Alzheimer’s Disease Trial of Crenezumab – Phase 3

  • Study Director: Adam Boxer, MD, PhD
  • Sponsor: F. Hoffmann-La Roche Ltd.
  • Recruiting? Yes
  • Official Study Title: A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy and Safety Study of Crenezumab in Patients with Prodromal to Mild Alzheimer’s Disease
  • ClinicalTrials.gov Identifier: NCT02670083
  • Conditions Studied: Prodromal to mild Alzheimer’s disease
  • Intervention: Crenezumab 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 is administered intravenously (IV) once every 4 weeks.
  • Phase: Phase 3

Purpose of the Study

The purpose of this study is to evaluate the efficacy and safety of crenezumab in patients with prodromal to mild Alzheimer’s disease.

Eligibility

Inclusion Criteria: Participants must be between 50–85 years old, meet criteria for prodromal to mild Alzheimer’s disease and have a reliable study partner who can accurately report the participant’s behavior and is able to accompany them to all study visits. Participants may take symptomatic Alzheimer’s disease medications but must be on stable doses of these medications for three months. Participants must be willing and able to have MRIs throughout the course of the study and have a florbetapir PET scan consistent with the presence of amyloid pathology at screening. Participants must also have a Mini Mental state Examination (MMSE) score between 22–30, inclusive, at the time of screening and a Clinical Dementia Rating Score of 0.5 or 1.0. Participants should also have completed six years of education.

Exclusion Criteria: Participants 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. Participants also should not have a history of vascular disease affecting the brain or a history of severe brain injury. Participants must also not have a history of stroke, transient ischemic attack, myocardial infarction or any other clinically significant cardiovascular disease, or alcohol and/or substance abuse within the past two years. Participants must also not have impaired renal or liver function, HIV infection or significant metabolic or endocrine disorders. Participants must not be currently enrolled in another clinical trial.

What to Expect

Testing: Monthly infusions, neurological and physical examinations, MRIs, at least one PET scan, cognitive testing and neuropsychiatric assessments, EKGs, blood and urine specimen collection, and vital signs

The Frequency of Visits:

  • Screening phase: 2–3 visits within eight weeks of the first infusion
  • Dose administration in placebo-controlled period: Monthly infusions for 100 weeks
  • Follow up visits after dose administration period: two visits over one year
  • Dose administration in open-label extension period: TBD

Materials Needed Before Evaluation: Meets NIAAA core clinical criteria for probable AD dementia or prodromal AD (Consistent with the NIAAA diagnostic criteria and guidelines for MCI)

Costs: No costs will be charged for any of the study procedures. Parking will be validated at UCSF public garages for all study visits, and participants will be reimbursed up to $100 for each scheduled visit to help defray any incidental expenses incurred in the course of participating in this study.

Contact Information

Coordinator: Lauren Fisher – Lauren.Fisher@ucsf.edu, 415.514.5745
Clinical Trials Nurse: Mary Koestler, RN, PhD, CCRC – Mary.Koestler@ucsf.edu, 415.476.0661