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Alzheimers DiseasePhase 2/3GS1NCT02565511

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

A Phase 2/3 study testing CAD106 Immunotherapy, CNP520 and Alum in people with Alzheimers Disease, run by Novartis Pharmaceuticals at 129 sites in 10 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 60 to 75 years
Conditions the study is for
Alzheimers Disease
What is being tested?
CAD106 Immunotherapy, CNP520 and Alum
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
480 participants
Where
129 sitesin 10 countries
Study dates
30 Nov 2015to 30 Apr 2020
Phase
Phase 2/3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).
Show all 13Show fewer
  • 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.

Trial locations and contacts

129 sites in 10 countries.

129 sites in 10 countries

United States78 sites

  • Novartis Investigative Site

    Atlanta, Georgia, 30322

  • JEM Research Institute

    Atlantis, Florida, 33462-6608

  • Senior Adults Specialty Research

    Austin, Texas, 78757

  • Novartis Investigative Site

    Bangor, Maine, 04401

  • Novartis Investigative Site

    Basalt, Colorado, 81621

  • University Hospitals Cleveland Medical Center / Case Western Reserve University

    Beachwood, Ohio, 44122

  • The Memory Clinic

    Bennington, Vermont, 05201

  • Florida Atlantic University, Clinical Translational Research Unit

    Boca Raton, Florida, 33431

  • Novartis Investigative Site

    Boston, Massachusetts, 02115

  • Novartis Investigative Site

    Boston, Massachusetts, 02118

  • Novartis Investigative Site

    Centerville, Ohio, 45459

  • Roper St. Francis - CBRI

    Charleston, South Carolina, 29401

  • Alzheimer's Memory Center

    Charlotte, North Carolina, 28270

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Great Lakes Clinical Trials

    Chicago, Illinois, 60640

  • Medical Research & Health Education Foundation, Inc.

    Columbus, Georgia, 31909

  • Novartis Investigative Site

    Columbus, Ohio, 43210

  • ATP Clinical Research, Inc.

    Costa Mesa, California, 92626

  • Kerwin Research Center & Memory Care

    Dallas, Texas, 75231

  • NeuroStudies

    Decatur, Georgia, 30033

  • Brain Matters Research

    Delray Beach, Florida, 33445

  • Duke University Medical center

    Durham, North Carolina, 27705

  • Memory Enhancement Center

    Eatontown, New Jersey, 07724

  • University of Kansas Alzheimer's Disease Center

    Fairway, Kansas, 66205

  • Triad Clinical Trials, LLC

    Greensboro, North Carolina, 27410

  • Houston Methodist Hospital

    Houston, Texas, 77030

  • University of Texas Health Science Center, Houston

    Houston, Texas, 77054

  • Clinical Trial Network

    Houston, Texas, 77074

  • Indiana University

    Indianapolis, Indiana, 46202

  • Irvine Center for Clinical Research

    Irvine, California, 92614

  • Novartis Investigative Site

    Jacksonville, Florida, 32224

  • The Clinical Trial Center, LLC

    Jenkintown, Pennsylvania, 19046

  • Novartis Investigative Site

    Kalamazoo, Michigan, 49008

  • Novartis Investigative Site

    Knoxville, Tennessee, 37920

  • Cleveland Clinic Lou Ruvo Center for Brain Health

    Las Vegas, Nevada, 89106

  • The Memory Center of Northeastern New York

    Latham, New York, 12110

  • Sanders Brown Center on Aging, University of Kentucky

    Lexington, Kentucky, 40504

  • University of Southern California Keck School of Medicine Alzheimer Disease Research Center

    Los Angeles, California, 90033

  • Meridien Research

    Maitland, Florida, 32751

  • CNS Healthcare

    Memphis, Tennessee, 38119

  • Advanced Clinical Research

    Meridian, Idaho, 83642

  • Merritt Island Medical Research

    Merritt Island, Florida, 32952

  • University of Miami

    Miami, Florida, 33136

  • Mount Sinai Medical Center - The Wien Center

    Miami Beach, Florida, 33140

  • The Medical College of WI

    Milwaukee, Wisconsin, 53226

  • Novartis Investigative Site

    Nashville, Tennessee, 37212

  • Yale University Alzheimer's Disease Research Unit

    New Haven, Connecticut, 06510

  • NYU Langone Medical Center

    New York, New York, 10016

  • IPS Research Company

    Oklahoma City, Oklahoma, 73103

  • Novartis Investigative Site

    Oklahoma City, Oklahoma, 73112

  • Memory Disorders Program, Department of Neurological Sciences, University of Nebraska Medical Center

    Omaha, Nebraska, 68198-7680

  • The Nathan S. Kline Institute

    Orangeburg, New York, 10962

  • Novartis Investigative Site

    Orlando, Florida, 32806

  • Compass Research

    Orlando, Florida, 32812

  • Novartis Investigative Site

    Palo Alto, California, 94304

  • Novartis Investigative Site

    Philadelphia, Pennsylvania, 19104

  • Banner Alzheimer's Institute

    Phoenix, Arizona, 85006

  • Novartis Investigative Site

    Phoenix, Arizona, 85006

  • Progressive Medical Research

    Port Orange, Florida, 32127

  • Memory Health Center at Summit Research Network

    Portland, Oregon, 97210

  • Butler Hospital Memory and Aging Program

    Providence, Rhode Island, 02906

  • University of Rochester Medical Center

    Rochester, New York, 14620

  • Novartis Investigative Site

    Saint Paul, Minnesota, 55130

  • Novartis Investigative Site

    San Diego, California, 92103

  • Syrentis Clinical Research

    Santa Ana, California, 92705

  • Novartis Investigative Site

    Scottsdale, Arizona, 85259

  • Novartis Investigative Site

    Sebastopol, California, 95472

  • California Neuroscience Research Medical Group, Inc.

    Sherman Oaks, California, 91316

  • Novartis Investigative Site

    St Louis, Missouri, 63104

  • New England Institute for Clinical Research

    Stamford, Connecticut, 06905

  • Banner Sun City Research Institute

    Sun City, Arizona, 85351

  • Universal Research Group

    Tacoma, Washington, 98405

  • USF Health Byrd Alzheimer's Institute

    Tampa, Florida, 33613

  • Novartis Investigative Site

    Temecula, California, 92591

  • Georgetown University

    Washington D.C., District of Columbia, 20057

  • Novartis Investigative Site

    Washington D.C., District of Columbia, 20059

  • Via Christi Research

    Wichita, Kansas, 67214

  • Abington Neurological Associates

    Willow Grove, Pennsylvania, 19090

Other trials in United States

United Kingdom15 sites

  • Novartis Investigative Site

    Avon, BA1 3NG

  • Novartis Investigative Site

    Birmingham, B16 8QQ

  • Novartis Investigative Site

    Dundee, DD1 9SY

  • Novartis Investigative Site

    Exeter, Devon, EX2 5DW

  • Novartis Investigative Site

    Glasgow, G20 0XA

  • Novartis Investigative Site

    Glasgow

  • Novartis Investigative Site

    Guildford, Surrey, GU27YD

  • Novartis Investigative Site

    London, SE5 8AD

  • Novartis Investigative Site

    London, W12 0HS

  • Novartis Investigative Site

    London, W1G 9JF

  • Novartis Investigative Site

    London, W2 1NY

  • Novartis Investigative Site

    London, W2 1PG

  • Novartis Investigative Site

    Manchester, M13 9WL

  • Novartis Investigative Site

    Plymouth, Devon, PL6 8BT

  • Novartis Investigative Site

    Westbruy on Trym, Bristol, BS10 5NB

Other trials in United Kingdom

Germany12 sites

  • Novartis Investigative Site

    Bayreuth, 95445

  • Novartis Investigative Site

    Berlin, 13353

  • Novartis Investigative Site

    Böblingen, 71032

  • Novartis Investigative Site

    Cologne, 50937

  • Novartis Investigative Site

    Göttingen, 37075

  • Novartis Investigative Site

    Halle, 06120

  • Novartis Investigative Site

    Kiel, 24105

  • Novartis Investigative Site

    Leipzig, 04107

  • Novartis Investigative Site

    Mannheim, 68159

  • Novartis Investigative Site

    Münster, 48149

  • Novartis Investigative Site

    Siegen, 57076

  • Novartis Investigative Site

    Wenzenbach, 93173

Other trials in Germany

Canada11 sites

  • Novartis Investigative Site

    Gatineau, Quebec, J8T 8J1

  • Novartis Investigative Site

    Halifax, Nova Scotia, B3S 1M7

  • Okanagan Clinical Trials

    Kelowna, British Columbia, V1Y1Z9

  • Novartis Investigative Site

    Kentville, Nova Scota, B4N 4K9

  • Novartis Investigative Site

    London, Ontario, N6C 0A7

  • Novartis Investigative Site

    Québec, Quebec, G1J 1Z4

  • Novartis Investigative Site

    Sherbrooke, Quebec, J1H 5N4

  • Novartis Investigative Site

    Sherbrooke, Quebec, J1J 2G2

  • Toronto Memory Program

    Toronto, Ontario, M3B 2S7

  • The Centre for Memory and Aging

    Toronto, Ontario, M4G 3E8

  • Novartis Investigative Site

    Toronto, Ontario, M4N 3M5

Other trials in Canada

Spain5 sites

  • Novartis Investigative Site

    Barcelona, 08005

  • Novartis Investigative Site

    Barcelona, 08014

  • Novartis Investigative Site

    Donostia / San Sebastian, 20009

  • Novartis Investigative Site

    Pozuelo de Alarcón, Madrid, 28223

  • Novartis Investigative Site

    Terrassa, Barcelona, 08221

Other trials in Spain

Australia3 sites

  • Novartis Investigative Site

    Darlinghurst, New South Wales, 2010

  • Novartis Investigative Site

    Heidelberg Heights, Victoria, 3081

  • Novartis Investigative Site

    Nedlands, Western Australia, 6009

Other trials in Australia

Belgium2 sites

  • Novartis Investigative Site

    Ghent, 9000

  • Novartis Investigative Site

    Leuven, 3000

Other trials in Belgium

Finland1 site

  • Novartis Investigative Site

    Turku, 20520

Other trials in Finland

Netherlands1 site

  • Novartis Investigative Site

    Amsterdam, 1081 GN

Other trials in Netherlands

Switzerland1 site

  • Novartis Investigative Site

    Basel, CH, 4002

Other trials in Switzerland

About this study

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.

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.

Read the 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.

Being tested
CAD106 Immunotherapy, Placebo to CAD106, CNP520, Placebo to CNP520, Alum
Keywords
Randomization, Placebo controlled, Parallel-group, APOE4 Homozygotes, Preclinical Alzheimers Disease (AD), Aβ lowering, CNP520, CAD106, elderly, Brain Amyloid, BACE-1 inhibitor, Prevention, Unimpaired cognition
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CAD106 ImmunotherapyBiological

    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 to CAD106Other

    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.

  • CNP520Drug

    CNP520 50 mg capsule p.o. for the duration of the Treatment Epoch.

  • Placebo to CNP520Other

    Placebo to CNP520 p.o. for the duration of the Treatment Epoch

  • AlumOther

    Alum was mixed with reconstituted CAD106 as adjuvant therapy to maximize the effectiveness of CAD106

Study groups in NCT02565511
Study groupRoleWhat they receive
Cohort I (CAD106)ExperimentalCAD106 (450 µg) + Alum (450 µg) intra-muscular injection at Weeks 1, 7, 13 and every 13 weeks thereafter
Receives: Biological: CAD106 Immunotherapy; Other: Alum
Cohort I (CAD106 Placebo)Placebo comparatorPlacebo to CAD106 + Alum (450 µg) intra-muscular injection at Weeks 1, 7, 13 and every 13 weeks thereafter
Receives: Other: Placebo to CAD106; Other: Alum
Cohort II (CNP520)ExperimentalCNP520 (50 mg) capsules taken orally once daily
Receives: Drug: CNP520
Cohort II (CNP520 Placebo)Placebo comparatorMatching Placebo to CNP520 capsules taken orally once daily
Receives: Other: Placebo to CNP520

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to Event (Diagnosis of Mild Cognitive Impairment or Dementia, Due to Alzheimer's Disease (AD))

    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.

    Measured: Baseline to end of exposure for a maximum of 1455 days for CI and 907 days for CII

  2. Change in the Alzheimer's Prevention Initiative Composite Cognitive (APCC) Test Score

    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.

    Measured: 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

Secondary outcomes (17)

  1. Change in Clinical Dementia Rating Scale Sum of Boxes (CDR-SOB) Score

    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.

    Measured: 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

  2. Change in the Total Scores of the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS).

    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.

    Measured: 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

  3. Change in the Index Scores of the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS).

    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.

    Measured: 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

  4. Change in the Everyday Cognition Scale (ECog-Subject) Total Scores

    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.

    Measured: 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

  5. Change in the Everyday Cognition Scale (ECog-Informant) Total Scores

    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.

    Measured: 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

  6. Number of Participants With Newly Occurring Safety MRI Abnormalities (ARIA-E, ARIA-H,White Matter Disease and Any Other MRI Abnormalities)

    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.

    Measured: Baseline to end of exposure for a maximum of 1455 days for CI and 907 days for CII

  7. Annualized Percent Change on Volume of Brain Regions

    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.

    Measured: 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

  8. Change in Cerebrospinal Fluid (CSF) Levels of Amyloid Beta 40 (Aβ40)

    Alzheimer's Disease-related biomarkers analyzed in cerebrospinal fluid (CSF): Amyloid Beta 40 (Aβ40)

    Measured: Baseline to last assessment

  9. Change in Cerebrospinal Fluid (CSF) Levels of Amyloid Beta 42 (Aβ42)

    Alzheimer's Disease-related biomarkers analyzed in cerebrospinal fluid (CSF): Amyloid Beta 42 (Aβ42)

    Measured: Baseline to last assessment

  10. Change in Cerebrospinal Fluid (CSF) Levels of Total Tau and Phosphorylated Tau

    Alzheimer's Disease-related biomarkers analyzed in cerebrospinal fluid (CSF): total tau protein and phosphorylated tau protein levels

    Measured: Baseline to last assessment

  11. Change in Neurofibrillary Tangle Burden as Measured by Standardized Uptake Ratio (SUVR) of PET Scans With Tau Radiotracer (Where Available)

    To demonstrate the effects of CNP520 vs placebo on tau pathology in the brain

    Measured: Baseline to last assessment

  12. Cohort I : Annualized Change in Amyloid Deposition as Measured by Centiloids of Positron Emission Tomography (PET) Scan With Amyloid Radiotracer

    To demonstrate the effects of CAD106 vs placebo on Alzheimer's Disease-related biomarkers

    Measured: Baseline up to approximately Week 104

  13. Change in Serum Neurofilaments

    Alzheimer's Disease-related biomarkers analyzed in blood serum: light chain neurofilaments (NfL)

    Measured: Baseline to Week 26 and week 52, CI baseline to last assessment. CII baseline to last on-treatment and to last off-treatment

  14. Number of Suicidal Ideation or Behavior Events

    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.

    Measured: Baseline to end of exposure for a maximum of 1455 days for CI and 907 days for CII

  15. Cohort I : Change in Cognition as Measured by APCC and CDR-SOB Scores and Antibody Response

    Measured: Month 6 to Month 60

  16. Cohort I: Peak Concentration (Cmax) of CAD106 Induced Abeta-specific Antibody Titers

    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.

    Measured: Week 9, 13, 15, 26 and quarterly thereafter (trough values)

  17. Cohort I: Area Under the Concentration Curve (AUC) of CAD106 Induced Abeta-specific Antibody Titers

    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.).

    Measured: Week 9, 13, 15, 26 and quarterly thereafter (trough values)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2015 (estimated)
  2. Study start30 Nov 2015
  3. Primary completion30 Apr 2020
  4. Study completion30 Apr 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
480 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02565511
Sponsor's protocol ID
CAPI015A2201J
Other IDs
2015-002715-15, 1UF1AG046150-01, 2015
Acronym
GS1
Status last verified
Jul 2021
First submitted
28 Sep 2015
Last updated
8 Jul 2021
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing CAD106 Immunotherapy, CNP520 and Alum in people with Alzheimers Disease, run by Novartis Pharmaceuticals at 129 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 8 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 129 sites in United States, United Kingdom, Germany, Canada, Spain and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02565511.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2021.

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