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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00956410

Enrollment

Registered

2009-08-11

Start date

2009-09-30

Completion date

2011-06-30

Last updated

2020-02-11

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

Conditions

Alzheimer Disease

Keywords

Active immunization, Alzheimer disease, Antibody, Central Nervous System Diseases, Neurodegenerative diseases, Vaccine

Brief summary

This study will evaluate the safety and tolerability of repeated subcutaneous injections of CAD106 in patients with Alzheimer's disease.

Interventions

BIOLOGICALCAD106

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

40 Years to 85 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Safety/tolerability assessments at multiple timepoints including but not limited to screening, and through to the end of the study to week 66.	66 weeks

Secondary

Measure	Time frame
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.	66 weeks
Evaluate the antibody response after 4 additional injections in the Extension study in patients initially treated with CAD106 in the Core study.	66 weeks
Collect long-term safety information through SAEs collection for two years after completion of the core study, CAD106A2201, or extension study, CAD106A2201E1.	2 years

Countries

France, Sweden, Switzerland, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 17, 2026