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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02565511
Registration number
NCT02565511
Ethics application status
Date submitted
28/09/2015
Date registered
1/10/2015
Date last updated
8/07/2021
Titles & IDs
Public title
A Study of CAD106 and 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, Two-cohort, Parallel Group Study to Evaluate the Efficacy of CAD106 and CNP520 in Participants at Risk for the Onset of Clinical Symptoms of Alzheimer's Disease.
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Secondary ID [1]
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2015-002715-15
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Secondary ID [2]
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CAPI015A2201J
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Universal Trial Number (UTN)
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Trial acronym
GS1
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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
Other interventions - CAD106 Immunotherapy
Other interventions - Placebo to CAD106
Treatment: Drugs - CNP520
Other interventions - Placebo to CNP520
Other interventions - Alum
Experimental: Cohort I (CAD106) - CAD106 (450 µg) + Alum (450 µg) intra-muscular injection at Weeks 1, 7, 13 and every 13 weeks thereafter
Placebo Comparator: Cohort I (CAD106 Placebo) - Placebo to CAD106 + Alum (450 µg) intra-muscular injection at Weeks 1, 7, 13 and every 13 weeks thereafter
Experimental: Cohort II (CNP520) - CNP520 (50 mg) capsules taken orally once daily
Placebo Comparator: Cohort II (CNP520 Placebo) - Matching Placebo to CNP520 capsules taken orally once daily
Other interventions: CAD106 Immunotherapy
Participants will be given i.m. injections at Weeks 1, 7, 13 and quarterly i.m. injections (every 13 weeks) thereafter, until the last injection 3 month prior to completion of the Treatment Epoch.
Other interventions: Placebo to CAD106
Participants will be given i.m. injections at Weeks 1, 7, 13 and quarterly i.m. injections (every 13 weeks) thereafter, until the last injection 3 month prior to completion of the Treatment Epoch.
Treatment: Drugs: CNP520
CNP520 50 mg capsule p.o. for the duration of the Treatment Epoch.
Other interventions: Placebo to CNP520
Placebo to CNP520 p.o. for the duration of the Treatment Epoch
Other interventions: Alum
Alum was mixed with reconstituted CAD106 as adjuvant therapy to maximize the effectiveness of CAD106
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Intervention code [1]
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Other interventions
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Intervention code [2]
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Treatment: Drugs
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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 end of exposure for a maximum of 1455 days for CI and 907 days for CII
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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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CI = Baseline to Weeks 26, 52,78 104 and Baseline to last assessment; CII = Baseline to Weeks 26, 52, 78, 104 and Baseline to Last on-treatment and Baseline to Last off-treatment
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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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CI = Baseline to Weeks 26, 52,78 104 and Baseline to last assessment; CII = Baseline to Weeks 26, 52, 78, 104 and Baseline to Last on-treatment and Baseline to Last off-treatment
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Secondary outcome [2]
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Change in the Total 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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CI = Baseline to Weeks 26, 52,78 104 and Baseline to last assessment; CII = Baseline to Weeks 26, 52, 78, 104 and Baseline to Last on-treatment and Baseline to Last off-treatment
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Secondary outcome [3]
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Change in the Index Scores of the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS).
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Assessment method [3]
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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 [3]
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CI = Baseline to Weeks 26, 52 and Baseline to last assessment; CII = Baseline to Weeks 26, 52 and Baseline to Last on-treatment and Baseline to Last off-treatment
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Secondary outcome [4]
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Change in the Everyday Cognition Scale (ECog-Subject) 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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CI = Baseline to Weeks 26, 52 and Baseline to last assessment; CII = Baseline to Weeks 26, 52 and Baseline to Last on-treatment and Baseline to Last off-treatment
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Secondary outcome [5]
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Change in the Everyday Cognition Scale (ECog-Informant) Total Scores
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Assessment method [5]
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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. Cohort I=C I and Cohort II=C II.
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Timepoint [5]
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CI = Baseline to Weeks 26, 52 and Baseline to last assessment; CII = Baseline to Weeks 26, 52 and Baseline to Last on-treatment and Baseline to Last off-treatment
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Secondary outcome [6]
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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 [6]
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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 since baseline) and a general assessment of brain abnormalities. Assessment of cerebral amyloid angiopathy (CAA) is included in the overall safety MRI findings results.
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Timepoint [6]
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Baseline to end of exposure for a maximum of 1455 days for CI and 907 days for CII
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Secondary outcome [7]
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Annualized Percent Change on Volume of Brain Regions
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Assessment method [7]
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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 [7]
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CI = Baseline to Weeks 26, 52 and Baseline to last assessment; CII = Baseline to Weeks 26, 52 and Baseline to Last on-treatment and Baseline to Last off-treatment
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Secondary outcome [8]
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Change in Cerebrospinal Fluid (CSF) Levels of Amyloid Beta 40 (Aß40)
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Assessment method [8]
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Alzheimer's Disease-related biomarkers analyzed in cerebrospinal fluid (CSF): Amyloid Beta 40 (Aß40)
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Timepoint [8]
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Baseline to last assessment
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Secondary outcome [9]
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Change in Cerebrospinal Fluid (CSF) Levels of Amyloid Beta 42 (Aß42)
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Assessment method [9]
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Alzheimer's Disease-related biomarkers analyzed in cerebrospinal fluid (CSF): Amyloid Beta 42 (Aß42)
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Timepoint [9]
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Baseline to last assessment
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Secondary outcome [10]
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Change in Cerebrospinal Fluid (CSF) Levels of Total Tau and Phosphorylated Tau
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Assessment method [10]
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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 [10]
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Baseline to last assessment
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Secondary outcome [11]
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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 [11]
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To demonstrate the effects of CNP520 vs placebo on tau pathology in the brain
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Timepoint [11]
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Baseline to last assessment
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Secondary outcome [12]
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Cohort I : Annualized Change in Amyloid Deposition as Measured by Centiloids of Positron Emission Tomography (PET) Scan With Amyloid Radiotracer
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Assessment method [12]
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To demonstrate the effects of CAD106 vs placebo on Alzheimer's Disease-related biomarkers
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Timepoint [12]
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Baseline up to approximately Week 104
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Secondary outcome [13]
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Change in Serum Neurofilaments
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Assessment method [13]
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Alzheimer's Disease-related biomarkers analyzed in blood serum: light chain neurofilaments (NfL)
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Timepoint [13]
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Baseline to Week 26 and week 52, CI baseline to last assessment. CII baseline to last on-treatment and to last off-treatment
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Secondary outcome [14]
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Number of Suicidal Ideation or Behavior Events
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Assessment method [14]
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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 [14]
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Baseline to end of exposure for a maximum of 1455 days for CI and 907 days for CII
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Secondary outcome [15]
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Cohort I : Change in Cognition as Measured by APCC and CDR-SOB Scores and Antibody Response
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Assessment method [15]
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Timepoint [15]
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Month 6 to Month 60
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Secondary outcome [16]
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Cohort I: Peak Concentration (Cmax) of CAD106 Induced Abeta-specific Antibody Titers
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Assessment method [16]
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Cmax is the maximum Titer Concentration of any post-baseline 'on treatment' visit. A visit is considered as 'on treatment' if visit date is within {last injection + 180 days}.
- Geometric mean and CI's are back-transformed from the estimates for Log mean and CI's.
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Timepoint [16]
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Week 9, 13, 15, 26 and quarterly thereafter (trough values)
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Secondary outcome [17]
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Cohort I: Area Under the Concentration Curve (AUC) of CAD106 Induced Abeta-specific Antibody Titers
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Assessment method [17]
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AUC is calculated based on 'on treatment' visit only.(missing values for peak visits were linearly interpolated for calculation; missing values for trough visits were imputed by average of non-missing trough values.).
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Timepoint [17]
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Week 9, 13, 15, 26 and quarterly thereafter (trough values)
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Eligibility
Key inclusion criteria
Key
- Consented to receive disclosure of their risk estimates to develop clinical symptoms
of AD based on their APOE genotype.
- Male or female, age 60 to 75 years inclusive. Females were to be post-menopausal.
- Mini-Mental State Examination (MMSE) total score = 24 and cognitively unimpaired as
evaluated by memory tests
- Homozygous APOE4 genotype.
- Participant willing to have a study partner.
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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?
No
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Key exclusion criteria
- Any disability that prevented the participant 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 may 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 60 months
prior to screening.
- History of hypersensitivity to any of the investigational drugs or their excipients /
adjuvant or to drugs of similar chemical classes.
- Indication or on current treatment with ChEIs and/or another AD treatment (e.g.
memantine).
- Contraindication or intolerance to MRI or PET investigations (with fluorinated radio
ligands).
- Brain MRI results showing findings unrelated to AD that, in the opinion of the
Investigator could have been a leading cause to future cognitive decline, pose a risk
to the participant, or prevent a satisfactory MRI assessment for safety monitoring.
- Suicidal Ideation in the past six months or Suicidal Behavior in the past two years,
prior to screening.
- A positive drug screen at Screening, if, in the Investigator's opinion, this was due
to drug abuse.
- Significantly abnormal laboratory results at Screening, or infection not as a result
of a temporary condition.
- Current clinically significant ECG findings. For Cohort - I only: Participants with
previous organ transplantation or stem cell transplantation, or indication for
treatment with anti-coagulants.
For Cohort - II only: Participants with depigmenting or hypopigmenting conditions (e.g.
albinism vitiligo) or active / history of chronic urticarial 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/Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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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
30/11/2015
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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
30/04/2020
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Sample size
Target
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Accrual to date
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Final
480
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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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Novartis Investigative Site - Heidelberg Heights
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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 Heights
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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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Surrey
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Country [62]
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United Kingdom
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State/province [62]
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Avon
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Country [63]
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United Kingdom
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State/province [63]
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Birmingham
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Country [64]
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United Kingdom
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State/province [64]
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Dundee
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Country [65]
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United Kingdom
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Glasgow
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Country [66]
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United Kingdom
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State/province [66]
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London
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Country [67]
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United Kingdom
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State/province [67]
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Manchester
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Novartis Pharmaceuticals
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Address
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Other collaborator category [1]
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Other
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Name [1]
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Banner Alzheimer's Institute
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Government body
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Name [2]
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National Institute on Aging (NIA)
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Other collaborator category [3]
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Commercial sector/Industry
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Amgen
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Ethics approval
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Summary
Brief summary
The purpose of this study was to test whether two investigational drugs called CAD106 and
CNP520, administered separately, could slow down the onset and progression of clinical
symptoms associated with Alzheimer's disease (AD) in participants at the risk to develop
clinical symptoms based on their age and genotype.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02565511
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Public notes
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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
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02565511
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