A Study of CNP520 Versus Placebo in Participants at Risk for the Onset of Clinical Symptoms of Alzheimer's Disease (GS2)

August 4, 2021 updated by: Novartis Pharmaceuticals

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

1145

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Buenos Aires, Argentina, C1012AAR
        • Novartis Investigative Site
    • Buenos Aires
      • Caba, Buenos Aires, Argentina, C1428AQK
        • Novartis Investigative Site
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
        • Novartis Investigative Site
    • Victoria
      • Heidelberg West, Victoria, Australia, 3081
        • Novartis Investigative Site
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Novartis Investigative Site
      • Gent, Belgium, 9000
        • Novartis Investigative Site
      • Leuven, Belgium, 3000
        • Novartis Investigative Site
      • Quebec, Canada, G1J 1Z4
        • Novartis Investigative Site
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y1Z9
        • Novartis Investigative Site
    • Nova Scota
      • Kentville, Nova Scota, Canada, B4N 4K9
        • Novartis Investigative Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3S 1M7
        • Novartis Investigative Site
    • Ontario
      • Ottawa, Ontario, Canada, K1G 1Z3
        • Novartis Investigative Site
      • Toronto, Ontario, Canada, M4N 3M5
        • Novartis Investigative Site
      • Toronto, Ontario, Canada, M3B 2S7
        • Toronto Memory Program, 1 Valleybrook Drive Suite 400
      • Toronto, Ontario, Canada, M4G 3E8
        • Novartis Investigative Site
    • Quebec
      • Gatineau, Quebec, Canada, J8T 8J1
        • Novartis Investigative Site
      • Greenfield Park, Quebec, Canada, J4V 2J2
        • Novartis Investigative Site
      • Santiago, Chile, 7500710
        • Novartis Investigative Site
      • Santiago, Chile, 838 0456
        • Novartis Investigative Site
      • Beijing, China, 100053
        • Novartis Investigative Site
      • Guangdong, China, 510370
        • Novartis Investigative Site
    • Shanghai
      • Shanghai, Shanghai, China, 200080
        • Novartis Investigative Site
      • Kuopio, Finland, 70210
        • Novartis Investigative Site
      • Turku, Finland, 20520
        • Novartis Investigative Site
      • Lille Cedex, France, 59037
        • Novartis Investigative Site
      • PARIS Cedex 13, France, 75651
        • Novartis Investigative Site
      • Rouen, France, 76031
        • Novartis Investigative Site
      • Toulouse Cedex 9, France, 31059
        • Novartis Investigative Site
      • Villeurbanne, France, 69100
        • Novartis Investigative Site
    • Cedex
      • Strasbourg, Cedex, France, 67098
        • Novartis Investigative Site
      • Bayreuth, Germany, 95445
        • Novartis Investigative Site
      • Berlin, Germany, 13353
        • Novartis Investigative Site
      • Koeln, Germany, 50937
        • Novartis Investigative Site
      • Leipzig, Germany, 04107
        • Novartis Investigative Site
      • Mannheim, Germany, 68159
        • Novartis Investigative Site
      • Siegen, Germany, 57076
        • Novartis Investigative Site
      • Kopavogi, Iceland, IS-201
        • Novartis Investigative Site
      • Ashkelon, Israel, 78278
        • Novartis Investigative Site
      • Haifa, Israel, 31096
        • Novartis Investigative Site
      • Petach Tikva, Israel, 49100
        • Novartis Investigative Site
      • Ramat Gan, Israel, 52621
        • Novartis Investigative Site
      • Tel Aviv, Israel, 6423906
        • Novartis Investigative Site
      • Milan, Italy, 20112
        • Novartis Investigative Site
    • BS
      • Brescia, BS, Italy, 25100
        • Novartis Investigative Site
    • Lazio
      • Roma, Lazio, Italy, 00168
        • Novartis Investigative Site
    • MB
      • Monza, MB, Italy, 20900
        • Novartis Investigative Site
      • Chiba, Japan, 260 8677
        • Novartis Investigative Site
      • Osaka, Japan, 545-8586
        • Novartis Investigative Site
    • Ehime
      • Tōon, Ehime, Japan, 791-0295
        • Novartis Investigative Site
    • Fukuoka
      • Fukuoka city, Fukuoka, Japan, 814 0180
        • Novartis Investigative Site
    • Kanagawa
      • Yokohama-city, Kanagawa, Japan, 236-0004
        • Novartis Investigative Site
    • Osaka
      • Suita city, Osaka, Japan, 565 0871
        • Novartis Investigative Site
    • Tokyo
      • Bunkyo ku, Tokyo, Japan, 113-8431
        • Novartis Investigative Site
      • Bunkyo ku, Tokyo, Japan, 113 8655
        • Novartis Investigative Site
      • Kodaira, Tokyo, Japan, 187-8551
        • Novartis Investigative Site
      • Shinjuku-ku, Tokyo, Japan, 160 8582
        • Novartis Investigative Site
      • Busan, Korea, Republic of, 49201
        • Novartis Investigative Site
      • Incheon, Korea, Republic of, 22332
        • Novartis Investigative Site
      • Seoul, Korea, Republic of, 06351
        • Novartis Investigative Site
      • Seoul, Korea, Republic of, 05505
        • Novartis Investigative Site
    • Gyeonggi Do
      • Suwon, Gyeonggi Do, Korea, Republic of, 16499
        • Novartis Investigative Site
    • Mexico CP
      • Ciudad de Mexico, Mexico CP, Mexico, 14080
        • Novartis Investigative Site
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico, 64710
        • Novartis Investigative Site
    • Sinaloa
      • Culiacan, Sinaloa, Mexico, 80020
        • Novartis Investigative Site
      • Amsterdam, Netherlands, 1081 GN
        • Novartis Investigative Site
    • Noord Brabant
      • Den Bosch, Noord Brabant, Netherlands, 5223 LA
        • Novartis Investigative Site
      • Coimbra, Portugal, 3000 075
        • Novartis Investigative Site
      • Lisboa, Portugal, 1998-018
        • Novartis Investigative Site
      • Matosinhos, Portugal, 4454 513
        • Novartis Investigative Site
    • Lisbon
      • Torres Vedras, Lisbon, Portugal, 2560-280
        • Novartis Investigative Site
      • San Juan, Puerto Rico, 00918
        • Inspira Clinical Research, Ave Hostos 405
      • Singapore, Singapore, 308433
        • Novartis Investigative Site
    • Johannesburg
      • Rosebank, Johannesburg, South Africa, 2132
        • Novartis Investigative Site
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7530
        • Novartis Investigative Site
    • ZAF
      • George, ZAF, South Africa, 6529
        • Novartis Investigative Site
      • Barcelona, Spain, 08005
        • Novartis Investigative Site
      • Barcelona, Spain, 08014
        • Novartis Investigative Site
      • Donostia-San Sebastian, Spain, 20009
        • Novartis Investigative Site
      • Madrid, Spain, 28041
        • Novartis Investigative Site
      • Madrid, Spain, 28034
        • Novartis Investigative Site
    • Barcelona
      • Terrassa, Barcelona, Spain, 08221
        • Novartis Investigative Site
    • Madrid
      • Pozuelo de Alarcon, Madrid, Spain, 28223
        • Novartis Investigative Site
      • Geneve, Switzerland, 1227
        • Novartis Investigative Site
      • Lausanne, Switzerland, CH-1011
        • Novartis Investigative Site
    • CH
      • Basel, CH, Switzerland, 4002
        • Novartis Investigative Site
      • Kaoshiung, Taiwan, 83301
        • Novartis Investigative Site
      • New Taipei City, Taiwan, 23561
        • Novartis Investigative Site
      • Taipei, Taiwan, 11217
        • Novartis Investigative Site
      • Avon, United Kingdom, BA1 3NG
        • Novartis Investigative Site
      • Birmingham, United Kingdom, B16 8QQ
        • Novartis Investigative Site
      • Bristol, United Kingdom, BS10 5NB
        • Novartis Investigative Site
      • Dundee, United Kingdom, DD1 9SY
        • Novartis Investigative Site
      • Glasgow, United Kingdom
        • Novartis Investigative Site
      • London, United Kingdom, W12 0HS
        • Novartis Investigative Site
      • London, United Kingdom, W1G 9JF
        • Novartis Investigative Site
    • Devon
      • Exeter, Devon, United Kingdom, EX2 5DW
        • Novartis Investigative Site
      • Plymouth, Devon, United Kingdom, PL6 8BT
        • Novartis Investigative Site
    • GBR
      • London, GBR, United Kingdom, W12 7RH
        • Novartis Investigative Site
    • Surrey
      • Guildford, Surrey, United Kingdom, GU27YD
        • Novartis Investigative Site
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Banner Alzheimer's Institute, 901 East Willetta Street
      • Sun City, Arizona, United States, 85351
        • Banner Sun Health Research Institute, 10515 West Santa Fe Drive, Building B
      • Tucson, Arizona, United States, 85724
        • Novartis Investigative Site
    • California
      • Costa Mesa, California, United States, 92626
        • ATP Clinical Research Inc, 3151 Airway Avenue T 3
      • Irvine, California, United States, 92618
        • Irvine Center for Clinical Res, 2515 McCabe Way
      • Lomita, California, United States, 90717
        • Torrance Clinical Research Institute, 25043 Narbonne Avenue
      • Oxnard, California, United States, 93030
        • Novartis Investigative Site
      • Palo Alto, California, United States, 94304
        • Novartis Investigative Site
      • San Diego, California, United States, 92103
        • Novartis Investigative Site
      • Santa Ana, California, United States, 92705
        • Syrentis Clinical Research, 1401 N Tustin Ave, Suite 130
      • Sebastopol, California, United States, 95472
        • Novartis Investigative Site
      • Sherman Oaks, California, United States, 91403
        • Novartis Investigative Site
    • Colorado
      • Basalt, Colorado, United States, 81621
        • Mountain Neurological Research, 350 Market Street, Suite 316
      • Colorado Springs, Colorado, United States, 80907
        • Colorado Springs Neurological, 2312 North Nevada Avenue, Suite 100
      • Denver, Colorado, United States, 80210
        • Denver Neurological Clinic, 950 E Harvard Ave
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • Yale University, One Church Street, Suite 600
      • Stamford, Connecticut, United States, 06905
        • Novartis Investigative Site
    • District of Columbia
      • Washington, District of Columbia, United States, 20057
        • Novartis Investigative Site
    • Florida
      • Atlantis, Florida, United States, 33462-6608
        • Novartis Investigative Site
      • Deerfield Beach, Florida, United States, 33064
        • Quantum Laboratories
      • Delray Beach, Florida, United States, 33445
        • Brain Matters Research, Inc., 800 NW 17th Avenue
      • Hollywood, Florida, United States, 33021
        • Infinity Clinical Research LLC, 4925 Sheridan Street, Suite 200
      • Lake Worth, Florida, United States, 33449
        • Alzheimer's Research and Treatment Center, 5065 State Road 7, Suite 102
      • Maitland, Florida, United States, 32751
        • Meridien Research, 2300 Maitland center, Pkwy Ste 230
      • Melbourne, Florida, United States, 32940
        • Novartis Investigative Site
      • Merritt Island, Florida, United States, 32952
        • Novartis Investigative Site
      • Miami, Florida, United States, 33136
        • Novartis Investigative Site
      • Miami, Florida, United States, 33032
        • Novartis Investigative Site
      • Miami, Florida, United States, 33175
        • New Horizon Research Center, 11880 SW 40 St., Suite 405
      • Miami, Florida, United States, 33176
        • Miami-Dade Medical Research, 8955 SW 87 CT, Suite 112
      • Miami Beach, Florida, United States, 33140
        • Novartis Investigative Site
      • Orlando, Florida, United States, 32806
        • Novartis Investigative Site
      • Orlando, Florida, United States, 32806
        • Compass Research, LLC,100 West Gore Street, Suite 202
      • Ormond Beach, Florida, United States, 32174
        • Novartis Investigative Site
      • Palm Beach Gardens, Florida, United States, 33410
        • Novartis Investigative Site
      • Port Orange, Florida, United States, 32127
        • Novartis Investigative Site
      • Sarasota, Florida, United States, 34243
        • Roskamp Institute, Inc., 2040 Whitfield Avenue
      • Tallahassee, Florida, United States, 32308
        • Novartis Investigative Site
      • Tampa, Florida, United States, 33613
        • Novartis Investigative Site
      • West Palm Beach, Florida, United States, 33407
        • Novartis Investigative Site
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Novartis Investigative Site
      • Columbus, Georgia, United States, 31909
        • Novartis Investigative Site
      • Decatur, Georgia, United States, 30033
        • Novartis Investigative Site
    • Hawaii
      • Honolulu, Hawaii, United States, 96817
        • Hawaii Pacific Neuroscience, 2230 Liliha st 104
    • Idaho
      • Meridian, Idaho, United States, 83642
        • Advanced Clinical Research, 2950 E Magic View Dr, Suite 182
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Novartis Investigative Site
      • Chicago, Illinois, United States, 60640
        • Novartis Investigative Site
      • Elk Grove Village, Illinois, United States, 60007
        • Alexian Brothers Neuroscience, 800 Biesterfield Rd, Neuroscience Institute Brock
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Novartis Investigative Site
    • Kansas
      • Fairway, Kansas, United States, 66205
        • Novartis Investigative Site
      • Wichita, Kansas, United States, 67214
        • Novartis Investigative Site
      • Wichita, Kansas, United States, 67206
        • Novartis Investigative Site
    • Kentucky
      • Lexington, Kentucky, United States, 40536-0284
        • Novartis Investigative Site
    • Maine
      • Bangor, Maine, United States, 04401
        • Novartis Investigative Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Novartis Investigative Site
      • Boston, Massachusetts, United States, 02118
        • Novartis Investigative Site
    • Michigan
      • Farmington Hills, Michigan, United States, 48334
        • QUEST Research Institute, 28595 Orchard Lake Road, Suite 301
      • Kalamazoo, Michigan, United States, 49008
        • Novartis Investigative Site
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Novartis Investigative Site
    • Mississippi
      • Hattiesburg, Mississippi, United States, 39401
        • Hattiesburg Clinic, 415 South 28th Avenue
    • Missouri
      • Saint Louis, Missouri, United States, 63104
        • Novartis Investigative Site
    • Nebraska
      • Omaha, Nebraska, United States, 68198 7680
        • Novartis Investigative Site
    • New Jersey
      • West Long Branch, New Jersey, United States, 07764
        • Novartis Investigative Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • Albuquerque Neuroscience, 101 Hospital Loop ne, 209 209
    • New York
      • Brooklyn, New York, United States, 11235
        • Novartis Investigative Site
      • East Syracuse, New York, United States, 13057
        • Novartis Investigative Site
      • Latham, New York, United States, 12110
        • Novartis Investigative Site
      • New York, New York, United States, 10016
        • NYU Langone Medical Center, 145 East 32nd Street, 2nd Floor, Room 226
      • Orangeburg, New York, United States, 10962
        • Novartis Investigative Site
      • Rochester, New York, United States, 14642
        • Novartis Investigative Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28270
        • ANI Neurology, PLLC dba Alzhe, 7809 Sardis Road
      • Durham, North Carolina, United States, 27710
        • Novartis Investigative Site
      • Greensboro, North Carolina, United States, 27410
        • Novartis Investigative Site
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Novartis Investigative Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Novartis Investigative Site
      • Tulsa, Oklahoma, United States, 74104
        • Tulsa Clinical Research LLC, 1705 E 19th ST., STE 406/408
    • Oregon
      • Portland, Oregon, United States, 97239
        • Novartis Investigative Site
      • Portland, Oregon, United States, 97210
        • Summit Research Network, 2701 NW Vaughn St, Suite 350
    • Pennsylvania
      • Jenkintown, Pennsylvania, United States, 19046
        • Novartis Investigative Site
      • Philadelphia, Pennsylvania, United States, 19104
        • Novartis Investigative Site
      • Willow Grove, Pennsylvania, United States, 19090
        • Abington Neurological Associate Ltd., 2325 Maryland Road, Suite 100
    • Rhode Island
      • East Providence, Rhode Island, United States, 02914
        • Rhode Island Hospital and Memory Research Institute, 1018 Waterman Ave
      • Providence, Rhode Island, United States, 02906
        • Butler Hospital, 345 Blackstone Blvd.
    • South Carolina
      • Charleston, South Carolina, United States, 29401
        • Roper Hospital, 316 Calhoun Street 5th Floor
    • Tennessee
      • Knoxville, Tennessee, United States, 37920
        • Novartis Investigative Site
      • Memphis, Tennessee, United States, 38119
        • Novartis Investigative Site
      • Nashville, Tennessee, United States, 37212
        • Novartis Investigative Site
    • Texas
      • Austin, Texas, United States, 78757
        • Novartis Investigative Site
      • Dallas, Texas, United States, 75231
        • Novartis Investigative Site
      • Houston, Texas, United States, 77030
        • Novartis Investigative Site
      • Houston, Texas, United States, 77054
        • Novartis Investigative Site
      • San Antonio, Texas, United States, 78229
        • Novartis Investigative Site
    • Vermont
      • Bennington, Vermont, United States, 05201
        • Novartis Investigative Site
    • Washington
      • Tacoma, Washington, United States, 98405
        • Novartis Investigative Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

58 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • consent to receive disclosure of their risk estimates to develop clinical symptoms of AD based on their APOE genotype and, if Heterozygotes, evidence of elevated brain amyloid.
  • Male or female, age 60 to 75 years inclusive. Females must be considered post-menopausal and not of child bearing potential
  • Cognitively unimpaired as evaluated by memory tests performed at screening.
  • Participant's willingness to have a study partner.
  • Carrier of at least one APOE4 gene if Heterozygotes, elevated brain amyloid (as measured by CSF Abeta or amyloid PET imaging).

Exclusion Criteria:

  • Any disability that 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.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CNP520 50 mg
50 mg capsule taken orally once daily
50 mg capsule
Experimental: CNP520 15 mg
15 mg capsule taken orally once daily
15 mg capsule
Placebo Comparator: Placebo
Matching placebo to 15 and 50 mg CNP520 taken orally once daily
Matching placebo for 15 and 50 mg capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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.
Baseline to last cognitive assessment performed (up to day 648)
Change in the Alzheimer's Prevention Initiative Composite Cognitive (APCC) Test Score
Time Frame: Baseline to Week 26, Baseline to Last on-treatment (Day 547) and Baseline to Last off-treatment (Day 648)
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.
Baseline to Week 26, Baseline to Last on-treatment (Day 547) and Baseline to Last off-treatment (Day 648)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Clinical Dementia Rating Scale Sum of Boxes (CDR-SOB) Score
Time Frame: Baseline to Week 26, Baseline to Last on-treatment (Day 547) and Baseline to Last off-treatment (Day 648)
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
Baseline to Week 26, Baseline to Last on-treatment (Day 547) and Baseline to Last off-treatment (Day 648)
Change in the Total and Index Scores of the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Time Frame: Baseline to Week 26, Baseline to Last on-treatment (Day 547) and Baseline to Last off-treatment (Day 648)
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.
Baseline to Week 26, Baseline to Last on-treatment (Day 547) and Baseline to Last off-treatment (Day 648)
Change in the Everyday Cognition Scale (ECog-Subject) Total Scores
Time Frame: Baseline to Week 26, Baseline to Last on-treatment (Day 547) and Baseline to Last off-treatment (Day 648)
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.
Baseline to Week 26, Baseline to Last on-treatment (Day 547) and Baseline to Last off-treatment (Day 648)
Change in the Everyday Cognition Scale (ECog-Informant) Total Scores
Time Frame: Baseline to Week 26, Baseline to Last on-treatment (Day 547) and Baseline to Last off-treatment (Day 648)
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.
Baseline to Week 26, Baseline to Last on-treatment (Day 547) and Baseline to Last off-treatment (Day 648)
Number of Participants With Newly Occurring Safety MRI Abnormalities (ARIA-E, ARIA-H,White Matter Disease and Any Other MRI Abnormalities)
Time Frame: Baseline up to study termination approximately 617 days
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.
Baseline up to study termination approximately 617 days
Annualized Percent Change on Volume of Brain Regions
Time Frame: Baseline to Week 26, Baseline to Last on-treatment (Day 547) and Baseline to Last off-treatment (Day 648)
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.
Baseline to Week 26, Baseline to Last on-treatment (Day 547) and Baseline to Last off-treatment (Day 648)
Change in CSF Levels of Amyloid Beta 40 (Aβ40)
Time Frame: Baseline to Last on-treatment (Day 547) and Baseline to Last off-treatment (Day 648)
Alzheimer's Disease-related biomarkers analyzed in cerebrospinal fluid (CSF): Amyloid Beta 40 (Aβ40)
Baseline to Last on-treatment (Day 547) and Baseline to Last off-treatment (Day 648)
Change in CSF Levels of Amyloid Beta 42 (Aβ42)
Time Frame: Baseline to Last on-treatment (Day 547) and Baseline to Last off-treatment (Day 648)
Alzheimer's Disease-related biomarkers analyzed in cerebrospinal fluid (CSF): Amyloid Beta 42 (Aβ42).
Baseline to Last on-treatment (Day 547) and Baseline to Last off-treatment (Day 648)
Change in Neurofibrillary Tangle Burden as Measured by Standardized Uptake Ratio (SUVR) of PET Scans With Tau Radiotracer (Where Available)
Time Frame: Baseline to Months 24 and 60
To demonstrate the effects of CNP520 vs placebo on Alzheimer's Disease-related biomarkers
Baseline to Months 24 and 60
Change in Amyloid Deposition as Measured by Standardized Uptake Ratio (SUVR) of Positron Emission Tomography (PET) Scan With Amyloid Radiotracer
Time Frame: Baseline to Months 24 and 60
To demonstrate the effects of CNP520 vs placebo on Alzheimer's Disease-related biomarkers
Baseline to Months 24 and 60
Change in CSF Levels of Total Tau and Phosphorylated Tau
Time Frame: Baseline to Last on-treatment (Day 547) Baseline to Last off-treatment (Day 648)
Alzheimer's Disease-related biomarkers analyzed in cerebrospinal fluid (CSF): total tau protein and phosphorylated tau protein levels
Baseline to Last on-treatment (Day 547) Baseline to Last off-treatment (Day 648)
Change in Serum Neurofilaments
Time Frame: Baseline to Week 26, baseline to Last on-treatment (Day 547) Baseline to Last off-treatment (Day 648)
Alzheimer's Disease-related biomarkers analyzed in blood serum: light chain neurofilaments (NfL)
Baseline to Week 26, baseline to Last on-treatment (Day 547) Baseline to Last off-treatment (Day 648)
Number of Suicidal Ideation or Behavior Events
Time Frame: Baseline up to study termination approximately 617 days
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.
Baseline up to study termination approximately 617 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 3, 2017

Primary Completion (Actual)

March 26, 2020

Study Completion (Actual)

March 26, 2020

Study Registration Dates

First Submitted

April 5, 2017

First Submitted That Met QC Criteria

April 24, 2017

First Posted (Actual)

April 27, 2017

Study Record Updates

Last Update Posted (Actual)

August 5, 2021

Last Update Submitted That Met QC Criteria

August 4, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD 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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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