A Study of CAD106 and CNP520 Versus Placebo in Participants at Risk for the Onset of Clinical Symptoms of Alzheimer's Disease (GS1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT02565511

Recruitment Status : Terminated

First Posted : October 1, 2015

Results First Posted : July 8, 2021

Last Update Posted : July 8, 2021

View this study on the modernized ClinicalTrials.gov

Sponsor:

Collaborators:

Banner Alzheimer's Institute

National Institute on Aging (NIA)

Amgen

Information provided by (Responsible Party):

Novartis ( Novartis Pharmaceuticals )

Study Description

Brief Summary:

The purpose of this study was to test whether two investigational drugs called CAD106 and CNP520, administered separately, could 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
Alzheimers Disease	Biological: CAD106 Immunotherapy Other: Placebo to CAD106 Drug: CNP520 Other: Placebo to CNP520 Other: Alum	Phase 2 Phase 3

Detailed Description:

The study (also known as the Generation Study 1, GS1) was conducted as part of the Alzheimer's Prevention Initiative (API) program.

This trial was a randomized, double-blind, placebo-controlled, parallel group, adaptive design with variable treatment duration planned in cognitively unimpaired APOE4 homozygotes (HMs) aged 60 to 75 years. Participants were enrolled into Cohort I (CAD106) or Cohort II (CNP520).

The planned treatment period of 5 to 8 years was not achieved due to early study termination.

The study was terminated due to unexpected changes in cognitive function, brain volume loss, and body weight loss. Cohort II (CNP520) treatment was stopped and evaluated through an off-treatment follow-up period. After the decision to terminate Cohort II of the study (CNP520), treatment with CAD106 (Cohort I) was also terminated.

Study Design

Layout table for study information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	480 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
Actual Primary Completion Date :	April 30, 2020
Actual Study Completion Date :	April 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease

Genetic and Rare Diseases Information Center resources: Familial Alzheimer Disease

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Cohort I (CAD106) CAD106 (450 µg) + Alum (450 µg) intra-muscular injection at Weeks 1, 7, 13 and every 13 weeks 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. Other: Alum Alum was mixed with reconstituted CAD106 as adjuvant therapy to maximize the effectiveness of CAD106
Placebo Comparator: Cohort I (CAD106 Placebo) Placebo to CAD106 + Alum (450 µg) intra-muscular injection at Weeks 1, 7, 13 and every 13 weeks 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. Other: Alum Alum was mixed with reconstituted CAD106 as adjuvant therapy to maximize the effectiveness of CAD106
Experimental: Cohort II (CNP520) CNP520 (50 mg) capsules taken orally once daily	Drug: CNP520 CNP520 50 mg capsule p.o. for the duration of the Treatment Epoch.
Placebo Comparator: Cohort II (CNP520 Placebo) Matching Placebo to CNP520 capsules taken orally once daily	Other: Placebo to CNP520 Placebo to CNP520 p.o. for the duration of the Treatment Epoch

Outcome Measures

Primary Outcome Measures :

Time to Event (Diagnosis of Mild Cognitive Impairment or Dementia, Due to Alzheimer's Disease (AD)) [ Time Frame: Baseline to end of exposure for a maximum of 1455 days for CI and 907 days for CII ]
Event was defined as the first confirmed diagnosis of MCI due to Alzheimer's disease (AD) or dementia due to AD (whichever occurred first) after adjudication by the progression adjudication committee (PAC) as triggered either by an investigator diagnosis or an increase in the Clinical Dementia Rating (CDR) global score. An event had to be confirmed by the PAC at two consecutive visits. In case no confirmed event was observed for a participant, the observation was censored, and the censoring date was defined as the last date where the diagnostic classification was assessed. The Study was terminated and only confirmed events collected up to the data cut-off point were counted. Due to the early termination of the study only a small number of events were observed and time-to-event could not be analyzed. Kaplan-Meyer (KM) estimates were provided to estimate probability that a subject would have an event prior to the specified visit.
Change in the Alzheimer's Prevention Initiative Composite Cognitive (APCC) Test Score [ Time Frame: CI = Baseline to Weeks 26, 52,78 104 and Baseline to last assessment; CII = Baseline to Weeks 26, 52, 78, 104 and Baseline to Last on-treatment and Baseline to Last off-treatment ]
APCC is a composite score derived from the specific scores from the Repeatable Battery for the Assessment of Neurological Status (RBANS), Mini-Mental State Examination (MMSE) and the Raven's Progressive Matrices. The APCC score is a weighted score with ranges from from 0 to 100 where higher scores correspond to better cognitive performance.

Secondary Outcome Measures :

Change in Clinical Dementia Rating Scale Sum of Boxes (CDR-SOB) Score [ Time Frame: CI = Baseline to Weeks 26, 52,78 104 and Baseline to last assessment; CII = Baseline to Weeks 26, 52, 78, 104 and Baseline to Last on-treatment and Baseline to Last off-treatment ]
The CDR was obtained through semi-structured interviews of participants and informants, and cognitive functioning was rated on a 5-point scale of functioning in six domains: memory, orientation, judgement and problem solving, community affairs, home and hobbies, and personal care. The CDR global score ranged from zero to three, while the CDR-SOB was the sum of the ratings from the six domains, ranging from 0 to 18 with a minimum increment of 0.5. Higher scores indicated greater disease severity.
Change in the Total Scores of the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS). [ Time Frame: CI = Baseline to Weeks 26, 52,78 104 and Baseline to last assessment; CII = Baseline to Weeks 26, 52, 78, 104 and Baseline to Last on-treatment and Baseline to Last off-treatment ]
Repeatable Battery for the Assessment of Neurological Status (RBANS) is a clinical tool designed to detect and characterize the earliest neurocognitive changes associated with dementia. The RBANS generates age-adjusted index scores for five neurocognitive domains: Immediate Memory, Visuospatial/Constructional, Language, Attention and Delayed Memory, which are used to calculate a Total Scale Index score. Index scores and total score range from 40 to 160 and a higher score indicates better cognitive functioning.
Change in the Index Scores of the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS). [ Time Frame: CI = Baseline to Weeks 26, 52 and Baseline to last assessment; CII = Baseline to Weeks 26, 52 and Baseline to Last on-treatment and Baseline to Last off-treatment ]
Repeatable Battery for the Assessment of Neurological Status (RBANS) is a clinical tool designed to detect and characterize the earliest neurocognitive changes associated with dementia. The RBANS generates age-adjusted index scores for five neurocognitive domains: Immediate Memory, Visuospatial/Constructional, Language, Attention and Delayed Memory, which are used to calculate a Total Scale Index score. Index scores and total score range from 40 to 160 and a higher score indicates better cognitive functioning.
Change in the Everyday Cognition Scale (ECog-Subject) Total Scores [ Time Frame: CI = Baseline to Weeks 26, 52 and Baseline to last assessment; CII = Baseline to Weeks 26, 52 and Baseline to Last on-treatment and Baseline to Last off-treatment ]
Everyday Cognition Scale (ECog) measures cognitively-relevant everyday abilities comprised of 39 items covering 6 cognitively-relevant domains: Everyday Memory, Everyday Language, Everyday Visuospatial Abilities, Everyday Planning, Everyday Organization, and Everyday Divided Attention. The questionnaire is a self-reported measure completed by both participant and study partner (informant). The total score for the 39 items ranges from 39 to 195, with greater scores indicating worse daily function.
Change in the Everyday Cognition Scale (ECog-Informant) Total Scores [ Time Frame: CI = Baseline to Weeks 26, 52 and Baseline to last assessment; CII = Baseline to Weeks 26, 52 and Baseline to Last on-treatment and Baseline to Last off-treatment ]
Everyday Cognition Scale (ECog) measures cognitively-relevant everyday abilities comprised of 39 items covering 6 cognitively-relevant domains: Everyday Memory, Everyday Language, Everyday Visuospatial Abilities, Everyday Planning, Everyday Organization, and Everyday Divided Attention. The questionnaire is a self-reported measure completed by both participant and study partner (informant). The total score for the 39 items ranges from 39 to 195, with greater scores indicating worse daily function. Cohort I=C I and Cohort II=C II.
Number of Participants With Newly Occurring Safety MRI Abnormalities (ARIA-E, ARIA-H,White Matter Disease and Any Other MRI Abnormalities) [ Time Frame: Baseline to end of exposure for a maximum of 1455 days for CI and 907 days for CII ]
Safety MRI included sequences necessary for ascertainment of possible ARIA-E (Amyloid Related Imaging Abnormality-Edema), ARIA-H (Amyloid Related Imaging Abnormality- Hemorrhage, including superficial siderosis and microhemorrhages), assessment of recent infarcts and white matter integrity examination (White matter disease worsening since baseline) and a general assessment of brain abnormalities. Assessment of cerebral amyloid angiopathy (CAA) is included in the overall safety MRI findings results.
Annualized Percent Change on Volume of Brain Regions [ Time Frame: CI = Baseline to Weeks 26, 52 and Baseline to last assessment; CII = Baseline to Weeks 26, 52 and Baseline to Last on-treatment and Baseline to Last off-treatment ]
Annualized % change from baseline in volume of specific brain regions of interest (ROIs): whole brain (WB), hippocampus (Hip), and lateral ventricles (LV). Annualized percentage change was calculated as (percentage per participant / time interval (in days)) x 365.25. Time interval (in days) was derived as date of current MRI assessment on study drug - date of baseline MRI assessment + 1.
Change in Cerebrospinal Fluid (CSF) Levels of Amyloid Beta 40 (Aβ40) [ Time Frame: Baseline to last assessment ]
Alzheimer's Disease-related biomarkers analyzed in cerebrospinal fluid (CSF): Amyloid Beta 40 (Aβ40)
Change in Cerebrospinal Fluid (CSF) Levels of Amyloid Beta 42 (Aβ42) [ Time Frame: Baseline to last assessment ]
Alzheimer's Disease-related biomarkers analyzed in cerebrospinal fluid (CSF): Amyloid Beta 42 (Aβ42)
Change in Cerebrospinal Fluid (CSF) Levels of Total Tau and Phosphorylated Tau [ Time Frame: Baseline to last assessment ]
Alzheimer's Disease-related biomarkers analyzed in cerebrospinal fluid (CSF): total tau protein and phosphorylated tau protein levels
Change in Neurofibrillary Tangle Burden as Measured by Standardized Uptake Ratio (SUVR) of PET Scans With Tau Radiotracer (Where Available) [ Time Frame: Baseline to last assessment ]
To demonstrate the effects of CNP520 vs placebo on tau pathology in the brain
Cohort I : Annualized Change in Amyloid Deposition as Measured by Centiloids of Positron Emission Tomography (PET) Scan With Amyloid Radiotracer [ Time Frame: Baseline up to approximately Week 104 ]
To demonstrate the effects of CAD106 vs placebo on Alzheimer's Disease-related biomarkers
Change in Serum Neurofilaments [ Time Frame: Baseline to Week 26 and week 52, CI baseline to last assessment. CII baseline to last on-treatment and to last off-treatment ]
Alzheimer's Disease-related biomarkers analyzed in blood serum: light chain neurofilaments (NfL)
Number of Suicidal Ideation or Behavior Events [ Time Frame: Baseline to end of exposure for a maximum of 1455 days for CI and 907 days for CII ]
Prospective suicidality assessment was performed with the use of Columbia-Suicide Severity Rating Scale (C-SSRS), a questionnaire using a detailed branched logic algorithm evaluating participant's suicidality ideation and behavior. Answer "yes" on item 4 or 5 of the Suicidal Ideation section or "yes" on any item of the Suicidal Behavior section was considered positive.
Cohort I : Change in Cognition as Measured by APCC and CDR-SOB Scores and Antibody Response [ Time Frame: Month 6 to Month 60 ]
Cohort I: Peak Concentration (Cmax) of CAD106 Induced Abeta-specific Antibody Titers [ Time Frame: Week 9, 13, 15, 26 and quarterly thereafter (trough values) ]
Cmax is the maximum Titer Concentration of any post-baseline 'on treatment' visit. A visit is considered as 'on treatment' if visit date is within {last injection + 180 days}.

- Geometric mean and CI's are back-transformed from the estimates for Log mean and CI's.
Cohort I: Area Under the Concentration Curve (AUC) of CAD106 Induced Abeta-specific Antibody Titers [ Time Frame: Week 9, 13, 15, 26 and quarterly thereafter (trough values) ]
AUC is calculated based on 'on treatment' visit only.(missing values for peak visits were linearly interpolated for calculation; missing values for trough visits were imputed by average of non-missing trough values.).

Eligibility Criteria

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.

Layout table for eligibility information

Ages Eligible for Study:	60 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Key Inclusion Criteria:

Consented 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 were to be post-menopausal.
Mini-Mental State Examination (MMSE) total score ≥ 24 and cognitively unimpaired as evaluated by memory tests
Homozygous APOE4 genotype.
Participant willing to have a study partner.

Key Exclusion Criteria:

Any disability that prevented the participant from completing all study requirements.
Current medical or neurological condition that could have impacted cognition or performance on cognitive assessments.
Advanced, severe progressive or unstable disease that may have interfered 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 60 months prior to screening.
History of hypersensitivity to any of the investigational drugs or their excipients / adjuvant or to drugs of similar chemical classes.
Indication or on 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 could have been a leading cause to future cognitive decline, pose a risk to the participant, or prevent a satisfactory MRI assessment for safety monitoring.
Suicidal Ideation in the past six months or Suicidal Behavior in the past two years, prior to screening.
A positive drug screen at Screening, if, in the Investigator's opinion, this was 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.

Contacts and Locations

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

Locations

Show 129 study locations

Layout table for location information

United States, Arizona
Banner Alzheimer's Institute
Phoenix, Arizona, United States, 85006
Novartis Investigative Site
Phoenix, Arizona, United States, 85006
Novartis Investigative Site
Scottsdale, Arizona, United States, 85259
Banner Sun City Research Institute
Sun City, Arizona, United States, 85351
United States, California
ATP Clinical Research, Inc.
Costa Mesa, California, United States, 92626
Irvine Center for Clinical Research
Irvine, California, United States, 92614
University of Southern California Keck School of Medicine Alzheimer Disease Research Center
Los Angeles, California, United States, 90033
Novartis Investigative Site
Palo Alto, California, United States, 94304
Novartis Investigative Site
San Diego, California, United States, 92103
Syrentis Clinical Research
Santa Ana, California, United States, 92705
Novartis Investigative Site
Sebastopol, California, United States, 95472
California Neuroscience Research Medical Group, Inc.
Sherman Oaks, California, United States, 91316
Novartis Investigative Site
Temecula, California, United States, 92591
United States, Colorado
Novartis Investigative Site
Basalt, Colorado, United States, 81621
United States, Connecticut
Yale University Alzheimer's Disease Research Unit
New Haven, Connecticut, United States, 06510
New England Institute for Clinical Research
Stamford, Connecticut, United States, 06905
United States, District of Columbia
Georgetown University
Washington, District of Columbia, United States, 20057
Novartis Investigative Site
Washington, District of Columbia, United States, 20059
United States, Florida
JEM Research Institute
Atlantis, Florida, United States, 33462-6608
Florida Atlantic University, Clinical Translational Research Unit
Boca Raton, Florida, United States, 33431
Brain Matters Research
Delray Beach, Florida, United States, 33445
Novartis Investigative Site
Jacksonville, Florida, United States, 32224
Meridien Research
Maitland, Florida, United States, 32751
Merritt Island Medical Research
Merritt Island, Florida, United States, 32952
Mount Sinai Medical Center - The Wien Center
Miami Beach, Florida, United States, 33140
University of Miami
Miami, Florida, United States, 33136
Novartis Investigative Site
Orlando, Florida, United States, 32806
Compass Research
Orlando, Florida, United States, 32812
Progressive Medical Research
Port Orange, Florida, United States, 32127
USF Health Byrd Alzheimer's Institute
Tampa, Florida, United States, 33613
United States, Georgia
Novartis Investigative Site
Atlanta, Georgia, United States, 30322
Medical Research & Health Education Foundation, Inc.
Columbus, Georgia, United States, 31909
NeuroStudies
Decatur, Georgia, United States, 30033
United States, Idaho
Advanced Clinical Research
Meridian, Idaho, United States, 83642
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
Great Lakes Clinical Trials
Chicago, Illinois, United States, 60640
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
United States, Kansas
University of Kansas Alzheimer's Disease Center
Fairway, Kansas, United States, 66205
Via Christi Research
Wichita, Kansas, United States, 67214
United States, Kentucky
Sanders Brown Center on Aging, University of Kentucky
Lexington, Kentucky, United States, 40504
United States, Maine
Novartis Investigative Site
Bangor, Maine, United States, 04401
United States, Massachusetts
Novartis Investigative Site
Boston, Massachusetts, United States, 02115
Novartis Investigative Site
Boston, Massachusetts, United States, 02118
United States, Michigan
Novartis Investigative Site
Kalamazoo, Michigan, United States, 49008
United States, Minnesota
Novartis Investigative Site
Saint Paul, Minnesota, United States, 55130
United States, Missouri
Novartis Investigative Site
Saint Louis, Missouri, United States, 63104
United States, Nebraska
Memory Disorders Program, Department of Neurological Sciences, University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-7680
United States, Nevada
Cleveland Clinic Lou Ruvo Center for Brain Health
Las Vegas, Nevada, United States, 89106
United States, New Jersey
Memory Enhancement Center
Eatontown, New Jersey, United States, 07724
United States, New York
The Memory Center of Northeastern New York
Latham, New York, United States, 12110
NYU Langone Medical Center
New York, New York, United States, 10016
The Nathan S. Kline Institute
Orangeburg, New York, United States, 10962
University of Rochester Medical Center
Rochester, New York, United States, 14620
United States, North Carolina
Alzheimer's Memory Center
Charlotte, North Carolina, United States, 28270
Duke University Medical center
Durham, North Carolina, United States, 27705
Triad Clinical Trials, LLC
Greensboro, North Carolina, United States, 27410
United States, Ohio
University Hospitals Cleveland Medical Center / Case Western Reserve University
Beachwood, Ohio, United States, 44122
Novartis Investigative Site
Centerville, Ohio, United States, 45459
Novartis Investigative Site
Columbus, Ohio, United States, 43210
United States, Oklahoma
IPS Research Company
Oklahoma City, Oklahoma, United States, 73103
Novartis Investigative Site
Oklahoma City, Oklahoma, United States, 73112
United States, Oregon
Memory Health Center at Summit Research Network
Portland, Oregon, United States, 97210
United States, Pennsylvania
The Clinical Trial Center, LLC
Jenkintown, Pennsylvania, United States, 19046
Novartis Investigative Site
Philadelphia, Pennsylvania, United States, 19104
Abington Neurological Associates
Willow Grove, Pennsylvania, United States, 19090
United States, Rhode Island
Butler Hospital Memory and Aging Program
Providence, Rhode Island, United States, 02906
United States, South Carolina
Roper St. Francis - CBRI
Charleston, South Carolina, United States, 29401
United States, Tennessee
Novartis Investigative Site
Knoxville, Tennessee, United States, 37920
CNS Healthcare
Memphis, Tennessee, United States, 38119
Novartis Investigative Site
Nashville, Tennessee, United States, 37212
United States, Texas
Senior Adults Specialty Research
Austin, Texas, United States, 78757
Kerwin Research Center & Memory Care
Dallas, Texas, United States, 75231
Houston Methodist Hospital
Houston, Texas, United States, 77030
University of Texas Health Science Center, Houston
Houston, Texas, United States, 77054
Clinical Trial Network
Houston, Texas, United States, 77074
United States, Vermont
The Memory Clinic
Bennington, Vermont, United States, 05201
United States, Washington
Universal Research Group
Tacoma, Washington, United States, 98405
United States, Wisconsin
The Medical College of WI
Milwaukee, Wisconsin, United States, 53226
Australia, New South Wales
Novartis Investigative Site
Darlinghurst, New South Wales, Australia, 2010
Australia, Victoria
Novartis Investigative Site
Heidelberg Heights, Victoria, Australia, 3081
Australia, Western Australia
Novartis Investigative Site
Nedlands, Western Australia, Australia, 6009
Belgium
Novartis Investigative Site
Gent, Belgium, 9000
Novartis Investigative Site
Leuven, Belgium, 3000
Canada, British Columbia
Okanagan Clinical Trials
Kelowna, British Columbia, Canada, V1Y1Z9
Canada, Nova Scota
Novartis Investigative Site
Kentville, Nova Scota, Canada, B4N 4K9
Canada, Nova Scotia
Novartis Investigative Site
Halifax, Nova Scotia, Canada, B3S 1M7
Canada, Ontario
Novartis Investigative Site
London, Ontario, Canada, N6C 0A7
Toronto Memory Program
Toronto, Ontario, Canada, M3B 2S7
The Centre for Memory and Aging
Toronto, Ontario, Canada, M4G 3E8
Novartis Investigative Site
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
Novartis Investigative Site
Gatineau, Quebec, Canada, J8T 8J1
Novartis Investigative Site
Sherbrooke, Quebec, Canada, J1H 5N4
Novartis Investigative Site
Sherbrooke, Quebec, Canada, J1J 2G2
Canada
Novartis Investigative Site
Quebec, Canada, G1J 1Z4
Finland
Novartis Investigative Site
Turku, Finland, 20520
Germany
Novartis Investigative Site
Bayreuth, Germany, 95445
Novartis Investigative Site
Berlin, Germany, 13353
Novartis Investigative Site
Boblingen, Germany, 71032
Novartis Investigative Site
Gottingen, Germany, 37075
Novartis Investigative Site
Halle, Germany, 06120
Novartis Investigative Site
Kiel, Germany, 24105
Novartis Investigative Site
Koeln, Germany, 50937
Novartis Investigative Site
Leipzig, Germany, 04107
Novartis Investigative Site
Mannheim, Germany, 68159
Novartis Investigative Site
Münster, Germany, 48149
Novartis Investigative Site
Siegen, Germany, 57076
Novartis Investigative Site
Wenzenbach, Germany, 93173
Netherlands
Novartis Investigative Site
Amsterdam, Netherlands, 1081 GN
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
Switzerland
Novartis Investigative Site
Basel, CH, Switzerland, 4002
United Kingdom
Novartis Investigative Site
Westbruy On Trym, Bristol, United Kingdom, BS10 5NB
Novartis Investigative Site
Exeter, Devon, United Kingdom, EX2 5DW
Novartis Investigative Site
Plymouth, Devon, United Kingdom, PL6 8BT
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
Dundee, United Kingdom, DD1 9SY
Novartis Investigative Site
Glasgow, United Kingdom, G20 0XA
Novartis Investigative Site
Glasgow, United Kingdom
Novartis Investigative Site
London, United Kingdom, SE5 8AD
Novartis Investigative Site
London, United Kingdom, W12 0HS
Novartis Investigative Site
London, United Kingdom, W1G 9JF
Novartis Investigative Site
London, United Kingdom, W2 1NY
Novartis Investigative Site
London, United Kingdom, W2 1PG
Novartis Investigative Site
Manchester, United Kingdom, M13 9WL

Sponsors and Collaborators

Novartis Pharmaceuticals

Banner Alzheimer's Institute

National Institute on Aging (NIA)

Amgen

Investigators

Layout table for investigator information

Study Director:	Novartis Pharmaceuticals	Novartis Pharmaceuticals

Study Documents (Full-Text)

Documents provided by Novartis ( Novartis Pharmaceuticals ):

Study Protocol [PDF] January 7, 2020

Statistical Analysis Plan [PDF] January 29, 2021

More Information

Additional Information:

Generation Program web site This link exits the ClinicalTrials.gov site

Layout table for additonal information

Responsible Party:	Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT02565511
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
Results First Posted:	July 8, 2021
Last Update Posted:	July 8, 2021
Last Verified:	July 2021
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

Layout table for additional information

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 Alzheimers Disease (AD) Aβ lowering CNP520	CAD106 elderly Brain Amyloid BACE-1 inhibitor Prevention Unimpaired cognition

Additional relevant MeSH terms:

Layout table for MeSH terms

Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies	Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders Umibecestat Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action

To Top