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

Active, not 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
August 3, 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

Novartis Investigative Site
Scottsdale Arizona 85259

Banner Sun Health Research Institute, 10515 West Santa Fe Drive, Building B
Sun City Arizona 85351

Novartis Investigative Site
Tucson Arizona 85724

Novartis Investigative Site
Beverly Hills California 90211

ATP Clinical Research Inc, 3151 Airway Avenue T 3
Costa Mesa California 92626

Novartis Investigative Site
Garden Grove California 92845

Irvine Center for Clinical Res, 2515 McCabe Way
Irvine California 92618

Torrance Clinical Research Institute, 25043 Narbonne Avenue
Lomita California 90717

Novartis Investigative Site
Los Angeles California 90033

Novartis Investigative Site
Oxnard California 93030

Novartis Investigative Site
Palo Alto California 94304

Novartis Investigative Site
San Diego California 92103

Syrentis Clinical Research, 1401 N Tustin Ave, Suite 130
Santa Ana California 92705

Novartis Investigative Site
Sebastopol California 95472

Mountain Neurological Research, 350 Market Street, Suite 316
Basalt Colorado 81621

Colorado Springs Neurological, 2312 North Nevada Avenue, Suite 100
Colorado Springs Colorado 80907

Denver Neurological Clinic, 950 E Harvard Ave
Denver Colorado 80210

Yale University, One Church Street, Suite 600
New Haven Connecticut 06519

Novartis Investigative Site
Stamford Connecticut 06905

Novartis Investigative Site
Washington District of Columbia 20057

Novartis Investigative Site
Atlantis Florida 33462-6608

Quantum Laboratories
Deerfield Beach Florida 33064

Brain Matters Research, Inc., 800 NW 17th Avenue
Delray Beach Florida 33445

Infinity Clinical Research LLC, 4925 Sheridan Street, Suite 200
Hollywood Florida 33021

Alzheimer's Research and Treatment Center, 5065 State Road 7, Suite 102
Lake Worth Florida 33449

Meridien Research, 2300 Maitland center, Pkwy Ste 230
Maitland Florida 32751

Novartis Investigative Site
Melbourne Florida 32940

Novartis Investigative Site
Merritt Island Florida 32952

Novartis Investigative Site
Miami Florida 33032

Novartis Investigative Site
Miami Florida 33136

New Horizon Research Center, 11880 SW 40 St., Suite 405
Miami Florida 33175

Miami-Dade Medical Research, 8955 SW 87 CT, Suite 112
Miami Florida 33176

Novartis Investigative Site
Miami Beach Florida 33140

Compass Research, LLC,100 West Gore Street, Suite 202
Orlando Florida 32806

Novartis Investigative Site
Orlando Florida 32806

Novartis Investigative Site
Ormond Beach Florida 32174

Novartis Investigative Site
Palm Beach Gardens Florida 33410

Novartis Investigative Site
Port Orange Florida 32127

Roskamp Institute, Inc., 2040 Whitfield Avenue
Sarasota Florida 34243

Novartis Investigative Site
Tallahassee Florida 32308

Novartis Investigative Site
Tampa Florida 33613

Novartis Investigative Site
West Palm Beach Florida 33407

Novartis Investigative Site
Atlanta Georgia 30322

Novartis Investigative Site
Columbus Georgia 31909

Novartis Investigative Site
Decatur Georgia 30033

Hawaii Pacific Neuroscience, 2230 Liliha st 104
Honolulu Hawaii 96817

Advanced Clinical Research, 2950 E Magic View Dr, Suite 182
Meridian Idaho 83642

Novartis Investigative Site
Chicago Illinois 60612

Novartis Investigative Site
Chicago Illinois 60640

Alexian Brothers Neuroscience, 800 Biesterfield Rd, Neuroscience Institute Brock
Elk Grove Village Illinois 60007

Novartis Investigative Site
Indianapolis Indiana 46202

Novartis Investigative Site
Fairway Kansas 66205

Novartis Investigative Site
Wichita Kansas 67206

Novartis Investigative Site
Wichita Kansas 67214

Novartis Investigative Site
Lexington Kentucky 40536-0284

Novartis Investigative Site
Bangor Maine 04401

Novartis Investigative Site
Boston Massachusetts 02118

Novartis Investigative Site
Boston Massachusetts 02215

QUEST Research Institute, 28595 Orchard Lake Road, Suite 301
Farmington Hills Michigan 48334

Novartis Investigative Site
Kalamazoo Michigan 49008

Novartis Investigative Site
Rochester Minnesota 55905

Hattiesburg Clinic, 415 South 28th Avenue
Hattiesburg Mississippi 39401

Novartis Investigative Site
Saint Louis Missouri 63104

Novartis Investigative Site
West Long Branch New Jersey 07764

Albuquerque Neuroscience, 101 Hospital Loop ne, 209 209
Albuquerque New Mexico 87109

Novartis Investigative Site
Brooklyn New York 11235

Novartis Investigative Site
East Syracuse New York 13057

Novartis Investigative Site
Latham New York 12110

NYU Langone Medical Center, 145 East 32nd Street, 2nd Floor, Room 226
New York New York 10016

Novartis Investigative Site
Orangeburg New York 10962

Novartis Investigative Site
Rochester New York 14642

ANI Neurology, PLLC dba Alzhe, 7809 Sardis Road
Charlotte North Carolina 28270

Novartis Investigative Site
Durham North Carolina 27710

Novartis Investigative Site
Greensboro North Carolina 27410

Novartis Investigative Site
Cincinnati Ohio 45242

Novartis Investigative Site
Oklahoma City Oklahoma 73112

Tulsa Clinical Research LLC, 1705 E 19th ST., STE 406/408
Tulsa Oklahoma 74104

Summit Research Network, 2701 NW Vaughn St, Suite 350
Portland Oregon 97210

Novartis Investigative Site
Portland Oregon 97239

Novartis Investigative Site
Jenkintown Pennsylvania 19046

Abington Neurological Associate Ltd., 2325 Maryland Road, Suite 100
Willow Grove Pennsylvania 19090

Rhode Island Hospital and Memory Research Institute, 1018 Waterman Ave
East Providence Rhode Island 02914

Butler Hospital, 345 Blackstone Blvd.
Providence Rhode Island 02906

Roper Hospital, 316 Calhoun Street 5th Floor
Charleston South Carolina 29401

Novartis Investigative Site
Knoxville Tennessee 37920

Novartis Investigative Site
Memphis Tennessee 38119

Novartis Investigative Site
Nashville Tennessee 37212

Novartis Investigative Site
Austin Texas 78757

Novartis Investigative Site
Dallas Texas 75231

Novartis Investigative Site
Houston Texas 77030

Novartis Investigative Site
Houston Texas 77054

Novartis Investigative Site
San Antonio Texas 78229

Novartis Investigative Site
Bennington Vermont 05201

Novartis Investigative Site
Tacoma Washington 98405

Novartis Investigative Site
Milwaukee Wisconsin 53226

Novartis Investigative Site
Quebec G1J 1Z4

Novartis Investigative Site
Kelowna British Columbia V1Y1Z9

Novartis Investigative Site
Kentville Nova Scota B4N 4K9

Novartis Investigative Site
Halifax Nova Scotia B3S 1M7

Novartis Investigative Site
Ottawa Ontario K1G 1Z3

Toronto Memory Program, 1 Valleybrook Drive Suite 400
Toronto Ontario M3B 2S7

Novartis Investigative Site
Toronto Ontario M4G 3E8

Novartis Investigative Site
Toronto Ontario M4N 3M5

Novartis Investigative Site
Gatineau Quebec J8T 8J1

Novartis Investigative Site
Greenfield Park Quebec J4V 2J2

Novartis Investigative Site
Montreal Quebec H3A 2BA

Novartis Investigative Site
Sherbrooke Quebec J1J 2G2

Novartis Investigative Site
Ciudad de Mexico Mexico CP 14080

Novartis Investigative Site
Monterrey Nuevo Leon 64710

Novartis Investigative Site
Culiacan Sinaloa 80020

Novartis Pharmaceuticals

  • Amgen
  • Banner Alzheimer's Institute

Name Role Affiliation
Novartis Pharmaceuticals Study Director Novartis Pharmaceuticals

Name Phone Email
Novartis Pharmaceuticals 1-888-669-6682 novartis.email@novartis.com
Novartis Pharmaceuticals +41613241111 info@generationprogram.com

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).