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CAD106

Phase 2

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

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials3
Total Enrollment72

FDA Designations

No designations recorded

Clinical trial landscape

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 DiseaseUnlock trial analytics
PHASE2COMPLETED
To Investigate the Safety and Tolerability of Repeated Subcutaneous Injections of CAD106 in Alzheimer's Patients
Alzheimer DiseaseUnlock trial analytics
PHASE2COMPLETED
To Investigate the Safety and Tolerability of Repeated Subcutaneous Injections of CAD106 in Alzheimer's Patients
Alzheimer DiseaseUnlock trial analytics
PHASE2COMPLETED
Safety and Tolerability of Repeated Subcutaneous Injections of CAD 106 in Mild Alzheimer's Patients
Alzheimer's DiseaseUnlock trial analytics
PHASE2COMPLETED
Safety and Tolerability of Repeated Subcutaneous Injections of CAD106 in Mild Alzheimer's Patients.
Alzheimer DiseaseUnlock trial analytics

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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Frequently asked questions about CAD106

What is CAD106 used for?

CAD106 is an investigational monoclonal antibody being developed for Alzheimer's disease. It is designed to target the amyloid-beta protein, which is believed to play a role in the disease. CAD106 is currently in Phase 2 clinical trials and is not yet approved by regulatory authorities.

What does CAD106 target?

CAD106 targets the amyloid-beta protein, a key component of the plaques found in the brains of Alzheimer's disease patients. By binding to this protein, CAD106 aims to reduce its accumulation and potentially slow the progression of the disease. This mechanism is being studied in clinical trials.

Who makes CAD106?

CAD106 is being developed by Novartis AG, a multinational pharmaceutical company listed on the stock exchange under the ticker symbol NVS. Novartis is conducting clinical trials to evaluate the safety and efficacy of CAD106 in patients with Alzheimer's disease.

What phase is CAD106 in?

CAD106 is currently in Phase 2 clinical development. It has completed three clinical trials, including one Phase 1 and two Phase 2 studies. These trials have focused on evaluating the safety and tolerability of CAD106 in patients with mild to moderate Alzheimer's disease.

What clinical trials is CAD106 in?

CAD106 has been studied in three completed clinical trials. These include NCT00411580, a Phase 1 safety study in Sweden; NCT00733863, a Phase 2 study in France, Sweden, Switzerland, and the UK; and NCT00795418, a Phase 2 study in the US. A fourth trial, NCT01097096, also Phase 2, was conducted internationally.

Is CAD106 the same as other Alzheimer's treatments?

CAD106 is a distinct investigational monoclonal antibody targeting amyloid-beta. It is not the same as other approved Alzheimer's drugs, such as cholinesterase inhibitors or NMDA receptor antagonists. CAD106 is still in clinical development and has not been approved for use.