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
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...
2432
mi
from 91732
New York, NY
Click here to add this to my saved trials
201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
1919
mi
from 91732
Atlanta, GA
Click here to add this to my saved trials
3924 9th Avenue West
Bradenton, Florida 34205
2139
mi
from 91732
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...
1791
mi
from 91732
Indianapolis, IN
Click here to add this to my saved trials
4085 University Blvd S # 1
Jacksonville, Florida 32216
2134
mi
from 91732
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...
1762
mi
from 91732
Nashville, TN
Click here to add this to my saved trials
6161 Kempsville Circle
Norfolk, Virginia 23502
(757) 261-4986
2342
mi
from 91732
Norfolk, VA
Click here to add this to my saved trials
104 SE 1st Avenue
Ocala, Florida 34471
352-629-5800
2126
mi
from 91732
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...
2318
mi
from 91732
South Miami, FL
Click here to add this to my saved trials
2919 Swann Avenue
Tampa, Florida 33609
813-353-9613
2134
mi
from 91732
Tampa, FL
Click here to add this to my saved trials
3212 Cove Bend Drive
Tampa, Florida 33613
2135
mi
from 91732
Tampa, FL
Click here to add this to my saved trials
400 Patroon Creek Boulevard
Albany, New York 12206
2437
mi
from 91732
Albany, NY
Click here to add this to my saved trials
Albany, New York 12208
2440
mi
from 91732
Albany, NY
Click here to add this to my saved trials
Albuquerque, New Mexico 87109
654
mi
from 91732
Albuquerque, NM
Click here to add this to my saved trials
Auburn, Maine 04210
2615
mi
from 91732
Auburn, ME
Click here to add this to my saved trials
Austin, Texas 78757
1212
mi
from 91732
Austin, TX
Click here to add this to my saved trials
2311
mi
from 91732
Boca Raton, FL
Click here to add this to my saved trials
20
mi
from 91732
Carson, CA
Click here to add this to my saved trials
Centerville, Ohio
1898
mi
from 91732
Centerville, OH
Click here to add this to my saved trials
316 Calhoun Street
Charleston, South Carolina 29403
2183
mi
from 91732
Charleston, SC
Click here to add this to my saved trials
501 Billingsley Road
Charlotte, North Carolina 28211
2104
mi
from 91732
Charlotte, NC
Click here to add this to my saved trials
Charlotte, North Carolina 28211
2101
mi
from 91732
Charlotte, NC
Click here to add this to my saved trials
8198 Walnut Hill Lane
Dallas, Texas 75231
1225
mi
from 91732
Dallas, TX
Click here to add this to my saved trials
Danbury, Connecticut 06810
2458
mi
from 91732
Danbury, CT
Click here to add this to my saved trials
1 Elizabeth Place
Dayton, Ohio 45417
1896
mi
from 91732
Dayton, OH
Click here to add this to my saved trials
Decatur, Georgia 30033
1924
mi
from 91732
Decatur, GA
Click here to add this to my saved trials
Deerfield Beach, Florida 33064
2313
mi
from 91732
Deerfield Beach, FL
Click here to add this to my saved trials
Delray Beach, Florida 33445
2308
mi
from 91732
Delray Beach, FL
Click here to add this to my saved trials
15300 Jog Road
Delray Beach, Florida 33446
2306
mi
from 91732
Delray Beach, FL
Click here to add this to my saved trials
Denver, Colorado 80218
818
mi
from 91732
Denver, CO
Click here to add this to my saved trials
800 Biesterfield Road
Elk Grove Village, Illinois 60007
1711
mi
from 91732
Elk Grove Village, IL
Click here to add this to my saved trials
6345 Balboa Boulevard
Encino, California 91316
29
mi
from 91732
Encino, CA
Click here to add this to my saved trials
Flowood, Mississippi 39232
1596
mi
from 91732
Flowood, MS
Click here to add this to my saved trials
1192
mi
from 91732
Fort Worth, TX
Click here to add this to my saved trials
Greensboro, North Carolina 27405
2153
mi
from 91732
Greensboro, NC
Click here to add this to my saved trials
Hialeah, Florida 33016
2310
mi
from 91732
Hialeah, FL
Click here to add this to my saved trials
5200 Belfort Road
Jacksonville, Florida 32256
2135
mi
from 91732
Jacksonville, FL
Click here to add this to my saved trials
1836
mi
from 91732
Kalamazoo, MI
Click here to add this to my saved trials
Lake Worth, Florida 33449
2297
mi
from 91732
Lake Worth, FL
Click here to add this to my saved trials
Las Vegas, Nevada 89113
217
mi
from 91732
Las Vegas, NV
Click here to add this to my saved trials
19
mi
from 91732
Long Beach, CA
Click here to add this to my saved trials
Los Alamitos, California 90720
18
mi
from 91732
Los Alamitos, CA
Click here to add this to my saved trials
300 Medical Plaza Driveway
Los Angeles, California 90025
24
mi
from 91732
Los Angeles, CA
Click here to add this to my saved trials
Los Angeles, California 90033
11
mi
from 91732
Los Angeles, CA
Click here to add this to my saved trials
Merritt Island, Florida 32952
2230
mi
from 91732
Merritt Island, FL
Click here to add this to my saved trials
Miami, Florida 33137
2320
mi
from 91732
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...
1729
mi
from 91732
Milwaukee, WI
Click here to add this to my saved trials
New Haven, Connecticut 06510
2486
mi
from 91732
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...
2486
mi
from 91732
New Haven, CT
Click here to add this to my saved trials
1601 Dove Street
Newport Beach, California 92660
29
mi
from 91732
Newport Beach, CA
Click here to add this to my saved trials
Newport Beach, California 92663
33
mi
from 91732
Newport Beach, CA
Click here to add this to my saved trials
Norwalk, Connecticut 06851
2462
mi
from 91732
Norwalk, CT
Click here to add this to my saved trials
Oklahoma City, Oklahoma 73116
1164
mi
from 91732
Oklahoma City, OK
Click here to add this to my saved trials
Oklahoma City, Oklahoma 73116
1162
mi
from 91732
Oklahoma City, OK
Click here to add this to my saved trials
Orlando, Florida 32806
2185
mi
from 91732
Orlando, FL
Click here to add this to my saved trials
100 West Gore Street
Orlando, Florida 32806
2184
mi
from 91732
Orlando, FL
Click here to add this to my saved trials
Palo Alto, California 94304
326
mi
from 91732
Palo Alto, CA
Click here to add this to my saved trials
Patchogue, New York 11772
2484
mi
from 91732
Patchogue, NY
Click here to add this to my saved trials
2900 West Queen Lane
Philadelphia, Pennsylvania 19107
2374
mi
from 91732
Philadelphia, PA
Click here to add this to my saved trials
Phoenix, Arizona 85004
343
mi
from 91732
Phoenix, AZ
Click here to add this to my saved trials
Phoenix, Arizona 85013
342
mi
from 91732
Phoenix, AZ
Click here to add this to my saved trials
Phoenix, Arizona 85006
345
mi
from 91732
Phoenix, AZ
Click here to add this to my saved trials
Port Orange, Florida 32127
2194
mi
from 91732
Port Orange, FL
Click here to add this to my saved trials
Portland, Oregon 97210
829
mi
from 91732
Portland, OR
Click here to add this to my saved trials
828
mi
from 91732
Portland, OR
Click here to add this to my saved trials
10 East Cambridge Circle Drive
Prairie Village, Kansas 66206
1339
mi
from 91732
Prairie Village, KS
Click here to add this to my saved trials
Redlands, California 92374
49
mi
from 91732
Redlands, CA
Click here to add this to my saved trials
2261
mi
from 91732
Richmond, VA
Click here to add this to my saved trials
364
mi
from 91732
Sacramento, CA
Click here to add this to my saved trials
Saint Louis, Missouri 63132
1573
mi
from 91732
Saint Louis, MO
Click here to add this to my saved trials
Salt Lake City, Utah 84107
565
mi
from 91732
Salt Lake City, UT
Click here to add this to my saved trials
San Francisco, California 94143
356
mi
from 91732
San Francisco, CA
Click here to add this to my saved trials
11600 Wilshire Boulevard
Santa Monica, California 90025
25
mi
from 91732
Santa Monica, CA
Click here to add this to my saved trials
Scarborough, Maine 04074
2611
mi
from 91732
Scarborough, ME
Click here to add this to my saved trials
Sebastopol, California 95472
403
mi
from 91732
Sebastopol, CA
Click here to add this to my saved trials
Shaker Heights, Ohio 44122
2040
mi
from 91732
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...
1608
mi
from 91732
Springfield, IL
Click here to add this to my saved trials
Springfield, Massachusetts 01104
2501
mi
from 91732
Springfield, MA
Click here to add this to my saved trials
Springfield, New Jersey 07081
2402
mi
from 91732
Springfield, NJ
Click here to add this to my saved trials
10515 West Santa Fe Drive
Sun City, Arizona 85351
330
mi
from 91732
Sun City, AZ
Click here to add this to my saved trials
4001 East Fletcher Avenue
Tampa, Florida 33613
2135
mi
from 91732
Tampa, FL
Click here to add this to my saved trials
The Villages, Florida 32162
2141
mi
from 91732
The Villages, FL
Click here to add this to my saved trials
Toms River, New Jersey 08757
2423
mi
from 91732
Toms River, NJ
Click here to add this to my saved trials
Torrance, California 90502
22
mi
from 91732
Torrance, CA
Click here to add this to my saved trials
Tulsa, Oklahoma 74104
1252
mi
from 91732
Tulsa, OK
Click here to add this to my saved trials
West Long Branch, New Jersey 07764
2434
mi
from 91732
West Long Branch, NJ
Click here to add this to my saved trials
3980 Sheridan Drive
Williamsville, New York 14221
2185
mi
from 91732
Williamsville, NY
Click here to add this to my saved trials
Willow Grove, Pennsylvania 19090
2377
mi
from 91732
Willow Grove, PA
Click here to add this to my saved trials
28 Woodville Road
Woodville, South Australia 5011
8193
mi
from 91732
Woodville,
Click here to add this to my saved trials