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
Description
Brief Summary
This randomized, double-blind, placebo-controlled, parallel group study will evaluate the
efficacy and safety of crenezumab versus placebo in participants with prodromal to mild AD.
Participants will be randomized 1:1 to receive either intravenous (IV) infusion of
crenezumab or placebo every 4 weeks (q4w) for 100 weeks. The final efficacy and safety
assessment will be performed 52 weeks after the last crenezumab dose.
Phase
Phase 3 - a treatment has shown activity against a particular disease, where it is either added to existing treatment or compared to the standard treatment.Inclusion and Exclusion 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
- 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
Sites
Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.
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