Mild to Moderate Alzheimer's Disease Trial with Crenezumab

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Summary

  • Study director: Adam Boxer, MD, PhD
  • Sponsor: Genentech, Inc.
  • Recruiting?: Closed to enrollment, but continuing follow-up
  • Official study title: A Randomized, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter, Phase II Study to Evaluate the Efficacy and Safety of MABT5102A in Patients With Mild to Moderate Alzheimer's Disease (ABBY)
  • ClinicalTrials.gov identifier: NCT01343966
  • Conditions studied: Mild to moderate Alzheimer's disease
  • Intervention: Crenezumab (MABT5102A) and placebo control. Crenezumab is a monoclonal antibody targeted to amyloid protein (the presumed cause of Alzheimer's disease) and helps to remove amyloid protein from the brain. Crenezumab can be administered either intravenously (IV) or subcutaneously via injections.
  • Phase: Phase II
  • Purpose: The purpose of this study is to evaluate the efficacy and safety of Crenezumab in patients with mild to moderate Alzheimer's disease.

Eligibility

  • Inclusion criteria: Subjects must be between 50 and 80 years old, meet criteria for mild to moderate Alzheimer's disease and have a study partner who sees them at least 8 hours a week and is able to accompany them to all study visits. Subjects may take Aricept, Exelon, Razadyne and/or Namenda but must be on stable doses of these medications for 2 months. Subjects must be willing and able to have brain MRIs throughout the course of the study. Subjects must also have an Mini Mental State Examination (MMSE) score between 18 and 26, inclusive, at time of screening and a Geriatric Depression Scale (GDS-15) score of less than 6. Subjects should also have completed 6 years of education.
  • Exclusion criteria: Subjects must not have a severe or unstable medical condition that, in the opinion of the investigator or sponsor, would interfere with the patient's ability to complete the study assessments or would require the equivalent of institutional or hospital care. Subjects also should not have a history of vascular disease affecting the brain or a history of severe brain or spinal cord trauma. Hospitalizations within 4 weeks of the screening visit would also cause a delayed start to the trial.

What is involved?

  • Testing: Neurological and physical examinations, MRIs, cognitive testing and neuropsychiatric assessments, EKGs, blood and urine specimen collection, vital signs, and optional lumbar punctures
  • Frequency of visits: 22 months
    • IV cohort: 28 visits (~1 visit/month)
    • Subcutaneous Injection cohort: 40 visits (~2 visits/month)
  • Materials needed prior to evaluation: Diagnosis of probable Alzheimer's disease
  • Costs: No costs will be charged for any of the study procedures. Parking will be validated for the Millberry Union Public Garage at the UCSF Parnassus Heights campus for all study visits, and subjects will be reimbursed $50 per visit for meal and travel expenses.

Contact information

June 18, 2013