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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 Abeta-specific antibody response following three subcutaneous injections of CAD106

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 Abeta-specific antibody response following three subcutaneous injections of CAD106

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-000048-10-SE
Enrollment
60
Registered
2005-02-21
Start date
2005-04-20
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's disease

Interventions

Product Code: CAD106 Pharmaceutical Form: Solution for injection Current Sponsor code: CAD106 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 0.5- Pha

Sponsors

Novartis Pharma Services AG
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Males and females (non-child bearing0 aged 50 to 80 years old Mini Mental State Exam score between 16 and 26 Outpatients with caregiver Diagnostic and Statistical manual of Mental Disorders (4th edition) criteria for dentia of the Alzheimer's type Clinical diagnosis of probable Alzheimer's disease according to Natinal Institure of Neurological and Communicative Disordrs and Stroke-Alzheimer's Disease and Related Disorders Association Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Previous participation in Alzheimer's disease vaccine trial and received active treatment History or presence of aoutoimmune and/or cerebrovascular disease Immunosuppressive therapy, including steroids Vaccinated within 4 weeks before the first study drug injection

Design outcomes

Primary

MeasureTime frame
Main Objective: To evaluate safety and tolerabiltiy of repeated subcutaneous injections of CAD106 in patients with mild to moderate Alzheimer's disease. To determine time-course and decline, and isotype switch from IgM to Ig Gof the Abeta-specific antibody response in serum, using the Enzyme inked Immunosorbent Assay (ELISA), following rpeated subcutaneous injections of CAD106 or placebo;Secondary Objective: Explore characteristics of Abeta-antibodies in serum and CSF Characterize Abeta-specific T0cell lympohocytes Explore effects on disease progression Explore effects on concentrations of disease related markers Perform exploratory phamacogenetic assessments Conduct exploratory genomic, proteomic and metabonomic assessments;Primary end point(s): Adverse event reports Isotype switch from IgM to IgG of the Abeta-specific antibodies in serum—

Countries

Sweden

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026