Study With Lu AF87908 in Healthy Subjects and Patients With Alzheimer's Disease

• Status: Recruiting
• Trial end date: 2022-07-06
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: H. Lundbeck A/S

Criteria

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• Men and women with a clinical diagnosis of Alzheimer's disease, Stages 3-4 according to the FDA draft Guidance for Industry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