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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03131453




Registration number
NCT03131453
Ethics application status
Date submitted
5/04/2017
Date registered
24/04/2017
Date last updated
4/02/2019

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
Generation S2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer's 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 - Placebo to CNP520

Experimental: Arm#1: CNP520 50 mg - CNP520 50 mg capsule given p.o.

Experimental: Arm#2: CNP520 15 mg - CNP520 15 mg capsule given p.o.

Placebo Comparator: Arm#3: Placebo - Placebo to CNP520 capsule given p.o.


Treatment: Drugs: CNP520 50mg
Arm#1

Treatment: Drugs: CNP520 15mg
Arm#2

Other interventions: Placebo to CNP520
Arm#3

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 - Event is defined as diagnosis of MCI due to AD or dementia due to AD, whichever occurs first during the course of the study, after confirmation by the adjudication committee
Timepoint [1] 0 0
Through study completion, at least 5 years
Primary outcome [2] 0 0
Change in the Alzheimer's Prevention Initiative Composite Cognitive (APCC) Test Score - Composite score derived from the specific tests from the Repeatable Battery for the Assessment of Neurological Status (RBANS), Mini-Mental State Examination (MMSE), Raven's Progressive Matrices
Timepoint [2] 0 0
Baseline to Month 60
Secondary outcome [1] 0 0
Change in Clinical Dementia Rating Scale Sum of Boxes (CDR-SOB) score - To demonstrate the effects of CNP520, vs. placebo on global clinical status
Timepoint [1] 0 0
Baseline to Month 60
Secondary outcome [2] 0 0
Change on the Total Scale score and individual neurocognitive domain index scores of the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) - To demonstrate the effects of CNP520, vs. placebo on cognition
Timepoint [2] 0 0
Baseline to Month 60
Secondary outcome [3] 0 0
Change in the Everyday Cognition scale (ECog) total scores - To demonstrate the effects of CNP520, vs. placebo on function reported by the participant and study partner, respectively
Timepoint [3] 0 0
Baseline to Month 60
Secondary outcome [4] 0 0
Change in cerebral amyloid angiopathy (CAA) - To demonstrate the effects of CNP520 vs placebo on CAA, as measured by Magnetic Resonance Imaging (MRI)
Timepoint [4] 0 0
Through study completion, at least 5 years
Secondary outcome [5] 0 0
Change on volume of brain regions - To demonstrate the effects of CNP520 vs placebo on brain atrophy, as measured by volumetric Magnetic Resonance Imaging (MRI)
Timepoint [5] 0 0
Baseline to Month 60
Secondary outcome [6] 0 0
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
Timepoint [6] 0 0
Baseline to Months 24 and 60
Secondary outcome [7] 0 0
Change in CSF levels of Aß40, Aß42 - To demonstrate the effects of CNP520 vs placebo on Alzheimer's Disease-related biomarkers
Timepoint [7] 0 0
Baseline to Months 24 and 60
Secondary outcome [8] 0 0
Change in CSF levels of total tau and phosphorylated tau - To demonstrate the effects of CNP520 vs placebo on Alzheimer's Disease-related biomarkers
Timepoint [8] 0 0
Baseline to Months 24 and 60
Secondary outcome [9] 0 0
Number of participants with adverse events as a measure of safety - To demonstrate the safety and tolerability of CNP520 vs placebo
Timepoint [9] 0 0
Through study completion, at least 5 years
Secondary outcome [10] 0 0
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
Timepoint [10] 0 0
Baseline to Months 24 and 60

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
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Any disability that may prevent the participants from completing all study
requirements. -

- Current medical or neurological condition that might impact cognition or performance
on cognitive assessments.

- Advanced, severe progressive or unstable disease that may interfere 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, might pose a risk
to the participant, or might prevent 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, this 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/Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novartis Pharmaceuticals
Address
Country
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Commercial sector/Industry
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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
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.
Trial website
https://clinicaltrials.gov/show/NCT03131453
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
Novartis Pharmaceuticals
Address 0 0
Country 0 0
Phone 0 0
1-888-669-6682
Fax 0 0
Email 0 0
novartis.email@novartis.com
Contact person for scientific queries

No data has been provided for results reporting
Summary results
Not applicable