A Study to Evaluate the Efficacy and Safety of MABT5102A in Patients with Mild to Moderate Alzheimer's Disease

Overview

About this study

The purpose of this study is to evaluate the safety and effectiveness of MABT5102A in patients who have mild to moderate Alzheimer's Disease.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

  • Diagnosis of probable AD according to the NINCDS-ADRDA criteria
  • MMSE score of 18-26 points at screening
  • GDS-15 score of < 6
  • Completion of 6 years of education (or good work history consistent with exclusion of mental retardation or other pervasive developmental disorders)
  • If receiving concurrent AD treatment, must be on the medication for at least 3 months at a stable dose for at least 2 months prior to randomization

Exclusion Criteria

  • Severe or unstable medical condition that, in the opinion of the investigator or Sponsor, would interfere with the ability to complete the study assessments or would require the equivalent of institutional or hospital care
  • History or presence of clinically evident vascular disease potentially affecting the brain
  • History of severe, clinically significant (persistent neurologic deficit or structural brain damage) central nervous system trauma
  • Hospitalization within 4 weeks prior to screening
  • Previous treatment with MABT5102A or any other therapeutic that targets Abeta
  • Treatment with any biologic therapy within 5 half-lives or 3 months prior to screening, whichever is longer, with the exception of routinely recommended vaccinations, which are allowed

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Bryan Woodruff, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

.
CLS-20312132

Mayo Clinic Footer