CREAD Study: A Study of Crenezumab Versus Placebo to Evaluate the Efficacy and Safety in Participants With Prodromal to Mild Alzheimer's Disease (AD)
Status: | Active, not recruiting |
---|---|
Conditions: | Alzheimer Disease |
Therapuetic Areas: | Neurology |
Healthy: | No |
Age Range: | 50 - 85 |
Updated: | 3/10/2019 |
Start Date: | March 22, 2016 |
End Date: | May 29, 2019 |
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
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.
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.
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
We found this trial at
89
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Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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1211 Medical Center Dr
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Miami Research Associates Miami Research Associates (MRA) is the largest privately-owned multi-specialty clinical research center...
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400 Patroon Creek Boulevard
Albany, New York 12206
Albany, New York 12206
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3500 Camp Bowie Boulevard
Fort Worth, Texas 76107
Fort Worth, Texas 76107
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5200 Belfort Road
Jacksonville, Florida 32256
Jacksonville, Florida 32256
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1000 Oakland Drive
Kalamazoo, Michigan 49008
Kalamazoo, Michigan 49008
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300 Medical Plaza Driveway
Los Angeles, California 90025
Los Angeles, California 90025
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Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
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2900 West Queen Lane
Philadelphia, Pennsylvania 19107
Philadelphia, Pennsylvania 19107
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2315 Stockton Blvd
Sacramento, California 95817
Sacramento, California 95817
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801 N Rutledge St
Springfield, Illinois 62702
Springfield, Illinois 62702
(217) 545-8000
Southern Illinois University School of Medicine At SIU School of Medicine, research includes biologically oriented...
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4001 East Fletcher Avenue
Tampa, Florida 33613
Tampa, Florida 33613
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