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STARBRIGHT

CompletedPhase 3Results posted

Study of Idalopirdine in Patients With Mild - Moderate Alzheimer's Disease Treated With an Acetylcholinesterase Inhibitor

Randomised, Double-blind, Parallel-group, Placebo-controlled Study of Idalopirdine in Patients With Mild - Moderate Alzheimer's Disease Treated With an Acetylcholinesterase Inhibitor

Lead sponsor

H. Lundbeck A/S

Asset

Idalopirdine

Listed sites

107

Recruiting sites

Enrollment

734

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 ID14863A

Eudract number2012-004765-40

NCT IDNCT02006654

Timeline

Milestones

Study first posted2013-12-10estimated

Study start2014-03 (month precision)

Primary completion2017-01actual (month precision)

Study completion2017-01actual (month precision)

Last update posted2018-02-07actual

Results first posted2018-02-07actual

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 an AChEI.

•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 current AChEI 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 and Week 24

ADAS-Cog

change from baseline, improvement

Primary/registry result

Change in Cognition

Time frame:Baseline and Week 24

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), units on a scale	Standard error
Placebon=356 Participants	0.68	0.37
Idalopirdine 60 mg (or 30 mg)n=361 Participants	0.13	0.38

Mean Difference (Final Values)-0.5595% CI-1.45 - 0.36p0.2365Mixed 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 and 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=324 Participants	32	-
Idalopirdine 60 mg (or 30 mg)n=321 Participants	35	-

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=324 Participants	37	-
Idalopirdine 60 mg (or 30 mg)n=321 Participants	40	-

Secondary/registry result

Change in Cognitive Aspects of Mental Function

Time frame:Baseline and 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=323 Participants	-0.64	0.20
Idalopirdine 60 mg (or 30 mg)n=320 Participants	-0.35	0.20

Function / daily living

2 endpoints

Secondary/protocol endpoint

Change in Daily Functioning

Time frame:Baseline and Week 24

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Secondary/registry result

Change in Daily Functioning

Time frame:Baseline and 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=356 Participants	-1.72	0.50
Idalopirdine 60 mg (or 30 mg)n=361 Participants	-1.05	0.51

Mean Difference (Final Values)0.6795% CI-0.57 - 1.92p0.4064Mixed Models Analysis

Behavior / neuropsychiatric

12 endpoints

Secondary/protocol endpoint

Change in Global Impression

Time frame:Baseline and Week 24

change from baseline, improvement

Secondary/protocol endpoint

Change in Behavioural Disturbance

Time frame:Baseline and Week 24

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/protocol endpoint

Change in Individual Behavioural Disturbance Items

Time frame:Baseline and 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 and 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 and Week 24

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Baseline and Week 24

change from baseline, improvement

Secondary/registry result

Change in Global Impression

Time frame:Baseline and Week 24

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), units on a scale	Standard error
Placebon=353 Participants	4.32	0.07
Idalopirdine 60 mg (or 30 mg)n=357 Participants	4.39	0.07

Mean Difference (Final Values)0.0795% CI-0.09 - 0.23p0.4064Mixed Models Analysis

Secondary/registry result

Change in Behavioural Disturbance

Time frame:Baseline and Week 24

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), units on a scale	Standard error
Placebon=356 Participants	-0.46	0.53
Idalopirdine 60 mg (or 30 mg)n=361 Participants	-0.74	0.54

Secondary/registry result

Change in Individual Behavioural Disturbance Items

Time frame:Baseline and Week 24

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), units on a scale	Standard error
PlaceboDelusionsn=356 Participants	-0.00	0.10
Hallucinationsn=356 Participants	0.05	0.06
Agitation/aggressionn=356 Participants	0.15	0.11
Depression/dysphorian=356 Participants	-0.28	0.09
Anxietyn=356 Participants	-0.16	0.09
Elation/euphorian=356 Participants	0.02	0.04
Apathy/indifferencen=356 Participants	-0.06	0.15
Disinhibitionn=356 Participants	0.12	0.08
Irritability/labilityn=356 Participants	0.10	0.12
Aberrant motor behaviourn=356 Participants	0.08	0.11
Sleepn=356 Participants	-0.13	0.11
Appetite/eating disordern=356 Participants	-0.25	0.12
Idalopirdine 60 mg (or 30 mg)Delusionsn=361 Participants	0.03	0.10
Hallucinationsn=361 Participants	0.08	0.06
Agitation/aggressionn=361 Participants	0.03	0.11
Depression/dysphorian=361 Participants	-0.18	0.09
Anxietyn=361 Participants	-0.07	0.09
Elation/euphorian=361 Participants	0.03	0.04
Apathy/indifferencen=361 Participants	-0.19	0.15
Disinhibitionn=361 Participants	-0.00	0.08
Irritability/labilityn=361 Participants	-0.04	0.12
Aberrant motor behaviourn=361 Participants	0.11	0.11
Sleepn=361 Participants	-0.12	0.11
Appetite/eating disordern=361 Participants	-0.21	0.12

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 and Week 24

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), units on a scale	Standard error
Placebon=86 Participants	-1.93	0.32
Idalopirdine 60 mg (or 30 mg)n=83 Participants	-1.52	0.33

Secondary/registry result

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

Time frame:Baseline and Week 24

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), units on a scale	Standard error
Placebon=351 Participants	-0.01	0.01
Idalopirdine 60 mg (or 30 mg)n=354 Participants	-0.00	0.01

Secondary/registry result

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

Time frame:Baseline and Week 24

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), units on a scale	Standard error
Placebon=351 Participants	-0.40	1.00
Idalopirdine 60 mg (or 30 mg)n=353 Participants	0.51	1.02

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.