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A Study of CNP520 Versus Placebo in Participants at Risk for the Onset of Clinical Symptoms of Alzheimer's Disease (Generation S2)

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ClinicalTrials.gov Identifier: NCT03131453
Recruitment Status : Active, not recruiting
First Posted : April 27, 2017
Last Update Posted : July 18, 2019
Sponsor:
Collaborators:
Amgen
Banner Alzheimer's Institute
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief 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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: CNP520 50mg Drug: CNP520 15mg Other: Placebo to CNP520 Phase 2 Phase 3

Detailed Description:

The study uses a randomized, double-blind, placebo-controlled, parallel group, adaptive design with variable treatment duration in approximately 2000 cognitively unimpaired participants aged 60 to 75 years, with at least one APOE4 allele (Homozygotes or Heterozygotes) and, if Heterozygotes, with evidence of elevated brain amyloid.

The screening period is expected to last about 12 weeks. Participants will receive disclosure of their individual test results for APOE genotyping and brain amyloid status.

Treatment duration is variable (event driven trial) for at least 60 months, and up to an expected maximum of 84 months.

Participants will return to the study site every three months for drug dispensing and every six months for safety and efficacy assessments, including neuropsychological scales with input from the study partner. Brain MRI scans will be conducted at month 6 and month 12, and on a yearly basis thereafter.

The Follow-up visit will be scheduled 12 weeks after the end of the Treatment Epoch. An additional CSF and / or PET AD biomarker assessments will be conducted on a voluntary basis at year 2 and 5.

The study (also known as the Generation Study 2) is conducted as part of the Alzheimer's Prevention Initiative (API) program.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1145 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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).
Actual Study Start Date : August 3, 2017
Estimated Primary Completion Date : July 30, 2024
Estimated Study Completion Date : March 31, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm#1: CNP520 50 mg
CNP520 50 mg capsule given p.o.
Drug: CNP520 50mg
Arm#1
Other Name: CNP520 50 mg capsule p.o. for the duration of the Treatment Epoch

Experimental: Arm#2: CNP520 15 mg
CNP520 15 mg capsule given p.o.
Drug: CNP520 15mg
Arm#2
Other Name: CNP520 15 mg capsule p.o. for the duration of Treatment Epoch

Placebo Comparator: Arm#3: Placebo
Placebo to CNP520 capsule given p.o.
Other: Placebo to CNP520
Arm#3
Other Name: Placebo to CNP520 p.o. for the duration of Treatment Epoch




Primary Outcome Measures :
  1. Time to event [ Time Frame: Through study completion, at least 5 years ]
    Event is defined as diagnosis of MCI due to AD or dementia due to AD, whichever occurs first during the course of the study, after confirmation by the adjudication committee

  2. Change in the Alzheimer's Prevention Initiative Composite Cognitive (APCC) Test Score [ Time Frame: Baseline to Month 60 ]
    Composite score derived from the specific tests from the Repeatable Battery for the Assessment of Neurological Status (RBANS), Mini-Mental State Examination (MMSE), Raven's Progressive Matrices


Secondary Outcome Measures :
  1. Change in Clinical Dementia Rating Scale Sum of Boxes (CDR-SOB) score [ Time Frame: Baseline to Month 60 ]
    To demonstrate the effects of CNP520, vs. placebo on global clinical status

  2. Change on the Total Scale score and individual neurocognitive domain index scores of the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) [ Time Frame: Baseline to Month 60 ]
    To demonstrate the effects of CNP520, vs. placebo on cognition

  3. Change in the Everyday Cognition scale (ECog) total scores [ Time Frame: Baseline to Month 60 ]
    To demonstrate the effects of CNP520, vs. placebo on function reported by the participant and study partner, respectively

  4. Change in cerebral amyloid angiopathy (CAA) [ Time Frame: Through study completion, at least 5 years ]
    To demonstrate the effects of CNP520 vs placebo on CAA, as measured by Magnetic Resonance Imaging (MRI)

  5. Change on volume of brain regions [ Time Frame: Baseline to Month 60 ]
    To demonstrate the effects of CNP520 vs placebo on brain atrophy, as measured by volumetric Magnetic Resonance Imaging (MRI)

  6. Change in amyloid deposition as measured by standardized uptake ratio (SUVR) of positron emission tomography (PET) scan with amyloid radiotracer [ Time Frame: Baseline to Months 24 and 60 ]
    To demonstrate the effects of CNP520 vs placebo on Alzheimer's Disease-related biomarkers

  7. Change in CSF levels of Aβ40, Aβ42 [ Time Frame: Baseline to Months 24 and 60 ]
    To demonstrate the effects of CNP520 vs placebo on Alzheimer's Disease-related biomarkers

  8. Change in CSF levels of total tau and phosphorylated tau [ Time Frame: Baseline to Months 24 and 60 ]
    To demonstrate the effects of CNP520 vs placebo on Alzheimer's Disease-related biomarkers

  9. Number of participants with adverse events as a measure of safety [ Time Frame: Through study completion, at least 5 years ]
    To demonstrate the safety and tolerability of CNP520 vs placebo

  10. Change in neurofibrillary tangle burden as measured by standardized uptake ratio (SUVR) of PET scans with tau radiotracer (where available) [ Time Frame: Baseline to Months 24 and 60 ]
    To demonstrate the effects of CNP520 vs placebo on Alzheimer's Disease-related biomarkers



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   60 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • consent to receive disclosure of their risk estimates to develop clinical symptoms of AD based on their APOE genotype and, if Heterozygotes, evidence of elevated brain amyloid.
  • Male or female, age 60 to 75 years inclusive. Females must be considered post-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 (as measured by CSF Abeta or amyloid PET imaging).

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.
  • 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 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, not as a result of a temporary condition.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03131453


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Locations
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United States, Arizona
Banner Alzheimer's Institute, 901 East Willetta Street
Phoenix, Arizona, United States, 85006
Novartis Investigative Site
Scottsdale, Arizona, United States, 85259
Banner Sun Health Research Institute, 10515 West Santa Fe Drive, Building B
Sun City, Arizona, United States, 85351
Novartis Investigative Site
Tucson, Arizona, United States, 85724
United States, California
Novartis Investigative Site
Beverly Hills, California, United States, 90211
ATP Clinical Research Inc, 3151 Airway Avenue T 3
Costa Mesa, California, United States, 92626
Novartis Investigative Site
Garden Grove, California, United States, 92845
Irvine Center for Clinical Res, 2515 McCabe Way
Irvine, California, United States, 92618
Torrance Clinical Research Institute, 25043 Narbonne Avenue
Lomita, California, United States, 90717
Novartis Investigative Site
Los Angeles, California, United States, 90033
Novartis Investigative Site
Oxnard, California, United States, 93030
Novartis Investigative Site
Palo Alto, California, United States, 94304
Novartis Investigative Site
San Diego, California, United States, 92103
Syrentis Clinical Research, 1401 N Tustin Ave, Suite 130
Santa Ana, California, United States, 92705
Novartis Investigative Site
Sebastopol, California, United States, 95472
United States, Colorado
Mountain Neurological Research, 350 Market Street, Suite 316
Basalt, Colorado, United States, 81621
Colorado Springs Neurological, 2312 North Nevada Avenue, Suite 100
Colorado Springs, Colorado, United States, 80907
Denver Neurological Clinic, 950 E Harvard Ave
Denver, Colorado, United States, 80210
United States, Connecticut
Yale University, One Church Street, Suite 600
New Haven, Connecticut, United States, 06519
Novartis Investigative Site
Stamford, Connecticut, United States, 06905
United States, District of Columbia
Novartis Investigative Site
Washington, District of Columbia, United States, 20057
United States, Florida
Novartis Investigative Site
Atlantis, Florida, United States, 33462-6608
Quantum Laboratories
Deerfield Beach, Florida, United States, 33064
Brain Matters Research, Inc., 800 NW 17th Avenue
Delray Beach, Florida, United States, 33445
Infinity Clinical Research LLC, 4925 Sheridan Street, Suite 200
Hollywood, Florida, United States, 33021
Alzheimer's Research and Treatment Center, 5065 State Road 7, Suite 102
Lake Worth, Florida, United States, 33449
Meridien Research, 2300 Maitland center, Pkwy Ste 230
Maitland, Florida, United States, 32751
Novartis Investigative Site
Melbourne, Florida, United States, 32940
Novartis Investigative Site
Merritt Island, Florida, United States, 32952
Novartis Investigative Site
Miami Beach, Florida, United States, 33140
Novartis Investigative Site
Miami, Florida, United States, 33032
Novartis Investigative Site
Miami, Florida, United States, 33136
New Horizon Research Center, 11880 SW 40 St., Suite 405
Miami, Florida, United States, 33175
Miami-Dade Medical Research, 8955 SW 87 CT, Suite 112
Miami, Florida, United States, 33176
Compass Research, LLC,100 West Gore Street, Suite 202
Orlando, Florida, United States, 32806
Novartis Investigative Site
Orlando, Florida, United States, 32806
Novartis Investigative Site
Ormond Beach, Florida, United States, 32174
Novartis Investigative Site
Palm Beach Gardens, Florida, United States, 33410
Novartis Investigative Site
Port Orange, Florida, United States, 32127
Roskamp Institute, Inc., 2040 Whitfield Avenue
Sarasota, Florida, United States, 34243
Novartis Investigative Site
Tallahassee, Florida, United States, 32308
Novartis Investigative Site
Tampa, Florida, United States, 33613
Novartis Investigative Site
West Palm Beach, Florida, United States, 33407
United States, Georgia
Novartis Investigative Site
Atlanta, Georgia, United States, 30322
Novartis Investigative Site
Columbus, Georgia, United States, 31909
Novartis Investigative Site
Decatur, Georgia, United States, 30033
United States, Hawaii
Hawaii Pacific Neuroscience, 2230 Liliha st 104
Honolulu, Hawaii, United States, 96817
United States, Idaho
Advanced Clinical Research, 2950 E Magic View Dr, Suite 182
Meridian, Idaho, United States, 83642
United States, Illinois
Novartis Investigative Site
Chicago, Illinois, United States, 60612
Novartis Investigative Site
Chicago, Illinois, United States, 60640
Alexian Brothers Neuroscience, 800 Biesterfield Rd, Neuroscience Institute Brock
Elk Grove Village, Illinois, United States, 60007
United States, Indiana
Novartis Investigative Site
Indianapolis, Indiana, United States, 46202
United States, Kansas
Novartis Investigative Site
Fairway, Kansas, United States, 66205
Novartis Investigative Site
Wichita, Kansas, United States, 67206
Novartis Investigative Site
Wichita, Kansas, United States, 67214
United States, Kentucky
Novartis Investigative Site
Lexington, Kentucky, United States, 40536-0284
United States, Maine
Novartis Investigative Site
Bangor, Maine, United States, 04401
United States, Massachusetts
Novartis Investigative Site
Boston, Massachusetts, United States, 02118
Novartis Investigative Site
Boston, Massachusetts, United States, 02215
United States, Michigan
QUEST Research Institute, 28595 Orchard Lake Road, Suite 301
Farmington Hills, Michigan, United States, 48334
Novartis Investigative Site
Kalamazoo, Michigan, United States, 49008
United States, Minnesota
Novartis Investigative Site
Rochester, Minnesota, United States, 55905
United States, Mississippi
Hattiesburg Clinic, 415 South 28th Avenue
Hattiesburg, Mississippi, United States, 39401
United States, Missouri
Novartis Investigative Site
Saint Louis, Missouri, United States, 63104
United States, New Jersey
Novartis Investigative Site
West Long Branch, New Jersey, United States, 07764
United States, New Mexico
Albuquerque Neuroscience, 101 Hospital Loop ne, 209 209
Albuquerque, New Mexico, United States, 87109
United States, New York
Novartis Investigative Site
Brooklyn, New York, United States, 11235
Novartis Investigative Site
East Syracuse, New York, United States, 13057
Novartis Investigative Site
Latham, New York, United States, 12110
NYU Langone Medical Center, 145 East 32nd Street, 2nd Floor, Room 226
New York, New York, United States, 10016
Novartis Investigative Site
Orangeburg, New York, United States, 10962
Novartis Investigative Site
Rochester, New York, United States, 14642
United States, North Carolina
ANI Neurology, PLLC dba Alzhe, 7809 Sardis Road
Charlotte, North Carolina, United States, 28270
Novartis Investigative Site
Durham, North Carolina, United States, 27710
Novartis Investigative Site
Greensboro, North Carolina, United States, 27410
United States, Ohio
Novartis Investigative Site
Cincinnati, Ohio, United States, 45242
United States, Oklahoma
Novartis Investigative Site
Oklahoma City, Oklahoma, United States, 73112
Tulsa Clinical Research LLC, 1705 E 19th ST., STE 406/408
Tulsa, Oklahoma, United States, 74104
United States, Oregon
Summit Research Network, 2701 NW Vaughn St, Suite 350
Portland, Oregon, United States, 97210
Novartis Investigative Site
Portland, Oregon, United States, 97239
United States, Pennsylvania
Novartis Investigative Site
Jenkintown, Pennsylvania, United States, 19046
Abington Neurological Associate Ltd., 2325 Maryland Road, Suite 100
Willow Grove, Pennsylvania, United States, 19090
United States, Rhode Island
Rhode Island Hospital and Memory Research Institute, 1018 Waterman Ave
East Providence, Rhode Island, United States, 02914
Butler Hospital, 345 Blackstone Blvd.
Providence, Rhode Island, United States, 02906
United States, South Carolina
Roper Hospital, 316 Calhoun Street 5th Floor
Charleston, South Carolina, United States, 29401
United States, Tennessee
Novartis Investigative Site
Knoxville, Tennessee, United States, 37920
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Memphis, Tennessee, United States, 38119
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Nashville, Tennessee, United States, 37212
United States, Texas
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Austin, Texas, United States, 78757
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Dallas, Texas, United States, 75231
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Houston, Texas, United States, 77030
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Houston, Texas, United States, 77054
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San Antonio, Texas, United States, 78229
United States, Vermont
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Bennington, Vermont, United States, 05201
United States, Washington
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Tacoma, Washington, United States, 98405
United States, Wisconsin
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Milwaukee, Wisconsin, United States, 53226
Argentina
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Cordoba, ARG, Argentina, X5000BNB
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Caba, Buenos Aires, Argentina, C1428AQK
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Buenos Aires, Argentina, C1012AAR
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Buenos Aires, Argentina, C1427CCP
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Cordoba, Argentina, X5004AOA
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Mar del Plata, Argentina, B7600DWF
Australia, New South Wales
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Darlinghurst, New South Wales, Australia, 2010
Australia, Victoria
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Heidelberg West, Victoria, Australia, 3081
Australia, Western Australia
Novartis Investigative Site
Nedlands, Western Australia, Australia, 6009
Belgium
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Gent, Belgium, 9000
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Leuven, Belgium, 3000
Canada, British Columbia
Novartis Investigative Site
Kelowna, British Columbia, Canada, V1Y1Z9
Canada, Nova Scota
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Kentville, Nova Scota, Canada, B4N 4K9
Canada, Nova Scotia
Novartis Investigative Site
Halifax, Nova Scotia, Canada, B3S 1M7
Canada, Ontario
Novartis Investigative Site
Ottawa, Ontario, Canada, K1G 1Z3
Toronto Memory Program, 1 Valleybrook Drive Suite 400
Toronto, Ontario, Canada, M3B 2S7
Novartis Investigative Site
Toronto, Ontario, Canada, M4G 3E8
Novartis Investigative Site
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
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Gatineau, Quebec, Canada, J8T 8J1
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Greenfield Park, Quebec, Canada, J4V 2J2
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Montreal, Quebec, Canada, H3A 2BA
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Sherbrooke, Quebec, Canada, J1J 2G2
Canada
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Quebec, Canada, G1J 1Z4
Chile
Novartis Investigative Site
Santiago, Chile, 7500710
Novartis Investigative Site
Santiago, Chile, 838 0456
Finland
Novartis Investigative Site
Kuopio, Finland, 70210
Novartis Investigative Site
Turku, Finland, 20520
France
Novartis Investigative Site
Strasbourg, Cedex, France, 67098
Novartis Investigative Site
Lille Cedex, France, 59037
Novartis Investigative Site
Montpellier, France, 34295
Novartis Investigative Site
PARIS Cedex 13, France, 75651
Novartis Investigative Site
Rouen, France, 76031
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Toulouse Cedex 9, France, 31059
Novartis Investigative Site
Villeurbanne, France, 69100
Germany
Novartis Investigative Site
Bayreuth, Germany, 95445
Novartis Investigative Site
Berlin, Germany, 13353
Novartis Investigative Site
Boblingen, Germany, 71032
Novartis Investigative Site
Halle Saale, Germany, 06112
Novartis Investigative Site
Koeln, Germany, 50937
Novartis Investigative Site
Leipzig, Germany, 04107
Novartis Investigative Site
Mannheim, Germany, 68159
Novartis Investigative Site
Siegen, Germany, 57076
Novartis Investigative Site
Ulm, Germany, 89073
Iceland
Novartis Investigative Site
Reykjavik, Iceland, IS-101
Israel
Novartis Investigative Site
Ashkelon, Israel, 78278
Novartis Investigative Site
Haifa, Israel, 3525408
Novartis Investigative Site
Petach Tikva, Israel, 49100
Novartis Investigative Site
Ramat Gan, Israel, 52621
Novartis Investigative Site
Tel Aviv, Israel, 6423906
Italy
Novartis Investigative Site
Brescia, BS, Italy, 25100
Novartis Investigative Site
Roma, Lazio, Italy, 00168
Novartis Investigative Site
Milan, Italy, 20112
Japan
Novartis Investigative Site
Tōon, Ehime, Japan, 791-0295
Novartis Investigative Site
Fukuoka city, Fukuoka, Japan, 814 0180
Novartis Investigative Site
Yokohama-city, Kanagawa, Japan, 236-0004
Novartis Investigative Site
Suita city, Osaka, Japan, 565 0871
Novartis Investigative Site
Bunkyo ku, Tokyo, Japan, 113 8655
Novartis Investigative Site
Bunkyo ku, Tokyo, Japan, 113-8431
Novartis Investigative Site
Kodaira, Tokyo, Japan, 187-8551
Novartis Investigative Site
Shinjuku-ku, Tokyo, Japan, 160 8582
Novartis Investigative Site
Chiba, Japan, 260 8677
Novartis Investigative Site
Osaka, Japan, 545-8586
Korea, Republic of
Novartis Investigative Site
Suwon, Gyeonggi Do, Korea, Republic of, 16499
Novartis Investigative Site
Busan, Korea, Republic of, 49201
Novartis Investigative Site
Incheon, Korea, Republic of, 22332
Novartis Investigative Site
Seoul, Korea, Republic of, 05505
Novartis Investigative Site
Seoul, Korea, Republic of, 06351
Mexico
Novartis Investigative Site
Ciudad de Mexico, Mexico CP, Mexico, 14080
Novartis Investigative Site
Monterrey, Nuevo Leon, Mexico, 64710
Novartis Investigative Site
Culiacan, Sinaloa, Mexico, 80020
Netherlands
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Amsterdam, Netherlands, 1081 GN
Novartis Investigative Site
Hertogenbosch, Netherlands, 5200
Portugal
Novartis Investigative Site
Coimbra, Portugal, 3000 075
Novartis Investigative Site
Lisboa, Portugal, 1998-018
Novartis Investigative Site
Matosinhos, Portugal, 4454 513
Novartis Investigative Site
Torres Vedras, Portugal, 2560-280
Puerto Rico
Novartis Investigative Site
Guaynabo, Puerto Rico, 00968
Inspira Clinical Research, Ave Hostos 405
San Juan, Puerto Rico, 00918
Singapore
Novartis Investigative Site
Singapore, Singapore, 308433
South Africa
Novartis Investigative Site
Rosebank, Johannesburg, South Africa, 2132
Novartis Investigative Site
Cape Town, Western Cape, South Africa, 7530
Novartis Investigative Site
George, ZAF, South Africa, 6529
Spain
Novartis Investigative Site
Terrassa, Barcelona, Spain, 08221
Novartis Investigative Site
Pozuelo de Alarcon, Madrid, Spain, 28223
Novartis Investigative Site
Barcelona, Spain, 08005
Novartis Investigative Site
Barcelona, Spain, 08014
Novartis Investigative Site
Donostia-San Sebastian, Spain, 20009
Novartis Investigative Site
Madrid, Spain, 28034
Novartis Investigative Site
Madrid, Spain, 28041
Switzerland
Novartis Investigative Site
Basel, CH, Switzerland, 4002
Novartis Investigative Site
Geneve, Switzerland, 1227
Novartis Investigative Site
Lausanne, Switzerland, CH-1011
Taiwan
Novartis Investigative Site
Kaoshiung, Taiwan, 83301
Novartis Investigative Site
New Taipei City, Taiwan, 23561
Novartis Investigative Site
Taipei, Taiwan, 11217
United Kingdom
Novartis Investigative Site
Exeter, Devon, United Kingdom, EX2 5DW
Novartis Investigative Site
Plymouth, Devon, United Kingdom, PL6 8BT
Novartis Investigative Site
London, GBR, United Kingdom, W12 7RH
Novartis Investigative Site
Guildford, Surrey, United Kingdom, GU27YD
Novartis Investigative Site
Avon, United Kingdom, BA1 3NG
Novartis Investigative Site
Birmingham, United Kingdom, B16 8QQ
Novartis Investigative Site
Bristol, United Kingdom, BS10 5NB
Novartis Investigative Site
Dundee, United Kingdom, DD1 9SY
Novartis Investigative Site
Glasgow, United Kingdom
Novartis Investigative Site
London, United Kingdom, W12 0HS
Novartis Investigative Site
London, United Kingdom, W1G 9JF
Sponsors and Collaborators
Novartis Pharmaceuticals
Amgen
Banner Alzheimer's Institute
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Additional Information:
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03131453     History of Changes
Other Study ID Numbers: CCNP520A2202J
2016-002976-28 ( EudraCT Number )
First Posted: April 27, 2017    Key Record Dates
Last Update Posted: July 18, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

URL: https://www.clinicalstudydatarequest.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Placebo controlled,
APOE4 carriers,
Homozygotes,
Heterozygotes,
Brain Amyloid,
Preclinical Alzheimer's Disease (AD),
Aβ lowering,
BACE-1 inhibitor
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders