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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
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).
Secondary ID [1] 0 0
2016-002976-28
Secondary ID [2] 0 0
CCNP520A2202J
Universal Trial Number (UTN)
Trial acronym
GS2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimers Disease 0 0
Condition category
Condition code
Neurological 0 0 0 0
Alzheimer's disease
Neurological 0 0 0 0
Dementias

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to Event (Diagnosis of Mild Cognitive Impairment or Dementia, Due to Alzheimer's Disease (AD))
Timepoint [1] 0 0
Baseline to last cognitive assessment performed (up to day 648)
Primary outcome [2] 0 0
Change in the Alzheimer's Prevention Initiative Composite Cognitive (APCC) Test Score
Timepoint [2] 0 0
Baseline to Week 26, Baseline to Last on-treatment (Day 547) and Baseline to Last off-treatment (Day 648)
Secondary outcome [1] 0 0
Change in Clinical Dementia Rating Scale Sum of Boxes (CDR-SOB) Score
Timepoint [1] 0 0
Baseline to Week 26, Baseline to Last on-treatment (Day 547) and Baseline to Last off-treatment (Day 648)
Secondary outcome [2] 0 0
Change in the Total and Index Scores of the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Timepoint [2] 0 0
Baseline to Week 26, Baseline to Last on-treatment (Day 547) and Baseline to Last off-treatment (Day 648)
Secondary outcome [3] 0 0
Change in the Everyday Cognition Scale (ECog-Subject) Total Scores
Timepoint [3] 0 0
Baseline to Week 26, Baseline to Last on-treatment (Day 547) and Baseline to Last off-treatment (Day 648)
Secondary outcome [4] 0 0
Change in the Everyday Cognition Scale (ECog-Informant) Total Scores
Timepoint [4] 0 0
Baseline to Week 26, Baseline to Last on-treatment (Day 547) and Baseline to Last off-treatment (Day 648)
Secondary outcome [5] 0 0
Number of Participants With Newly Occurring Safety MRI Abnormalities (ARIA-E, ARIA-H,White Matter Disease and Any Other MRI Abnormalities)
Timepoint [5] 0 0
Baseline up to study termination approximately 617 days
Secondary outcome [6] 0 0
Annualized Percent Change on Volume of Brain Regions
Timepoint [6] 0 0
Baseline to Week 26, Baseline to Last on-treatment (Day 547) and Baseline to Last off-treatment (Day 648)
Secondary outcome [7] 0 0
Change in CSF Levels of Amyloid Beta 40 (Aß40)
Timepoint [7] 0 0
Baseline to Last on-treatment (Day 547) and Baseline to Last off-treatment (Day 648)
Secondary outcome [8] 0 0
Change in CSF Levels of Amyloid Beta 42 (Aß42)
Timepoint [8] 0 0
Baseline to Last on-treatment (Day 547) and Baseline to Last off-treatment (Day 648)
Secondary outcome [9] 0 0
Change in Neurofibrillary Tangle Burden as Measured by Standardized Uptake Ratio (SUVR) of PET Scans With Tau Radiotracer (Where Available)
Timepoint [9] 0 0
Baseline to Months 24 and 60
Secondary outcome [10] 0 0
Change in Amyloid Deposition as Measured by Standardized Uptake Ratio (SUVR) of Positron Emission Tomography (PET) Scan With Amyloid Radiotracer
Timepoint [10] 0 0
Baseline to Months 24 and 60
Secondary outcome [11] 0 0
Change in CSF Levels of Total Tau and Phosphorylated Tau
Timepoint [11] 0 0
Baseline to Last on-treatment (Day 547) Baseline to Last off-treatment (Day 648)
Secondary outcome [12] 0 0
Change in Serum Neurofilaments
Timepoint [12] 0 0
Baseline to Week 26, baseline to Last on-treatment (Day 547) Baseline to Last off-treatment (Day 648)
Secondary outcome [13] 0 0
Number of Suicidal Ideation or Behavior Events
Timepoint [13] 0 0
Baseline up to study termination approximately 617 days

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).
Minimum age
60 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/08/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
26/03/2020
Sample size
Target
Accrual to date
Final
1145
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
Novartis Investigative Site - Darlinghurst
Recruitment hospital [2] 0 0
Novartis Investigative Site - Heidelberg West
Recruitment hospital [3] 0 0
Novartis Investigative Site - Nedlands
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
3081 - Heidelberg West
Recruitment postcode(s) [3] 0 0
6009 - Nedlands
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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ZAF
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Madrid
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CH
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Switzerland
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Geneve
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Lausanne
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Taipei
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Devon
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GBR
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Surrey
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Birmingham
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Bristol
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Dundee
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Glasgow
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Amgen
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Banner Alzheimer's Institute
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03131453