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CompletedPhase 2

Lu AE58054 Added to Donepezil for the Treatment for Moderate Alzheimer's Disease

Randomised, Double-blind, Parallel-group, Placebo-controlled, Fixed-dose Study of Lu AE58054 in Patients With Moderate Alzheimer's Disease Treated With Donepezil

Lead sponsor

H. Lundbeck A/S

Asset

Idalopirdine

Listed sites

51

Recruiting sites

-

Enrollment

278

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•Study partner/caregiver required•AD symptomatic therapy: stable ≥3 months

Primary endpoint

•Cognition after 24 weeks

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 ID12936A
RegistryEudraCT 2009-011845-24EudraCT
NCT IDNCT01019421

Timeline

Milestones

Study first posted2009-11-25estimated
Study start2009-12 (month precision)
Primary completion2011-12actual (month precision)
Last update posted2012-01-06estimated

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 (or if applicable the legally acceptable representative (LAR) and if different from the responsible caregiver) and the responsible caregiver are able to read and understand the Informed Consent Form.
•The patient has a knowledgeable and reliable caregiver who will accompany the patient to all clinic visits during the study.
•The patient (or if applicable the LAR and if different from the responsible caregiver) and the responsible caregiver have signed the Informed Consent Form.
•The patient has probable AD consistent with NINCDS-ADRDA criteria.
•The patient is a man or woman, aged at least 50 years.
•The patient has been treated with donepezil on a stable dose for at least 3 months prior to screening

Exclusion criteria

•The patient has evidence of any clinically significant neurodegenerative disease or other serious neurological disorders other than AD including but not limited to Lewy body dementia, fronto-temporal dementia, Parkinson's disease, Huntington's disease, major cortical stroke, major head trauma and, primary or secondary cerebral neoplasia.
•The patient has a Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR) Axis I disorder other than AD including amnestic disorders, major depressive disorder, delirium, schizophrenia or schizoaffective disorder, bipolar disorder, psychosis, panic, post traumatic stress disorder or/and cognitive disorder not otherwise specified.
•The patient has clinical and radiological findings that fulfil the standards of the National Institute of Neurological Disorders and Stroke and Association Internationale pour la Recherché et l'Enseignement en Neurosciences (NINDS-AIREN) criteria for vascular dementia.
•The patient has CT or MRI evidence of hydrocephalus, stroke, a space-occupying lesion, cerebral infection or any clinically significant central nervous system disease other than AD.
•The patient has clinically significant abnormal vital signs.
•The patient has one or more laboratory values outside the normal range, based on the blood or urine samples, which are, in the investigator's judgement, considered to be clinically significant.
•The patient has a clinically significant abnormal ECG.
•The patient has an oncological diagnosis (haematological or solid tumour) that is currently being treated, or for which there has been treatment within 5 years preceding screening, or for which there is still evidence of active disease (patients with local dermatological tumours such as basal or squamous cell carcinoma may be included).
•The patient's donepezil therapy is likely to be interrupted or discontinued during the study.
•The patient has a disease or takes medication that, in the investigator's judgement, could interfere with the assessments of safety, tolerability, or efficacy.
•The patient is, in the investigator's judgement, unlikely to comply with the clinical study protocol or is unsuitable for any reason.
•The patient is a member of the site personnel or their immediate families.
•The patient is treated against his/her will (for example, by court order).
•The patient or patient caregiver is unwilling or unable to abide by the visit schedule and other requirements of the study.

Endpoints (2)

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

Function / daily living
1
Other (unclassified)
1

Function / daily living

1 endpoint
Secondary/protocol endpoint

Change in global function, activities of daily living, safety and tolerability, pharmacokinetics/pharmacodynamics

Time frame:Week 24

change from baseline, improvement

Other (unclassified)

1 endpoint
Primary/protocol endpoint/low confidence

Change in cognition after 24 weeks

Time frame:Week 24

change from baseline, improvement

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 tableno registry results posted yet

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.