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CNP520 to Slow or Prevent Alzheimer's (Generation 2)

Recruiting

The Generation 2 study will test the safety and effects of the investigational drug CNP520 in cognitively normal older adults who are at risk of developing dementia based on their age, genetic status, and brain amyloid levels.

Minimum Age Maximum Age Gender Healthy Volunteers
60 Years 75 Years All Yes
February 8, 2017
March 31, 2025
2000

  • Consent to receive disclosure of risk based on APOE genotype and evidence of elevated amyloid
  • Females must be post-menopausal and non-childbearing potential
  • Cognitively unimpaired as evaluated by memory tests at screening
  • Willingness to have a study partner
  • At least one APOE 4 allele (a genetic risk factor for developing Alzheimer's); if two APOE 4 alleles, then also must show evidence of elevated amyloid

  • Any disability that may prevent participant from completing study requirements
  • Medical or neurological condition that could impact cognitive assessments
  • Disease that is advanced, has a severe progressive, or is unstable
  • Organ malignancy in past 5 years
  • Clinically relevant depigmenting or hypopigmenting conditions, such as albinism or vitiligo, or chronic hives in the past year
  • Suicidal ideation in the past 6 months or suicidal behavior in the past 2 years
  • Current drug abuse
  • Inability to undergo magnetic resonance imaging (MRI)
  • Significantly abnormal laboratory results or electrocardiogram findings
  • Brain MRI results showing findings that could cause cognitive decline or might pose a risk to safety and outcomes
  • Prohibited medications: donepezil (Aricept), galantamine (Razadyne), rivastigmine (Exelon), memantine (Namenda), or Namzaric

CNP 520 is a beta-secretase inhibitor designed to prevent the production of different forms of amyloid. Amyloid plaques are found in the brain's of people with Alzheimer's disease, and researchers believe that preventing the buildup of these plaques may prevent or slow the disease.

Participants will be randomly assigned to take either a CNP520 capsule or placebo for 5 to 7 years. The study will include site visits every 3 months for drug dispensing and/or assessments and scans. Researchers will measure changes in cognitive function, amyloid levels, and brain volumes. Additional positron emission tomography scans and cerebrospinal fluid collection will be voluntary.

For more information about this trial or study sites, call 866-244-8907 or email info@generationprogram.com. You can also visit www.generationprogram.com. To contact Novartis Pharmaceuticals, call 888-669-6682 or email novartis.email@novartis.com.

Name City State Zip Status Primary Contact
Banner Alzheimer's Institute, 901 East Willetta Street
Phoenix Arizona 85006 Recruiting
602-839-6230
Kinal.bhatt@bannerhealth.com
Novartis Investigative Site
Scottsdale Arizona 85259 Recruiting

Banner Sun Health Research Institute, 10515 West Santa Fe Drive, Building B
Sun City Arizona 85351 Recruiting
623-832-6590
nadira.trncic@bannerhealth.com
Novartis Investigative Site
Tucson Arizona 85724 Recruiting

Novartis Investigative Site
Beverly Hills California 90211 Recruiting

ATP Clinical Research Inc, 3151 Airway Avenue T 3
Costa Mesa California 92626 Recruiting
714-277-4472
bshih@theatpgroup.net
Novartis Investigative Site
Garden Grove California 92845 Recruiting

Irvine Center for Clinical Res, 2515 McCabe Way
Irvine California 92618 Recruiting
949-753-1663
tara@irvineclinical.com
Torrance Clinical Research Institute, 25043 Narbonne Avenue
Lomita California 90717 Recruiting
310-373-8120
jgarcia.010186@gmail.com
Novartis Investigative Site
Oxnard California 93030 Recruiting

Novartis Investigative Site
Palo Alto California 94304 Recruiting

Novartis Investigative Site
San Diego California 92103 Recruiting

Syrentis Clinical Research, 1401 N Tustin Ave, Suite 130
Santa Ana California 92705 Recruiting
714-542-3008
lorriebisesiphd@gmail.com
Novartis Investigative Site
Sebastopol California 95472 Recruiting

Mountain Neurological Research, 350 Market Street, Suite 316
Basalt Colorado 81621 Recruiting
970-927-1141
rosie@roaringforkneurology.com
Colorado Springs Neurological, 2312 North Nevada Avenue, Suite 100
Colorado Springs Colorado 80907 Recruiting
719-389-1129
adeschaine711@gmail.com
Denver Neurological Clinic, 950 E Harvard Ave
Denver Colorado 80210 Recruiting
303-715-9024
Susie@Denverneuroresearch.com
Yale University, One Church Street, Suite 600
New Haven Connecticut 06519 Recruiting
203-764-8111
emily.kemp@yale.edu
Novartis Investigative Site
Stamford Connecticut 06905 Recruiting

Novartis Investigative Site
Washington District of Columbia 20057 Recruiting

Novartis Investigative Site
Atlantis Florida 33462-6608 Recruiting

Quantum Laboratories
Deerfield Beach Florida 33064 Recruiting
954-786-7331
quantmres2@aol.com
Brain Matters Research, Inc., 800 NW 17th Avenue
Delray Beach Florida 33445 Recruiting
561-374-8461
afuquay@brainmattersresearch.com
Infinity Clinical Research LLC, 4925 Sheridan Street, Suite 200
Hollywood Florida 33021 Recruiting
706-455-1220
jriveros@infinityclinicalresearch.com
Alzheimer's Research and Treatment Center, 5065 State Road 7, Suite 102
Lake Worth Florida 33449 Recruiting
561-209-2400
dwatson@researchalz.com
Meridien Research, 2300 Maitland center, Pkwy Ste 230
Maitland Florida 32751 Recruiting
407-644-1165
amarraffino@meridienresearch.net
Novartis Investigative Site
Melbourne Florida 32940 Recruiting

Novartis Investigative Site
Merritt Island Florida 32952 Recruiting

Novartis Investigative Site
Miami Florida 33032 Recruiting

Novartis Investigative Site
Miami Florida 33136 Recruiting

New Horizon Research Center, 11880 SW 40 St., Suite 405
Miami Florida 33175 Recruiting
305-226-3933
juliom@nhorizonresearch.com
Miami-Dade Medical Research, 8955 SW 87 CT, Suite 112
Miami Florida 33176 Recruiting
305-722-7210
ravellana@miamimedresearch.com
Novartis Investigative Site
Miami Beach Florida 33140 Recruiting

Compass Research, LLC,100 West Gore Street, Suite 202
Orlando Florida 32806 Recruiting
407-426-9299
Amy.edridge@Bioclinica.com
Novartis Investigative Site
Orlando Florida 32806 Recruiting

Novartis Investigative Site
Ormond Beach Florida 32174 Recruiting

Novartis Investigative Site
Palm Beach Gardens Florida 33410 Recruiting

Novartis Investigative Site
Port Orange Florida 32127 Recruiting

Roskamp Institute, Inc., 2040 Whitfield Avenue
Sarasota Florida 34243 Recruiting
941-256-8018
dyildirim@roskampinstitute.net
Novartis Investigative Site
Tallahassee Florida 32308 Recruiting

Novartis Investigative Site
Tampa Florida 33613 Recruiting

Novartis Investigative Site
West Palm Beach Florida 33407 Recruiting

Novartis Investigative Site
Atlanta Georgia 30322 Recruiting

Novartis Investigative Site
Columbus Georgia 31909 Recruiting

Novartis Investigative Site
Decatur Georgia 30033 Recruiting

Hawaii Pacific Neuroscience, 2230 Liliha st 104
Honolulu Hawaii 96817 Recruiting
808-261-4476
research@hawaiineuroscience.com
Advanced Clinical Research, 2950 E Magic View Dr, Suite 182
Meridian Idaho 83642 Recruiting
208-377-8653
kwalk@acr-research.com
Novartis Investigative Site
Chicago Illinois 60612 Recruiting

Novartis Investigative Site
Chicago Illinois 60640 Recruiting

Alexian Brothers Neuroscience, 800 Biesterfield Rd, Neuroscience Institute Brock
Elk Grove Village Illinois 60007 Recruiting
847-981-3645
Carolyn.ferrari@amitahealth.org
Novartis Investigative Site
Indianapolis Indiana 46202 Recruiting

Novartis Investigative Site
Fairway Kansas 66205 Recruiting

Novartis Investigative Site
Wichita Kansas 67206 Recruiting

Novartis Investigative Site
Wichita Kansas 67214 Recruiting

Novartis Investigative Site
Lexington Kentucky 40536-0284 Recruiting

Novartis Investigative Site
Bangor Maine 04401 Recruiting

Novartis Investigative Site
Boston Massachusetts 02118 Recruiting

Novartis Investigative Site
Boston Massachusetts 02215 Recruiting

QUEST Research Institute, 28595 Orchard Lake Road, Suite 301
Farmington Hills Michigan 48334 Recruiting
248-957-8940
mbelkin@mindonline.com
Novartis Investigative Site
Rochester Minnesota 55905 Recruiting

Hattiesburg Clinic, 415 South 28th Avenue
Hattiesburg Mississippi 39401 Recruiting
601-579-5016
Kayleigh.Moring@hattiesburgclinic.com
Novartis Investigative Site
Eatontown New Jersey 07724 Withdrawn

Novartis Investigative Site
West Long Branch New Jersey 07764 Recruiting

Albuquerque Neuroscience, 101 Hospital Loop ne, 209 209
Albuquerque New Mexico 87109 Recruiting
505-848-3773
Andy@albneuro.com
Novartis Investigative Site
Brooklyn New York 11235 Recruiting

Novartis Investigative Site
East Syracuse New York 13057 Recruiting

Novartis Investigative Site
Latham New York 12110 Recruiting

NYU Langone Medical Center, 145 East 32nd Street, 2nd Floor, Room 226
New York New York 10016 Recruiting
212-263-5845
Shannon.chen@nyumc.org
Novartis Investigative Site
Orangeburg New York 10962 Recruiting

Novartis Investigative Site
Rochester New York 14642 Recruiting

ANI Neurology, PLLC dba Alzhe, 7809 Sardis Road
Charlotte North Carolina 28270 Recruiting
704-364-4005
sbolouri@amcneurology.com
Novartis Investigative Site
Durham North Carolina 27710 Recruiting

Novartis Investigative Site
Greensboro North Carolina 27410 Recruiting

Novartis Investigative Site
Cincinnati Ohio 45242 Recruiting

Novartis Investigative Site
Norman Oklahoma 73071 Recruiting

Tulsa Clinical Research LLC, 1705 E 19th ST., STE 406/408
Tulsa Oklahoma 74104 Recruiting
918-743-2349
ctoegel@tulsaclinicalresearch.com
Summit Research Network, 2701 NW Vaughn St, Suite 350
Portland Oregon 97210 Recruiting
503-293-5039
afeldman@summitnetwork.com
Novartis Investigative Site
Portland Oregon 97239 Recruiting
503-494-7647
adresearch@ohsu.edu
Novartis Investigative Site
Jenkintown Pennsylvania 19046 Recruiting

Abington Neurological Associate Ltd., 2325 Maryland Road, Suite 100
Willow Grove Pennsylvania 19090 Recruiting
215-957-9250
denisegallagher.ana@gmail.com
Rhode Island Hospital and Memory Research Institute, 1018 Waterman Ave
East Providence Rhode Island 02914 Recruiting
401-435-8950
lgiven@rimmri.com
Butler Hospital, 345 Blackstone Blvd.
Providence Rhode Island 02906 Recruiting
401-455-6211
lothompson@butler.org
Roper Hospital, 316 Calhoun Street 5th Floor
Charleston South Carolina 29401 Recruiting
843-724-2302
ric.freeman@rsfh.com
Novartis Investigative Site
Knoxville Tennessee 37920 Recruiting

Novartis Investigative Site
Nashville Tennessee 37212 Recruiting

Novartis Investigative Site
Austin Texas 78757 Recruiting

Novartis Investigative Site
Dallas Texas 75231 Recruiting

Novartis Investigative Site
Houston Texas 77030 Recruiting

Novartis Investigative Site
Houston Texas 77054 Recruiting

Novartis Investigative Site
San Antonio Texas 78229 Recruiting

Novartis Investigative Site
Bennington Vermont 05201 Recruiting

Novartis Investigative Site
Tacoma Washington 98405 Recruiting

Novartis Investigative Site
Middleton Wisconsin 53562 Withdrawn

Novartis Investigative Site
Milwaukee Wisconsin 53226 Recruiting

Novartis Investigative Site
Quebec G1J 1Z4 Recruiting

Novartis Investigative Site
Kelowna British Columbia V1Y1Z9 Recruiting

Novartis Investigative Site
Kentville Nova Scota B4N 4K9 Recruiting

Novartis Investigative Site
Halifax Nova Scotia B3S 1M7 Recruiting

Toronto Memory Program, 1 Valleybrook Drive Suite 400
Toronto Ontario M3B 2S7 Not yet recruiting
1 416 386 9761
sramotar@memorydisorders.ca
Novartis Investigative Site
Toronto Ontario M4G 3E8 Recruiting

Novartis Investigative Site
Toronto Ontario M4N 3M5 Recruiting

Novartis Investigative Site
Gatineau Quebec J8T 8J1 Recruiting

Novartis Investigative Site
Greenfield Park Quebec J4V 2J2 Recruiting

Novartis Investigative Site
Montreal Quebec H3A 2BA Recruiting

Novartis Investigative Site
Sherbrooke Quebec J1J 2G2 Completed

Novartis Investigative Site
Aguascalientes 20127 Recruiting

Novartis Investigative Site
Monterrey Nuevo Leon 64710 Recruiting

Novartis Investigative Site
Culiacan Sinaloa 80020 Recruiting

Novartis Pharmaceuticals

  • Amgen
  • Banner Alzheimer's Institute

Name Role Affiliation
Novartis Pharmaceuticals Study Director Novartis Pharmaceuticals

NCT03131453

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