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CAD106

Phase 2

Alzheimer Disease | Monoclonal antibody | Neurology |Novartis AG|Trials Updated: Mar 5, 2021

CAD106 development status

Highest phase Phase 2
Registered trials 6 across 2 sponsors since Dec 2006

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials6
Total Enrollment338

FDA Designations

No designations recorded

CAD106 clinical trials

CAD106 · 6 trials · 2 indications

Phase 2 5Phase 1 1
NCT01097096Safety, Tolerability and Abeta-specific Antibody Response of Repeated i.m. Injections of Adjuvanted CAD106 in Mild Alzheimer PatientsAlzheimer's Disease
COMPLETED177 Analytics
NCT01023685To Investigate the Safety and Tolerability of Repeated Subcutaneous Injections of CAD106 in Alzheimer's PatientsAlzheimer Disease
COMPLETED24 Analytics
NCT00956410To Investigate the Safety and Tolerability of Repeated Subcutaneous Injections of CAD106 in Alzheimer's PatientsAlzheimer Disease
COMPLETED21 Analytics
NCT00795418Safety and Tolerability of Repeated Subcutaneous Injections of CAD 106 in Mild Alzheimer's PatientsAlzheimer's Disease
COMPLETED31 Analytics
NCT00733863Safety and Tolerability of Repeated Subcutaneous Injections of CAD106 in Mild Alzheimer's Patients.Alzheimer Disease
COMPLETED27 Analytics
PHASE2COMPLETED
Safety, Tolerability and Abeta-specific Antibody Response of Repeated i.m. Injections of Adjuvanted CAD106 in Mild Alzheimer Patients
Alzheimer's Disease
NCT01097096177
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PHASE2COMPLETED
To Investigate the Safety and Tolerability of Repeated Subcutaneous Injections of CAD106 in Alzheimer's Patients
Alzheimer Disease
NCT0102368524
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PHASE2COMPLETED
To Investigate the Safety and Tolerability of Repeated Subcutaneous Injections of CAD106 in Alzheimer's Patients
Alzheimer Disease
NCT0095641021
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PHASE2COMPLETED
Safety and Tolerability of Repeated Subcutaneous Injections of CAD 106 in Mild Alzheimer's Patients
Alzheimer's Disease
NCT0079541831
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PHASE2COMPLETED
Safety and Tolerability of Repeated Subcutaneous Injections of CAD106 in Mild Alzheimer's Patients.
Alzheimer Disease
NCT0073386327
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Study Endpoints

Primary Endpoints

Safety and tolerability assessments (physical/neurological examinations, electrocardiogram (ECG), vital signs, standard and special laboratory evaluations, Magnetic Resonance Imaging (MRIs), Adverse events / Serious adverse events (AE/SAE) monitoring).
Screening and through the end of the study to Week 90
Safety/tolerability assessments at multiple time points including but not limited to screening, and through to the end of the study to week 66.
66 weeks
Safety/tolerability assessments at multiple timepoints including but not limited to screening, and through to the end of the study to week 66.
66 weeks
Safety/tolerability of repeated injection of CAD106 at multiple timepoints including but not limited to screening, baseline and through the end of the study (adverse events, physical/neurologic exams, vital signs, 12- lead ECGs, clinical labs, brain MRI)
52 weeks
Safety/tolerability assessments at multiple timepoints including but not limited to screening, baseline, and through the end of the study to Week 52.
52 weeks
Tolerability/safety assessments (physical/neurol.exam., ECG, vital signs, standard and special immunological laboratory evaluations, MRIs, EEGs, AE/SAE monitoring).
at multiple timepoints including but not limited to screening, baseline, and through the end of the study to Week 52.
Antibody titers (IgM and IgM titers against amyloid and carrier protein).
at multiple timepoints including but not limited to baseline and through the end of the study to Week 52

Secondary Endpoints

Amyloid beta (Aβ)-specific and Qβ carrier-specific antibody response to CAD106 (with either adjuvant) in serum and cerebrospinal fluid (CSF)
Screening and through the end of the study to Week 90
Amyloid beta (Aβ)-specific and Qβ carrier-specific T-cell response to CAD106 (with either adjuvant) using peripheral blood mononuclear cells (PBMCs)
Screening and at week 8
Changes over time of the concentrations of disease related markers (Aβ1-40 and Aβ1-42 in plasma; Aβ1-40, Aβ1-42, total-tau, phospho-tau in CSF, or other markers) in patients with mild AD receiving CAD106 (with either adjuvant) compared to placebo
Screening and through the end of the study to Week 90
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
CAD106 150μg + Adjuvant 1 at middle doseACTIVE_COMPARATOR -
CAD106 150μg + Adjuvant 1 at low doseACTIVE_COMPARATOR -
Placebo + Adjuvant 1 at middle dosePLACEBO_COMPARATOR -
CAD106 150μg + Adjuvant 2 at middle doseACTIVE_COMPARATOR -
CAD106 150μg + Adjuvant 2 at low doseACTIVE_COMPARATOR -
Placebo + Adjuvant 2 at middle dosePLACEBO_COMPARATOR -
CAD106 450μg + either Adjuvant 1 or 2 at middle doseACTIVE_COMPARATOR -
CAD106 450μg + either Adjuvant 1 or 2 at low doseACTIVE_COMPARATOR -
Placebo + either Adjuvant 1 or 2 at middle dosePLACEBO_COMPARATOR -
CAD106EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
1EXPERIMENTAL -
2PLACEBO_COMPARATOR -

Interventions

NameTypeDescription
CAD106BIOLOGICAL150μg and 450μg doses were reconstituted and administered via intramuscular injection
PlaceboBIOLOGICALIdentical placebo to CAD106 administered via intramuscular injection
AlumBIOLOGICALAn adjuvant (additive to increase potency ) of low, middle or high doses which was mixed with reconstituted active CAD106
MF59BIOLOGICALAn adjuvant (additive to increase potency) of low, middle and high doses which was mixed with reconstituted active CAD106
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Eligibility Criteria

Age RangeN/A to 85 Years
SexALL
Healthy VolunteersNo
Study Sites31

Inclusion Criteria: * Male and/or female patients below 85 years of age (inclusive) * Diagnosis of mild Alzheimer's Disease * Mini-Mental State Examination (MMSE) 20 to 26 (inclusive) at screening, untreated or on stable dose of cholinesterase inhibitor or memantine over the last 4 weeks prior to c...

Countries:United StatesBelgiumCanadaGermanyItalyNetherlandsNorwaySpainSwedenSwitzerlandFranceUnited Kingdom
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Competitive Landscape -Alzheimer's Disease 105 trials (matched to "Alzheimer Disease")

Top 20 of 30 competitors

CompanyTickerTrialsLead PhaseDrugs
Bristol-Myers Squibb CompanyBMY11PHASE3Xanomeline and trospium chloride, KarX-EC, Xanomeline/Trospium Chloride, BMS-986446, X/T+ X-EC
Eli Lilly and CompanyLLY18PHASE3Donanemab, Remternetug, LY4405094, LY4560736, LY3954068
Biogen Inc.BIIB2PHASE3Lecanemab
Annovis Bio IncANVS1PHASE3Buntanetap
ACADIA Pharmaceuticals Inc.ACAD2PHASE3ACP-204
Hoffmann-La RocheRHHBY9PHASE3Trontinemab, RO7269162, RO7568282, RO7812653
Novartis AG Sponsored ADRNVS2PHASE2VHB937, NIO752
Johnson & JohnsonJNJ1PHASE2JNJ-64042056
Merck & Co., Inc.MRK1PHASE2MK-2214
Lantheus Holdings IncLNTH2PHASE3PI2620
Acumen Pharmaceuticals, Inc.ABOS1PHASE2sabirnetug
Cognition Therapeutics, Inc.CGTX1PHASE2CT1812
Aclaris Therapeutics, Inc.ACRS1PHASE2ATI-045
IGC Pharma, Inc.IGC1PHASE2IGC-AD1
GSK plc Sponsored ADRGSK1PHASE2GSK4527226
Alnylam Pharmaceuticals, IncALNY2PHASE1ALN-5288, ALN-APP
Denali Therapeutics Inc.DNLI2PHASE1DNL628, DNL921
Arrowhead Pharmaceuticals, Inc.ARWR1PHASE1ARO-MAPT
Sanofi SA Sponsored ADRSNY1PHASE2SAR448851
Neurocrine Biosciences, Inc.NBIX1PHASE2NBI-1117567
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Frequently asked questions about CAD106

What is CAD106 used for?

CAD106 is an investigational therapy being studied for Alzheimer disease. It has been evaluated in Phase 2 clinical trials in patients with mild Alzheimer disease. It is not approved for any indication and remains in clinical development.

Who is developing CAD106?

CAD106 is being developed by Novartis AG, which trades under the ticker NVS. Novartis has sponsored the clinical trial program for CAD106 in Alzheimer disease.

What phase is CAD106 in?

CAD106 is in Phase 2 clinical development. All six of its trials are completed, and no trials are currently active. It is an investigational agent and has not been approved for marketing.

What clinical trials is CAD106 in?

CAD106 has been studied in six completed Phase 2 trials, including NCT01097096, NCT01023685, NCT00956410, and NCT00795418. These trials enrolled patients with mild Alzheimer disease across the United States, Canada, and several European countries, with a total enrollment of 338 participants.

How was CAD106 administered in clinical trials?

CAD106 was administered as repeated intramuscular or subcutaneous injections in Phase 2 trials. The studies were randomized, double-blind, and placebo-controlled, evaluating safety and tolerability in patients with mild Alzheimer disease.

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