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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

4

Recruiting sites

-

Enrollment

21

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Age 40-85

Primary endpoint

•Safety/tolerability assessments at multiple timepoints

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 IDCCAD106A2201E1
NCT IDNCT00956410

Timeline

Milestones

Study first posted2009-08-11estimated
Study start2009-09 (month precision)
Primary completion2011-06actual (month precision)
Study completion2011-06actual (month precision)
Last update posted2020-02-11actual

Assets

Drug assets

CAD106

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age40 Years
Maximum age85 Years
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.

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 timepoints 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 SAEs collection for two years after completion of the core study, CAD106A2201, or extension study, CAD106A2201E1.

Time frame:2 years

descriptive

Other (unclassified)

2 endpoints
Secondary/protocol endpoint/low confidence

Immune response, cognitive and functional assessments at multiple timepoints 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.