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
well it is tolerated and what the body does to the drug in healthy subjects and patients with
-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to the FDA draft Guidance for Industry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.
– 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
Any other in- and exclusion criteria may apply
- California Clinical Trials Medical Group, Los Angeles, California, United States, 91206-4007