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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03131453
Registration number
NCT03131453
Ethics application status
Date submitted
5/04/2017
Date registered
27/04/2017
Titles & IDs
Public title
A Study of CNP520 Versus Placebo in Participants at Risk for the Onset of Clinical Symptoms of Alzheimer's Disease
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Scientific 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).
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Secondary ID [1]
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2016-002976-28
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Secondary ID [2]
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CCNP520A2202J
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Universal Trial Number (UTN)
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Trial acronym
GS2
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Alzheimers Disease
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Condition category
Condition code
Neurological
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Alzheimer's disease
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Neurological
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Dementias
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - CNP520 50mg
Treatment: Drugs - CNP520 15mg
Other interventions - Matching placebo
Experimental: CNP520 50 mg - 50 mg capsule taken orally once daily
Experimental: CNP520 15 mg - 15 mg capsule taken orally once daily
Placebo comparator: Placebo - Matching placebo to 15 and 50 mg CNP520 taken orally once daily
Treatment: Drugs: CNP520 50mg
50 mg capsule
Treatment: Drugs: CNP520 15mg
15 mg capsule
Other interventions: Matching placebo
Matching placebo for 15 and 50 mg capsules
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Time to Event (Diagnosis of Mild Cognitive Impairment or Dementia, Due to Alzheimer's Disease (AD))
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline to last cognitive assessment performed (up to day 648)
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Primary outcome [2]
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Change in the Alzheimer's Prevention Initiative Composite Cognitive (APCC) Test Score
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Assessment method [2]
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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.
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Timepoint [2]
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Baseline to Week 26, Baseline to Last on-treatment (Day 547) and Baseline to Last off-treatment (Day 648)
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Secondary outcome [1]
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Change in Clinical Dementia Rating Scale Sum of Boxes (CDR-SOB) Score
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Assessment method [1]
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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
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Timepoint [1]
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Baseline to Week 26, Baseline to Last on-treatment (Day 547) and Baseline to Last off-treatment (Day 648)
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Secondary outcome [2]
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Change in the Total and Index Scores of the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
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Assessment method [2]
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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.
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Timepoint [2]
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Baseline to Week 26, Baseline to Last on-treatment (Day 547) and Baseline to Last off-treatment (Day 648)
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Secondary outcome [3]
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Change in the Everyday Cognition Scale (ECog-Subject) Total Scores
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Assessment method [3]
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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.
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Timepoint [3]
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Baseline to Week 26, Baseline to Last on-treatment (Day 547) and Baseline to Last off-treatment (Day 648)
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Secondary outcome [4]
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Change in the Everyday Cognition Scale (ECog-Informant) Total Scores
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Assessment method [4]
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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.
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Timepoint [4]
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Baseline to Week 26, Baseline to Last on-treatment (Day 547) and Baseline to Last off-treatment (Day 648)
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Secondary outcome [5]
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Number of Participants With Newly Occurring Safety MRI Abnormalities (ARIA-E, ARIA-H,White Matter Disease and Any Other MRI Abnormalities)
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Assessment method [5]
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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.
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Timepoint [5]
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Baseline up to study termination approximately 617 days
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Secondary outcome [6]
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Annualized Percent Change on Volume of Brain Regions
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Assessment method [6]
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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.
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Timepoint [6]
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Baseline to Week 26, Baseline to Last on-treatment (Day 547) and Baseline to Last off-treatment (Day 648)
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Secondary outcome [7]
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Change in CSF Levels of Amyloid Beta 40 (Aß40)
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Assessment method [7]
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Alzheimer's Disease-related biomarkers analyzed in cerebrospinal fluid (CSF): Amyloid Beta 40 (Aß40)
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Timepoint [7]
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Baseline to Last on-treatment (Day 547) and Baseline to Last off-treatment (Day 648)
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Secondary outcome [8]
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Change in CSF Levels of Amyloid Beta 42 (Aß42)
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Assessment method [8]
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Alzheimer's Disease-related biomarkers analyzed in cerebrospinal fluid (CSF): Amyloid Beta 42 (Aß42).
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Timepoint [8]
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Baseline to Last on-treatment (Day 547) and Baseline to Last off-treatment (Day 648)
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Secondary outcome [9]
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Change in Neurofibrillary Tangle Burden as Measured by Standardized Uptake Ratio (SUVR) of PET Scans With Tau Radiotracer (Where Available)
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Assessment method [9]
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To demonstrate the effects of CNP520 vs placebo on Alzheimer's Disease-related biomarkers
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Timepoint [9]
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Baseline to Months 24 and 60
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Secondary outcome [10]
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Change in Amyloid Deposition as Measured by Standardized Uptake Ratio (SUVR) of Positron Emission Tomography (PET) Scan With Amyloid Radiotracer
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Assessment method [10]
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To demonstrate the effects of CNP520 vs placebo on Alzheimer's Disease-related biomarkers
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Timepoint [10]
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Baseline to Months 24 and 60
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Secondary outcome [11]
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Change in CSF Levels of Total Tau and Phosphorylated Tau
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Assessment method [11]
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Alzheimer's Disease-related biomarkers analyzed in cerebrospinal fluid (CSF): total tau protein and phosphorylated tau protein levels
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Timepoint [11]
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Baseline to Last on-treatment (Day 547) Baseline to Last off-treatment (Day 648)
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Secondary outcome [12]
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Change in Serum Neurofilaments
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Assessment method [12]
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Alzheimer's Disease-related biomarkers analyzed in blood serum: light chain neurofilaments (NfL)
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Timepoint [12]
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Baseline to Week 26, baseline to Last on-treatment (Day 547) Baseline to Last off-treatment (Day 648)
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Secondary outcome [13]
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Number of Suicidal Ideation or Behavior Events
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Assessment method [13]
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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.
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Timepoint [13]
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Baseline up to study termination approximately 617 days
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Eligibility
Key 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).
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Minimum age
60
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Maximum age
75
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
3/08/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
26/03/2020
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Sample size
Target
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Accrual to date
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Final
1145
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Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
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Recruitment hospital [1]
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Novartis Investigative Site - Darlinghurst
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Recruitment hospital [2]
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Novartis Investigative Site - Heidelberg West
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Recruitment hospital [3]
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Novartis Investigative Site - Nedlands
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Recruitment postcode(s) [1]
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2010 - Darlinghurst
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Recruitment postcode(s) [2]
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3081 - Heidelberg West
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Recruitment postcode(s) [3]
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6009 - Nedlands
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Recruitment outside Australia
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United States of America
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Arizona
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California
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Israel
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Haifa
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Israel
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Petach Tikva
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Israel
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Ramat Gan
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Israel
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Tel Aviv
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Italy
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BS
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Italy
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Italy
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Milan
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Ehime
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Fukuoka
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Japan
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Kanagawa
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Japan
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Osaka
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Tokyo
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Japan
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Chiba
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Korea, Republic of
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Gyeonggi Do
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Busan
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Incheon
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Seoul
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Mexico
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Mexico CP
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Mexico
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Netherlands
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CH
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Novartis Pharmaceuticals
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Amgen
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Other
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Banner Alzheimer's Institute
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Ethics approval
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT03131453
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Contacts
Principal investigator
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Novartis Pharmaceuticals
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Novartis Pharmaceuticals
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
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
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
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What supporting documents are/will be available?
No Supporting Document Provided
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Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/53/NCT03131453/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/53/NCT03131453/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT03131453