NCT02565511 (GS1) is a Phase 2, PHASE3 clinical trial of CAD106 Immunotherapy in Alzheimers Disease, sponsored by Novartis Pharmaceuticals.

Who is sponsoring NCT02565511?

NCT02565511 is sponsored by Novartis Pharmaceuticals.

What drugs are being tested in NCT02565511?

Interventions in NCT02565511: CAD106 Immunotherapy, Placebo to CAD106, CNP520, Placebo to CNP520, Alum.

What condition does NCT02565511 study?

NCT02565511 studies Alzheimers Disease.

Is NCT02565511 still recruiting?

NCT02565511 is currently terminated. Last updated 8 July 2021.

Are results published for NCT02565511?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2021-07-08 · How we verify

NCT02565511: GS1

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study of CAD106 and CNP520 Versus Placebo in Participants at Risk for the Onset of Clinical Symptoms of Alzheimer's Disease

Terminated Phase 2, PHASE3 Results posted Last updated 8 July 2021

What this trial tests

Phase 2, PHASE3 trial testing CAD106 Immunotherapy in Alzheimers Disease in 480 participants. Terminated before completion.

Timeline

30 November 2015

Primary endpoint
30 April 2020

30 April 2020

Quick facts

Lead sponsor	Novartis Pharmaceuticals
Phase	Phase 2, PHASE3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	480
Start date	30 November 2015
Primary completion	30 April 2020
Estimated completion	30 April 2020
Sites	129 locations across Finland, Netherlands, Belgium, United Kingdom, Germany, Canada, Switzerland, Australia

Drugs / interventions tested

CAD106 Immunotherapy — full drug profile →
Placebo to CAD106
CNP520 — full drug profile →
Placebo to CNP520
Alum (Alum) — full drug profile →

Conditions studied

Alzheimers Disease — all drugs for Alzheimers Disease →

Sponsor

Novartis Pharmaceuticals — full company profile →

Who can join

Adults 60 to 75, any sex, with Alzheimers Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Time to Event (Diagnosis of Mild Cognitive Impairment or Dementia, Due to Alzheimer's Disease (AD)) Primary · Baseline to end of exposure for a maximum of 1455 days for CI and 907 days for CII

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 termin

Week 26

Group	Value	95% CI
Cohort I (CI) CAD106	1.00	1.00 – 1.00
Cohort I (CI) CAD106 Placebo	1.00	1.00 – 1.00
Cohort II (CII) CNP520	0.98	0.95 – 0.99
Cohort II (CII) CNP520 Placebo	0.98	0.94 – 0.99

Week 52

Group	Value	95% CI
Cohort I (CI) CAD106	1.00	1.00 – 1.00
Cohort I (CI) CAD106 Placebo	1.00	1.00 – 1.00
Cohort II (CII) CNP520	0.93	0.88 – 0.96
Cohort II (CII) CNP520 Placebo	0.95	0.90 – 0.98

Week 78

Group	Value	95% CI
Cohort I (CI) CAD106	0.97	0.83 – 1.00
Cohort I (CI) CAD106 Placebo	1.00	1.00 – 1.00
Cohort II (CII) CNP520	0.88	0.79 – 0.93
Cohort II (CII) CNP520 Placebo	0.85	0.63 – 0.94

Week 104

Group	Value	95% CI
Cohort I (CI) CAD106	0.97	0.83 – 1.00
Cohort I (CI) CAD106 Placebo	1.00	1.00 – 1.00
Cohort II (CII) CNP520	0.88	0.79 – 0.93
Cohort II (CII) CNP520 Placebo	0.85	0.63 – 0.94

Change in the Alzheimer's Prevention Initiative Composite Cognitive (APCC) Test Score Primary · 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

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.

Week 26

Group	Value	95% CI
Cohort I (CI) CAD106	-1.1	± 4.10
Cohort I (CI) CAD106 Placebo	-2.0	± 3.90
Cohort II (CII) CNP520	-3.3	± 4.54
Cohort II (CII) CNP520 Placebo	-1.0	± 4.65

Week 52

Group	Value	95% CI
Cohort I (CI) CAD106	0.9	± 4.24
Cohort I (CI) CAD106 Placebo	1.4	± 3.36
Cohort II (CII) CNP520	0.3	± 4.27
Cohort II (CII) CNP520 Placebo	2.2	± 6.11

Week 78

Group	Value	95% CI
Cohort I (CI) CAD106	0.2	± 4.15
Cohort I (CI) CAD106 Placebo	-0.7	± 5.48
Cohort II (CII) CNP520	-4.1	± 4.14
Cohort II (CII) CNP520 Placebo	2.4	± 4.23

Week 104

Group	Value	95% CI
Cohort I (CI) CAD106	-1.4	± 4.67
Cohort I (CI) CAD106 Placebo	0.3	± 4.00
Cohort II (CII) CNP520	-6.7	± 3.95

CI-Last post BL assessment

Group	Value	95% CI
Cohort I (CI) CAD106	0.0	± 4.62
Cohort I (CI) CAD106 Placebo	0.1	± 3.87

CII - Last on treatment

Group	Value	95% CI
Cohort II (CII) CNP520	-1.7	± 4.81
Cohort II (CII) CNP520 Placebo	0.1	± 4.58

CII-Last off treatment

Group	Value	95% CI
Cohort II (CII) CNP520	-0.1	± 4.72
Cohort II (CII) CNP520 Placebo	0.2	± 4.56

Change in Clinical Dementia Rating Scale Sum of Boxes (CDR-SOB) Score Secondary · 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

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.

Week 26

Group	Value	95% CI
Cohort I (CI) CAD106	-0.04	± 0.234
Cohort I (CI) CAD106 Placebo	0.00	± 0.000
Cohort II (CII) CNP520	0.04	± 0.361
Cohort II (CII) CNP520 Placebo	0.00	± 0.336

Week 52

Group	Value	95% CI
Cohort I (CI) CAD106	-0.01	± 0.237
Cohort I (CI) CAD106 Placebo	0.02	± 0.104
Cohort II (CII) CNP520	-0.02	± 0.281
Cohort II (CII) CNP520 Placebo	-0.08	± 0.541

Week 78

Group	Value	95% CI
Cohort I (CI) CAD106	-0.04	± 0.237
Cohort I (CI) CAD106 Placebo	0.03	± 0.118
Cohort II (CII) CNP520	0.14	± 0.802
Cohort II (CII) CNP520 Placebo	-0.14	± 0.244

Week 104

Group	Value	95% CI
Cohort I (CI) CAD106	0.15	± 0.460
Cohort I (CI) CAD106 Placebo	0.06	± 0.167
Cohort II (CII) CNP520	-0.17	± 0.764

CI Last post baseline assessment

Group	Value	95% CI
Cohort I (CI) CAD106	0.04	± 0.343
Cohort I (CI) CAD106 Placebo	0.00	± 0.302

CII Last on-treatment

Group	Value	95% CI
Cohort II (CII) CNP520	0.06	± 0.505
Cohort II (CII) CNP520 Placebo	0.03	± 0.410

CII Last off-treatment

Group	Value	95% CI
Cohort II (CII) CNP520	0.05	± 0.464
Cohort II (CII) CNP520 Placebo	-0.01	± 0.519

Change in the Total Scores of the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS). Secondary · 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

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.

Total Week 26

Group	Value	95% CI
Cohort I (CI) CAD106	-5.1	± 7.25
Cohort I (CI) CAD106 Placebo	-3.0	± 7.51
Cohort II (CII) CNP520	-4.1	± 8.58
Cohort II (CII) CNP520 Placebo	-2.6	± 7.83

Total Week 52

Group	Value	95% CI
Cohort I (CI) CAD106	-1.2	± 7.82
Cohort I (CI) CAD106 Placebo	4.5	± 7.10
Cohort II (CII) CNP520	-0.1	± 7.91
Cohort II (CII) CNP520 Placebo	1.4	± 8.06

Total Week 78

Group	Value	95% CI
Cohort I (CI) CAD106	-2.1	± 7.69
Cohort I (CI) CAD106 Placebo	-4.0	± 7.82
Cohort II (CII) CNP520	-12.1	± 7.40
Cohort II (CII) CNP520 Placebo	-4.8	± 5.99

Total Week 104

Group	Value	95% CI
Cohort I (CI) CAD106	-1.4	± 6.74
Cohort I (CI) CAD106 Placebo	-3.0	± 8.34
Cohort II (CII) CNP520	-7.7	± 15.57

Total CI Last post baseline assessment

Group	Value	95% CI
Cohort I (CI) CAD106	-1.0	± 9.27
Cohort I (CI) CAD106 Placebo	0.4	± 7.20

Total CII Last on-treatment

Group	Value	95% CI
Cohort II (CII) CNP520	-2.7	± 8.65
Cohort II (CII) CNP520 Placebo	-0.2	± 9.22

Total CII Last off-treatment

Group	Value	95% CI
Cohort II (CII) CNP520	-1.5	± 9.20
Cohort II (CII) CNP520 Placebo	-0.6	± 8.83

Change in the Index Scores of the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS). Secondary · 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

Immediate memory - Week 26

Group	Value	95% CI
Cohort I (CI) CAD106	-8.6	± 10.68
Cohort I (CI) CAD106 Placebo	-3.8	± 11.16
Cohort II (CII) CNP520	-7.4	± 13.11
Cohort II (CII) CNP520 Placebo	-3.7	± 12.15

Immediate memory - Week 52

Group	Value	95% CI
Cohort I (CI) CAD106	1.3	± 10.81
Cohort I (CI) CAD106 Placebo	4.8	± 8.68
Cohort II (CII) CNP520	0.6	± 13.55
Cohort II (CII) CNP520 Placebo	5.1	± 11.73

CI Immediate memory - Last post baseline assessment

Group	Value	95% CI
Cohort I (CI) CAD106	-1.1	± 13.11
Cohort I (CI) CAD106 Placebo	1.1	± 14.52

CII Immediate memory - Last on-treatment

Group	Value	95% CI
Cohort II (CII) CNP520	-3.7	± 14.43
Cohort II (CII) CNP520 Placebo	0.6	± 13.54

CII Immediate memory - Last off-treatment

Group	Value	95% CI
Cohort II (CII) CNP520	-3.2	± 13.76
Cohort II (CII) CNP520 Placebo	-2.0	± 11.90

Visuospatial Week 26

Group	Value	95% CI
Cohort I (CI) CAD106	-6.5	± 15.21
Cohort I (CI) CAD106 Placebo	0.7	± 12.39
Cohort II (CII) CNP520	-3.5	± 14.98
Cohort II (CII) CNP520 Placebo	-2.4	± 13.00

Visuospatial Week 52

Group	Value	95% CI
Cohort I (CI) CAD106	-6.5	± 14.59
Cohort I (CI) CAD106 Placebo	3.0	± 15.09
Cohort II (CII) CNP520	-1.4	± 14.29
Cohort II (CII) CNP520 Placebo	-4.8	± 12.60

CI Visuospatial Last post baseline assessment

Group	Value	95% CI
Cohort I (CI) CAD106	-4.7	± 13.91
Cohort I (CI) CAD106 Placebo	1.9	± 12.72

Change in the Everyday Cognition Scale (ECog-Subject) Total Scores Secondary · 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

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.

Week 26

Group	Value	95% CI
Cohort I (CI) CAD106	-1.0	± 2.94
Cohort I (CI) CAD106 Placebo	2.3	± 4.80
Cohort II (CII) CNP520	1.8	± 6.03
Cohort II (CII) CNP520 Placebo	0.6	± 6.45

Week 52

Group	Value	95% CI
Cohort I (CI) CAD106	0.6	± 5.23
Cohort I (CI) CAD106 Placebo	0.4	± 2.99
Cohort II (CII) CNP520	2.7	± 6.16
Cohort II (CII) CNP520 Placebo	0.2	± 5.01

CI Last post baseline assessment

Group	Value	95% CI
Cohort I (CI) CAD106	0.6	± 5.02
Cohort I (CI) CAD106 Placebo	1.6	± 4.07

CII Last on-treatment

Group	Value	95% CI
Cohort II (CII) CNP520	2.6	± 7.81
Cohort II (CII) CNP520 Placebo	0.9	± 6.48

CII Last off-treatment

Group	Value	95% CI
Cohort II (CII) CNP520	1.6	± 6.77
Cohort II (CII) CNP520 Placebo	0.8	± 6.13

Change in the Everyday Cognition Scale (ECog-Informant) Total Scores Secondary · 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

Week 26

Group	Value	95% CI
Cohort I (CI) CAD106	-0.4	± 4.21
Cohort I (CI) CAD106 Placebo	-1.0	± 4.87
Cohort II (CII) CNP520	0.1	± 6.84
Cohort II (CII) CNP520 Placebo	-0.7	± 8.69

Week 52

Group	Value	95% CI
Cohort I (CI) CAD106	-0.2	± 3.15
Cohort I (CI) CAD106 Placebo	-0.3	± 5.12
Cohort II (CII) CNP520	1.4	± 5.18
Cohort II (CII) CNP520 Placebo	-0.2	± 9.59

CI Last post baseline assessment

Group	Value	95% CI
Cohort I (CI) CAD106	-1.1	± 4.23
Cohort I (CI) CAD106 Placebo	-1.0	± 4.88

CII Last on-treatment

Group	Value	95% CI
Cohort II (CII) CNP520	1.3	± 8.76
Cohort II (CII) CNP520 Placebo	0.1	± 9.12

CII Last off-treatment

Group	Value	95% CI
Cohort II (CII) CNP520	1.4	± 8.49
Cohort II (CII) CNP520 Placebo	-0.5	± 10.10

Number of Participants With Newly Occurring Safety MRI Abnormalities (ARIA-E, ARIA-H,White Matter Disease and Any Other MRI Abnormalities) Secondary · Baseline to end of exposure for a maximum of 1455 days for CI and 907 days for CII

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.

Questionable presence of ARIA-E

Group	Value	95% CI
Cohort I (CI) CAD106	0
Cohort I (CI) CAD106 Placebo	0
Cohort II (CII) CNP520	0
Cohort II (CII) CNP520 Placebo	1

Presence of ARIA-E

Group	Value	95% CI
Cohort I (CI) CAD106	1
Cohort I (CI) CAD106 Placebo	0
Cohort II (CII) CNP520	0
Cohort II (CII) CNP520 Placebo	2

ARIA-E - If present, the worst Severity=moderate

Group	Value	95% CI
Cohort I (CI) CAD106	1
Cohort I (CI) CAD106 Placebo	0
Cohort II (CII) CNP520	0
Cohort II (CII) CNP520 Placebo	2

Presence of ARIA-H - >4 microhemorrhages (new hemosiderin deposits < 10 mm)

Group	Value	95% CI
Cohort I (CI) CAD106	2
Cohort I (CI) CAD106 Placebo	0
Cohort II (CII) CNP520	6
Cohort II (CII) CNP520 Placebo	2

White matter disease worsening: 1-3 increase

Group	Value	95% CI
Cohort I (CI) CAD106	0
Cohort I (CI) CAD106 Placebo	2
Cohort II (CII) CNP520	6
Cohort II (CII) CNP520 Placebo	1

White matter disease worsening: 4 - 8 increase

Group	Value	95% CI
Cohort I (CI) CAD106	0
Cohort I (CI) CAD106 Placebo	0
Cohort II (CII) CNP520	0
Cohort II (CII) CNP520 Placebo	0

White matter disease worsening > 8 increase

Group	Value	95% CI
Cohort I (CI) CAD106	0
Cohort I (CI) CAD106 Placebo	0
Cohort II (CII) CNP520	0
Cohort II (CII) CNP520 Placebo	0

Any other MRI abnormalities

Group	Value	95% CI
Cohort I (CI) CAD106	2
Cohort I (CI) CAD106 Placebo	1
Cohort II (CII) CNP520	0
Cohort II (CII) CNP520 Placebo	0

Annualized Percent Change on Volume of Brain Regions Secondary · 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

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.

WB Week 26

Group	Value	95% CI
Cohort I (CI) CAD106	-0.7570	± 1.33114
Cohort I (CI) CAD106 Placebo	-0.6044	± 1.29608
Cohort II (CII) CNP520	-0.9318	± 1.06843
Cohort II (CII) CNP520 Placebo	-0.4616	± 1.00537

WB Week 52

Group	Value	95% CI
Cohort I (CI) CAD106	-0.5144	± 0.66578
Cohort I (CI) CAD106 Placebo	-0.3395	± 0.75810
Cohort II (CII) CNP520	-0.6590	± 0.64838
Cohort II (CII) CNP520 Placebo	-0.4227	± 0.58778

WB CI Last post baseline assessment

Group	Value	95% CI
Cohort I (CI) CAD106	-0.4645	± 0.57503
Cohort I (CI) CAD106 Placebo	-0.5321	± 0.46526

WB CII Last on-treatment

Group	Value	95% CI
Cohort II (CII) CNP520	-0.8268	± 0.94889
Cohort II (CII) CNP520 Placebo	-0.5181	± 0.92086

WB CII Last off-treatment

Group	Value	95% CI
Cohort II (CII) CNP520	-0.6748	± 0.62542
Cohort II (CII) CNP520 Placebo	-0.3317	± 0.62616

Hip Week 26

Group	Value	95% CI
Cohort I (CI) CAD106	-1.3262	± 2.35453
Cohort I (CI) CAD106 Placebo	-0.9245	± 2.81731
Cohort II (CII) CNP520	-1.6603	± 2.65529
Cohort II (CII) CNP520 Placebo	-0.8817	± 2.06227

Hip Week 52

Group	Value	95% CI
Cohort I (CI) CAD106	-1.0376	± 1.44310
Cohort I (CI) CAD106 Placebo	-0.7780	± 1.81604
Cohort II (CII) CNP520	-1.2438	± 1.79988
Cohort II (CII) CNP520 Placebo	-0.9567	± 1.42941

Hip CI Last post baseline assessment

Group	Value	95% CI
Cohort I (CI) CAD106	-1.0801	± 1.38061
Cohort I (CI) CAD106 Placebo	-1.0477	± 1.33603

Cohort I : Annualized Change in Amyloid Deposition as Measured by Centiloids of Positron Emission Tomography (PET) Scan With Amyloid Radiotracer Secondary · Baseline up to approximately Week 104

To demonstrate the effects of CAD106 vs placebo on Alzheimer's Disease-related biomarkers

Group	Value	95% CI
Cohort I (CI) CAD106	-0.911	± 5.6596
Cohort I (CI) CAD106 Placebo	8.367	± 6.6805

Change in Serum Neurofilaments Secondary · Baseline to Week 26 and week 52, CI baseline to last assessment. CII baseline to last on-treatment and to last off-treatment

Alzheimer's Disease-related biomarkers analyzed in blood serum: light chain neurofilaments (NfL)

Week 26

Group	Value	95% CI
Cohort I (CI) CAD106	1.44	± 3.165
Cohort I (CI) CAD106 Placebo	-3.89	± 13.058
Cohort II (CII) CNP520	0.644	± 3.4879
Cohort II (CII) CNP520 Placebo	0.362	± 6.7547

Week 52

Group	Value	95% CI
Cohort I (CI) CAD106	2.63	± 5.716
Cohort I (CI) CAD106 Placebo	-6.09	± 16.542
Cohort II (CII) CNP520	1.921	± 4.0515
Cohort II (CII) CNP520 Placebo	-4.852	± 14.2270

C I Last post baseline assessment

Group	Value	95% CI
Cohort I (CI) CAD106	1.77	± 4.643
Cohort I (CI) CAD106 Placebo	-3.31	± 12.858

C II Last on-treatment

Group	Value	95% CI
Cohort II (CII) CNP520	0.647	± 3.5357
Cohort II (CII) CNP520 Placebo	0.280	± 6.8289

C II Last off-treatment

Group	Value	95% CI
Cohort II (CII) CNP520	-0.004	± 3.7102
Cohort II (CII) CNP520 Placebo	-2.145	± 2.6799

Number of Suicidal Ideation or Behavior Events Secondary · Baseline to end of exposure for a maximum of 1455 days for CI and 907 days for CII

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.

Any suicidal ideation

Group	Value	95% CI
Cohort I (CI) CAD106	2
Cohort I (CI) CAD106 Placebo	1
Cohort II (CII) CNP520	12
Cohort II (CII) CNP520 Placebo	4

Any suicidal behavior

Group	Value	95% CI
Cohort I (CI) CAD106	0
Cohort I (CI) CAD106 Placebo	0
Cohort II (CII) CNP520	1
Cohort II (CII) CNP520 Placebo	1

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were reported from first dose of study treatment plus 31 days of washout period for a maximum duration of 1455 days for CI and 907 days for CII. Reporting threshold: 2.5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Cohort I @CAD106

Serious: 4/42 (10%)

Deaths: 0/42

Cohort I @Placebo

Serious: 3/23 (13%)

Deaths: 0/23

Cohort II (CNP520 50)

Serious: 8/249 (3%)

Deaths: 0/249

Cohort II Placebo

Serious: 7/163 (4%)

Deaths: 0/163

Serious adverse events (28 terms)

Reaction	System	Cohort I @CAD106	Cohort I @Placebo	Cohort II (CNP520 50)	Cohort II Placebo
Atrial flutter	Cardiac disorders	—	—	—	—
Cardiac failure congestive	Cardiac disorders	—	—	—	—
Coronary artery disease	Cardiac disorders	—	—	—	—
Stress cardiomyopathy	Cardiac disorders	—	—	—	—
Hiatus hernia	Gastrointestinal disorders	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—
Asthenia	General disorders	—	—	—	—
Feeling jittery	General disorders	—	—	—	—
Non-cardiac chest pain	General disorders	—	—	—	—
Abscess limb	Infections and infestations	—	—	—	—
Cellulitis	Infections and infestations	—	—	—	—
Animal bite	Injury, poisoning and procedural complications	—	—	—	—
Fall	Injury, poisoning and procedural complications	—	—	—	—
Femoral neck fracture	Injury, poisoning and procedural complications	—	—	—	—
Fibula fracture	Injury, poisoning and procedural complications	—	—	—	—
Rib fracture	Injury, poisoning and procedural complications	—	—	—	—
Hyponatraemia	Metabolism and nutrition disorders	—	—	—	—
Osteoarthritis	Musculoskeletal and connective tissue disorders	—	—	—	—
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	—	—	—	—
Malignant melanoma in situ	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—
Cerebellar haemorrhage	Nervous system disorders	—	—	—	—
Cerebrovascular accident	Nervous system disorders	—	—	—	—
Subarachnoid haemorrhage	Nervous system disorders	—	—	—	—
Syncope	Nervous system disorders	—	—	—	—
Transient ischaemic attack	Nervous system disorders	—	—	—	—

Other adverse events (101 terms — click to expand)

Reaction	System	Cohort I @CAD106	Cohort I @Placebo	Cohort II (CNP520 50)	Cohort II Placebo
Abnormal dreams	Psychiatric disorders	—	—	—	—
Fatigue	General disorders	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—
Anxiety	Psychiatric disorders	—	—	—	—
Injection site pain	General disorders	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—	—	—
Urine albumin/creatinine ratio increased	Investigations	—	—	—	—
Headache	Nervous system disorders	—	—	—	—
Insomnia	Psychiatric disorders	—	—	—	—
Bronchitis	Infections and infestations	—	—	—	—
Sinusitis	Infections and infestations	—	—	—	—
Fall	Injury, poisoning and procedural complications	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—
Pyrexia	General disorders	—	—	—	—
Weight decreased	Investigations	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—
Influenza like illness	General disorders	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—
Muscle spasms	Musculoskeletal and connective tissue disorders	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Injection site reaction	General disorders	—	—	—	—
Arthropod bite	Injury, poisoning and procedural complications	—	—	—	—
Vitamin B12 deficiency	Metabolism and nutrition disorders	—	—	—	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Tinnitus	Ear and labyrinth disorders	—	—	—	—
Malaise	General disorders	—	—	—	—
Influenza	Infections and infestations	—	—	—	—
Contusion	Injury, poisoning and procedural complications	—	—	—	—
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	—	—	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—	—	—
Atrial fibrillation	Cardiac disorders	—	—	—	—
Deafness bilateral	Ear and labyrinth disorders	—	—	—	—
Hypothyroidism	Endocrine disorders	—	—	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—	—	—

Most-reported serious reactions: Atrial flutter, Cardiac failure congestive, Coronary artery disease, Stress cardiomyopathy, Hiatus hernia, Nausea, Asthenia, Feeling jittery.

Data from ClinicalTrials.gov NCT02565511 adverse events section.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Recent advances in Alzheimer's disease: Mechanisms, clinical trials and new drug development strategies.
Zhang J, Zhang Y, Wang J, Xia Y, et al · · 2024 · cited 489× · PMID 39174535 · DOI 10.1038/s41392-024-01911-3
Alzheimer's disease drug development pipeline: 2019.
Cummings J, Lee G, Ritter A, Sabbagh M, et al · · 2019 · cited 485× · PMID 31334330 · DOI 10.1016/j.trci.2019.05.008
Alzheimer's disease prevention: from risk factors to early intervention.
Crous-Bou M, Minguillón C, Gramunt N, Molinuevo JL. · · 2017 · cited 437× · PMID 28899416 · DOI 10.1186/s13195-017-0297-z
Anti-Amyloid-β Monoclonal Antibodies for Alzheimer's Disease: Pitfalls and Promise.
van Dyck CH. · · 2018 · cited 415× · PMID 28967385 · DOI 10.1016/j.biopsych.2017.08.010
Alzheimer's disease drug development pipeline: 2018.
Cummings J, Lee G, Ritter A, Zhong K. · · 2018 · cited 402× · PMID 29955663 · DOI 10.1016/j.trci.2018.03.009
Alzheimer's disease drug development pipeline: 2020.
Cummings J, Lee G, Ritter A, Sabbagh M, et al · · 2020 · cited 350× · PMID 32695874 · DOI 10.1002/trc2.12050
Drug candidates in clinical trials for Alzheimer's disease.
Hung SY, Fu WM. · · 2017 · cited 281× · PMID 28720101 · DOI 10.1186/s12929-017-0355-7
Alzheimer's disease drug development pipeline: 2017.
Cummings J, Lee G, Mortsdorf T, Ritter A, et al · · 2017 · cited 258× · PMID 29067343 · DOI 10.1016/j.trci.2017.05.002

Verify or expand the search:

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02565511 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
Last refreshed: 8 July 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02565511.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT02565511: GS1

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (28 terms)

Sponsor's own description

Publications & conference data

Related trials

Other recruiting trials for Alzheimers Disease

Other Novartis Pharmaceuticals trials

Verify against primary sources