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STAR Extension

CompletedPhase 3Results posted

Long-term Safety and Tolerability of Idalopirdine (Lu AE58054) as Adjunctive Treatment to Donepezil in Patients With Mild-moderate Alzheimer's Disease

An Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Idalopirdine (Lu AE58054) as Adjunctive Treatment to Donepezil in Patients With Mild-moderate Alzheimer's Disease

Lead sponsor

H. Lundbeck A/S

Asset

Idalopirdine

Listed sites

258

Recruiting sites

Enrollment

1,463

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Age ≥50

Primary endpoints

•Number of Treatment Emergent Adverse Events (TEAEs) in the OLEX•Number of TEAEs in the OLEX-MEM

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 ID14861B

Eudract number2013-000001-23

NCT IDNCT02079246

Timeline

Milestones

Study first posted2014-03-05estimated

Study start2014-04-07actual

Primary completion2017-07-06actual

Study completion2017-07-06actual

Last update posted2018-08-10actual

Results first posted2018-08-10actual

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 completed Visit 7 (Completion Visit) in the lead-in double-blind, placebo controlled clinical studies 14861A/NCT01955161 or 14862A/NCT02006641

For patients in the OLEX-MEM:

•The patient has completed Visit 6 (Week 28) of the OLEX.

•The patient, according to the judgement of the investigator, requires initiation of treatment with memantine as per local label/SmPC/treatment guidelines

Exclusion criteria

•The patient has a moderate or severe ongoing adverse event from the lead-in study considered a potential safety risk by the investigator.

•The patient has experienced seizures before Completion Visit in the lead-in study.

•The patient has evidence of clinically significant disease.

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

•The patient is receiving therapy with another acetylcholinesterase inhibitors (AChEI).

Other protocol-defined inclusion and exclusion criteria may apply.

Endpoints (16)

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

Global cognition

Behavior / neuropsychiatric

Safety / tolerability / PK

Function / daily living

Global cognition

6 endpoints

Secondary/protocol endpoint

Change in Cognition

Time frame:Baseline II (start of OLEX, Week 0) to Week 28

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

Change in Cognitive Aspects of Mental Function

Time frame:Baseline II (start of OLEX, Week 0) to Week 28

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Secondary/protocol endpoint

Change in Cognitive Aspects of Mental Function

Time frame:Baseline III (start of OLEX-MEM, Week 28) to Week 52

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Secondary/registry result

Change in Cognition

Time frame:Baseline II (start of OLEX, Week 0) to Week 28

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	Standard error
Idalopirdine 60 mg (OLEX); Patients From lead-in Study 14681An=693 Participants	3.01	0.22
Idalopirdine 60 mg (OLEX); Patients From lead-in Study 14862An=602 Participants	2.67	0.23

Secondary/registry result

Change in Cognitive Aspects of Mental Function

Time frame:Baseline II (start of OLEX, Week 0) to Week 28

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	Standard error
Idalopirdine 60 mg (OLEX); Patients From lead-in Study 14681An=730 Participants	-1.28	0.10
Idalopirdine 60 mg (OLEX); Patients From lead-in Study 14862An=646 Participants	-1.02	0.11

Secondary/registry result

Change in Cognitive Aspects of Mental Function

Time frame:Baseline III (start of OLEX-MEM, Week 28) to Week 52

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	Standard error
Idalopirdine 60 mg + Memantine (OLEX-MEM)n=93 Participants	-0.55	0.26

Function / daily living

2 endpoints

Secondary/protocol endpoint

Change in Daily Functioning

Time frame:Baseline II (start of OLEX, Week 0) to Week 28

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Secondary/registry result

Change in Daily Functioning

Time frame:Baseline II (start of OLEX, Week 0) to Week 28

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	Standard error
Idalopirdine 60 mg (OLEX); Patients From lead-in Study 14681An=696 Participants	-3.71	0.28
Idalopirdine 60 mg (OLEX); Patients From lead-in Study 14862An=601 Participants	-3.88	0.32

Behavior / neuropsychiatric

4 endpoints

Secondary/protocol endpoint

Clinical Global Impression Score

Time frame:Week 28

change from baseline, improvement

Secondary/protocol endpoint

Change in Behavioural Disturbance

Time frame:Baseline II (start of OLEX, Week 0) to Week 28

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/registry result

Clinical Global Impression Score

Time frame:Week 28

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	Standard error
Idalopirdine 60 mg (OLEX); Patients From lead-in Study 14681An=693 Participants	4.58	0.005
Idalopirdine 60 mg (OLEX); Patients From lead-in Study 14862An=594 Participants	4.61	0.05

Secondary/registry result

Change in Behavioural Disturbance

Time frame:Baseline II (start of OLEX, Week 0) to Week 28

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	Standard error
Idalopirdine 60 mg (OLEX); Patients From lead-in Study 14681An=697 Participants	1.80	0.35
Idalopirdine 60 mg (OLEX); Patients From lead-in Study 14862An=602 Participants	1.36	0.34

Safety / tolerability / PK

4 endpoints

Primary/protocol endpoint

Number of Treatment Emergent Adverse Events (TEAEs) in the OLEX

Time frame:Baseline II (start of OLEX, week 0) to end of OLEX (week 28)

event count, event

Primary/protocol endpoint

Number of TEAEs in the OLEX-MEM

Time frame:From Baseline III (start of OLEX-MEM, Week 28) to end of OLEX-MEM (Week 52)

event count, event

Primary/registry result

Number of Treatment Emergent Adverse Events (TEAEs) in the OLEX

Time frame:Baseline II (start of OLEX, week 0) to end of OLEX (week 28)

event count, event

Posted result

Group	Value (number), TEAEs	Reported bounds
Idalopirdine 60 mgn=1462 Participants	2130	-

Primary/registry result

Number of TEAEs in the OLEX-MEM

Time frame:From Baseline III (start of OLEX-MEM, Week 28) to end of OLEX-MEM (Week 52)

event count, event

Posted result

Group	Value (number), TEAEs	Reported bounds
Idalopirdine 60 mg + Memantinen=101 Participants	93	-

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.