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CREAD Study: A Study of Crenezumab Versus Placebo to Evaluate the Efficacy and Safety in Participants With Prodromal to Mild Alzheimer’s Disease (AD)
Neurodegenerative Disorder Alzheimer's Disease (AD)
Basic Details
Study 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. 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.
Eligibility 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 (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
- 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
The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical study see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.
The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.
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Study results
LPS BN29552 CREAD Final Results March 2022 English
(PDF, 0.4 MB)
LPS BN29552 CREAD Final Results March 2022 Bulgarian
(PDF, 2.3 MB)
LPS BN29552 CREAD Final Results March 2022 Chinese Simplified PRC
(PDF, 0.9 MB)
LPS BN29552 CREAD Final Results March 2022 Chinese Traditional Hong Kong
(PDF, 1.0 MB)
LPS BN29552 CREAD Final Results March 2022 Croatian
(PDF, 0.6 MB)
LPS BN29552 CREAD Final Results March 2022 Danish
(PDF, 0.6 MB)
LPS BN29552 CREAD Final Results March 2022 Dutch Netherlands
(PDF, 2.6 MB)
LPS BN29552 CREAD Final Results March 2022 Finnish
(PDF, 2.3 MB)
LPS BN29552 CREAD Final Results March 2022 French France
(PDF, 2.6 MB)
LPS BN29552 CREAD Final Results March 2022 German Germany
(PDF, 2.6 MB)
LPS BN29552 CREAD Final Results March 2022 Hungarian
(PDF, 2.6 MB)
LPS BN29552 CREAD Final Results March 2022 Italian Italy
(PDF, 2.3 MB)
LPS BN29552 CREAD Final Results March 2022 Japanese
(PDF, 0.8 MB)
LPS BN29552 CREAD Final Results March 2022 Korean
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LPS BN29552 CREAD Final Results March 2022 Lithuanian
(PDF, 0.4 MB)
LPS BN29552 CREAD Final Results March 2022 Polish
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LPS BN29552 CREAD Final Results March 2022 Portuguese Portugal
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LPS BN29552 CREAD Final Results March 2022 Russian Russia
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LPS BN29552 CREAD Final Results March 2022 Slovenian
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LPS BN29552 CREAD Final Results March 2022 Spanish Mexico
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LPS BN29552 CREAD Final Results March 2022 Spanish Spain
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LPS BN29552 CREAD Final Results March 2022 Swedish
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LPS BN29552 CREAD Final Results March 2022 Turkish
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LPS BN29552 CREAD Final Results March 2022 Ukrainian
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LPS BN29552 CREAD Final Results April 2022 Czech
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For the latest version of this information please go to www.forpatients.roche.com