TerminatedPhase 1

Positron Emission Tomography (PET) Study in Patients With Alzheimer's Disease

Interventional, Open-label, Positron Emission Tomography (PET) Study Investigating the Brain Receptor Occupancy of Idalopirdine in Patients With Alzheimer's Disease

Lead sponsor

H. Lundbeck A/S

Asset

Idalopirdine

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•Amyloid biomarker required (PET)•MMSE ≥15•Study partner/caregiver required

Primary endpoints

•5-HT6 Receptor Occupancy (RO)•Idalopirdine plasma concentration (CPET)

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 ID17475A

NCT IDNCT03307993

Timeline

Milestones

Study start2017-09-22actual

Study first posted2017-10-12actual

Primary completion2018-02-19actual

Study completion2018-02-19actual

Last update posted2018-04-04actual

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 probable AD diagnosed according to National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's disease and Related Disorders Association (NINCDS-ADRDA) criteria.

•The patient has had a positive amyloid PET scan, which in the opinion of the principal investigator is consistent with a diagnosis of AD.

•The patient has a Mini Mental State Examination (MMSE) score at screening of at least 15 and no greater than 22.

•The patient has a knowledgeable and reliable caregiver who will accompany the patient to all clinic visits during the study and answer questions about the patient.

•The patient is a man or woman of at least 50 years of age and has a body mass index (BMI) ≥ 18.5 kg/m2

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, primary or secondary cerebral neoplasia or systemic medical diseases that are, in the investigator's opinion, likely to affect central nervous system functioning and may influence the outcome or analysis of the scan results.

•The patient is, in the investigator's opinion, unlikely to comply with the protocol or is unsuitable for any reason.

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

Safety / tolerability / PK

Other (unclassified)

Safety / tolerability / PK

1 endpoint

Primary/protocol endpoint

Idalopirdine plasma concentration (CPET)

Time frame:Prior to and after PET scan on treatment day 10

concentration, descriptive

Other (unclassified)

1 endpoint

Primary/protocol endpoint/low confidence

5-HT6 Receptor Occupancy (RO)

Time frame:Treatment day 10 (24 hours post dose)

descriptive

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.