CompletedPhase 1

Study With Lu AF87908 in Healthy Participants and Participants With Alzheimer's Disease

Interventional, Randomized, Double-blind, Placebo-controlled, Single-ascending-dose Study Investigating the Safety, Tolerability, and Pharmacokinetic Properties of Lu AF87908 in Healthy Subjects and Patients With Alzheimer's Disease

Lead sponsor

H. Lundbeck A/S

Asset

Lu AF87908

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•Amyloid biomarker required (PET)•MMSE 15-30•Healthy volunteers

Primary endpoints

•Treatment Emergent Adverse Events•AUC(0-t) of Lu AF87908•Cmax of Lu AF87908

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 ID18146A

NCT IDNCT04149860

Timeline

Milestones

Study start2019-09-27actual

Study first posted2019-11-04actual

Primary completion2023-07-19actual

Study completion2023-07-19actual

Last update posted2023-08-04actual

Assets

Drug assets

Lu AF87908

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age18 Years

Maximum age65 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

Healthy Participants:

-Men and women ≥18 and ≤65 years of age with a body mass index (BMI) ≥18 and ≤32 kilograms (kg)/square meter (m^2) and a minimum weight of 50 kg.

Participants with Alzheimer's disease:

•Men and women with a clinical diagnosis of Alzheimer's disease, Stages 3-4 according to the FDA guidelines.

•Mini-Mental State Examination (MMSE) of 15-30.

•Clinical Dementia Scale (CDR) global score up to and including 2.0.

•Confirmed or determined (via amyloid positron emission tomography [PET] scan) to be amyloid positive.

•If on FDA approved Alzheimer's disease medication, the treatment has been stable for 4 months prior to Day 1.

-≥50 years of age.

•BMI ≥18 and ≤40 kg/m^2 and a minimum weight of 50 kg

Exclusion criteria

•Clinically relevant structural brain abnormality as assessed using magnetic resonance imaging (MRI).

•Any past or current treatment with an anti-Abeta or anti-tau active vaccine.

•Any past or current treatment with a monoclonal anti-tau antibody or a tau anti-sense oligomer within the last 6 months.

•Treatment with covid-19, influenza or pneumonia vaccine within the last 30 days prior to dosing of investigational medicinal product (IMP).

Other eligibility criteria may apply.

Endpoints (4)

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.

Safety / tolerability / PK

4 endpoints

Primary/protocol endpoint

Number of Participants with Treatment Emergent Adverse Events

Time frame:From Day 0 to Day 84

event count, event

Primary/protocol endpoint

AUC(0-t) of Lu AF87908

Time frame:From Day 0 to Day 84

concentration, descriptive

Primary/protocol endpoint

Cmax of Lu AF87908

Time frame:From Day 0 to Day 84

concentration, descriptive

Primary/protocol endpoint

Tmax Lu AF87908

Time frame:From Day 0 to Day 84

concentration, 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.