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to the FDA draft Guidance for Industry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