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CompletedPhase 2

To Investigate the Safety and Tolerability of Repeated Subcutaneous Injections of CAD106 in Alzheimer's Patients

An Open-label Extension to a 52-week, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group Study in Patients With Alzheimer's Disease to Investigate the Safety and Tolerability of Repeated Subcutaneous Injections of CAD106.

Lead sponsor

Novartis

Asset

CAD106

Listed sites

8

Recruiting sites

-

Enrollment

24

actual

Study population

Alzheimer’s disease

Key I/E criterion

-

Primary endpoint

•Safety/tolerability assessments at multiple time points

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

Org study IDCCAD106A2202E1
NCT IDNCT01023685

Timeline

Milestones

Study start2009-12 (month precision)
Study first posted2009-12-02estimated
Primary completion2012-02actual (month precision)
Study completion2012-02actual (month precision)
Last update posted2020-12-17actual

Assets

Drug assets

CAD106

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Patients who have completed the core study with no significant safety concerns

Exclusion criteria

•Diagnosis of other neurodegenerative disease and/or psychiatric disorders (with the exception of successfully treated depression).
•Diagnosis or presence of an active, uncontrolled seizure disorder and/or cerebrovascular disease.
•Diagnosis or presence of an active autoimmune and/or with an acute or chronic inflammation.

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

Safety / tolerability / PK
2
Other (unclassified)
2

Safety / tolerability / PK

2 endpoints
Primary/protocol endpoint

Safety/tolerability assessments at multiple time points including but not limited to screening, and through to the end of the study to week 66.

Time frame:66 weeks

descriptive

Secondary/protocol endpoint

Collect long-term safety information through SAE's collection for two years after completion of the extension study.

Time frame:2 years

descriptive

Other (unclassified)

2 endpoints
Secondary/protocol endpoint/low confidence

Immune response, cognitive and functional assessments at multiple time points including but not limited to baseline, and through to the end of the study to week 66.

Time frame:66 weeks

descriptive

Secondary/protocol endpoint/low confidence

Evaluate the antibody response after 4 additional injections in the Extension study, in patients initially treated with CAD106 in the Core study.

Time frame:66 weeks

descriptive

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

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.