Alzheimer's Disease
Conditions
Interventions
investigational material(s)
Generic name etc : CNP520
INN of investigational material : -
Therapeutic category code : 119 Other agents affecting central nervous system
Dosage and Administration for In
Sponsors
Novartis Pharma K.K.
Amgen, Banner Alzheimer's Institute
Eligibility
Sex/Gender
All
Inclusion 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
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 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. Other protocol defined inclusion/exclusion criteria may apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy 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 efficacy 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy 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 efficacy 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 efficacy 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 efficacy 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) efficacy 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) | — |
Countries
Asia except Japan, Europe, Japan, North America, Oceania, South America
Outcome results
None listed