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TerminatedPhase 2Results posted

Study Comparing 3 Dosage Levels Of SAM-531 In Outpatients With Mild To Moderate Alzheimer Disease

A 52-Week, Two-Period, Multicenter, Randomized, Double-Blind, Donepezil-Referenced, Placebo-Controlled, Efficacy And Safety Study Of 3 Dosage Levels Of SAM-531 In Outpatients With Mild To Moderate Alzheimer Disease

Lead sponsor

Pfizer

Assets

Donepezil / SAM-531

Listed sites

96

Recruiting sites

-

Enrollment

526

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 12-24

Primary endpoint

•ADAS-Cog

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 ID3193A1-2005
SecondaryB1961007
NCT IDNCT00895895

Timeline

Milestones

Study start2009-05 (month precision)
Study first posted2009-05-08estimated
Primary completion2011-05actual (month precision)
Study completion2011-05actual (month precision)
Last update posted2013-01-31estimated
Results first posted2013-01-31estimated

Assets

Drug assets

DonepezilSAM-531

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Diagnosis of probable Alzheimer Disease according to the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Diseases and Related Disorders Association (NINCDS-ADRDA) criteria.
•Mini-Mental State Examination (MMSE) score of 12 to 24 at screening
•Rosen Modified Hachinski Ischemic score < or equal to 4 at screening

Exclusion criteria

•Relevant neurologic disease other than Alzheimer Disease that may affect cognition or ability to complete the study.
•Current major depressive disorder or other current major psychiatric disorder.
•History of clinically evident stroke or clinically important carotid or vertebrobasilar stenosis or plaque.
•Use of prescription or nonprescription medications for cognitive enhancement (including memantine, ginkgo biloba, huperzine A, and cholinesterase inhibitors) within 3 months before the baseline visit.

Endpoints (40)

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

Memory
12
Other (unclassified)
12
Other clinical outcomes
6
Global cognition
4
Behavior / neuropsychiatric
4
Function / daily living
2

Global cognition

4 endpoints
Primary/protocol endpoint

Change From Baseline in the Alzheimer's Disease Assessment Scale-Cognition (ADAS-Cog) Total Score at Week 24

Time frame:Baseline, Week 24

ADAS-Cog

change from baseline, improvement

Primary/registry result

Change From Baseline in the Alzheimer's Disease Assessment Scale-Cognition (ADAS-Cog) Total Score at Week 24

Time frame:Baseline, Week 24

ADAS-Cog

change from baseline, improvement

Posted result

GroupValue (mean), units on a scaleStandard deviation
Placebo, Then SAM-531Baselinen=99 Participants23.610.3
Week 24n=99 Participants23.812.0
SAM-531 (1.5 mg)Baselinen=98 Participants24.111.7
Week 24n=98 Participants24.213.1
SAM-531 (3.0 mg)Baselinen=100 Participants23.610.6
Week 24n=100 Participants23.512.0
SAM-531 (5.0 mg)Baselinen=101 Participants22.69.8
Week 24n=101 Participants21.910.6
DonepezilBaselinen=103 Participants23.410.0
Week 24n=103 Participants22.410.9
Mean Difference (Final Values)0.795% CI-1.0 - 2.3p0.424Mixed Models Analysis

Analysis of adjusted difference in change from baseline.

Mean Difference (Final Values)-0.295% CI-1.8 - 1.5p0.849Mixed Models Analysis

Analysis of adjusted difference in change from baseline.

Mean Difference (Final Values)-0.595% CI-2.2 - 1.1p0.520Mixed Models Analysis

Analysis of adjusted difference in change from baseline.

Mean Difference (Final Values)-1.095% CI-2.6 - 0.7p0.258Mixed Models Analysis

Analysis of adjusted difference in change from baseline.

Secondary/protocol endpoint

Percentage of Participants Who Were Responders at Week 24

Time frame:Week 24

ADAS-Cog

threshold achievement, improvement

Secondary/registry result

Percentage of Participants Who Were Responders at Week 24

Time frame:Week 24

ADAS-Cog

threshold achievement, improvement

Posted result

GroupValue (number), percentage of participantsReported bounds
Placebo, Then SAM-531n=87 Participants9.2-
SAM-531 (1.5 mg)n=85 Participants7.1-
SAM-531 (3.0 mg)n=86 Participants10.5-
SAM-531 (5.0 mg)n=92 Participants15.2-
Donepeziln=87 Participants20.7-
Odds Ratio (OR)0.7395% CI0.24 - 2.22p0.581Regression, Logistic
Odds Ratio (OR)1.1695% CI0.42 - 3.19p0.770Regression, Logistic
Odds Ratio (OR)1.8095% CI0.71 - 4.55p0.216Regression, Logistic
Odds Ratio (OR)2.6195% CI1.06 - 6.42p0.037Regression, Logistic

Memory

12 endpoints
Secondary/protocol endpoint

Change From Baseline in Cambridge Neuropsychological Test Automated Battery (CANTAB) Paired Associate Learning (PAL)Total Errors (N, Shapes, Adjusted) at Week 24

Time frame:Baseline, Week 24

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in CANTAB PAL - Number of Patterns Reached at Week 24

Time frame:Baseline, Week 24

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in CANTAB PAL - First Trial Memory Score, Patterns at Week 24

Time frame:Baseline, Week 24

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in CANTAB Spatial Working Memory (SWM) - Between Errors (4 Boxes) at Week 24

Time frame:Baseline, Week 24

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in CANTAB Pattern Recognition Memory (PRM)-Mean Correct Latency at Week 24

Time frame:Baseline, Week 24

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in CANTAB PRM-Percentage Correct at Week 24

Time frame:Baseline, Week 24

change from baseline, improvement

Secondary/registry result

Change From Baseline in Cambridge Neuropsychological Test Automated Battery (CANTAB) Paired Associate Learning (PAL)Total Errors (N, Shapes, Adjusted) at Week 24

Time frame:Baseline, Week 24

change from baseline, improvement

Posted result

GroupValue (mean), errorsStandard deviation
Placebo, Then SAM-531Baselinen=94 Participants68.327.4
Week 24n=94 Participants66.427.4
SAM-531 (1.5 mg)Baselinen=93 Participants66.929.6
Week 24n=93 Participants68.129.2
SAM-531 (3.0 mg)Baselinen=97 Participants66.528.6
Week 24n=97 Participants67.529.8
SAM-531 (5.0 mg)Baselinen=96 Participants67.628.8
Week 24n=96 Participants64.930.8
DonepezilBaselinen=98 Participants67.829.3
Week 24n=98 Participants66.728.6
Mean Difference (Final Values)1.795% CI-3.9 - 7.3p0.553Mixed Models Analysis

Analysis of adjusted difference in change from baseline.

Mean Difference (Final Values)-0.495% CI-6.0 - 5.2p0.886Mixed Models Analysis

Analysis of adjusted difference in change from baseline.

Mean Difference (Final Values)-1.095% CI-6.6 - 4.5p0.712Mixed Models Analysis

Analysis of adjusted difference in change from baseline.

Mean Difference (Final Values)0.895% CI-4.8 - 6.4p0.785Mixed Models Analysis

Analysis of adjusted difference in change from baseline.

Secondary/registry result

Change From Baseline in CANTAB PAL - Number of Patterns Reached at Week 24

Time frame:Baseline, Week 24

change from baseline, improvement

Posted result

GroupValue (mean), patternsStandard deviation
Placebo, Then SAM-531Baselinen=94 Participants4.11.3
Week 24n=94 Participants4.31.3
SAM-531 (1.5 mg)Baselinen=93 Participants4.21.3
Week 24n=93 Participants4.11.4
SAM-531 (3.0 mg)Baselinen=97 Participants4.21.3
Week 24n=97 Participants4.21.4
SAM-531 (5.0 mg)Baselinen=96 Participants4.11.4
Week 24n=96 Participants4.21.5
DonepezilBaselinen=98 Participants4.11.3
Week 24n=98 Participants4.21.4
Mean Difference (Final Values)-0.295% CI-0.5 - 0.1p0.251Mixed Models Analysis

Analysis of adjusted difference in change from baseline.

Mean Difference (Final Values)-0.095% CI-0.3 - 0.3p0.993Mixed Models Analysis

Analysis of adjusted difference in change from baseline.

Mean Difference (Final Values)-0.195% CI-0.4 - 0.2p0.553Mixed Models Analysis

Analysis of adjusted difference in change from baseline.

Mean Difference (Final Values)-0.195% CI-0.4 - 0.2p0.611Mixed Models Analysis

Analysis of adjusted difference in change from baseline.

Secondary/registry result

Change From Baseline in CANTAB PAL - First Trial Memory Score, Patterns at Week 24

Time frame:Baseline, Week 24

change from baseline, improvement

Posted result

GroupValue (mean), correct choicesStandard deviation
Placebo, Then SAM-531Baselinen=94 Participants4.63.9
Week 24n=94 Participants4.84.0
SAM-531 (1.5 mg)Baselinen=93 Participants4.84.5
Week 24n=93 Participants4.44.2
SAM-531 (3.0 mg)Baselinen=97 Participants4.74.3
Week 24n=97 Participants4.84.5
SAM-531 (5.0 mg)Baselinen=96 Participants4.64.1
Week 24n=96 Participants5.14.5
DonepezilBaselinen=98 Participants4.64.4
Week 24n=98 Participants4.54.1
Mean Difference (Final Values)-0.595% CI-1.5 - 0.5p0.340Mixed Models Analysis

Analysis of adjusted difference in change from baseline.

Mean Difference (Final Values)0.295% CI-0.8 - 1.2p0.630Mixed Models Analysis

Analysis of adjusted difference in change from baseline.

Mean Difference (Final Values)0.295% CI-0.8 - 1.2p0.678Mixed Models Analysis

Analysis of adjusted difference in change from baseline.

Mean Difference (Final Values)-0.395% CI-1.3 - 0.7p0.518Mixed Models Analysis

Analysis of adjusted difference in change from baseline.

Secondary/registry result

Change From Baseline in CANTAB Spatial Working Memory (SWM) - Between Errors (4 Boxes) at Week 24

Time frame:Baseline, Week 24

change from baseline, improvement

Posted result

GroupValue (mean), errorsStandard deviation
Placebo, Then SAM-531Baselinen=95 Participants3.82.0
Week 24n=95 Participants3.72.3
SAM-531 (1.5 mg)Baselinen=93 Participants3.62.4
Week 24n=93 Participants3.62.3
SAM-531 (3.0 mg)Baselinen=97 Participants3.82.7
Week 24n=97 Participants3.72.5
SAM-531 (5.0 mg)Baselinen=97 Participants3.52.1
Week 24n=97 Participants3.12.3
DonepezilBaselinen=98 Participants3.92.4
Week 24n=98 Participants3.52.3
Mean Difference (Final Values)-0.095% CI-0.7 - 0.7p0.953Mixed Models Analysis

Analysis of adjusted difference in change from baseline.

Mean Difference (Final Values)-0.095% CI-0.7 - 0.6p0.956Mixed Models Analysis

Analysis of adjusted difference in change from baseline.

Mean Difference (Final Values)-0.495% CI-1.1 - 0.2p0.216Mixed Models Analysis

Analysis of adjusted difference in change from baseline.

Mean Difference (Final Values)-0.195% CI-0.8 - 0.5p0.665Mixed Models Analysis

Analysis of adjusted difference in change from baseline.

Secondary/registry result

Change From Baseline in CANTAB Pattern Recognition Memory (PRM)-Mean Correct Latency at Week 24

Time frame:Baseline, Week 24

change from baseline, improvement

Posted result

GroupValue (mean), msecStandard deviation
Placebo, Then SAM-531Baselinen=95 Participants4583.73121.2
Week 24n=95 Participants4288.32082.7
SAM-531 (1.5 mg)Baselinen=96 Participants4121.12358.8
Week 24n=96 Participants3979.13002.3
SAM-531 (3.0 mg)Baselinen=97 Participants4973.42784.3
Week 24n=97 Participants3793.51698.0
SAM-531 (5.0 mg)Baselinen=98 Participants4216.42208.6
Week 24n=98 Participants4301.52931.4
DonepezilBaselinen=99 Participants4303.02705.2
Week 24n=99 Participants4387.82703.8
Mean Difference (Final Values)-60.495% CI-739.7 - 618.8p0.861Mixed Models Analysis

Analysis of adjusted difference in change from baseline.

Mean Difference (Final Values)-926.695% CI-1596.9 - -256.3p0.007Mixed Models Analysis

Analysis of adjusted difference in change from baseline.

Mean Difference (Final Values)141.395% CI-522.1 - 804.6p0.676Mixed Models Analysis

Analysis of adjusted difference in change from baseline.

Mean Difference (Final Values)230.695% CI-449.7 - 910.9p0.505Mixed Models Analysis

Analysis of adjusted difference in change from baseline.

Secondary/registry result

Change From Baseline in CANTAB PRM-Percentage Correct at Week 24

Time frame:Baseline, Week 24

change from baseline, improvement

Posted result

GroupValue (mean), percentage of correct answersStandard deviation
Placebo, Then SAM-531Baselinen=95 Participants59.318.7
Week 24n=95 Participants59.416.3
SAM-531 (1.5 mg)Baselinen=96 Participants62.218.4
Week 24n=96 Participants63.020.2
SAM-531 (3.0 mg)Baselinen=97 Participants63.417.1
Week 24n=97 Participants64.418.4
SAM-531 (5.0 mg)Baselinen=98 Participants66.717.7
Week 24n=98 Participants65.917.6
DonepezilBaselinen=99 Participants63.918.9
Week 24n=99 Participants63.716.9
Mean Difference (Final Values)2.895% CI-2.2 - 7.8p0.267Mixed Models Analysis

Analysis of adjusted difference in change from baseline.

Mean Difference (Final Values)3.695% CI-1.3 - 8.6p0.145Mixed Models Analysis

Analysis of adjusted difference in change from baseline.

Mean Difference (Final Values)3.795% CI-1.2 - 8.6p0.139Mixed Models Analysis

Analysis of adjusted difference in change from baseline.

Mean Difference (Final Values)2.295% CI-2.8 - 7.2p0.386Mixed Models Analysis

Analysis of adjusted difference in change from baseline.

Function / daily living

2 endpoints
Secondary/protocol endpoint

Change From Baseline in Disability Assessment for Dementia (DAD) Total Score at Week 24

Time frame:Baseline, Week 24

change from baseline, improvement

Secondary/registry result

Change From Baseline in Disability Assessment for Dementia (DAD) Total Score at Week 24

Time frame:Baseline, Week 24

change from baseline, improvement

Posted result

GroupValue (mean), percentage of yes answersStandard deviation
Placebo, Then SAM-531Baselinen=97 Participants77.421.8
Week 24n=97 Participants76.724.2
SAM-531 (1.5 mg)Baselinen=97 Participants73.120.9
Week 24n=97 Participants71.425.0
SAM-531 (3.0 mg)Baselinen=98 Participants72.922.5
Week 24n=98 Participants73.024.4
SAM-531 (5.0 mg)Baselinen=100 Participants75.521.0
Week 24n=100 Participants76.823.1
DonepezilBaselinen=102 Participants73.222.9
Week 24n=102 Participants75.624.5
Mean Difference (Final Values)-1.695% CI-5.2 - 1.9p0.367Mixed Models Analysis

Analysis of adjusted difference in change from baseline.

Mean Difference (Final Values)0.295% CI-3.3 - 3.7p0.910Mixed Models Analysis

Analysis of adjusted difference in change from baseline.

Mean Difference (Final Values)2.595% CI-1.0 - 6.0p0.160Mixed Models Analysis

Analysis of adjusted difference in change from baseline.

Mean Difference (Final Values)3.495% CI-0.1 - 6.9p0.060Mixed Models Analysis

Analysis of adjusted difference in change from baseline.

Behavior / neuropsychiatric

4 endpoints
Secondary/protocol endpoint

Change From Baseline in Neuropsychiatry Inventory (NPI) at Week 24

Time frame:Baseline, Week 24

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/protocol endpoint

Number of Participants With Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC) Scores at Week 24

Time frame:Baseline, Week 24

event count, event

Secondary/registry result

Change From Baseline in Neuropsychiatry Inventory (NPI) at Week 24

Time frame:Baseline, Week 24

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Posted result

GroupValue (mean), unit on a scaleStandard deviation
Placebo, Then SAM-531Baselinen=96 Participants10.613.9
Week 24n=96 Participants10.714.4
SAM-531 (1.5 mg)Baselinen=96 Participants14.616.6
Week 24n=96 Participants11.914.6
SAM-531 (3.0 mg)Baselinen=98 Participants14.818.1
Week 24n=98 Participants9.711.3
SAM-531 (5.0 mg)Baselinen=99 Participants13.413.4
Week 24n=99 Participants10.411.4
DonepezilBaselinen=102 Participants12.114.8
Week 24n=102 Participants9.312.9
Mean Difference (Final Values)0.195% CI-2.8 - 3.1p0.931Mixed Models Analysis

Analysis of adjusted difference in change from baseline.

Mean Difference (Final Values)-2.995% CI-5.8 - 0.1p0.054Mixed Models Analysis

Analysis of adjusted difference in change from baseline.

Mean Difference (Final Values)-1.795% CI-4.6 - 1.2p0.246Mixed Models Analysis

Analysis of adjusted difference in change from baseline.

Mean Difference (Final Values)-1.295% CI-4.1 - 1.7p0.426Mixed Models Analysis

Analysis of adjusted difference in change from baseline.

Secondary/registry result

Number of Participants With Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC) Scores at Week 24

Time frame:Baseline, Week 24

event count, event

Posted result

GroupValue (number), participantsReported bounds
Placebo, Then SAM-531marked improvementn=86 Participants0-
moderate improvementn=86 Participants1-
minimal improvementn=86 Participants20-
no changen=86 Participants32-
minimal worseningn=86 Participants30-
moderate worseningn=86 Participants2-
marked worseningn=86 Participants1-
SAM-531 (1.5 mg)marked improvementn=85 Participants1-
moderate improvementn=85 Participants2-
minimal improvementn=85 Participants23-
no changen=85 Participants36-
minimal worseningn=85 Participants17-
moderate worseningn=85 Participants5-
marked worseningn=85 Participants1-
SAM-531 (3.0 mg)marked improvementn=84 Participants1-
moderate improvementn=84 Participants5-
minimal improvementn=84 Participants19-
no changen=84 Participants33-
minimal worseningn=84 Participants19-
moderate worseningn=84 Participants6-
marked worseningn=84 Participants1-
SAM-531 (5.0 mg)marked improvementn=92 Participants1-
moderate improvementn=92 Participants3-
minimal improvementn=92 Participants17-
no changen=92 Participants45-
minimal worseningn=92 Participants22-
moderate worseningn=92 Participants4-
marked worseningn=92 Participants0-
Donepezilmarked improvementn=87 Participants1-
moderate improvementn=87 Participants4-
minimal improvementn=87 Participants23-
no changen=87 Participants30-
minimal worseningn=87 Participants25-
moderate worseningn=87 Participants3-
marked worseningn=87 Participants1-
p0.265Cochran-Mantel-Haenszel
p0.682Cochran-Mantel-Haenszel
p0.532Cochran-Mantel-Haenszel
p0.087Cochran-Mantel-Haenszel
p0.751Cochran-Mantel-Haenszel

Other clinical outcomes

6 endpoints
Secondary/protocol endpoint

Change From Baseline in CANTAB-SWM - Between Errors (6 Boxes) at Week 24

Time frame:Baseline, Week 24

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in CANTAB SWM - Between Errors (8 Boxes) at Week 24

Time frame:Baseline, Week 24

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in CANTAB SWM - Between Errors (N Boxes) at Week 24

Time frame:Baseline, Week 24

change from baseline, improvement

Secondary/registry result

Change From Baseline in CANTAB-SWM - Between Errors (6 Boxes) at Week 24

Time frame:Baseline, Week 24

change from baseline, improvement

Posted result

GroupValue (mean), errorsStandard deviation
Placebo, Then SAM-531Baselinen=95 Participants9.23.9
Week 24n=95 Participants8.92.9
SAM-531 (1.5 mg)Baselinen=93 Participants9.14.2
Week 24n=93 Participants9.24.9
SAM-531 (3.0 mg)Baselinen=97 Participants9.13.9
Week 24n=97 Participants9.04.1
SAM-531 (5.0 mg)Baselinen=97 Participants8.64.0
Week 24n=97 Participants9.13.9
DonepezilBaselinen=98 Participants10.04.8
Week 24n=98 Participants8.93.7
Mean Difference (Final Values)0.595% CI-0.6 - 1.7p0.373Mixed Models Analysis

Analysis of adjusted difference in change from baseline.

Mean Difference (Final Values)0.295% CI-1.0 - 1.3p0.781Mixed Models Analysis

Analysis of adjusted difference in change from baseline.

Mean Difference (Final Values)0.595% CI-0.7 - 1.6p0.417Mixed Models Analysis

Analysis of adjusted difference in change from baseline.

Mean Difference (Final Values)-0.195% CI-1.3 - 1.0p0.853Mixed Models Analysis

Analysis of adjusted difference in change from baseline.

Secondary/registry result

Change From Baseline in CANTAB SWM - Between Errors (8 Boxes) at Week 24

Time frame:Baseline, Week 24

change from baseline, improvement

Posted result

GroupValue (mean), errorsStandard deviation
Placebo, Then SAM-531Baselinen=95 Participants20.75.9
Week 24n=95 Participants21.15.6
SAM-531 (1.5 mg)Baselinen=93 Participants20.15.8
Week 24n=93 Participants20.06.4
SAM-531 (3.0 mg)Baselinen=97 Participants20.86.1
Week 24n=97 Participants20.85.4
SAM-531 (5.0 mg)Baselinen=97 Participants19.36.9
Week 24n=97 Participants19.77.1
DonepezilBaselinen=98 Participants20.26.5
Week 24n=98 Participants19.85.8
Mean Difference (Final Values)-0.795% CI-2.6 - 1.1p0.428Mixed Models Analysis

Analysis of adjusted difference in change from baseline.

Mean Difference (Final Values)-0.395% CI-2.1 - 1.5p0.763Mixed Models Analysis

Analysis of adjusted difference in change from baseline.

Mean Difference (Final Values)-0.995% CI-2.7 - 0.9p0.312Mixed Models Analysis

Analysis of adjusted difference in change from baseline.

Mean Difference (Final Values)-1.295% CI-3.0 - 0.7p0.215Mixed Models Analysis

Analysis of adjusted difference in change from baseline.

Secondary/registry result

Change From Baseline in CANTAB SWM - Between Errors (N Boxes) at Week 24

Time frame:Baseline, Week 24

change from baseline, improvement

Posted result

GroupValue (mean), errorsStandard deviation
Placebo, Then SAM-531Baselinen=95 Participants33.89.0
Week 24n=95 Participants33.87.8
SAM-531 (1.5 mg)Baselinen=93 Participants32.89.4
Week 24n=93 Participants32.810.3
SAM-531 (3.0 mg)Baselinen=97 Participants33.710.0
Week 24n=97 Participants33.59.6
SAM-531 (5.0 mg)Baselinen=97 Participants31.48.9
Week 24n=97 Participants32.010.2
DonepezilBaselinen=98 Participants34.210.4
Week 24n=98 Participants32.29.5
Mean Difference (Final Values)-0.195% CI-2.7 - 2.5p0.956Mixed Models Analysis

Analysis of adjusted difference in change from baseline.

Mean Difference (Final Values)-0.095% CI-2.6 - 2.5p0.988Mixed Models Analysis

Analysis of adjusted difference in change from baseline.

Mean Difference (Final Values)-0.295% CI-2.7 - 2.4p0.890Mixed Models Analysis

Analysis of adjusted difference in change from baseline.

Mean Difference (Final Values)-1.495% CI-4.0 - 1.2p0.280Mixed Models Analysis

Analysis of adjusted difference in change from baseline.

Other (unclassified)

12 endpoints
Secondary/protocol endpoint/low confidence

Change From Baseline in CANTAB SWM Strategy at Week 24

Time frame:Baseline, Week 24

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change From Baseline in CANTAB Reaction Time (RTI) Five-Choice Accuracy at Week 24

Time frame:Baseline, Week 24

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change From Baseline in CANTAB RTI Five-Choice Movement Time at Week 24

Time frame:Baseline, Week 24

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change From Baseline in CANTAB RTI Five-Choice Reaction Time at Week 24

Time frame:Baseline, Week 24

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change From Baseline in CANTAB RTI Simple Movement Time at Week 24

Time frame:Baseline, Week 24

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change From Baseline in CANTAB RTI Simple Reaction Time at Week 24

Time frame:Baseline, Week 24

change from baseline, improvement

Secondary/registry result/low confidence

Change From Baseline in CANTAB SWM Strategy at Week 24

Time frame:Baseline, Week 24

change from baseline, improvement

Posted result

GroupValue (mean), boxesStandard deviation
Placebo, Then SAM-531Baselinen=95 Participants19.73.1
Week 24n=95 Participants20.02.2
SAM-531 (1.5 mg)Baselinen=93 Participants19.43.3
Week 24n=93 Participants19.13.3
SAM-531 (3.0 mg)Baselinen=97 Participants19.22.8
Week 24n=97 Participants19.42.3
SAM-531 (5.0 mg)Baselinen=97 Participants19.13.6
Week 24n=97 Participants19.03.9
DonepezilBaselinen=98 Participants19.03.6
Week 24n=98 Participants20.02.0
Mean Difference (Final Values)-0.695% CI-1.5 - 0.2p0.154Mixed Models Analysis

Analysis of adjusted difference in change from baseline.

Mean Difference (Final Values)-0.195% CI-1.0 - 0.7p0.740Mixed Models Analysis

Analysis of adjusted difference in change from baseline.

Mean Difference (Final Values)-0.695% CI-1.4 - 0.3p0.179Mixed Models Analysis

Analysis of adjusted difference in change from baseline.

Mean Difference (Final Values)0.395% CI-0.6 - 1.1p0.543Mixed Models Analysis

Analysis of adjusted difference in change from baseline.

Secondary/registry result/low confidence

Change From Baseline in CANTAB Reaction Time (RTI) Five-Choice Accuracy at Week 24

Time frame:Baseline, Week 24

change from baseline, improvement

Posted result

GroupValue (mean), correct trialsStandard deviation
Placebo, Then SAM-531Baselinen=89 Participants27.34.4
Week 24n=89 Participants27.83.2
SAM-531 (1.5 mg)Baselinen=93 Participants26.95.8
Week 24n=93 Participants26.75.9
SAM-531 (3.0 mg)Baselinen=96 Participants27.05.6
Week 24n=96 Participants28.14.0
SAM-531 (5.0 mg)Baselinen=96 Participants28.14.4
Week 24n=96 Participants28.13.4
DonepezilBaselinen=95 Participants27.05.4
Week 24n=95 Participants27.94.6
Mean Difference (Final Values)-1.295% CI-2.3 - -0.1p0.032Mixed Models Analysis

Analysis of adjusted difference in change from baseline.

Mean Difference (Final Values)0.695% CI-0.5 - 1.7p0.264Mixed Models Analysis

Analysis of adjusted difference in change from baseline.

Mean Difference (Final Values)0.195% CI-1.0 - 1.1p0.893Mixed Models Analysis

Analysis of adjusted difference in change from baseline.

Mean Difference (Final Values)0.495% CI-0.7 - 1.4p0.525Mixed Models Analysis

Analysis of adjusted difference in change from baseline.

Secondary/registry result/low confidence

Change From Baseline in CANTAB RTI Five-Choice Movement Time at Week 24

Time frame:Baseline, Week 24

change from baseline, improvement

Posted result

GroupValue (mean), msecStandard deviation
Placebo, Then SAM-531Baselinen=88 Participants573.5218.6
Week 24n=88 Participants539.9199.0
SAM-531 (1.5 mg)Baselinen=93 Participants583.1307.5
Week 24n=93 Participants578.8290.9
SAM-531 (3.0 mg)Baselinen=96 Participants617.6381.9
Week 24n=96 Participants584.7284.9
SAM-531 (5.0 mg)Baselinen=96 Participants564.4310.0
Week 24n=96 Participants546.4191.0
DonepezilBaselinen=95 Participants583.6292.8
Week 24n=95 Participants560.6284.6
Mean Difference (Final Values)60.995% CI-1.6 - 123.5p0.056Mixed Models Analysis

Analysis of adjusted difference in change from baseline.

Mean Difference (Final Values)21.895% CI-40.0 - 83.5p0.488Mixed Models Analysis

Analysis of adjusted difference in change from baseline.

Mean Difference (Final Values)8.695% CI-52.6 - 69.8p0.783Mixed Models Analysis

Analysis of adjusted difference in change from baseline.

Mean Difference (Final Values)17.695% CI-44.6 - 79.8p0.578Mixed Models Analysis

Analysis of adjusted difference in change from baseline.

Secondary/registry result/low confidence

Change From Baseline in CANTAB RTI Five-Choice Reaction Time at Week 24

Time frame:Baseline, Week 24

change from baseline, improvement

Posted result

GroupValue (mean), msecStandard deviation
Placebo, Then SAM-531Baselinen=88 Participants488.6275.8
Week 24n=88 Participants447.3139.3
SAM-531 (1.5 mg)Baselinen=93 Participants503.7215.2
Week 24n=93 Participants483.6211.3
SAM-531 (3.0 mg)Baselinen=96 Participants488.6200.8
Week 24n=96 Participants473.7184.4
SAM-531 (5.0 mg)Baselinen=96 Participants438.2172.1
Week 24n=96 Participants438.5170.7
DonepezilBaselinen=95 Participants475.7205.9
Week 24n=95 Participants443.3145.5
Mean Difference (Final Values)31.195% CI-13.9 - 76.1p0.175Mixed Models Analysis

Analysis of adjusted difference in change from baseline.

Mean Difference (Final Values)21.095% CI-23.3 - 65.4p0.352Mixed Models Analysis

Analysis of adjusted difference in change from baseline.

Mean Difference (Final Values)5.795% CI-38.1 - 49.6p0.797Mixed Models Analysis

Analysis of adjusted difference in change from baseline.

Mean Difference (Final Values)-10.995% CI-55.6 - 33.9p0.633Mixed Models Analysis

Analysis of adjusted difference in change from baseline.

Secondary/registry result/low confidence

Change From Baseline in CANTAB RTI Simple Movement Time at Week 24

Time frame:Baseline, Week 24

change from baseline, improvement

Posted result

GroupValue (mean), msecStandard deviation
Placebo, Then SAM-531Baselinen=89 Participants620.4299.0
Week 24n=89 Participants585.2253.2
SAM-531 (1.5 mg)Baselinen=92 Participants631.2379.2
Week 24n=92 Participants630.6359.5
SAM-531 (3.0 mg)Baselinen=96 Participants669.0473.8
Week 24n=96 Participants641.8366.4
SAM-531 (5.0 mg)Baselinen=96 Participants641.2443.0
Week 24n=96 Participants604.6262.2
DonepezilBaselinen=95 Participants624.0336.0
Week 24n=95 Participants621.0331.8
Mean Difference (Final Values)71.295% CI-4.7 - 147.0p0.066Mixed Models Analysis

Analysis of adjusted difference in change from baseline.

Mean Difference (Final Values)20.095% CI-54.6 - 94.7p0.598Mixed Models Analysis

Analysis of adjusted difference in change from baseline.

Mean Difference (Final Values)11.295% CI-62.9 - 85.3p0.766Mixed Models Analysis

Analysis of adjusted difference in change from baseline.

Mean Difference (Final Values)33.895% CI-41.5 - 109.1p0.378Mixed Models Analysis

Analysis of adjusted difference in change from baseline.

Secondary/registry result/low confidence

Change From Baseline in CANTAB RTI Simple Reaction Time at Week 24

Time frame:Baseline, Week 24

change from baseline, improvement

Posted result

GroupValue (mean), msecStandard deviation
Placebo, Then SAM-531Baselinen=89 Participants471.8219.7
Week 24n=89 Participants449.2195.8
SAM-531 (1.5 mg)Baselinen=92 Participants510.9295.1
Week 24n=92 Participants479.7327.7
SAM-531 (3.0 mg)Baselinen=96 Participants487.1255.1
Week 24n=96 Participants460.4213.5
SAM-531 (5.0 mg)Baselinen=96 Participants442.8247.3
Week 24n=96 Participants445.3206.0
DonepezilBaselinen=95 Participants501.3302.9
Week 24n=95 Participants445.5203.6
Mean Difference (Final Values)22.595% CI-40.2 - 85.2p0.481Mixed Models Analysis

Analysis of adjusted difference in change from baseline.

Mean Difference (Final Values)4.295% CI-57.5 - 65.9p0.894Mixed Models Analysis

Analysis of adjusted difference in change from baseline.

Mean Difference (Final Values)-0.395% CI-61.5 - 60.8p0.991Mixed Models Analysis

Analysis of adjusted difference in change from baseline.

Mean Difference (Final Values)-25.595% CI-87.9 - 36.9p0.422Mixed Models Analysis

Analysis of adjusted difference in change from baseline.

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.