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CompletedPhase 1

Safety and Tolerability Study in Patients With Mild to Moderate Alzheimer's Disease (AD)

A 52-week, Multi-center, Randomized, Double-blind, Placebo-controlled, Time-lagged, Parallel Group Study in Patients With Mild to Moderate Alzheimer's Disease (AD) to Investigate the Safety, Tolerability and Aß-specific Antibody Response Following Three Subcutaneous Injections of CAD106

Asset

CAD106

Listed sites

3

Recruiting sites

-

Enrollment

58

actual

Study population

Alzheimer’s disease

Key I/E criterion

•mild-to-moderate AD

Primary endpoints

•Tolerability/safety assessments•Antibody titers

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 IDCCAD106A2101
NCT IDNCT00411580

Timeline

Milestones

Study start2005-06 (month precision)
Study first posted2006-12-14estimated
Primary completion2008-12actual (month precision)
Study completion2008-12actual (month precision)
Last update posted2013-03-29estimated

Assets

Drug assets

CAD106

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years
Maximum age80 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•males and/or females patients between 50 to 80 years of age (both inclusive).
•female patients must be without childbearing potential (post-menopausal or surgically sterilized).
•diagnosis of dementia of the Alzheimer's type according to the DSM-IV criteria (Diagnostic and Statistical Manual of Mental Disorders, 4th edition).
•mild to moderate AD as confirmed by Mini-Mental State Exam score of 16 to 26 (both inclusive) at screening.
•able to provide written informed consent and having a responsible caregiver that can provide written assent prior to study participation. For patients who have been declared mentally incompetent, a legal representative will need to provide informed consent on their behalf

Exclusion criteria

•previously participated in an AD vaccine study and received active treatment
•history or presence of an active autoimmune and/or cerebrovascular disease
•history or presence of seizures, with an acute or chronic inflammation
•clinically relevant atopic condition, who suffer from an other neurodegenerative disease and/or psychiatric disorders (with the exception of successfully treated depression)
•immunosuppressive treatment including systemic steroids
•obtained a vaccination (e.g. against influenza) within 4 weeks before the first study drug injection
•advanced, severe, progressive or unstable disease that might interfere with the safety of the patient
•started treatment with psychotropic medication within 3 months (4 weeks for SSRIs and other newer antidepressants without anticholinergic properties) prior to randomization with the exception of mild hypnotic drugs (e.g. zolpidem, zopiclone, oxazepam) and low doses of neuroleptic drugs (e.g. up to 2 mg risperidone).

Patients, who are on stable treatment with cholinesterase-inhibitors (ChEIs) and/or memantine for at least 3 months, and/or with SSRIs and/or other newer antidepressants (without anticholinergic properties) for at least 4 weeks before randomization, can be included into the study.

Endpoints (3)

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
1
Safety / tolerability / PK
1
Other (unclassified)
1

Amyloid biomarkers

1 endpoint
Primary/protocol endpoint

Antibody titers (IgM and IgM titers against amyloid and carrier protein).

Time frame:at multiple timepoints including but not limited to baseline and through the end of the study to Week 52

descriptive

Safety / tolerability / PK

1 endpoint
Primary/protocol endpoint

Tolerability/safety assessments (physical/neurol.exam., ECG, vital signs, standard and special immunological laboratory evaluations, MRIs, EEGs, AE/SAE monitoring).

Time frame:at multiple timepoints including but not limited to screening, baseline, and through the end of the study to Week 52.

descriptive

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

Immune response, cognitive and functional assessments

Time frame:at multiple timepoints including but not limited to baseline and through the end of the study to Week 52

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.