05
Week 24, 133, 132, 125, 55n=165 Participants-0.32.53
RSG XR 2 mgWeek 4, n=160, 161, 153, 79n=166 Participants0.41.76
Week 8, n=150, 157, 147, 66n=166 Participants0.51.73
Week 12, n=143, 149, 136, 61n=166 Participants0.62.06
Week 16, n=143, 146, 132, 61n=166 Participants0.72.20
Week 24, 133, 132, 125, 55n=166 Participants0.82.63
RSG XR 8 mgWeek 4, n=160, 161, 153, 79n=165 Participants0.31.61
Week 8, n=150, 157, 147, 66n=165 Participants0.82.16
Week 12, n=143, 149, 136, 61n=165 Participants0.92.03
Week 16, n=143, 146, 132, 61n=165 Participants1.12.08
Week 24, 133, 132, 125, 55n=165 Participants0.82.54
Donepezil 10 mgWeek 4, n=160, 161, 153, 79n=83 Participants-0.11.39
Week 8, n=150, 157, 147, 66n=83 Participants-0.41.46
Week 12, n=143, 149, 136, 61n=83 Participants-0.91.71
Week 16, n=143, 146, 132, 61n=83 Participants-1.02.05
Week 24, 133, 132, 125, 55n=83 Participants-0.82.28
Secondary/registry result/low confidence

Change From Baseline (W0) in Hemoglobin

Time frame:Baseline (W0) and up to W24

change from baseline, improvement

Posted result

GroupValue (mean), Grams per liter (G/L)Standard deviation
PlaceboWeek 4, n=152, 152, 138, 76n=165 Participants0.15.84
Week 12, n=132, 142, 132, 60n=165 Participants-0.26.55
Week 24, n=128, 124, 115, 54n=165 Participants-1.37.54
RSG XR 2 mgWeek 4, n=152, 152, 138, 76n=166 Participants-2.87.04
Week 12, n=132, 142, 132, 60n=166 Participants-4.58.65
Week 24, n=128, 124, 115, 54n=166 Participants-4.28.34
RSG XR 8 mgWeek 4, n=152, 152, 138, 76n=165 Participants-3.97.57
Week 12, n=132, 142, 132, 60n=165 Participants-10.58.67
Week 24, n=128, 124, 115, 54n=165 Participants-11.910.58
Donepezil 10 mgWeek 4, n=152, 152, 138, 76n=83 Participants-0.46.03
Week 12, n=132, 142, 132, 60n=83 Participants-0.66.59
Week 24, n=128, 124, 115, 54n=83 Participants0.26.51
Secondary/registry result/low confidence

Change From Baseline (W0) in Hematocrit

Time frame:Baseline (W0) and Up to W24

change from baseline, improvement

Posted result

GroupValue (mean), Percentage of red blood cells in bloodStandard deviation
PlaceboWeek 4, n=152, 152, 138, 76n=165 Participants-0.00110.01886
Week 12, n=132, 142, 132, 60n=165 Participants-0.00070.02137
Week 24, n=128, 124, 115, 54n=165 Participants-0.00100.02500
RSG XR 2 mgWeek 4, n=152, 152, 138, 76n=166 Participants-0.00880.02285
Week 12, n=132, 142, 132, 60n=166 Participants-0.01520.02813
Week 24, n=128, 124, 115, 54n=166 Participants-0.01230.02304
RSG XR 8 mgWeek 4, n=152, 152, 138, 76n=165 Participants-0.01250.02322
Week 12, n=132, 142, 132, 60n=165 Participants-0.03160.02629
Week 24, n=128, 124, 115, 54n=165 Participants-0.03260.03195
Donepezil 10 mgWeek 4, n=152, 152, 138, 76n=83 Participants-0.00240.01829
Week 12, n=132, 142, 132, 60n=83 Participants-0.00550.01932
Week 24, n=128, 124, 115, 54n=83 Participants-0.00010.02135
Secondary/registry result/low confidence

Change From Baseline (W0) in Periodic HbA1c Assessment

Time frame:Baseline (W0) and up to W24

change from baseline, improvement

Posted result

GroupValue (mean), PercentageStandard deviation
PlaceboWeek 12, n=48, 46, 38, 22n=165 Participants-0.10.56
Week 24, n=123, 120, 117, 52n=165 Participants0.10.52
RSG XR 2 mgWeek 12, n=48, 46, 38, 22n=166 Participants0.20.62
Week 24, n=123, 120, 117, 52n=166 Participants0.20.66
RSG XR 8 mgWeek 12, n=48, 46, 38, 22n=165 Participants0.10.41
Week 24, n=123, 120, 117, 52n=165 Participants0.10.52
Donepezil 10 mgWeek 12, n=48, 46, 38, 22n=83 Participants-0.20.81
Week 24, n=123, 120, 117, 52n=83 Participants0.00.56
Secondary/registry result/low confidence

Number of Par. With Hematology Data of Potential Clinical Concern Any Time on Treatment

Time frame:Up to W24

concentration, descriptive

Posted result

GroupValue (number), ParticipantsReported bounds
PlaceboEosinophils H, n=156, 161, 151, 72n=165 Participants2-
Hematocrit H, n=157, 161,151, 76n=165 Participants0-
Hematocrit L, n=157, 161,151, 76n=165 Participants0-
Hemoglobin H, n=157, 161,151, 76n=165 Participants0-
Hemoglobin L, n=157, 161,151, 76n=165 Participants0-
Lymphocytes L, n=156, 161,151, 76n=165 Participants2-
MCH H, n=157, 161,151, 76n=165 Participants0-
MCH L, n=157, 161,151, 76n=165 Participants0-
MCV L, n=156, 161,151, 76n=165 Participants0-
Monocytes H, n=156, 161,151, 76n=165 Participants0-
Monocytes L, n=156, 161,151, 76n=165 Participants9-
Platelet H, n=157, 160,150, 76n=165 Participants1-
Platelet L, n=157, 160,150, 76n=165 Participants2-
RDW H, n=157, 161,151, 76n=165 Participants4-
RBC L, n=157, 161,151, 76n=165 Participants0-
Total neutrophil H, n=156, 161, 151, 76n=165 Participants0-
Total neutrophil L, n=156, 161, 151, 76n=165 Participants2-
WBC H, n=157, 161,151, 76n=165 Participants0-
WBC L, n=157, 161,151, 76n=165 Participants4-
RSG XR 2 mgEosinophils H, n=156, 161, 151, 72n=166 Participants0-
Hematocrit H, n=157, 161,151, 76n=166 Participants1-
Hematocrit L, n=157, 161,151, 76n=166 Participants0-
Hemoglobin H, n=157, 161,151, 76n=166 Participants2-
Hemoglobin L, n=157, 161,151, 76n=166 Participants3-
Lymphocytes L, n=156, 161,151, 76n=166 Participants2-
MCH H, n=157, 161,151, 76n=166 Participants0-
MCH L, n=157, 161,151, 76n=166 Participants1-
MCV L, n=156, 161,151, 76n=166 Participants0-
Monocytes H, n=156, 161,151, 76n=166 Participants0-
Monocytes L, n=156, 161,151, 76n=166 Participants10-
Platelet H, n=157, 160,150, 76n=166 Participants0-
Platelet L, n=157, 160,150, 76n=166 Participants1-
RDW H, n=157, 161,151, 76n=166 Participants6-
RBC L, n=157, 161,151, 76n=166 Participants1-
Total neutrophil H, n=156, 161, 151, 76n=166 Participants0-
Total neutrophil L, n=156, 161, 151, 76n=166 Participants5-
WBC H, n=157, 161,151, 76n=166 Participants0-
WBC L, n=157, 161,151, 76n=166 Participants4-
RSG XR 8 mgEosinophils H, n=156, 161, 151, 72n=165 Participants1-
Hematocrit H, n=157, 161,151, 76n=165 Participants0-
Hematocrit L, n=157, 161,151, 76n=165 Participants1-
Hemoglobin H, n=157, 161,151, 76n=165 Participants0-
Hemoglobin L, n=157, 161,151, 76n=165 Participants8-
Lymphocytes L, n=156, 161,151, 76n=165 Participants2-
MCH H, n=157, 161,151, 76n=165 Participants0-
MCH L, n=157, 161,151, 76n=165 Participants0-
MCV L, n=156, 161,151, 76n=165 Participants0-
Monocytes H, n=156, 161,151, 76n=165 Participants0-
Monocytes L, n=156, 161,151, 76n=165 Participants15-
Platelet H, n=157, 160,150, 76n=165 Participants0-
Platelet L, n=157, 160,150, 76n=165 Participants0-
RDW H, n=157, 161,151, 76n=165 Participants10-
RBC L, n=157, 161,151, 76n=165 Participants1-
Total neutrophil H, n=156, 161, 151, 76n=165 Participants1-
Total neutrophil L, n=156, 161, 151, 76n=165 Participants7-
WBC H, n=157, 161,151, 76n=165 Participants1-
WBC L, n=157, 161,151, 76n=165 Participants7-
Donepezil 10 mgEosinophils H, n=156, 161, 151, 72n=83 Participants0-
Hematocrit H, n=157, 161,151, 76n=83 Participants0-
Hematocrit L, n=157, 161,151, 76n=83 Participants0-
Hemoglobin H, n=157, 161,151, 76n=83 Participants0-
Hemoglobin L, n=157, 161,151, 76n=83 Participants0-
Lymphocytes L, n=156, 161,151, 76n=83 Participants0-
MCH H, n=157, 161,151, 76n=83 Participants1-
MCH L, n=157, 161,151, 76n=83 Participants0-
MCV L, n=156, 161,151, 76n=83 Participants1-
Monocytes H, n=156, 161,151, 76n=83 Participants1-
Monocytes L, n=156, 161,151, 76n=83 Participants4-
Platelet H, n=157, 160,150, 76n=83 Participants0-
Platelet L, n=157, 160,150, 76n=83 Participants0-
RDW H, n=157, 161,151, 76n=83 Participants1-
RBC L, n=157, 161,151, 76n=83 Participants1-
Total neutrophil H, n=156, 161, 151, 76n=83 Participants1-
Total neutrophil L, n=156, 161, 151, 76n=83 Participants3-
WBC H, n=157, 161,151, 76n=83 Participants1-
WBC L, n=157, 161,151, 76n=83 Participants0-
Secondary/registry result/low confidence

Number of Par. With Clinical Chemistry Values of Potential Clinical Concern Any Time on Treatment

Time frame:Up to W24

event count, event

Posted result

GroupValue (number), ParticipantsReported bounds
PlaceboALT H, n=156, 162, 151, 77n=165 Participants2-
AST H, n=156, 162, 151, 77n=165 Participants2-
BUN/Creatinine ratio H, n=156, 162, 151, 77n=165 Participants8-
Cholesterol H, n=141, 148, 137, 62n=165 Participants7-
Creatinine H, n=156, 162, 151, 77n=165 Participants5-
CPK H, n=156, 162, 151, 77n=165 Participants5-
GGT H, n=156, 162, 151, 77n=165 Participants2-
Glucose H, n=156, 162, 151, 77n=165 Participants12-
Glucose L, n=156, 162, 151, 77n=165 Participants3-
LDL H, n=141, 147, 136, 62n=165 Participants36-
Phosphorus L, n=156, 162, 151, 77n=165 Participants0-
Potassium H, n=156, 162, 150, 77n=165 Participants4-
Sodium H, n=156, 162, 151, 77n=165 Participants0-
Sodium L, n=156, 162, 151, 77n=165 Participants0-
BUN H, n=156, 162, 151, 77n=165 Participants7-
Total Bilirubin H, n=156, 162, 151, 77n=165 Participants0-
RSG XR 2 mgALT H, n=156, 162, 151, 77n=166 Participants0-
AST H, n=156, 162, 151, 77n=166 Participants0-
BUN/Creatinine ratio H, n=156, 162, 151, 77n=166 Participants8-
Cholesterol H, n=141, 148, 137, 62n=166 Participants17-
Creatinine H, n=156, 162, 151, 77n=166 Participants1-
CPK H, n=156, 162, 151, 77n=166 Participants13-
GGT H, n=156, 162, 151, 77n=166 Participants1-
Glucose H, n=156, 162, 151, 77n=166 Participants19-
Glucose L, n=156, 162, 151, 77n=166 Participants5-
LDL H, n=141, 147, 136, 62n=166 Participants51-
Phosphorus L, n=156, 162, 151, 77n=166 Participants0-
Potassium H, n=156, 162, 150, 77n=166 Participants2-
Sodium H, n=156, 162, 151, 77n=166 Participants0-
Sodium L, n=156, 162, 151, 77n=166 Participants0-
BUN H, n=156, 162, 151, 77n=166 Participants5-
Total Bilirubin H, n=156, 162, 151, 77n=166 Participants1-
RSG XR 8 mgALT H, n=156, 162, 151, 77n=165 Participants0-
AST H, n=156, 162, 151, 77n=165 Participants0-
BUN/Creatinine ratio H, n=156, 162, 151, 77n=165 Participants19-
Cholesterol H, n=141, 148, 137, 62n=165 Participants29-
Creatinine H, n=156, 162, 151, 77n=165 Participants4-
CPK H, n=156, 162, 151, 77n=165 Participants11-
GGT H, n=156, 162, 151, 77n=165 Participants0-
Glucose H, n=156, 162, 151, 77n=165 Participants9-
Glucose L, n=156, 162, 151, 77n=165 Participants4-
LDL H, n=141, 147, 136, 62n=165 Participants55-
Phosphorus L, n=156, 162, 151, 77n=165 Participants1-
Potassium H, n=156, 162, 150, 77n=165 Participants2-
Sodium H, n=156, 162, 151, 77n=165 Participants0-
Sodium L, n=156, 162, 151, 77n=165 Participants1-
BUN H, n=156, 162, 151, 77n=165 Participants12-
Total Bilirubin H, n=156, 162, 151, 77n=165 Participants0-
Donepezil 10 mgALT H, n=156, 162, 151, 77n=83 Participants0-
AST H, n=156, 162, 151, 77n=83 Participants0-
BUN/Creatinine ratio H, n=156, 162, 151, 77n=83 Participants9-
Cholesterol H, n=141, 148, 137, 62n=83 Participants1-
Creatinine H, n=156, 162, 151, 77n=83 Participants3-
CPK H, n=156, 162, 151, 77n=83 Participants5-
GGT H, n=156, 162, 151, 77n=83 Participants1-
Glucose H, n=156, 162, 151, 77n=83 Participants8-
Glucose L, n=156, 162, 151, 77n=83 Participants1-
LDL H, n=141, 147, 136, 62n=83 Participants10-
Phosphorus L, n=156, 162, 151, 77n=83 Participants0-
Potassium H, n=156, 162, 150, 77n=83 Participants2-
Sodium H, n=156, 162, 151, 77n=83 Participants1-
Sodium L, n=156, 162, 151, 77n=83 Participants2-
BUN H, n=156, 162, 151, 77n=83 Participants5-
Total Bilirubin H, n=156, 162, 151, 77n=83 Participants0-

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

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.