AzTrials
AzTrials

Alzheimers DiseasePhase 2/3GS2NCT03131453

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

A Phase 2/3 study testing CNP520 50mg and CNP520 15mg in people with Alzheimers Disease, run by Novartis Pharmaceuticals at 194 sites in 25 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 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. Read more about this study

Who is it for?
Ages 60 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Alzheimers Disease
What is being tested?
CNP520 50mg and CNP520 15mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,145 participants
Where
194 sitesin 25 countries
Study dates
3 Aug 2017to 26 Mar 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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • Any disability that could have prevented the participants 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 could 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 the past 60 months.
  • Indication for, or current treatment with ChEIs and/or another AD treatment (e.g. memantine).
  • Contraindication or intolerance to MRI.
Show all 12Show fewer
  • Brain MRI results showing findings unrelated to AD that, in the opinion of the Investigator might be a leading cause to future cognitive decline, could have posed a risk to the participant, or could have prevented 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, was 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.

Trial locations and contacts

194 sites in 25 countries.

194 sites in 25 countries

United States95 sites

  • Albuquerque Neuroscience, 101 Hospital Loop ne, 209 209

    Albuquerque, New Mexico, 87109

  • Novartis Investigative Site

    Atlanta, Georgia, 30322

  • Novartis Investigative Site

    Atlantis, Florida, 33462-6608

  • Novartis Investigative Site

    Austin, Texas, 78757

  • Novartis Investigative Site

    Bangor, Maine, 04401

  • Mountain Neurological Research, 350 Market Street, Suite 316

    Basalt, Colorado, 81621

  • Novartis Investigative Site

    Bennington, Vermont, 05201

  • Novartis Investigative Site

    Boston, Massachusetts, 02118

  • Novartis Investigative Site

    Boston, Massachusetts, 02215

  • Novartis Investigative Site

    Brooklyn, New York, 11235

  • Roper Hospital, 316 Calhoun Street 5th Floor

    Charleston, South Carolina, 29401

  • ANI Neurology, PLLC dba Alzhe, 7809 Sardis Road

    Charlotte, North Carolina, 28270

  • Novartis Investigative Site

    Chicago, Illinois, 60612

  • Novartis Investigative Site

    Chicago, Illinois, 60640

  • Novartis Investigative Site

    Cincinnati, Ohio, 45242

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

    Colorado Springs, Colorado, 80907

  • Novartis Investigative Site

    Columbus, Georgia, 31909

  • ATP Clinical Research Inc, 3151 Airway Avenue T 3

    Costa Mesa, California, 92626

  • Novartis Investigative Site

    Dallas, Texas, 75231

  • Novartis Investigative Site

    Decatur, Georgia, 30033

  • Quantum Laboratories

    Deerfield Beach, Florida, 33064

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

    Delray Beach, Florida, 33445

  • Denver Neurological Clinic, 950 E Harvard Ave

    Denver, Colorado, 80210

  • Novartis Investigative Site

    Durham, North Carolina, 27710

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

    East Providence, Rhode Island, 02914

  • Novartis Investigative Site

    East Syracuse, New York, 13057

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

    Elk Grove Village, Illinois, 60007

  • Novartis Investigative Site

    Fairway, Kansas, 66205

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

    Farmington Hills, Michigan, 48334

  • Novartis Investigative Site

    Greensboro, North Carolina, 27410

  • Hattiesburg Clinic, 415 South 28th Avenue

    Hattiesburg, Mississippi, 39401

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

    Hollywood, Florida, 33021

  • Hawaii Pacific Neuroscience, 2230 Liliha st 104

    Honolulu, Hawaii, 96817

  • Novartis Investigative Site

    Houston, Texas, 77030

  • Novartis Investigative Site

    Houston, Texas, 77054

  • Novartis Investigative Site

    Indianapolis, Indiana, 46202

  • Irvine Center for Clinical Res, 2515 McCabe Way

    Irvine, California, 92618

  • Novartis Investigative Site

    Jenkintown, Pennsylvania, 19046

  • Novartis Investigative Site

    Kalamazoo, Michigan, 49008

  • Novartis Investigative Site

    Knoxville, Tennessee, 37920

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

    Lake Worth, Florida, 33449

  • Novartis Investigative Site

    Latham, New York, 12110

  • Novartis Investigative Site

    Lexington, Kentucky, 40536-0284

  • Torrance Clinical Research Institute, 25043 Narbonne Avenue

    Lomita, California, 90717

  • Meridien Research, 2300 Maitland center, Pkwy Ste 230

    Maitland, Florida, 32751

  • Novartis Investigative Site

    Melbourne, Florida, 32940

  • Novartis Investigative Site

    Memphis, Tennessee, 38119

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

    Meridian, Idaho, 83642

  • Novartis Investigative Site

    Merritt Island, Florida, 32952

  • Novartis Investigative Site

    Miami, Florida, 33032

  • Novartis Investigative Site

    Miami, Florida, 33136

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

    Miami, Florida, 33175

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

    Miami, Florida, 33176

  • Novartis Investigative Site

    Miami Beach, Florida, 33140

  • Novartis Investigative Site

    Milwaukee, Wisconsin, 53226

  • Novartis Investigative Site

    Nashville, Tennessee, 37212

  • Yale University, One Church Street, Suite 600

    New Haven, Connecticut, 06519

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

    New York, New York, 10016

  • Novartis Investigative Site

    Oklahoma City, Oklahoma, 73112

  • Novartis Investigative Site

    Omaha, Nebraska, 68198 7680

  • Novartis Investigative Site

    Orangeburg, New York, 10962

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

    Orlando, Florida, 32806

  • Novartis Investigative Site

    Orlando, Florida, 32806

  • Novartis Investigative Site

    Ormond Beach, Florida, 32174

  • Novartis Investigative Site

    Oxnard, California, 93030

  • Novartis Investigative Site

    Palm Beach Gardens, Florida, 33410

  • Novartis Investigative Site

    Palo Alto, California, 94304

  • Novartis Investigative Site

    Philadelphia, Pennsylvania, 19104

  • Banner Alzheimer's Institute, 901 East Willetta Street

    Phoenix, Arizona, 85006

  • Novartis Investigative Site

    Port Orange, Florida, 32127

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

    Portland, Oregon, 97210

  • Novartis Investigative Site

    Portland, Oregon, 97239

  • Butler Hospital, 345 Blackstone Blvd.

    Providence, Rhode Island, 02906

  • Novartis Investigative Site

    Rochester, Minnesota, 55905

  • Novartis Investigative Site

    Rochester, New York, 14642

  • Novartis Investigative Site

    San Antonio, Texas, 78229

  • Novartis Investigative Site

    San Diego, California, 92103

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

    Santa Ana, California, 92705

  • Roskamp Institute, Inc., 2040 Whitfield Avenue

    Sarasota, Florida, 34243

  • Novartis Investigative Site

    Sebastopol, California, 95472

  • Novartis Investigative Site

    Sherman Oaks, California, 91403

  • Novartis Investigative Site

    St Louis, Missouri, 63104

  • Novartis Investigative Site

    Stamford, Connecticut, 06905

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

    Sun City, Arizona, 85351

  • Novartis Investigative Site

    Tacoma, Washington, 98405

  • Novartis Investigative Site

    Tallahassee, Florida, 32308

  • Novartis Investigative Site

    Tampa, Florida, 33613

  • Novartis Investigative Site

    Tucson, Arizona, 85724

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

    Tulsa, Oklahoma, 74104

  • Novartis Investigative Site

    Washington D.C., District of Columbia, 20057

  • Novartis Investigative Site

    West Long Branch, New Jersey, 07764

  • Novartis Investigative Site

    West Palm Beach, Florida, 33407

  • Novartis Investigative Site

    Wichita, Kansas, 67206

  • Novartis Investigative Site

    Wichita, Kansas, 67214

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

    Willow Grove, Pennsylvania, 19090

Other trials in United States

United Kingdom11 sites

  • Novartis Investigative Site

    Avon, BA1 3NG

  • Novartis Investigative Site

    Birmingham, B16 8QQ

  • Novartis Investigative Site

    Bristol, BS10 5NB

  • Novartis Investigative Site

    Dundee, DD1 9SY

  • Novartis Investigative Site

    Exeter, Devon, EX2 5DW

  • Novartis Investigative Site

    Glasgow

  • Novartis Investigative Site

    Guildford, Surrey, GU27YD

  • Novartis Investigative Site

    London, GBR, W12 7RH

  • Novartis Investigative Site

    London, W12 0HS

  • Novartis Investigative Site

    London, W1G 9JF

  • Novartis Investigative Site

    Plymouth, Devon, PL6 8BT

Other trials in United Kingdom

Canada10 sites

  • Novartis Investigative Site

    Gatineau, Quebec, J8T 8J1

  • Novartis Investigative Site

    Greenfield Park, Quebec, J4V 2J2

  • Novartis Investigative Site

    Halifax, Nova Scotia, B3S 1M7

  • Novartis Investigative Site

    Kelowna, British Columbia, V1Y1Z9

  • Novartis Investigative Site

    Kentville, Nova Scota, B4N 4K9

  • Novartis Investigative Site

    Ottawa, Ontario, K1G 1Z3

  • Novartis Investigative Site

    Québec, Quebec, G1J 1Z4

  • Toronto Memory Program, 1 Valleybrook Drive Suite 400

    Toronto, Ontario, M3B 2S7

  • Novartis Investigative Site

    Toronto, Ontario, M4G 3E8

  • Novartis Investigative Site

    Toronto, Ontario, M4N 3M5

Other trials in Canada

Japan10 sites

  • Novartis Investigative Site

    Bunkyo Ku, Tokyo, 113 8655

  • Novartis Investigative Site

    Bunkyo Ku, Tokyo, 113-8431

  • Novartis Investigative Site

    Chiba, 260 8677

  • Novartis Investigative Site

    Fukuoka, Fukuoka, 814 0180

  • Novartis Investigative Site

    Kodaira, Tokyo, 187-8551

  • Novartis Investigative Site

    Osaka, 545-8586

  • Novartis Investigative Site

    Shinjuku-ku, Tokyo, 160 8582

  • Novartis Investigative Site

    Suita, Osaka, 565 0871

  • Novartis Investigative Site

    Tōon, Ehime, 791-0295

  • Novartis Investigative Site

    Yokohama, Kanagawa, 236-0004

Other trials in Japan

Spain7 sites

  • Novartis Investigative Site

    Barcelona, 08005

  • Novartis Investigative Site

    Barcelona, 08014

  • Novartis Investigative Site

    Donostia / San Sebastian, 20009

  • Novartis Investigative Site

    Madrid, 28034

  • Novartis Investigative Site

    Madrid, 28041

  • Novartis Investigative Site

    Pozuelo de Alarcón, Madrid, 28223

  • Novartis Investigative Site

    Terrassa, Barcelona, 08221

Other trials in Spain

France6 sites

  • Novartis Investigative Site

    Lille, 59037

  • Novartis Investigative Site

    Paris, 75651

  • Novartis Investigative Site

    Rouen, 76031

  • Novartis Investigative Site

    Strasbourg, Cedex, 67098

  • Novartis Investigative Site

    Toulouse, 31059

  • Novartis Investigative Site

    Villeurbanne, 69100

Other trials in France

Germany6 sites

  • Novartis Investigative Site

    Bayreuth, 95445

  • Novartis Investigative Site

    Berlin, 13353

  • Novartis Investigative Site

    Cologne, 50937

  • Novartis Investigative Site

    Leipzig, 04107

  • Novartis Investigative Site

    Mannheim, 68159

  • Novartis Investigative Site

    Siegen, 57076

Other trials in Germany

Israel5 sites

  • Novartis Investigative Site

    Ashkelon, 78278

  • Novartis Investigative Site

    Haifa, 31096

  • Novartis Investigative Site

    Petah Tikva, 49100

  • Novartis Investigative Site

    Ramat Gan, 52621

  • Novartis Investigative Site

    Tel Aviv, 6423906

Other trials in Israel

South Korea5 sites

  • Novartis Investigative Site

    Busan, 49201

  • Novartis Investigative Site

    Incheon, 22332

  • Novartis Investigative Site

    Seoul, 05505

  • Novartis Investigative Site

    Seoul, 06351

  • Novartis Investigative Site

    Suwon, Gyeonggi-do, 16499

Other trials in South Korea

Italy4 sites

  • Novartis Investigative Site

    Brescia, BS, 25100

  • Novartis Investigative Site

    Milan, 20112

  • Novartis Investigative Site

    Monza, MB, 20900

  • Novartis Investigative Site

    Rome, Lazio, 00168

Other trials in Italy

Portugal4 sites

  • Novartis Investigative Site

    Coimbra, 3000 075

  • Novartis Investigative Site

    Lisbon, 1998-018

  • Novartis Investigative Site

    Matosinhos Municipality, 4454 513

  • Novartis Investigative Site

    Torres Vedras, Lisbon District, 2560-280

Other trials in Portugal

Australia3 sites

  • Novartis Investigative Site

    Darlinghurst, New South Wales, 2010

  • Novartis Investigative Site

    Heidelberg West, Victoria, 3081

  • Novartis Investigative Site

    Nedlands, Western Australia, 6009

Other trials in Australia

China3 sites

  • Novartis Investigative Site

    Beijing, 100053

  • Novartis Investigative Site

    Guangdong, 510370

  • Novartis Investigative Site

    Shanghai, Shanghai Municipality, 200080

Other trials in China

Mexico3 sites

  • Novartis Investigative Site

    Culiacán, Sinaloa, 80020

  • Novartis Investigative Site

    Mexico City, Mexico CP, 14080

  • Novartis Investigative Site

    Monterrey, Nuevo León, 64710

Other trials in Mexico

South Africa3 sites

  • Novartis Investigative Site

    Cape Town, Western Cape, 7530

  • Novartis Investigative Site

    George, ZAF, 6529

  • Novartis Investigative Site

    Rosebank, Johannesburg, 2132

Other trials in South Africa

Switzerland3 sites

  • Novartis Investigative Site

    Basel, CH, 4002

  • Novartis Investigative Site

    Geneva, 1227

  • Novartis Investigative Site

    Lausanne, CH-1011

Other trials in Switzerland

Taiwan3 sites

  • Novartis Investigative Site

    Kaoshiung, 83301

  • Novartis Investigative Site

    New Taipei City, 23561

  • Novartis Investigative Site

    Taipei, 11217

Other trials in Taiwan

Argentina2 sites

  • Novartis Investigative Site

    Buenos Aires, C1012AAR

  • Novartis Investigative Site

    CABA, Buenos Aires, C1428AQK

Other trials in Argentina

Belgium2 sites

  • Novartis Investigative Site

    Ghent, 9000

  • Novartis Investigative Site

    Leuven, 3000

Other trials in Belgium

Chile2 sites

  • Novartis Investigative Site

    Santiago, 7500710

  • Novartis Investigative Site

    Santiago, 838 0456

Other trials in Chile

Finland2 sites

  • Novartis Investigative Site

    Kuopio, 70210

  • Novartis Investigative Site

    Turku, 20520

Other trials in Finland

Netherlands2 sites

  • Novartis Investigative Site

    's-Hertogenbosch, North Brabant, 5223 LA

  • Novartis Investigative Site

    Amsterdam, 1081 GN

Other trials in Netherlands

Iceland1 site

  • Novartis Investigative Site

    Kopavogur, IS-201

Other trials in Iceland

Puerto Rico1 site

  • Inspira Clinical Research, Ave Hostos 405

    San Juan, 00918

Other trials in Puerto Rico

Singapore1 site

  • Novartis Investigative Site

    Singapore, 308433

Other trials in Singapore

About this study

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).

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.

Read the detailed description

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

Being tested
CNP520 50mg, CNP520 15mg, Matching placebo
Keywords
Placebo controlled, APOE4 carriers, Homozygotes, Heterozygotes, Brain Amyloid, Aβ lowering, BACE-1 inhibitor, CNP520, elderly, preclinical Alzheimers disease, Alzheimers Disease, 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.

  • CNP520 50mgDrug

    50 mg capsule

  • CNP520 15mgDrug

    15 mg capsule

  • Matching placeboOther

    Matching placebo for 15 and 50 mg capsules

Study groups in NCT03131453
Study groupRoleWhat they receive
CNP520 50 mgExperimental50 mg capsule taken orally once daily
Receives: Drug: CNP520 50mg
CNP520 15 mgExperimental15 mg capsule taken orally once daily
Receives: Drug: CNP520 15mg
PlaceboPlacebo comparatorMatching placebo to 15 and 50 mg CNP520 taken orally once daily
Receives: Other: Matching placebo

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 last cognitive assessment performed (up to day 648)

  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: Baseline to Week 26, Baseline to Last on-treatment (Day 547) and Baseline to Last off-treatment (Day 648)

Secondary outcomes (13)

  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: Baseline to Week 26, Baseline to Last on-treatment (Day 547) and Baseline to Last off-treatment (Day 648)

  2. Change in the Total and 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: Baseline to Week 26, Baseline to Last on-treatment (Day 547) and Baseline to Last off-treatment (Day 648)

  3. 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: Baseline to Week 26, Baseline to Last on-treatment (Day 547) and Baseline to Last off-treatment (Day 648)

  4. 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.

    Measured: Baseline to Week 26, Baseline to Last on-treatment (Day 547) and Baseline to Last off-treatment (Day 648)

  5. 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) and a general assessment of brain abnormalities.

    Measured: Baseline up to study termination approximately 617 days

  6. 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: Baseline to Week 26, Baseline to Last on-treatment (Day 547) and Baseline to Last off-treatment (Day 648)

  7. Change in 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 on-treatment (Day 547) and Baseline to Last off-treatment (Day 648)

  8. Change in 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 on-treatment (Day 547) and Baseline to Last off-treatment (Day 648)

  9. 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 Alzheimer's Disease-related biomarkers

    Measured: Baseline to Months 24 and 60

  10. Change in Amyloid Deposition as Measured by Standardized Uptake Ratio (SUVR) of Positron Emission Tomography (PET) Scan With Amyloid Radiotracer

    To demonstrate the effects of CNP520 vs placebo on Alzheimer's Disease-related biomarkers

    Measured: Baseline to Months 24 and 60

  11. Change in 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 on-treatment (Day 547) Baseline to Last off-treatment (Day 648)

  12. Change in Serum Neurofilaments

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

    Measured: Baseline to Week 26, baseline to Last on-treatment (Day 547) Baseline to Last off-treatment (Day 648)

  13. 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 up to study termination approximately 617 days

Timeline

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

  1. First posted27 Apr 2017
  2. Study start3 Aug 2017
  3. Primary completion26 Mar 2020
  4. Study completion26 Mar 2020

Why it stopped: The study was terminated due to safety issues.

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
1,145 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03131453
Sponsor's protocol ID
CCNP520A2202J
Other IDs
2016-002976-28, 2016
Acronym
GS2
Status last verified
Aug 2021
First submitted
5 Apr 2017
Last updated
5 Aug 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 CNP520 50mg and CNP520 15mg in people with Alzheimers Disease, run by Novartis Pharmaceuticals at 194 sites in 25 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 12 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 5 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 194 sites in United States, United Kingdom, Canada, Japan, Spain and 20 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 5 Aug 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 last cognitive assessment performed (up to day 648)). 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 NCT03131453.

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 5 Aug 2021.

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