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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00795418

Enrollment

Registered

2008-11-21

Start date

2008-10-31

Completion date

Unknown

Last updated

2020-12-17

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

Conditions

Alzheimer's Disease

Keywords

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

Brief summary

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

Interventions

BIOLOGICALPlacebo

Placebo comparator

BIOLOGICALCAD106

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

40 Years to 85 Years

Healthy volunteers

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/

Design outcomes

Primary

Measure	Time frame
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)	52 weeks

Secondary

Measure	Time frame
Immune response at multiple timepoints including but not limited to screening, baseline and through the end of the study.	52 weeks
Cognitive assessments at multiple timepoints including but not limited to screening, baseline and through the end of the study.	52 weeks
Functional assessments at multiple timepoints including but not limited to screening, baseline and through the end of the study.	52 weeks

Countries

United States

Outcome results

None listed

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