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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


Brief Summary:

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 subjects and patients with
Alzheimer’s Disease


Inclusion criteria

Healthy subjects:

-Men and women ≥30 and ≤65 years of age with a body mass index (BMI) ≥18 and ≤32 kg/m2 and
a minimum weight of 50 kg.

Patients with Alzheimer’s disease:

– Men and women with a clinical diagnosis of Alzheimer’s disease, Stages 3-4 according
to the FDA draft Guidance for Industry

– MMSE 20-30, AND

– CDR global score of 0.5 or 1.0.

– Confirmed or determined (via amyloid 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 ≤34 kg/m2 and a minimum weight of 50 kg.

Exclusion criteria

– Clinically relevant structural brain abnormality as assessed using MRI

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

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

– Treatment with influenza or pneumonia vaccine within the last 30 days prior to dosing
of IMP

Any other in- and exclusion criteria may apply


  • California Clinical Trials Medical Group, Los Angeles, California, United States, 91206-4007
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