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

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy, Alzheimer Disease

In brief

The purpose of this study is to investigate the safety of a single dose of Lu AF87908, how well it is tolerated and what the body does to the drug in healthy participants and participants with Alzheimer's disease.

Key facts

Study ID

NCT04149860

Run by

H. Lundbeck A/S

People needed

86

Starts

2019-09-27

Expected to finish

2023-07-19

Last updated by the study team

2023-08-04

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• PAREXEL International — Glendale, California, United States
• Research Center of America — Hollywood, Florida, United States
• Panax Clinical Research — Miami, Florida, United States
• iResearch Atlanta LLC — Decatur, Georgia, United States
• Princeton Medical Institute — Princeton, New Jersey, United States
• Clinilabs, Inc. — New York, New York, United States

Full record on ClinicalTrials.gov

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