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

Primary Purpose

Alzheimers Disease

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
CNP520 50mg
CNP520 15mg
Matching placebo
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimers Disease focused on measuring Placebo controlled, APOE4 carriers, Homozygotes, Heterozygotes, Brain Amyloid, Aβ lowering, BACE-1 inhibitor, CNP520, elderly, preclinical Alzheimers disease, Alzheimers Disease, Prevention, Unimpaired cognition

Eligibility Criteria

60 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Banner Alzheimer's Institute, 901 East Willetta Street
  • Banner Sun Health Research Institute, 10515 West Santa Fe Drive, Building B
  • Novartis Investigative Site
  • ATP Clinical Research Inc, 3151 Airway Avenue T 3
  • Irvine Center for Clinical Res, 2515 McCabe Way
  • Torrance Clinical Research Institute, 25043 Narbonne Avenue
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Syrentis Clinical Research, 1401 N Tustin Ave, Suite 130
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Mountain Neurological Research, 350 Market Street, Suite 316
  • Colorado Springs Neurological, 2312 North Nevada Avenue, Suite 100
  • Denver Neurological Clinic, 950 E Harvard Ave
  • Yale University, One Church Street, Suite 600
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Quantum Laboratories
  • Brain Matters Research, Inc., 800 NW 17th Avenue
  • Infinity Clinical Research LLC, 4925 Sheridan Street, Suite 200
  • Alzheimer's Research and Treatment Center, 5065 State Road 7, Suite 102
  • Meridien Research, 2300 Maitland center, Pkwy Ste 230
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • New Horizon Research Center, 11880 SW 40 St., Suite 405
  • Miami-Dade Medical Research, 8955 SW 87 CT, Suite 112
  • Compass Research, LLC,100 West Gore Street, Suite 202
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Roskamp Institute, Inc., 2040 Whitfield Avenue
  • Novartis Investigative Site
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  • Novartis Investigative Site
  • Hawaii Pacific Neuroscience, 2230 Liliha st 104
  • Advanced Clinical Research, 2950 E Magic View Dr, Suite 182
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Alexian Brothers Neuroscience, 800 Biesterfield Rd, Neuroscience Institute Brock
  • Novartis Investigative Site
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  • QUEST Research Institute, 28595 Orchard Lake Road, Suite 301
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Hattiesburg Clinic, 415 South 28th Avenue
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Albuquerque Neuroscience, 101 Hospital Loop ne, 209 209
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • NYU Langone Medical Center, 145 East 32nd Street, 2nd Floor, Room 226
  • Novartis Investigative Site
  • Novartis Investigative Site
  • ANI Neurology, PLLC dba Alzhe, 7809 Sardis Road
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Tulsa Clinical Research LLC, 1705 E 19th ST., STE 406/408
  • Summit Research Network, 2701 NW Vaughn St, Suite 350
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Abington Neurological Associate Ltd., 2325 Maryland Road, Suite 100
  • Rhode Island Hospital and Memory Research Institute, 1018 Waterman Ave
  • Butler Hospital, 345 Blackstone Blvd.
  • Roper Hospital, 316 Calhoun Street 5th Floor
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
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  • Toronto Memory Program, 1 Valleybrook Drive Suite 400
  • Novartis Investigative Site
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  • Novartis Investigative Site
  • Inspira Clinical Research, Ave Hostos 405
  • Novartis Investigative Site
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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

CNP520 50 mg

CNP520 15 mg

Placebo

Arm Description

50 mg capsule taken orally once daily

15 mg capsule taken orally once daily

Matching placebo to 15 and 50 mg CNP520 taken orally once daily

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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
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.
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.
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.
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.
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.
Change in CSF Levels of Amyloid Beta 40 (Aβ40)
Alzheimer's Disease-related biomarkers analyzed in cerebrospinal fluid (CSF): Amyloid Beta 40 (Aβ40)
Change in CSF Levels of Amyloid Beta 42 (Aβ42)
Alzheimer's Disease-related biomarkers analyzed in cerebrospinal fluid (CSF): Amyloid Beta 42 (Aβ42).
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
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
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
Change in Serum Neurofilaments
Alzheimer's Disease-related biomarkers analyzed in blood serum: light chain neurofilaments (NfL)
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.

Full Information

First Posted
April 5, 2017
Last Updated
August 4, 2021
Sponsor
Novartis Pharmaceuticals
Collaborators
Amgen, Banner Alzheimer's Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03131453
Brief Title
A Study of CNP520 Versus Placebo in Participants at Risk for the Onset of Clinical Symptoms of Alzheimer's Disease
Acronym
GS2
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).
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Terminated
Why Stopped
The study was terminated due to safety issues.
Study Start Date
August 3, 2017 (Actual)
Primary Completion Date
March 26, 2020 (Actual)
Study Completion Date
March 26, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
Collaborators
Amgen, Banner Alzheimer's Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimers Disease
Keywords
Placebo controlled, APOE4 carriers, Homozygotes, Heterozygotes, Brain Amyloid, Aβ lowering, BACE-1 inhibitor, CNP520, elderly, preclinical Alzheimers disease, Alzheimers Disease, Prevention, Unimpaired cognition

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1145 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CNP520 50 mg
Arm Type
Experimental
Arm Description
50 mg capsule taken orally once daily
Arm Title
CNP520 15 mg
Arm Type
Experimental
Arm Description
15 mg capsule taken orally once daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo to 15 and 50 mg CNP520 taken orally once daily
Intervention Type
Drug
Intervention Name(s)
CNP520 50mg
Intervention Description
50 mg capsule
Intervention Type
Drug
Intervention Name(s)
CNP520 15mg
Intervention Description
15 mg capsule
Intervention Type
Other
Intervention Name(s)
Matching placebo
Intervention Description
Matching placebo for 15 and 50 mg capsules
Primary Outcome Measure Information:
Title
Time to Event (Diagnosis of Mild Cognitive Impairment or Dementia, Due to Alzheimer's Disease (AD))
Description
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.
Time Frame
Baseline to last cognitive assessment performed (up to day 648)
Title
Change in the Alzheimer's Prevention Initiative Composite Cognitive (APCC) Test Score
Description
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.
Time Frame
Baseline to Week 26, Baseline to Last on-treatment (Day 547) and Baseline to Last off-treatment (Day 648)
Secondary Outcome Measure Information:
Title
Change in Clinical Dementia Rating Scale Sum of Boxes (CDR-SOB) Score
Description
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
Time Frame
Baseline to Week 26, Baseline to Last on-treatment (Day 547) and Baseline to Last off-treatment (Day 648)
Title
Change in the Total and Index Scores of the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Description
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.
Time Frame
Baseline to Week 26, Baseline to Last on-treatment (Day 547) and Baseline to Last off-treatment (Day 648)
Title
Change in the Everyday Cognition Scale (ECog-Subject) Total Scores
Description
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.
Time Frame
Baseline to Week 26, Baseline to Last on-treatment (Day 547) and Baseline to Last off-treatment (Day 648)
Title
Change in the Everyday Cognition Scale (ECog-Informant) Total Scores
Description
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.
Time Frame
Baseline to Week 26, Baseline to Last on-treatment (Day 547) and Baseline to Last off-treatment (Day 648)
Title
Number of Participants With Newly Occurring Safety MRI Abnormalities (ARIA-E, ARIA-H,White Matter Disease and Any Other MRI Abnormalities)
Description
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.
Time Frame
Baseline up to study termination approximately 617 days
Title
Annualized Percent Change on Volume of Brain Regions
Description
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.
Time Frame
Baseline to Week 26, Baseline to Last on-treatment (Day 547) and Baseline to Last off-treatment (Day 648)
Title
Change in CSF Levels of Amyloid Beta 40 (Aβ40)
Description
Alzheimer's Disease-related biomarkers analyzed in cerebrospinal fluid (CSF): Amyloid Beta 40 (Aβ40)
Time Frame
Baseline to Last on-treatment (Day 547) and Baseline to Last off-treatment (Day 648)
Title
Change in CSF Levels of Amyloid Beta 42 (Aβ42)
Description
Alzheimer's Disease-related biomarkers analyzed in cerebrospinal fluid (CSF): Amyloid Beta 42 (Aβ42).
Time Frame
Baseline to Last on-treatment (Day 547) and Baseline to Last off-treatment (Day 648)
Title
Change in Neurofibrillary Tangle Burden as Measured by Standardized Uptake Ratio (SUVR) of PET Scans With Tau Radiotracer (Where Available)
Description
To demonstrate the effects of CNP520 vs placebo on Alzheimer's Disease-related biomarkers
Time Frame
Baseline to Months 24 and 60
Title
Change in Amyloid Deposition as Measured by Standardized Uptake Ratio (SUVR) of Positron Emission Tomography (PET) Scan With Amyloid Radiotracer
Description
To demonstrate the effects of CNP520 vs placebo on Alzheimer's Disease-related biomarkers
Time Frame
Baseline to Months 24 and 60
Title
Change in CSF Levels of Total Tau and Phosphorylated Tau
Description
Alzheimer's Disease-related biomarkers analyzed in cerebrospinal fluid (CSF): total tau protein and phosphorylated tau protein levels
Time Frame
Baseline to Last on-treatment (Day 547) Baseline to Last off-treatment (Day 648)
Title
Change in Serum Neurofilaments
Description
Alzheimer's Disease-related biomarkers analyzed in blood serum: light chain neurofilaments (NfL)
Time Frame
Baseline to Week 26, baseline to Last on-treatment (Day 547) Baseline to Last off-treatment (Day 648)
Title
Number of Suicidal Ideation or Behavior Events
Description
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.
Time Frame
Baseline up to study termination approximately 617 days

10. Eligibility

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

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
Links:
URL
https://www.generationprogram.com
Description
Generation Program Website

Learn more about this trial

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

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