CompletedPhase 2

Safety, Tolerability and Abeta-specific Antibody Response of Repeated i.m. Injections of Adjuvanted CAD106 in Mild Alzheimer Patients

A 90-week, Multi-center, Randomized, Double-blind, Placebo-controlled Study in Patients With Mild Alzheimer's Disease (AD) to Investigate the Safety, Tolerability and Abeta-specific Antibody Response Following Repeated i.m. Injections of Adjuvanted CAD106

Lead sponsor

Novartis Pharmaceuticals

Asset

CAD106

Listed sites

Recruiting sites

Enrollment

177

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 20-26•AD symptomatic therapy: stable ≥4 weeks

Primary endpoint

•Safety and tolerability assessments, vital signs, standard

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Eudract number2009-012394-35

Org study IDCCAD106A2203

NCT IDNCT01097096

Timeline

Milestones

Study start2010-03 (month precision)

Study first posted2010-04-01estimated

Primary completion2012-12actual (month precision)

Study completion2012-12actual (month precision)

Last update posted2021-03-05actual

Assets

Drug assets

CAD106

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

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 clinical assessments

Exclusion criteria

•Previously participated in an AD vaccine study and received active treatment

•History or presence of an active autoimmune disease

•History or presence of seizure disorder

•Presence of significant coronary heart disease and/or cerebrovascular disease

•Presence of other neurodegenerative disease and/or psychiatric disorders (with the exception of successfully treated depression)

•Advanced, severe, progressive or unstable disease that might interfere with the safety, tolerability and pharmacodynamic assessments of the patient

Other protocol-defined inclusion/exclusion criteria may apply

Endpoints (4)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Amyloid biomarkers

Neuroimaging

Amyloid biomarkers

3 endpoints

Secondary/protocol endpoint

Amyloid beta (Aβ)-specific and Qβ carrier-specific antibody response to CAD106 (with either adjuvant) in serum and cerebrospinal fluid (CSF)

Time frame:Screening and through the end of the study to Week 90

descriptive

Secondary/protocol endpoint

Amyloid beta (Aβ)-specific and Qβ carrier-specific T-cell response to CAD106 (with either adjuvant) using peripheral blood mononuclear cells (PBMCs)

Time frame:Screening and at week 8

descriptive

Secondary/protocol endpoint

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

Time frame:Screening and through the end of the study to Week 90

concentration, descriptive

Neuroimaging

1 endpoint

Primary/protocol endpoint

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).

Time frame:Screening and through the end of the study to Week 90

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.