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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Alzheimer's Disease

In brief

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. Participants will then have the option to enter the Open Label Extension (OLE) study if eligible. Participants who do not enter the OLE study will have additional follow-up visits at 16 and 52 weeks after the last dose, primarily for safety and also for limited efficacy assessments.

Key facts

Study ID: NCT02670083
Run by: Hoffmann-La Roche
People needed: 813
Starts: 2016-03-22
Expected to finish: 2019-05-31
Last updated by the study team: 2020-07-16

Who can join

Age: 50 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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 (up to 4 weeks before screening begins) or screening (FCSRT cueing index =<0.67 AND free recall =<27)
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
Participant must have completed at least 6 years of formal education after the age of 5 years

You may not qualify if…

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
Any abnormal MRI findings, such as presence of cerebral vascular pathology, cortical stroke, etc or inability to tolerate MRI procedures or contraindication to MRI
Unstable or clinically significant cardiovascular (e.g., myocardial infarction), kidney or liver disease
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

Where it is running

Pharmacology Research Inst — Encino, California, United States
Collaborative Neuroscience Network Inc. — Long Beach, California, United States
Alliance for Wellness, dba Alliance for Research — Long Beach, California, United States
Pharmacology Research Institute — Los Alamitos, California, United States
USC Keck School Of Medicine — Los Angeles, California, United States
UCLA Medical Center, Department of Neurology — Los Angeles, California, United States
Pharmacology Research Inst — Newport Beach, California, United States
Shankle Clinic — Newport Beach, California, United States
Stanford Univ Medical Center — Palo Alto, California, United States
Anderson Clinical Research, Inc. — Redlands, California, United States
University of California, Davis; Alzheimers Disease Center, Department of Neurology — Sacramento, California, United States
UCSF - Memory and Aging Center — San Francisco, California, United States
Neurological Research Inst — Santa Monica, California, United States
North Bay Neuro Science Institute — Sebastopol, California, United States
Associated Neurologists PC - Danbury — Danbury, Connecticut, United States
Institute for Neurodegenerative Disorders — New Haven, Connecticut, United States
Yale University School Of Medicine — New Haven, Connecticut, United States
Research Center for Clinical Studies, Inc. — Norwalk, Connecticut, United States
Bradenton Research Center — Bradenton, Florida, United States
Quantum Laboratories — Deerfield Beach, Florida, United States
Brain Matters Research, Inc. — Delray Beach, Florida, United States
Galiz Research, LLC — Hialeah, Florida, United States
Jacksonville Center For Clinical Research — Jacksonville, Florida, United States
Alzheimer's Research and Treatment Center — Lake Worth, Florida, United States
Banner Alzheimer's Institute — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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