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STARSHINE

CompletedPhase 3Results posted

Study of Idalopirdine in Patients With Mild - Moderate Alzheimer's Disease Treated With Donepezil

Randomised, Double-blind, Parallel-group, Placebo-controlled, Fixed-dose Study of Idalopirdine in Patients With Mild - Moderate Alzheimer's Disease Treated With Donepezil

Lead sponsor

H. Lundbeck A/S

Asset

Idalopirdine

Listed sites

137

Recruiting sites

Enrollment

933

actual

Study population

Alzheimer’s disease

Key I/E criteria

•mild-to-moderate AD•Study partner/caregiver required

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 ID14861A

Eudract number2012-004763-45

NCT IDNCT01955161

Timeline

Milestones

Study start2013-10 (month precision)

Study first posted2013-10-07estimated

Primary completion2016-07actual (month precision)

Study completion2016-07actual (month precision)

Last update posted2017-09-19actual

Results first posted2017-09-19actual

Assets

Drug assets

Idalopirdine

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•The patient has a knowledgeable and reliable caregiver.

•The patient is an outpatient.

•The patient has probable AD.

•The patient has mild to moderate AD.

•Stable treatment with donepezil.

•The patient, if a woman, must have had her last natural menstruation ≥24 months prior to baseline, OR be surgically sterile.

•The patient, if a man, agrees to protocol-defined use of effective contraception if his female partner is of childbearing potential, OR must have been surgically sterilised prior to the screening visit

Exclusion criteria

•The patient has evidence of any clinically significant neurodegenerative disease, or other serious neurological disorders other than AD.

•The patient has a Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR) Axis I disorder other than AD.

•The patient has evidence of clinically significant disease.

•The patient's donepezil therapy is likely to be interrupted or discontinued during the study.

•The patient is currently receiving memantine or has taken memantine within 2 months prior to screening.

Other inclusion and exclusion criteria may apply.

Endpoints (22)

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

Behavior / neuropsychiatric

Global cognition

Function / daily living

Global cognition

8 endpoints

Primary/protocol endpoint

Change in Cognition

Time frame:Baseline to Week 24

ADAS-Cog

change from baseline, improvement

Primary/registry result

Change in Cognition

Time frame:Baseline to Week 24

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), units on a scale	Standard error
Placebon=304 Participants	0.13	0.35
Idalopirdine 30 mgn=310 Participants	0.47	0.35
Idalopirdine 60 mgn=308 Participants	0.18	0.35

Mean Difference (Final Values)0.3395% CI-0.59 - 1.26p0.9591Mixed Models Analysis

Mean Difference (Final Values)0.0595% CI-0.88 - 0.98p1.000Mixed Models Analysis

Secondary/protocol endpoint

Clinical Improvement

Time frame:Week 24

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

Clinical Worsening

Time frame:Week 24

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

Change in Cognitive Aspects of Mental Function

Time frame:Baseline to Week 24

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Secondary/registry result

Clinical Improvement

Time frame:Week 24

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
Placebon=284 Participants	34	-
Idalopirdine 30 mgn=290 Participants	37	-
Idalopirdine 60 mgn=278 Participants	27	-

Secondary/registry result

Clinical Worsening

Time frame:Week 24

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
Placebon=284 Participants	40	-
Idalopirdine 30 mgn=290 Participants	42	-
Idalopirdine 60 mgn=278 Participants	33	-

Secondary/registry result

Change in Cognitive Aspects of Mental Function

Time frame:Baseline to Week 24

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), units on a scale	Standard error
Placebon=282 Participants	0.06	0.16
Idalopirdine 30 mgn=288 Participants	-0.27	0.16
Idalopirdine 60 mgn=274 Participants	0.27	0.17

Function / daily living

2 endpoints

Secondary/protocol endpoint

Change in Daily Functioning

Time frame:Baseline to Week 24

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Secondary/registry result

Change in Daily Functioning

Time frame:Baseline to Week 24

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), units on a scale	Standard error
Placebon=304 Participants	-2.03	0.49
Idalopirdine 30 mgn=310 Participants	-2.12	0.48
Idalopirdine 60 mgn=308 Participants	-2.02	0.49

Mean Difference (Final Values)-0.0895% CI-1.37 - 1.21p1.000Mixed Models Analysis

Mean Difference (Final Values)0.0195% CI-1.29 - 1.31p1.000Mixed Models Analysis

Behavior / neuropsychiatric

12 endpoints

Secondary/protocol endpoint

Change in Global Impression

Time frame:Baseline to Week 24

change from baseline, improvement

Secondary/protocol endpoint

Change in Behavioural Disturbance

Time frame:Baseline to Week 24

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/protocol endpoint

Change in Individual Behavioural Disturbance Items

Time frame:Baseline to Week 24

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/protocol endpoint

Change in NPI Anxiety Item Score in Patients With an NPI Anxiety Item Score of at Least 2 at Baseline

Time frame:Baseline to Week 24

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/protocol endpoint

Change in Health-related Quality of Life (EQ-5D) Utility Score

Time frame:Baseline to Week 24

change from baseline, improvement

Secondary/protocol endpoint

Change in Health-related Quality of Life (EQ-5D VAS)

Time frame:Baseline to Week 24

change from baseline, improvement

Secondary/registry result

Change in Global Impression

Time frame:Baseline to Week 24

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), units on a scale	Standard error
Placebon=303 Participants	4.29	0.07
Idalopirdine 30 mgn=309 Participants	4.32	0.07
Idalopirdine 60 mgn=307 Participants	4.13	0.07

Mean Difference (Final Values)0.0395% CI-0.15 - 0.20p1.000Mixed Models Analysis

Mean Difference (Final Values)-0.1695% CI-0.34 - 0.02p1.000Mixed Models Analysis

Secondary/registry result

Change in Behavioural Disturbance

Time frame:Baseline to Week 24

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), units on a scale	Standard error
Placebon=304 Participants	-0.21	0.62
Idalopirdine 30 mgn=310 Participants	-0.21	0.62
Idalopirdine 60 mgn=308 Participants	-0.39	0.63

Secondary/registry result

Change in Individual Behavioural Disturbance Items

Time frame:Baseline to Week 24

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), units on a scale	Standard error
PlaceboDelusionsn=304 Participants	-0.11	0.09
Hallucinationsn=304 Participants	0.13	0.07
Agitation/aggressionn=304 Participants	0.01	0.11
Depression/dysphorian=304 Participants	0.02	0.09
Anxietyn=304 Participants	-0.02	0.11
Elation/euphorian=304 Participants	0.09	0.05
Apathy/indifferencen=304 Participants	-0.18	0.15
Disinhibitionn=304 Participants	0.05	0.08
Irritability/labilityn=304 Participants	-0.14	0.12
Aberrant motor behaviourn=304 Participants	0.03	0.12
Sleepn=304 Participants	0.03	0.11
Appetite/eating disordern=304 Participants	-0.08	0.13
Idalopirdine 30 mgDelusionsn=310 Participants	-0.04	0.09
Hallucinationsn=310 Participants	0.03	0.07
Agitation/aggressionn=310 Participants	0.04	0.11
Depression/dysphorian=310 Participants	-0.06	0.09
Anxietyn=310 Participants	-0.13	0.11
Elation/euphorian=310 Participants	0.03	0.05
Apathy/indifferencen=310 Participants	-0.23	0.15
Disinhibitionn=310 Participants	-0.06	0.08
Irritability/labilityn=310 Participants	0.02	0.12
Aberrant motor behaviourn=310 Participants	0.33	0.12
Sleepn=308 Participants	0.01	0.11
Appetite/eating disordern=310 Participants	-0.14	0.13
Idalopirdine 60 mgDelusionsn=308 Participants	-0.01	0.09
Hallucinationsn=308 Participants	-0.03	0.07
Agitation/aggressionn=308 Participants	0.10	0.11
Depression/dysphorian=308 Participants	-0.08	0.10
Anxietyn=308 Participants	-0.13	0.11
Elation/euphorian=308 Participants	0.03	0.05
Apathy/indifferencen=308 Participants	-0.27	0.15
Disinhibitionn=308 Participants	-0.01	0.08
Irritability/labilityn=308 Participants	0.00	0.12
Aberrant motor behaviourn=308 Participants	-0.13	0.13
Sleepn=308 Participants	0.03	0.11
Appetite/eating disordern=308 Participants	-0.04	0.13

Secondary/registry result

Change in NPI Anxiety Item Score in Patients With an NPI Anxiety Item Score of at Least 2 at Baseline

Time frame:Baseline to Week 24

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), units on a scale	Standard error
Placebon=88 Participants	-1.12	0.30
Idalopirdine 30 mgn=83 Participants	-1.56	0.30
Idalopirdine 60 mgn=76 Participants	-1.64	0.32

Secondary/registry result

Change in Health-related Quality of Life (EQ-5D) Utility Score

Time frame:Baseline to Week 24

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), units on a scale	Standard error
Placebon=301 Participants	-0.01	0.01
Idalopirdine 30 mgn=306 Participants	0.00	0.01
Idalopirdine 60 mgn=304 Participants	0.00	0.01

Secondary/registry result

Change in Health-related Quality of Life (EQ-5D VAS)

Time frame:Baseline to Week 24

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), units on a scale	Standard error
Placebon=301 Participants	-0.40	1.01
Idalopirdine 30 mgn=307 Participants	-0.12	1.01
Idalopirdine 60 mgn=304 Participants	0.34	1.03

Publications (3)

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.