CREAD Study: A Study of Crenezumab Versus Placebo to Evaluate the Efficacy and Safety in Participants With Prodromal to Mild Alzheimer's Disease (AD)

Trial Purpose and Description

This study is a Phase III, placebo-controlled, parallel group, double-blind, multi center randomized clinical trial involving 750 participants with prodromal and mild Alzheimer's disease (AD). It is designed to examine the efficacy and safety of crenezumab as treatment for prodromal and mild AD participants.

Ages: 50 - 85 years

Gender: Both


Eligibility Criteria

Inclusion Criteria:

  • Weight between 40 and 120 kilograms (Kg) inclusive
  • Availability of a person (referred to as the "caregiver") who in the investigator's judgment:
  • Has frequent and sufficient contact with the participant to be able to provide accurate information regarding the participant's cognitive and functional abilities, agrees to provide information at clinic visits (which require partner input for scale completion), signs the necessary consent form, and has sufficient cognitive capacity to accurately report upon the participant's behavior and cognitive and functional abilities
  • Fluency in the language of the tests used at the study site
  • Adequate visual and auditory acuity, in the investigator's judgment, sufficient to perform the neuropsychological testing (eye glasses and hearing aids are permitted)
  • Evidence of the AD pathological process, by a positive amyloid assessment either on cerebrospinal fluid (CSF) amyloid beta 1-42 levels as measured on the Elecsys beta-amyloid(1-42) test system or amyloid PET scan by qualitative read by the core/central PET laboratory
  • Demonstrated abnormal memory function at screening
  • Screening mini mental state examination (MMSE) score of greater than or equal to (>=) 22 points and Clinical Dementia Rating-Global Score (CDR-GS) of 0.5 or 1.0
  • Meets National Institute on Aging/Alzheimer's Association (NIAAA) core clinical criteria for probable AD dementia or prodromal AD (consistent with the NIAAA diagnostic criteria and guidelines for mild cognitive impairment (MCI)
  • If receiving symptomatic AD medications, the dosing regimen must have been stable for 3 months prior to screening

Exclusion Criteria:

  • Any evidence of a condition other than AD that may affect cognition such as other dementias, stroke, brain damage, autoimmune disorders (e.g. multiple sclerosis) or infections with neurological sequelae.
  • History of major psychiatric illness such as schizophrenia or major depression (if not considered in remission)
  • At risk of suicide in the opinion of the investigator
  • Presence of significant cerebral vascular pathology as assessed by MRI central reader
  • Unstable or clinically significant cardiovascular, kidney or liver disease (e.g., myocardial infarction)
  • Uncontrolled hypertension
  • Screening hemoglobin A1c (HbA1C) >8%
  • Poor peripheral venous access
  • History of cancer except:

If considered to be cured or If not being actively treated with anti-cancer therapy or radiotherapy

- Known history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric, human, or humanized antibodies or fusion proteins

http://www.alzheimers.yale.edu/


F. Hoffman-La Roche Ltd

Start Date: 08/18/2016

End Date: 08/31/2020

Last Updated: 02/22/2018

Study HIC#: 1601017095

Get Involved

For more information about this study, contact:
Chenee Gallaher
+1 203-764-8100
chenee.gallaher@yale.edu

If you would prefer to contact a member of the Help us Discover team about this trial and other similar trials, please email helpusdiscover@yale.edu or call 1-877-978-8348.

Trial Image

Investigators

Christopher H Van Dyck

Principal Investigator

Sub-Investigators