A Study of CNP520 Versus Placebo in Participants at Risk for the Onset of Clinical Symptoms of Alzheimer's Disease (Generation S2)
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|ClinicalTrials.gov Identifier: NCT03131453|
Recruitment Status : Recruiting
First Posted : April 27, 2017
Last Update Posted : February 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer's Disease||Drug: CNP520 50mg Drug: CNP520 15mg Other: Placebo to CNP520||Phase 2 Phase 3|
The study uses a randomized, double-blind, placebo-controlled, parallel group, adaptive design with variable treatment duration in approximately 2000 cognitively unimpaired participants aged 60 to 75 years, with at least one APOE4 allele (Homozygotes or Heterozygotes) and, if Heterozygotes, with evidence of elevated brain amyloid.
The screening period is expected to last about 12 weeks. Participants will receive disclosure of their individual test results for APOE genotyping and brain amyloid status.
Treatment duration is variable (event driven trial) for at least 60 months, and up to an expected maximum of 84 months.
Participants will return to the study site every three months for drug dispensing and every six months for safety and efficacy assessments, including neuropsychological scales with input from the study partner. Brain MRI scans will be conducted at month 6 and month 12, and on a yearly basis thereafter.
The Follow-up visit will be scheduled 12 weeks after the end of the Treatment Epoch. An additional CSF and / or PET AD biomarker assessments will be conducted on a voluntary basis at year 2 and 5.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2000 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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).|
|Actual Study Start Date :||August 3, 2017|
|Estimated Primary Completion Date :||July 30, 2024|
|Estimated Study Completion Date :||July 30, 2024|
Experimental: Arm#1: CNP520 50 mg
CNP520 50 mg capsule given p.o.
Drug: CNP520 50mg
Other Name: CNP520 50 mg capsule p.o. for the duration of the Treatment Epoch
Experimental: Arm#2: CNP520 15 mg
CNP520 15 mg capsule given p.o.
Drug: CNP520 15mg
Other Name: CNP520 15 mg capsule p.o. for the duration of Treatment Epoch
Placebo Comparator: Arm#3: Placebo
Placebo to CNP520 capsule given p.o.
Other: Placebo to CNP520
Other Name: Placebo to CNP520 p.o. for the duration of Treatment Epoch
- Time to event [ Time Frame: Through study completion, at least 5 years ]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
- Change in the Alzheimer's Prevention Initiative Composite Cognitive (APCC) Test Score [ Time Frame: Baseline to Month 60 ]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
- Change in Clinical Dementia Rating Scale Sum of Boxes (CDR-SOB) score [ Time Frame: Baseline to Month 60 ]To demonstrate the effects of CNP520, vs. placebo on global clinical status
- Change on the Total Scale score and individual neurocognitive domain index scores of the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) [ Time Frame: Baseline to Month 60 ]To demonstrate the effects of CNP520, vs. placebo on cognition
- Change in the Everyday Cognition scale (ECog) total scores [ Time Frame: Baseline to Month 60 ]To demonstrate the effects of CNP520, vs. placebo on function reported by the participant and study partner, respectively
- Change in cerebral amyloid angiopathy (CAA) [ Time Frame: Through study completion, at least 5 years ]To demonstrate the effects of CNP520 vs placebo on CAA, as measured by Magnetic Resonance Imaging (MRI)
- Change on volume of brain regions [ Time Frame: Baseline to Month 60 ]To demonstrate the effects of CNP520 vs placebo on brain atrophy, as measured by volumetric Magnetic Resonance Imaging (MRI)
- Change in amyloid deposition as measured by standardized uptake ratio (SUVR) of radiotracer positron emission tomography (PET) scan [ Time Frame: Baseline to Months 24 and 60 ]To demonstrate the effects of CNP520 vs placebo on Alzheimer's Disease-related biomarkers
- Change in CSF levels of Aβ40, Aβ42 [ Time Frame: Baseline to Months 24 and 60 ]To demonstrate the effects of CNP520 vs placebo on Alzheimer's Disease-related biomarkers
- Change in CSF levels of total tau and phosphorylated tau [ Time Frame: Baseline to Months 24 and 60 ]To demonstrate the effects of CNP520 vs placebo on Alzheimer's Disease-related biomarkers
- Number of participants with adverse events as a measure of safety [ Time Frame: Through study completion, at least 5 years ]To demonstrate the safety and tolerability of CNP520 vs placebo
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03131453
|Contact: Novartis Pharmaceuticalsfirstname.lastname@example.org|
|Contact: UBC Call Centeremail@example.com|
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|Study Director:||Novartis Pharmaceuticals||Novartis Pharmaceuticals|