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

Use our guide to learn which trials are right for you!

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.


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
sites
201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
3924 9th Avenue West
Bradenton, Florida 34205
?
mi
from
Bradenton, FL
Click here to add this to my saved trials
425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
4085 University Blvd S # 1
Jacksonville, Florida 32216
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
?
mi
from
Nashville, TN
Click here to add this to my saved trials
6161 Kempsville Circle
Norfolk, Virginia 23502
(757) 261-4986
?
mi
from
Norfolk, VA
Click here to add this to my saved trials
104 SE 1st Avenue
Ocala, Florida 34471
352-629-5800
?
mi
from
Ocala, FL
Click here to add this to my saved trials
6141 Sunset Dr # 301
South Miami, Florida 33143
(305) 598-3125
Miami Research Associates Miami Research Associates (MRA) is the largest privately-owned multi-specialty clinical research center...
?
mi
from
South Miami, FL
Click here to add this to my saved trials
2919 Swann Avenue
Tampa, Florida 33609
813-353-9613
?
mi
from
Tampa, FL
Click here to add this to my saved trials
3212 Cove Bend Drive
Tampa, Florida 33613
?
mi
from
Tampa, FL
Click here to add this to my saved trials
400 Patroon Creek Boulevard
Albany, New York 12206
?
mi
from
Albany, NY
Click here to add this to my saved trials
Albany, New York 12208
?
mi
from
Albany, NY
Click here to add this to my saved trials
Albuquerque, New Mexico 87109
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
Auburn, Maine 04210
?
mi
from
Auburn, ME
Click here to add this to my saved trials
Austin, Texas 78757
?
mi
from
Austin, TX
Click here to add this to my saved trials
?
mi
from
Boca Raton, FL
Click here to add this to my saved trials
?
mi
from
Carson, CA
Click here to add this to my saved trials
Centerville, Ohio
?
mi
from
Centerville, OH
Click here to add this to my saved trials
316 Calhoun Street
Charleston, South Carolina 29403
?
mi
from
Charleston, SC
Click here to add this to my saved trials
501 Billingsley Road
Charlotte, North Carolina 28211
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
Charlotte, North Carolina 28211
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
8198 Walnut Hill Lane
Dallas, Texas 75231
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Danbury, Connecticut 06810
?
mi
from
Danbury, CT
Click here to add this to my saved trials
1 Elizabeth Place
Dayton, Ohio 45417
?
mi
from
Dayton, OH
Click here to add this to my saved trials
Decatur, Georgia 30033
?
mi
from
Decatur, GA
Click here to add this to my saved trials
Deerfield Beach, Florida 33064
?
mi
from
Deerfield Beach, FL
Click here to add this to my saved trials
Delray Beach, Florida 33445
?
mi
from
Delray Beach, FL
Click here to add this to my saved trials
15300 Jog Road
Delray Beach, Florida 33446
?
mi
from
Delray Beach, FL
Click here to add this to my saved trials
Denver, Colorado 80218
?
mi
from
Denver, CO
Click here to add this to my saved trials
800 Biesterfield Road
Elk Grove Village, Illinois 60007
?
mi
from
Elk Grove Village, IL
Click here to add this to my saved trials
6345 Balboa Boulevard
Encino, California 91316
?
mi
from
Encino, CA
Click here to add this to my saved trials
Flowood, Mississippi 39232
?
mi
from
Flowood, MS
Click here to add this to my saved trials
?
mi
from
Fort Worth, TX
Click here to add this to my saved trials
Greensboro, North Carolina 27405
?
mi
from
Greensboro, NC
Click here to add this to my saved trials
Hialeah, Florida 33016
?
mi
from
Hialeah, FL
Click here to add this to my saved trials
5200 Belfort Road
Jacksonville, Florida 32256
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
?
mi
from
Kalamazoo, MI
Click here to add this to my saved trials
Lake Worth, Florida 33449
?
mi
from
Lake Worth, FL
Click here to add this to my saved trials
Las Vegas, Nevada 89113
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
?
mi
from
Long Beach, CA
Click here to add this to my saved trials
Los Alamitos, California 90720
?
mi
from
Los Alamitos, CA
Click here to add this to my saved trials
300 Medical Plaza Driveway
Los Angeles, California 90025
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Los Angeles, California 90033
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Merritt Island, Florida 32952
?
mi
from
Merritt Island, FL
Click here to add this to my saved trials
Miami, Florida 33137
?
mi
from
Miami, FL
Click here to add this to my saved trials
8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
?
mi
from
Milwaukee, WI
Click here to add this to my saved trials
New Haven, Connecticut 06510
?
mi
from
New Haven, CT
Click here to add this to my saved trials
333 Cedar St
New Haven, Connecticut 06504
(203) 432-4771
Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
?
mi
from
New Haven, CT
Click here to add this to my saved trials
630 W 168th St
New York, New York
212-305-2862
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
?
mi
from
New York, NY
Click here to add this to my saved trials
1601 Dove Street
Newport Beach, California 92660
?
mi
from
Newport Beach, CA
Click here to add this to my saved trials
Newport Beach, California 92663
?
mi
from
Newport Beach, CA
Click here to add this to my saved trials
Norwalk, Connecticut 06851
?
mi
from
Norwalk, CT
Click here to add this to my saved trials
Oklahoma City, Oklahoma 73116
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
Oklahoma City, Oklahoma 73116
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
Orlando, Florida 32806
?
mi
from
Orlando, FL
Click here to add this to my saved trials
100 West Gore Street
Orlando, Florida 32806
?
mi
from
Orlando, FL
Click here to add this to my saved trials
Palo Alto, California 94304
?
mi
from
Palo Alto, CA
Click here to add this to my saved trials
Patchogue, New York 11772
?
mi
from
Patchogue, NY
Click here to add this to my saved trials
2900 West Queen Lane
Philadelphia, Pennsylvania 19107
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Phoenix, Arizona 85004
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Phoenix, Arizona 85013
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Phoenix, Arizona 85006
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Port Orange, Florida 32127
?
mi
from
Port Orange, FL
Click here to add this to my saved trials
Portland, Oregon 97210
?
mi
from
Portland, OR
Click here to add this to my saved trials
?
mi
from
Portland, OR
Click here to add this to my saved trials
10 East Cambridge Circle Drive
Prairie Village, Kansas 66206
?
mi
from
Prairie Village, KS
Click here to add this to my saved trials
Redlands, California 92374
?
mi
from
Redlands, CA
Click here to add this to my saved trials
?
mi
from
Richmond, VA
Click here to add this to my saved trials
?
mi
from
Sacramento, CA
Click here to add this to my saved trials
Saint Louis, Missouri 63132
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
Salt Lake City, Utah 84107
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
San Francisco, California 94143
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
11600 Wilshire Boulevard
Santa Monica, California 90025
?
mi
from
Santa Monica, CA
Click here to add this to my saved trials
Scarborough, Maine 04074
?
mi
from
Scarborough, ME
Click here to add this to my saved trials
Sebastopol, California 95472
?
mi
from
Sebastopol, CA
Click here to add this to my saved trials
Shaker Heights, Ohio 44122
?
mi
from
Shaker Heights, OH
Click here to add this to my saved trials
801 N Rutledge St
Springfield, Illinois 62702
(217) 545-8000
Southern Illinois University School of Medicine At SIU School of Medicine, research includes biologically oriented...
?
mi
from
Springfield, IL
Click here to add this to my saved trials
Springfield, Massachusetts 01104
?
mi
from
Springfield, MA
Click here to add this to my saved trials
Springfield, New Jersey 07081
?
mi
from
Springfield, NJ
Click here to add this to my saved trials
10515 West Santa Fe Drive
Sun City, Arizona 85351
?
mi
from
Sun City, AZ
Click here to add this to my saved trials
4001 East Fletcher Avenue
Tampa, Florida 33613
?
mi
from
Tampa, FL
Click here to add this to my saved trials
The Villages, Florida 32162
?
mi
from
The Villages, FL
Click here to add this to my saved trials
Toms River, New Jersey 08757
?
mi
from
Toms River, NJ
Click here to add this to my saved trials
Torrance, California 90502
?
mi
from
Torrance, CA
Click here to add this to my saved trials
Tulsa, Oklahoma 74104
?
mi
from
Tulsa, OK
Click here to add this to my saved trials
West Long Branch, New Jersey 07764
?
mi
from
West Long Branch, NJ
Click here to add this to my saved trials
3980 Sheridan Drive
Williamsville, New York 14221
?
mi
from
Williamsville, NY
Click here to add this to my saved trials
Willow Grove, Pennsylvania 19090
?
mi
from
Willow Grove, PA
Click here to add this to my saved trials
28 Woodville Road
Woodville, South Australia 5011
?
mi
from
Woodville,
Click here to add this to my saved trials