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

Last updated: August 4, 2021
Sponsor: Novartis Pharmaceuticals
Overall Status: Terminated

Phase

2/3

Condition

Neurologic Disorders

Treatment

N/A

Clinical Study ID

NCT03131453
CCNP520A2202J
2016-002976-28
  • Ages 60-75
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The purpose of this study is to determine the effects of CNP520 on cognition, global clinical status, and underlying AD pathology, as well as the safety of CNP520, in people at risk for the onset of clinical symptoms of AD based on their age, APOE genotype and elevated amyloid.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • consent to receive disclosure of their risk estimates to develop clinical symptoms ofAD based on their APOE genotype and, if Heterozygotes, evidence of elevated brainamyloid.
  • Male or female, age 60 to 75 years inclusive. Females must be consideredpost-menopausal and not of child bearing potential
  • Cognitively unimpaired as evaluated by memory tests performed at screening.
  • Participant's willingness to have a study partner.
  • Carrier of at least one APOE4 gene if Heterozygotes, elevated brain amyloid (asmeasured by CSF Abeta or amyloid PET imaging).

Exclusion

Exclusion Criteria:

  • Any disability that could have prevented the participants from completing all studyrequirements. -
  • Current medical or neurological condition that could have impacted cognition orperformance on cognitive assessments.
  • Advanced, severe progressive or unstable disease that could have interfered with thesafety, tolerability and study assessments, or put the participant at special risk.
  • History of malignancy of any organ system, treated or untreated, within the past 60months.
  • Indication for, or current treatment with ChEIs and/or another AD treatment (e.g.memantine).
  • Contraindication or intolerance to MRI.
  • Brain MRI results showing findings unrelated to AD that, in the opinion of theInvestigator might be a leading cause to future cognitive decline, could have posed arisk to the participant, or could have prevented a satisfactory MRI assessment forsafety 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, was is due todrug abuse.
  • Significantly abnormal laboratory results at Screening, not as a result of a temporarycondition.
  • Current clinically significant ECG findings.
  • Clinically relevant depigmenting or hypopigmenting conditions (e.g. albinism,vitiligo) or active / history of chronic urticaria in the past year.

Study Design

Total Participants: 1145
Study Start date:
August 03, 2017
Estimated Completion Date:
March 26, 2020

Study Description

This trial was a randomized, double-blind, placebo-controlled, parallel group, adaptive design with variable treatment duration planned in cognitively unimpaired participants aged 60 to 75 years, with at least one apolipoprotein E allele (APOE4), (homozygotes (HMs) or heterozygotes (HTs)) and, if HTs, with evidence of elevated brain amyloid. The participants were randomized to either CNP520 50 mg, CNP520 15 mg or placebo a 2:1:2 ratio and was stratified based on amyloid status. The planned treatment period of 5 to 8 years was not achieved due to early study termination.

Connect with a study center

  • Novartis Investigative Site

    Cordoba, ARG X5000BNB
    Argentina

    Site Not Available

  • Novartis Investigative Site

    Caba, Buenos Aires C1428AQK
    Argentina

    Site Not Available

  • Novartis Investigative Site

    Buenos Aires, C1012AAR
    Argentina

    Site Not Available

  • Novartis Investigative Site

    Mar del Plata, B7600DWF
    Argentina

    Site Not Available

  • Novartis Investigative Site

    Darlinghurst, New South Wales 2010
    Australia

    Site Not Available

  • Novartis Investigative Site

    Heidelberg West, Victoria 3081
    Australia

    Site Not Available

  • Novartis Investigative Site

    Nedlands, Western Australia 6009
    Australia

    Site Not Available

  • Novartis Investigative Site

    Gent, 9000
    Belgium

    Site Not Available

  • Novartis Investigative Site

    Leuven, 3000
    Belgium

    Site Not Available

  • Novartis Investigative Site

    Kelowna, British Columbia V1Y1Z9
    Canada

    Site Not Available

  • Novartis Investigative Site

    Kentville, Nova Scota B4N 4K9
    Canada

    Site Not Available

  • Novartis Investigative Site

    Halifax, Nova Scotia B3S 1M7
    Canada

    Site Not Available

  • Novartis Investigative Site

    Ottawa, Ontario K1G 1Z3
    Canada

    Site Not Available

  • Novartis Investigative Site

    Toronto, Ontario M4N 3M5
    Canada

    Site Not Available

  • Toronto Memory Program, 1 Valleybrook Drive Suite 400

    Toronto, Ontario M3B 2S7
    Canada

    Site Not Available

  • Novartis Investigative Site

    Gatineau, Quebec J8T 8J1
    Canada

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  • Novartis Investigative Site

    Greenfield Park, Quebec J4V 2J2
    Canada

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  • Novartis Investigative Site

    Montreal, Quebec H3A 2BA
    Canada

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  • Novartis Investigative Site

    Sherbrooke, Quebec J1J 2G2
    Canada

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  • Novartis Investigative Site

    Quebec, G1J 1Z4
    Canada

    Site Not Available

  • Novartis Investigative Site

    Santiago, 7500710
    Chile

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    Shanghai, Shanghai 200080
    China

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    Beijing, 100053
    China

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    Guang Zhou,
    China

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    Guangdong, 510370
    China

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    Kuopio, 70210
    Finland

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    Turku, 20520
    Finland

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    Strasbourg, Cedex 67098
    France

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    Lille Cedex, 59037
    France

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    Montpellier, 34295
    France

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  • Novartis Investigative Site

    PARIS Cedex 13, 75651
    France

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    Rouen, 76031
    France

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    Toulouse Cedex 9, 31059
    France

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    Villeurbanne, 69100
    France

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    Bayreuth, 95445
    Germany

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    Berlin, 13353
    Germany

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    Boblingen, 71032
    Germany

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    Halle Saale, 06112
    Germany

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    Koeln, 50937
    Germany

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    Leipzig, 04107
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    Mannheim, 68159
    Germany

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    Siegen, 57076
    Germany

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    Ulm, 89073
    Germany

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    Kopavogi, IS-201
    Iceland

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    Reykjavik, IS-101
    Iceland

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    Ashkelon, 78278
    Israel

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    Haifa, 31096
    Israel

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    Petach Tikva, 49100
    Israel

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    Ramat Gan, 52621
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    Tel Aviv, 6423906
    Israel

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    Brescia, BS 25100
    Italy

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    Roma, Lazio 00168
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    Monza, MB 20900
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    Milan, 20112
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  • Ehime University Hospital, Shitsukawa

    Tooncity, Ehime 791-0295
    Japan

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    Tōon, Ehime 791-0295
    Japan

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    Fukuoka city, Fukuoka 814 0180
    Japan

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    Yokohama-city, Kanagawa 236-0004
    Japan

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    Osaka-city, Osaka 545-8586
    Japan

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    Suita city, Osaka 565 0871
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    Suita-city, Osaka 565-0871
    Japan

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    Bunkyo ku, Tokyo 113 8655
    Japan

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    Bunkyo-ku, Tokyo 113-8431
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    Kodaira, Tokyo 187-8551
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    Shinjuku-ku, Tokyo 160 8582
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    Chiba, 260 8677
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    Osaka, 545-8586
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    Suwon, Gyeonggi Do 16499
    Korea, Republic of

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    Busan, 49201
    Korea, Republic of

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    Incheon, 22332
    Korea, Republic of

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    Seoul, 06351
    Korea, Republic of

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    Ciudad de Mexico, Mexico CP 14080
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    Monterrey, Nuevo Leon 64710
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    Coimbra, 3000 075
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    Lisboa, 1998-018
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    Matosinhos, 4454 513
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    Guaynabo, 00968
    Puerto Rico

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  • Inspira Clinical Research, Ave Hostos 405

    San Juan, 00918
    Puerto Rico

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    Singapore, 308433
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    Rosebank, Johannesburg 2132
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    Cape Town, Western Cape 7530
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    George, ZAF 6529
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    Terrassa, Barcelona 08221
    Spain

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    Pozuelo de Alarcon, Madrid 28223
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    Donostia-San Sebastian, 20009
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    Madrid, 28034
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    Basel, CH 4002
    Switzerland

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    Geneve, 1227
    Switzerland

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    Lausanne, CH-1011
    Switzerland

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    Kaohsiung, 83301
    Taiwan

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    Kaoshiung, 83301
    Taiwan

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    New Taipei City, 23561
    Taiwan

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  • Novartis Investigative Site

    Taipei, 11217
    Taiwan

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  • Novartis Investigative Site

    Exeter, Devon EX2 5DW
    United Kingdom

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  • Novartis Investigative Site

    Plymouth, Devon PL6 8BT
    United Kingdom

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    Guildford, Surrey GU27YD
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    Avon Dassett, BA1 3NG
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    Bath, BA1 2NG
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    Birmingham, B16 8QQ
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    Bristol, BS10 5NB
    United Kingdom

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    Dundee, DD1 9SY
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  • Novartis Investigative Site

    Glasgow,
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  • Novartis Investigative Site

    London, W1G 9JF
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  • Banner Alzheimer's Institute, 901 East Willetta Street

    Phoenix, Arizona 85006
    United States

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  • Novartis Investigative Site

    Scottsdale, Arizona 85259
    United States

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  • Banner Sun Health Research Institute, 10515 West Santa Fe Drive, Building B

    Sun City, Arizona 85351
    United States

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  • Novartis Investigative Site

    Tucson, Arizona 85724
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    Beverly Hills, California 90211
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  • ATP Clinical Research Inc, 3151 Airway Avenue T 3

    Costa Mesa, California 92626
    United States

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  • Novartis Investigative Site

    Garden Grove, California 92845
    United States

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  • Irvine Center for Clinical Res, 2515 McCabe Way

    Irvine, California 92618
    United States

    Site Not Available

  • Torrance Clinical Research Institute, 25043 Narbonne Avenue

    Lomita, California 90717
    United States

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  • Novartis Investigative Site

    Los Angeles, California 90033
    United States

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  • Novartis Investigative Site

    Oxnard, California 93030
    United States

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  • Novartis Investigative Site

    Palo Alto, California 94304
    United States

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  • Novartis Investigative Site

    San Diego, California 92103
    United States

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  • Syrentis Clinical Research, 1401 N Tustin Ave, Suite 130

    Santa Ana, California 92705
    United States

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  • Novartis Investigative Site

    Sebastopol, California 95472
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  • Novartis Investigative Site

    Sherman Oaks, California 91403
    United States

    Site Not Available

  • Mountain Neurological Research, 350 Market Street, Suite 316

    Basalt, Colorado 81621
    United States

    Site Not Available

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

    Colorado Springs, Colorado 80907
    United States

    Site Not Available

  • Denver Neurological Clinic, 950 E Harvard Ave

    Denver, Colorado 80210
    United States

    Site Not Available

  • Yale University, One Church Street, Suite 600

    New Haven, Connecticut 06519
    United States

    Site Not Available

  • Novartis Investigative Site

    Stamford, Connecticut 06905
    United States

    Site Not Available

  • Novartis Investigative Site

    Washington, District of Columbia 20057
    United States

    Site Not Available

  • Novartis Investigative Site

    Atlantis, Florida 33462-6608
    United States

    Site Not Available

  • Quantum Laboratories

    Deerfield Beach, Florida 33064
    United States

    Site Not Available

  • Brain Matters Research, Inc., 800 NW 17th Avenue

    Delray Beach, Florida 33445
    United States

    Site Not Available

  • Infinity Clinical Research LLC, 4925 Sheridan Street, Suite 200

    Hollywood, Florida 33021
    United States

    Site Not Available

  • Alzheimer's Research and Treatment Center, 5065 State Road 7, Suite 102

    Lake Worth, Florida 33449
    United States

    Site Not Available

  • Meridien Research, 2300 Maitland center, Pkwy Ste 230

    Maitland, Florida 32751
    United States

    Site Not Available

  • Novartis Investigative Site

    Melbourne, Florida 32940
    United States

    Site Not Available

  • Novartis Investigative Site

    Merritt Island, Florida 32952
    United States

    Site Not Available

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

    Miami, Florida 33176
    United States

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  • New Horizon Research Center, 11880 SW 40 St., Suite 405

    Miami, Florida 33175
    United States

    Site Not Available

  • Novartis Investigative Site

    Miami, Florida 33032
    United States

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  • Novartis Investigative Site

    Miami Beach, Florida 33140
    United States

    Site Not Available

  • Compass Research, LLC,100 West Gore Street, Suite 202

    Orlando, Florida 32806
    United States

    Site Not Available

  • Novartis Investigative Site

    Orlando, Florida 32806
    United States

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  • Novartis Investigative Site

    Ormond Beach, Florida 32174
    United States

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  • Novartis Investigative Site

    Palm Beach Gardens, Florida 33410
    United States

    Site Not Available

  • Novartis Investigative Site

    Port Orange, Florida 32127
    United States

    Site Not Available

  • Roskamp Institute, Inc., 2040 Whitfield Avenue

    Sarasota, Florida 34243
    United States

    Site Not Available

  • Novartis Investigative Site

    Tallahassee, Florida 32308
    United States

    Site Not Available

  • Novartis Investigative Site

    Tampa, Florida 33613
    United States

    Site Not Available

  • Novartis Investigative Site

    West Palm Beach, Florida 33407
    United States

    Site Not Available

  • Novartis Investigative Site

    Atlanta, Georgia 30322
    United States

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  • Novartis Investigative Site

    Columbus, Georgia 31909
    United States

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  • Novartis Investigative Site

    Decatur, Georgia 30033
    United States

    Site Not Available

  • Hawaii Pacific Neuroscience, 2230 Liliha st 104

    Honolulu, Hawaii 96817
    United States

    Site Not Available

  • Advanced Clinical Research, 2950 E Magic View Dr, Suite 182

    Meridian, Idaho 83642
    United States

    Site Not Available

  • Novartis Investigative Site

    Chicago, Illinois 60640
    United States

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  • Alexian Brothers Neuroscience, 800 Biesterfield Rd, Neuroscience Institute Brock

    Elk Grove Village, Illinois 60007
    United States

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  • Novartis Investigative Site

    Indianapolis, Indiana 46202
    United States

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    Fairway, Kansas 66205
    United States

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  • Novartis Investigative Site

    Wichita, Kansas 67206
    United States

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  • Novartis Investigative Site

    Lexington, Kentucky 40536-0284
    United States

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  • Novartis Investigative Site

    Bangor, Maine 04401
    United States

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  • Novartis Investigative Site

    Boston, Massachusetts 02118
    United States

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  • QUEST Research Institute, 28595 Orchard Lake Road, Suite 301

    Farmington Hills, Michigan 48334
    United States

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  • Novartis Investigative Site

    Kalamazoo, Michigan 49008
    United States

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  • Hattiesburg Clinic, 415 South 28th Avenue

    Hattiesburg, Mississippi 39401
    United States

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  • Novartis Investigative Site

    Saint Louis, Missouri 63104
    United States

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  • Novartis Investigative Site

    Omaha, Nebraska 68198 7680
    United States

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  • Novartis Investigative Site

    Eatontown, New Jersey 07724
    United States

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  • Novartis Investigative Site

    West Long Branch, New Jersey 07764
    United States

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  • Albuquerque Neuroscience, 101 Hospital Loop ne, 209 209

    Albuquerque, New Mexico 87109
    United States

    Site Not Available

  • Novartis Investigative Site

    Brooklyn, New York 11235
    United States

    Site Not Available

  • Novartis Investigative Site

    East Syracuse, New York 13057
    United States

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  • Novartis Investigative Site

    Latham, New York 12110
    United States

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  • NYU Langone Medical Center, 145 East 32nd Street, 2nd Floor, Room 226

    New York, New York 10016
    United States

    Site Not Available

  • Novartis Investigative Site

    Orangeburg, New York 10962
    United States

    Site Not Available

  • Novartis Investigative Site

    Rochester, New York 14642
    United States

    Site Not Available

  • ANI Neurology, PLLC dba Alzhe, 7809 Sardis Road

    Charlotte, North Carolina 28270
    United States

    Site Not Available

  • Novartis Investigative Site

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Novartis Investigative Site

    Greensboro, North Carolina 27410
    United States

    Site Not Available

  • Novartis Investigative Site

    Cincinnati, Ohio 45242
    United States

    Site Not Available

  • Novartis Investigative Site

    Norman, Oklahoma 73071
    United States

    Site Not Available

  • Novartis Investigative Site

    Oklahoma City, Oklahoma 73112
    United States

    Site Not Available

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

    Tulsa, Oklahoma 74104
    United States

    Site Not Available

  • Novartis Investigative Site

    Portland, Oregon 97239
    United States

    Site Not Available

  • Summit Research Network, 2701 NW Vaughn St, Suite 350

    Portland, Oregon 97210
    United States

    Site Not Available

  • Novartis Investigative Site

    Jenkintown, Pennsylvania 19046
    United States

    Site Not Available

  • Novartis Investigative Site

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Abington Neurological Associate Ltd., 2325 Maryland Road, Suite 100

    Willow Grove, Pennsylvania 19090
    United States

    Site Not Available

  • Rhode Island Hospital and Memory Research Institute, 1018 Waterman Ave

    East Providence, Rhode Island 02914
    United States

    Site Not Available

  • Butler Hospital, 345 Blackstone Blvd.

    Providence, Rhode Island 02906
    United States

    Site Not Available

  • Roper Hospital, 316 Calhoun Street 5th Floor

    Charleston, South Carolina 29401
    United States

    Site Not Available

  • Novartis Investigative Site

    Knoxville, Tennessee 37920
    United States

    Site Not Available

  • Novartis Investigative Site

    Memphis, Tennessee 38119
    United States

    Site Not Available

  • Novartis Investigative Site

    Nashville, Tennessee 37212
    United States

    Site Not Available

  • Novartis Investigative Site

    Austin, Texas 78757
    United States

    Site Not Available

  • Novartis Investigative Site

    Dallas, Texas 75231
    United States

    Site Not Available

  • Novartis Investigative Site

    Houston, Texas 77054
    United States

    Site Not Available

  • Novartis Investigative Site

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Novartis Investigative Site

    Bennington, Vermont 05201
    United States

    Site Not Available

  • Novartis Investigative Site

    Tacoma, Washington 98405
    United States

    Site Not Available

  • Novartis Investigative Site

    Middleton, Wisconsin 53562
    United States

    Site Not Available

  • Novartis Investigative Site

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

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