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Lu AF87908 for Alzheimer's Disease

Recruiting

This Phase 1 clinical trial will test the safety of a single dose of Lu AF87908 (a tau protein antibody), how well it is tolerated, and what the drug does to the body in healthy subjects and individuals with Alzheimer's disease.

Minimum Age Maximum Age Gender Healthy Volunteers
30 Years N/A All Yes
September 27, 2019
March 2021
96

Healthy participants:

  • Men and women between 30 and 65 years of age
  • Body mass index (BMI) between 18 and 32 and a minimum weight of 110 pounds

Alzheimer's disease participants:

  • At least 50 years of age
  • BMI between 18 and 34 kg/m2 and a minimum weight of 110 pounds
  • Alzheimer's disease diagnosis, Stages 3-4 according to the FDA draft Guidance for Industry
  • Mini-Mental State Exam score of 20-30
  • Clinical Dementia Rating global score of 0.5 or 1.0
  • Amyloid-positive, as determined from an amyloid PET scan
  • If on any FDA-approved Alzheimer's disease medication, the treatment has been stable for four months before the start of the study

  • Clinically-relevant structural brain abnormality, as determined by an MRI scan
  • Treatment with an anti-amyloid beta or anti-tau vaccine
  • Treatment with a monoclonal antibody or antisense oligomer targeting tau within six months prior to the start of the study
  • Influenza or pneumonia vaccine within 30 days prior to the start of the study

Participants will be randomized to either take the study drug, Lu AF87908, or a placebo for up to 12 weeks. Researchers will monitor participant safety and measure the concentration of the study drug in the blood at specified time points. In addition, participants will receive laboratory tests, electrocardiograms, and physical examinations.

Name City State Zip Status Primary Contact
California Clinical Trials Medical Group
Los Angeles California 91206-4007 Recruiting Email contact via H. Lundbeck A/S

LundbeckClinicalTrials@Lundbeck.com

H. Lundbeck A/S

Name Role Affiliation
H. Lundbeck A/S Study Director LundbeckClinicalTrials@Lundbeck.com

Name Phone Email
H. Lundbeck A/S +45 36301311 LundbeckClinicalTrials@Lundbeck.com

NCT04149860

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