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CompletedPhase 2

Safety and Tolerability of Repeated Subcutaneous Injections of CAD 106 in Mild Alzheimer's Patients

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

Lead sponsor

Novartis

Asset

CAD106

Listed sites

10

Recruiting sites

-

Enrollment

31

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 20-26•AD symptomatic therapy: stable ≥6 weeks

Primary endpoint

•Safety/tolerability of repeated injection of CAD106 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 IDCCAD106A2202
NCT IDNCT00795418

Timeline

Milestones

Study start2008-10 (month precision)
Study first posted2008-11-21estimated
Primary completion2010-11actual (month precision)
Last update posted2020-12-17actual

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

•Male and/or female patients between 40 and 85 years of age (both inclusive)
•Diagnosis of mild Alzheimer's Disease (AD)
•Mini-Mental State Examination (MMSE) 20 to 26 at screening, untreated or on stable dose of cholinesterase inhibitor or memantine over the last 6 weeks

Exclusion criteria

•Previously participated in an AD vaccine study and received active treatment.
•History or presence of an active autoimmune and/or with an acute or chronic inflammation, and/or clinically relevant atopic condition.
•History or presence of seizures 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 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

Other (unclassified)
3
Neuroimaging
1

Neuroimaging

1 endpoint
Primary/protocol endpoint

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)

Time frame:52 weeks

event count, event

Other (unclassified)

3 endpoints
Secondary/protocol endpoint/low confidence

Immune response at multiple timepoints including but not limited to screening, baseline and through the end of the study.

Time frame:52 weeks

descriptive

Secondary/protocol endpoint/low confidence

Cognitive assessments at multiple timepoints including but not limited to screening, baseline and through the end of the study.

Time frame:52 weeks

descriptive

Secondary/protocol endpoint/low confidence

Functional assessments at multiple timepoints including but not limited to screening, baseline and through the end of the study.

Time frame:52 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.