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

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

Official Title
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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

Conditions
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Alzheimer's Disease

Intervention / Treatment
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* Biological: Placebo
* Biological: CAD106


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CAD106<br> | Biological: CAD106<br> <br> |
| Placebo Comparator: Placebo<br> | Biological: Placebo<br>* Placebo comparator<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Active immunization, Alzheimer's disease, Antibody, Vaccine, Central Nervous System Diseases, Neurodegenerative diseases