A Study of CAD106 and CNP520 Versus Placebo in Participants at Risk for the Onset of Clinical Symptoms of Alzheimer's Disease



Status:Recruiting
Conditions:Alzheimer Disease
Therapuetic Areas:Neurology
Healthy:No
Age Range:60 - 75
Updated:3/30/2019
Start Date:February 5, 2016
End Date:January 31, 2025
Contact:Novartis Pharmaceuticals
Email:trialandresults.registries@novartis.com
Phone:1-888-669-6682

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

A Randomized, Double-blind, Placebo-controlled, Two-cohort, Parallel Group Study to Evaluate the Efficacy of CAD106 and CNP520 in Participants at Risk for the Onset of Clinical Symptoms of Alzheimer's Disease.

The purpose of this study is to test whether two investigational drugs called CAD106 and
CNP520, administered separately, can slow down the onset and progression of clinical symptoms
associated with Alzheimer's disease (AD) in participants at the risk to develop clinical
symptoms based on their age and genotype.

This study will assess the effects of each of the two therapies given separately, both
targeting amyloid, on cognition, global clinical status, and underlying pathology in
participants at risk for the onset of clinical symptoms of Alzheimer's disease (AD).
Cognitively unimpaired individuals with two APOE4 genes and age 60 to 75 years, inclusive,
are selected as they represent a population at particularly high risk of progression to Mild
Cognitive Impairment and/or dementia due to Alzheimer's disease.

The study follows a randomized, double-blind, placebo-controlled, two-cohort, parallel group
design in which participants receive one of the investigational treatments or their matching
placebo for at least 60 months up to a maximum of 96 months and no longer than when the
target number of events for the TTE endpoint has been observed and confirmed in either
cohort.

An unbalanced randomization (active: placebo) of 5:3 ratio in Cohort I (430 CAD106 :260
Placebo) and 3:2 ratio in Cohort II (390 CNP520 : 260 Placebo) will be applied. Randomization
will be stratified by age group (60-64 years, 65-75 years) and region (North America/Other ,
Europe).

Participants who meet study entry requirements will be required to undergo at least one PET
scan during the course of the study. Additional PET scans, blood and CSF collection will be
voluntary. The study (also known as the Generation Study 1) is conducted as part of the
Alzheimer's Prevention Initiative (API) program.

Key Inclusion Criteria:

- Consent to receive disclosure of their risk estimates to develop clinical symptoms of
AD based on their APOE genotype.

- Male or female, age 60 to 75 years inclusive. Females must be considered
post-menopausal and not of child bearing potential.

- Mini-Mental State Examination (MMSE) total score ≥ 24 (at screening or in previous 3
months) and cognitively unimpaired as evaluated by memory tests performed at
screening.

- Homozygous APOE4 genotype.

- Participant's willingness to have a study partner.

Key Exclusion Criteria:

- Any disability that may prevent the participants from completing all study
requirements.

- Current medical or neurological condition that might impact cognition or performance
on cognitive assessments.

- Advanced, severe progressive or unstable disease that may interfere with the safety,
tolerability and study assessments, or put the participant at special risk.

- History of malignancy of any organ system, treated or untreated, within the past 60
months.

- History of hypersensitivity to any of the investigational drugs or their excipients /
adjuvant or to drugs of similar chemical classes.

- Indication for, or current treatment with ChEIs and/or another AD treatment (e.g.
memantine).

- Contraindication or intolerance to MRI or PET investigations (with fluorinated radio
ligands).

- Brain MRI results showing findings unrelated to AD that, in the opinion of the
Investigator might be a leading cause to future cognitive decline, might pose a risk
to the participant, or might prevent a satisfactory MRI assessment for safety
monitoring.

- Suicidal Ideation in the past six months, or Suicidal Behavior in the past two years.

- A positive drug screen at Screening, if, in the Investigator's opinion, this is due to
drug abuse.

- Significantly abnormal laboratory results at Screening, or infection not as a result
of a temporary condition.

- Current clinically significant ECG findings. For Cohort - I only: Participants with
previous organ transplantation or stem cell transplantation, or indication for
treatment with anti-coagulants.

For Cohort - II only: Participants with depigmenting or hypopigmenting conditions (e.g.
albinism vitiligo) or active / history of chronic urticarial in the past year.
We found this trial at
79
sites
Greensboro, North Carolina 27410
Phone: 336-235-0991
?
mi
from
Greensboro, NC
Click here to add this to my saved trials
7000 Fannin St
Houston, Texas 77030
(713) 500-4472
Phone: 713-486-0500
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
?
mi
from
Houston, TX
Click here to add this to my saved trials
425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Phone: 317-963-7440
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
Miami, Florida 33124
(305) 284-2211
Phone: 305-355-9120
University of Miami A private research university with more than 15,000 students from around the...
?
mi
from
Miami, FL
Click here to add this to my saved trials
100 West Gore St # 202
Orlando, Florida 32806
(407) 426-9299
Phone: 407-210-1337
Compass Research LLC Compass Research is a clinical research company dedicated to testing new medications...
?
mi
from
Orlando, FL
Click here to add this to my saved trials
601 Elmwood Avenue
Rochester, New York 14642
(585) 275-2100
Phone: 585-760-6562
Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
?
mi
from
Rochester, NY
Click here to add this to my saved trials
1100 N. St. Francis
Wichita, Kansas 67214
316-291-4774
Phone: 316-291-4673
?
mi
from
Wichita, KS
Click here to add this to my saved trials
Atlanta, Georgia 30322
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Atlantis, Florida 33462
Phone: 561-968-2933
?
mi
from
Atlantis, FL
Click here to add this to my saved trials
Austin, Texas 78757
Phone: 512-407-8628
?
mi
from
Austin, TX
Click here to add this to my saved trials
Basalt, Colorado 81621
Phone: 970-927-1141
?
mi
from
Basalt, CO
Click here to add this to my saved trials
Basalt, Maine
Phone: 207-973-4263
?
mi
from
Basalt, ME
Click here to add this to my saved trials
11100 Euclid Avenue
Beachwood, Ohio 44122
Phone: 216-464-6474
?
mi
from
Beachwood, OH
Click here to add this to my saved trials
Bennington, Vermont 05201
Phone: 802-447-1409
?
mi
from
Bennington, VT
Click here to add this to my saved trials
Boca Raton, Florida 33431
Phone: 561-297-0164
?
mi
from
Boca Raton, FL
Click here to add this to my saved trials
Boston, Massachusetts 01801
Phone: 617-525-8383
?
mi
from
Boston, MA
Click here to add this to my saved trials
Boston, Massachusetts 02118
Phone: 617-358-5382
?
mi
from
Boston, MA
Click here to add this to my saved trials
Centerville, Ohio 45459
Phone: 937-424-3033
?
mi
from
Centerville, OH
Click here to add this to my saved trials
Charleston, South Carolina 29401
Phone: 843-724-2302
?
mi
from
Charleston, SC
Click here to add this to my saved trials
Charlotte, North Carolina 28211
Phone: 704-364-4000
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Phone: 312-942-0050
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Chicago, Illinois 60640
Phone: 773-275-3500
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Columbus, Georgia 31909
Phone: 706-653-8455
?
mi
from
Columbus, GA
Click here to add this to my saved trials
Columbus, Ohio 43205
Phone: 614-366-8642
?
mi
from
Columbus, OH
Click here to add this to my saved trials
Costa Mesa, California 92626
Phone: 714-277-4472
?
mi
from
Costa Mesa, CA
Click here to add this to my saved trials
Dallas, Texas 75231
Phone: 214-345-4449
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Darlinghurst, New South Wales 2010
?
mi
from
Darlinghurst,
Click here to add this to my saved trials
Decatur, Georgia 30033
Phone: 404-475-0552
?
mi
from
Decatur, GA
Click here to add this to my saved trials
Delray Beach, Florida 33445
Phone: 561-381-9060
?
mi
from
Delray Beach, FL
Click here to add this to my saved trials
2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Phone: 919-668-2841
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
?
mi
from
Durham, NC
Click here to add this to my saved trials
Eatontown, New Jersey
Phone: 732-263-0101
?
mi
from
Eatontown, NJ
Click here to add this to my saved trials
Fairway, Kansas 66205
Phone: 913-588-0555
?
mi
from
Fairway, KS
Click here to add this to my saved trials
Houston, Texas 77074
Phone: 713-484-6947
?
mi
from
Houston, TX
Click here to add this to my saved trials
6550 Fannin St
Houston, Texas 77030
(713) 790-3311
Phone: 346-238-0083
Houston Methodist Hospital Houston Methodist is comprised of a leading academic medical center in the...
?
mi
from
Houston, TX
Click here to add this to my saved trials
Irvine, California 92618
Phone: 949-753-1663
?
mi
from
Irvine, CA
Click here to add this to my saved trials
Jacksonville, Florida 32216
Phone: 904-953-8014
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
Jenkintown, Pennsylvania 19046
Phone: 215-884-1700
?
mi
from
Jenkintown, PA
Click here to add this to my saved trials
Kalamazoo, Michigan 49048
?
mi
from
Kalamazoo, MI
Click here to add this to my saved trials
Knoxville, Tennessee 37934
?
mi
from
Knoxville, TN
Click here to add this to my saved trials
Las Vegas, Nevada 89106
Phone: 702-483-6026
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
Latham, New York 12110
Phone: 518-785-1000
?
mi
from
Latham, NY
Click here to add this to my saved trials
Lexington, Kentucky 40504
Phone: 859-323-1331
?
mi
from
Lexington, KY
Click here to add this to my saved trials
Los Angeles, California 90095
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Maitland, Florida 32751
Phone: 407-644-1165
?
mi
from
Maitland, FL
Click here to add this to my saved trials
Memphis, Tennessee 38119
Phone: 901-843-1045
?
mi
from
Memphis, TN
Click here to add this to my saved trials
Meridian, Idaho 83642
Phone: 208-377-8653
?
mi
from
Meridian, ID
Click here to add this to my saved trials
Merritt Island, Florida 32952
Phone: 321-305-5015
?
mi
from
Merritt Island, FL
Click here to add this to my saved trials
Miami Beach, Florida 33140
Phone: 305-674-2037
?
mi
from
Miami Beach, FL
Click here to add this to my saved trials
8701 West Watertown Plank Road
Milwaukee, Wisconsin 53226
Phone: 414-805-8328
?
mi
from
Milwaukee, WI
Click here to add this to my saved trials
Nashville, Tennessee 37205
Phone: 615-936-0231
?
mi
from
Nashville, TN
Click here to add this to my saved trials
New Haven, Connecticut
Phone: 203-764-8100
?
mi
from
New Haven, CT
Click here to add this to my saved trials
New York, New York 10016
Phone: 212-263-5845
?
mi
from
New York, NY
Click here to add this to my saved trials
Oklahoma City, Oklahoma 73104
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
Oklahoma City, Oklahoma 73103
Phone: 405-235-8188
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
?
mi
from
Omaha, NE
Click here to add this to my saved trials
140 Old Orangeburg Road
Orangeburg, New York 10962
Phone: 845-398-5582
?
mi
from
Orangeburg, NY
Click here to add this to my saved trials
Palo Alto, California 94304
Phone: 650-485-9560, 650-223-9662
?
mi
from
Palo Alto, CA
Click here to add this to my saved trials
Phoenix, Arizona 85006
Phone: 602-839-6500
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Phoenix, Arizona 85012
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Port Orange, Florida 32127
Phone: 386-304-7070
?
mi
from
Port Orange, FL
Click here to add this to my saved trials
2701 Northwest Vaughn Street
Portland, Oregon 97210
Phone: 503-228-2273
?
mi
from
Portland, OR
Click here to add this to my saved trials
Providence, Rhode Island 02906
Phone: 401-455-6402
?
mi
from
Providence, RI
Click here to add this to my saved trials
Rochester, Minnesota 55905
?
mi
from
Rochester, MN
Click here to add this to my saved trials
Saint Louis, Missouri 63128
Phone: 314-977-4900
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
Saint Paul, Minnesota 55102
?
mi
from
Saint Paul, MN
Click here to add this to my saved trials
San Diego, California 92123
?
mi
from
San Diego, CA
Click here to add this to my saved trials
Santa Ana, California 92705
Phone: 714-542-3008
?
mi
from
Santa Ana, CA
Click here to add this to my saved trials
Scottsdale, Arizona 85251
?
mi
from
Scottsdale, AZ
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
Sherman Oaks, California 91403
Phone: 818-990-2671
?
mi
from
Sherman Oaks, CA
Click here to add this to my saved trials
Spokane, Washington 99202
?
mi
from
Spokane, WA
Click here to add this to my saved trials
Stamford, Connecticut 06905
Phone: 203-914-1903
?
mi
from
Stamford, CT
Click here to add this to my saved trials
10515 West Santa Fe Drive
Sun City, Arizona 85351
Phone: 623-832-6500
?
mi
from
Sun City, AZ
Click here to add this to my saved trials
Tacoma, Washington 98405
Phone: 253-882-1070
?
mi
from
Tacoma, WA
Click here to add this to my saved trials
Tampa, Florida 33613
Phone: 813-974-9383
?
mi
from
Tampa, FL
Click here to add this to my saved trials
Temecula, California 92591
?
mi
from
Temecula, CA
Click here to add this to my saved trials
3700 O St NW
Washington, District of Columbia 20057
(202) 687-0100
Phone: 202-687-8800
Georgetown University Georgetown University is one of the world's leading academic and research institutions, offering...
?
mi
from
Washington,
Click here to add this to my saved trials
Washington, District of Columbia 20007
?
mi
from
Washington,
Click here to add this to my saved trials
Willow Grove, Pennsylvania 19090
Phone: 215-957-9250
?
mi
from
Willow Grove, PA
Click here to add this to my saved trials