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

Study Overview
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Brief Summary
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This study will evaluate the safety and tolerability and Aß-specific antibody response of CAD106 in patients with mild to moderate Alzheimer's Disease. Patients also had a 2 year follow-up to assess disease progression where no drug was administered.

Official Title
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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 Aß-specific Antibody Response Following Three Subcutaneous Injections of CAD106

Conditions
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Alzheimer's Disease

Intervention / Treatment
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* Biological: CAD106
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 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: 1<br>CAD106 | Biological: CAD106<br> <br> |
| Placebo Comparator: 2<br>Placebo | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability/safety assessments (physical/neurol.exam., ECG, vital signs, standard and special immunological laboratory evaluations, MRIs, EEGs, AE/SAE monitoring). |  | at multiple timepoints including but not limited to screening, baseline, and through the end of the study to Week 52. | 
| Antibody titers (IgM and IgM titers against amyloid and carrier protein). |  | at multiple timepoints including but not limited to baseline and through the end of the study to Week 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immune response, cognitive and functional assessments |  | at multiple timepoints including but not limited to baseline and through the end of the study to Week 52 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mild, moderate Alzheimer's Disease (AD), Aß-specific antibody, CAD106