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A Study of CAD106 and CNP520 Versus Placebo in Participants at Risk for the Onset of Clinical Symptoms of Alzheimer's Disease (Generation S1)

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ClinicalTrials.gov Identifier: NCT02565511
Recruitment Status : Recruiting
First Posted : October 1, 2015
Last Update Posted : October 31, 2018
Sponsor:
Collaborators:
Banner Alzheimer's Institute
National Institute on Aging (NIA)
Alzheimer's Association
Amgen
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Biological: CAD106 Immunotherapy Other: Placebo to CAD106 Drug: CNP520 Other: Placebo to CNP520 Phase 2 Phase 3

Detailed Description:

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 two PET scans 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 715 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, 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.
Actual Study Start Date : November 30, 2015
Estimated Primary Completion Date : August 30, 2024
Estimated Study Completion Date : September 2, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm#1
CAD106 (450 µg) + Alum (450 µg) given i.m. at week 1, 7, 13 and quarterly thereafter
Biological: CAD106 Immunotherapy
Participants will be given i.m. injections at Weeks 1, 7, 13 and quarterly i.m. injections (every 13 weeks) thereafter, until the last injection 3 month prior to completion of the Treatment Epoch.

Placebo Comparator: Arm#2
Placebo to CAD106 + Alum (450 µg) given i.m. at week 1, 7, 13 and quarterly thereafter
Other: Placebo to CAD106
Participants will be given i.m. injections at Weeks 1, 7, 13 and quarterly i.m. injections (every 13 weeks) thereafter, until the last injection 3 month prior to completion of the Treatment Epoch.

Experimental: Arm#3
CNP520 (50 mg) capsules oral intake (p.o.)
Drug: CNP520
CNP520 50 mg capsule p.o. for the duration of the Treatment Epoch.

Placebo Comparator: Arm#4
Placebo to CNP520 capsules oral intake (p.o.)
Other: Placebo to CNP520
Placebo to CNP520 p.o. for the duration of the Treatment Epoch




Primary Outcome Measures :
  1. Time to diagnosis of MCI due to Alzheimer's Disease (AD) or dementia due to Alzheimer's Disease [ Time Frame: Through study completion, an average of 5 years ]
    Time when diagnosis is confirmed by 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 assess the effects of CAD106 and CNP520, vs. respective placebo on global clinical status as measured by the change in Clinical Dementia Rating Scale Sum of Boxes (CDR-SOB) score.

  2. Number of participants with Adverse Events as a measure of Safety and Tolerability [ Time Frame: Through study completion, an average of 5 years ]

    To assess the safety and tolerability of CAD106 and CNP520, vs. respective placebo by measured adverse events (AEs), and changes in the brain structural MRI, laboratory tests, non-cognitive neurological and psychiatric examinations including the Columbia Suicide Severity Rating Scale (C-SSRS), vital signs and electrocardiogram (ECG).

    Cohort - I: Injection-related reactions will also be analyzed. Cohort - II: Skin related AEs by regular skin examinations and centralized dermatological monitoring.


  3. 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 assess the effects of CAD106 and CNP520, vs. respective placebo on cognition as measured by changes on the Total Scale score and individual neurocognitive domain index scores of the RBANS.

  4. Change in the Everyday Cognition scale (ECog) total scores [ Time Frame: Baseline to Month 60 ]
    To assess the effects of CAD106 and CNP520, vs. respective placebo on function as measured by the change in ECog total score reported by the participant and study partner, respectively.

  5. Change in Alzheimer's Disease related biomarkers [ Time Frame: Baseline to Months 24 and 60 ]

    To assess the effects of CAD106 and CNP520, vs. respective placebo on AD-related biomarkers (amyloid deposition and measures of neurodegeneration) as measured by changes on:

    amyloid tracer and tau tracer obtained using brain positron emission tomography (PET) imaging, volumetric MRI measurements, and CSF Aβ40, Aβ42, total tau and phosphorylated tau181 levels.


  6. Change in APCC Test Score [ Time Frame: Month 6 to Month 60 ]
    To assess the effects of antibody response to CAD106 vs. placebo on cognition as measured by changes on the APCC test score

  7. Change in CDR-SOB [ Time Frame: Month 6 to Month 60 ]
    To assess the effects of antibody response to CAD106 vs. placebo on cognition as measured by changes on the CDR-SOB.

  8. Aβ-specific immune response [ Time Frame: Through study completion, an average of 5 years ]
    To describe serological immune response to CAD106 injections as measured by Aβ-specific antibody titers generated



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.


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

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.


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): NCT02565511


Contacts
Contact: Novartis Pharmaceuticals 1-888-669-6682 trialandresults.registries@novartis.com
Contact: Novartis Pharmaceuticals +41613241111 info@generationprogram.com

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Locations
United States, Arizona
Banner Alzheimer's Institute Recruiting
Phoenix, Arizona, United States, 85006
Contact    602-839-6500    roma.patel@bannerhealth.com   
Novartis Investigative Site Recruiting
Phoenix, Arizona, United States, 85006
Mayo Clinic Arizona Recruiting
Scottsdale, Arizona, United States, 85259
Contact    480-301-6726    Thomas.martha1@mayo.edu   
Banner Sun City Research Institute Recruiting
Sun City, Arizona, United States, 85351
Contact    623-832-6500    bannerresearch@bannerhealth.com   
United States, California
ATP Clinical Research, Inc. Recruiting
Costa Mesa, California, United States, 92626
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Irvine Center for Clinical Research Recruiting
Irvine, California, United States, 92614
Contact    949-753-1663    studies@irvineclinical.com   
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Los Angeles, California, United States, 90033
Novartis Investigative Site Recruiting
Palo Alto, California, United States, 94304
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San Diego, California, United States, 92103
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San Diego, California, United States, 92123
Syrentis Clinical Research Recruiting
Santa Ana, California, United States, 92705
Contact    714-542-3008    lorriebisesiphd@gmail.com   
Novartis Investigative Site Recruiting
Sebastopol, California, United States, 95472
California Neuroscience Research Medical Group, Inc. Recruiting
Sherman Oaks, California, United States, 91316
Contact    818-990-2671    marlene@cnrmg.com   
Novartis Investigative Site Withdrawn
Temecula, California, United States, 92591
United States, Colorado
Novartis Investigative Site Recruiting
Basalt, Colorado, United States, 81621
Contact    970-927-1141      
United States, Connecticut
Yale University Alzheimer's Disease Research Unit Recruiting
New Haven, Connecticut, United States, 06510
Contact    203-764-8100    Emily.kemp@yale.edu   
Contact    203-764-8145      
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Stamford, Connecticut, United States, 06905
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Washington, District of Columbia, United States, 20057
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Washington, District of Columbia, United States, 20059
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Atlantis, Florida, United States, 33462-6608
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Delray Beach, Florida, United States, 33445
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Jacksonville, Florida, United States, 32224
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Maitland, Florida, United States, 32751
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Merritt Island, Florida, United States, 32952
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Miami Beach, Florida, United States, 33140
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Miami, Florida, United States, 33136
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Orlando, Florida, United States, 32812
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Port Orange, Florida, United States, 32127
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Tampa, Florida, United States, 33613
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Atlanta, Georgia, United States, 30322
Medical Research & Health Education Foundation, Inc. Recruiting
Columbus, Georgia, United States, 31909
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Lexington, Kentucky, United States, 40504
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Boston, Massachusetts, United States, 01801
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Boston, Massachusetts, United States, 02115
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Boston, Massachusetts, United States, 02118
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Rochester, Minnesota, United States, 55905
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Omaha, Nebraska, United States, 68198-7680
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Cleveland Clinic Lou Ruvo Center for Brain Health Recruiting
Las Vegas, Nevada, United States, 89106
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Eatontown, New Jersey, United States, 07724
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Latham, New York, United States, 12110
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New York, New York, United States, 10016
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Orangeburg, New York, United States, 10962
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Rochester, New York, United States, 14620
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Alzheimer's Memory Center Recruiting
Charlotte, North Carolina, United States, 28270
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Durham, North Carolina, United States, 27705
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Greensboro, North Carolina, United States, 27410
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Beachwood, Ohio, United States, 44122
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Centerville, Ohio, United States, 45459
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Oklahoma City, Oklahoma, United States, 73103
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Oklahoma City, Oklahoma, United States, 73112
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Portland, Oregon, United States, 97210
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Jenkintown, Pennsylvania, United States, 19046
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Willow Grove, Pennsylvania, United States, 19090
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Providence, Rhode Island, United States, 02906
Contact    401-455-6402    memory@butler.org   
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Roper St. Francis - CBRI Recruiting
Charleston, South Carolina, United States, 29401
Contact    843-724-2302    Allison.lapp@rsfh.com   
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Novartis Investigative Site Recruiting
Knoxville, Tennessee, United States, 37920
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Memphis, Tennessee, United States, 38119
Contact    901-843-1045    meminfo@cnshealthcare.com   
Contact    877-267-2122      
Novartis Investigative Site Recruiting
Nashville, Tennessee, United States, 37212
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United States, Texas
Senior Adults Specialty Research Recruiting
Austin, Texas, United States, 78757
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Kerwin Research Center & Memory Care Recruiting
Dallas, Texas, United States, 75231
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Houston Methodist Hospital Recruiting
Houston, Texas, United States, 77030
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University of Texas Health Science Center, Houston Recruiting
Houston, Texas, United States, 77054
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Houston, Texas, United States, 77074
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United States, Vermont
The Memory Clinic Recruiting
Bennington, Vermont, United States, 05201
Contact    802-447-1409    megan@memorydoc.org   
United States, Washington
Novartis Investigative Site Withdrawn
Spokane, Washington, United States, 99204
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Tacoma, Washington, United States, 98405
Contact    253-882-1070    Info.uniresearch@gmail.com   
United States, Wisconsin
The Medical College of WI Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact    414-805-8328    bblaney@mcw.edu   
Australia, New South Wales
Novartis Investigative Site Recruiting
Darlinghurst, New South Wales, Australia, 2010
Australia, Victoria
Novartis Investigative Site Recruiting
Heidelberg Heights, Victoria, Australia, 3081
Australia, Western Australia
Novartis Investigative Site Recruiting
Nedlands, Western Australia, Australia, 6009
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Leuven, Belgium, 3000
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Okanagan Clinical Trials Recruiting
Kelowna, British Columbia, Canada, V1Y1Z9
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Canada, Nova Scota
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Kentville, Nova Scota, Canada, B4N 4K9
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Canada, Nova Scotia
Novartis Investigative Site Recruiting
Halifax, Nova Scotia, Canada, B3S 1M7
Contact       Nicole.blanchard@truenorthcr.com   
Canada, Ontario
Toronto Memory Program Recruiting
Toronto, Ontario, Canada, M3B 2S7
Contact    416-386-9606    research@memorydisorders.ca   
The Centre for Memory and Aging Recruiting
Toronto, Ontario, Canada, M4G 3E8
Contact    416-663-6897 ext 23    lcornejo@memorycentre.ca   
Novartis Investigative Site Recruiting
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
Novartis Investigative Site Recruiting
Gatineau, Quebec, Canada, J8T 8J1
Novartis Investigative Site Recruiting
Montreal, Quebec, Canada, H3A 2BA
Contact    (514) 398-5500    info-CRU.neuro@mcgill.ca   
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Sherbrooke, Quebec, Canada, J1J 2G2
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Canada
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Quebec, Canada, G1J 1Z4
Finland
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Turku, Finland, 20520
Germany
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Berlin, Germany, 12203
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Boblingen, Germany, 71032
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Halle, Germany, 06120
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Kiel, Germany, 24105
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Koeln, Germany, 50937
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Leipzig, Germany, 04107
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Mannheim, Germany, 68159
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Münster, Germany, 48149
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Siegen, Germany, 57076
Novartis Investigative Site Recruiting
Wenzenbach, Germany, 93173
Netherlands
Novartis Investigative Site Recruiting
Amsterdam, Netherlands, 1081 GN
Spain
Novartis Investigative Site Recruiting
Terrassa, Barcelona, Spain, 08221
Novartis Investigative Site Recruiting
Pozuelo de Alarcon, Madrid, Spain, 28223
Novartis Investigative Site Recruiting
Barcelona, Spain, 08005
Novartis Investigative Site Recruiting
Barcelona, Spain, 08014
Novartis Investigative Site Recruiting
Donostia-San Sebastian, Spain, 20009
Switzerland
Novartis Investigative Site Recruiting
Basel, CH, Switzerland, 4002
Novartis Investigative Site Recruiting
Lausanne, Switzerland, CH-1011
United Kingdom
Novartis Investigative Site Recruiting
Westbruy On Trym, Bristol, United Kingdom, BS10 5NB
Novartis Investigative Site Recruiting
Exeter, Devon, United Kingdom, EX1 2LU
Novartis Investigative Site Recruiting
Plymouth, Devon, United Kingdom, PL6 8BT
Novartis Investigative Site Recruiting
Guildford, Surrey, United Kingdom, GU27YD
Novartis Investigative Site Recruiting
Avon, United Kingdom, BA1 3NG
Novartis Investigative Site Recruiting
Birmingham, United Kingdom, B16 8QQ
Novartis Investigative Site Recruiting
Dundee, United Kingdom, DD1 9SY
Novartis Investigative Site Recruiting
Glasgow, United Kingdom, G20 0XA
Novartis Investigative Site Recruiting
Glasgow, United Kingdom
Novartis Investigative Site Recruiting
London, United Kingdom, SE5 8AD
Novartis Investigative Site Recruiting
London, United Kingdom, W12 0HS
Novartis Investigative Site Recruiting
London, United Kingdom, W1G 9JF
Novartis Investigative Site Recruiting
London, United Kingdom, W2 1PG
Novartis Investigative Site Recruiting
Manchester, United Kingdom, M13 9WL
Sponsors and Collaborators
Novartis Pharmaceuticals
Banner Alzheimer's Institute
National Institute on Aging (NIA)
Alzheimer's Association
Amgen
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Additional Information:
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02565511     History of Changes
Other Study ID Numbers: CAPI015A2201J
2015-002715-15 ( EudraCT Number )
1UF1AG046150-01 ( U.S. NIH Grant/Contract )
First Posted: October 1, 2015    Key Record Dates
Last Update Posted: October 31, 2018
Last Verified: October 2018
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


Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Randomization, Placebo controlled, Parallel-group, APOE4 Homozygotes, Preclinical Alzheimer's Disease (AD), Aβ lowering

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders