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

Purpose

The CREAD study is a Phase III clinical trial sponsored by Genentech/F. Hoffman-La Roche of the investigational drug, crenezumab, which is an anti-amyloid antibody. The goal of the study is to test whether monthly infusions of crenezumab, will slow down disease progression and memory loss by reducing brain amyloid levels. Participants will have a 50% chance of receiving active study drug versus placebo (an inactive substance). The study lasts approximately 2 years, with 26 infusion visits and the possibility of an open label extension upon completion. Individuals ages 50-85 with a diagnosis of mild cognitive impairment (prodromal Alzheimer’s disease) and mild dementia due to Alzheimer’s disease may be eligible to participate. To learn more, please contact Celine Ossinalde by phone (310) 794-6191 or email: This email address is being protected from spambots. You need JavaScript enabled to view it..

Sponsor: Biogen
ClinicalTrials.gov Identifier: NCT02670083

Condition: Intervention: Phase:
Alzheimer's Disease Drug: Crenezumab
Drug: Placebo
Phase III

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official 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
Length of Study: 100 Weeks
Eligibility
Ages Eligible for Study: 50 Years to 85 Years (Adult, Senior)
Genders Eligible for Study: Both
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.

Contact: Celine Ossinalde at (310) 794-6191 or This email address is being protected from spambots. You need JavaScript enabled to view it. to participate in this study or for more information.