Clinical- and Immunological Activity, Safety and Tolerability of Different Doses / Formulations of AFFITOPE AD02 in Early Alzheimer's Disease

Study Overview
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Brief Summary
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This is a multiple vaccination study to find out if it is a safe treatment and what effects it has on the symptoms of early Alzheimer's disease in male and female patients aged 50 to 80 years. Approximately 40 study sites in Europe will be involved. Patients will be randomized to receive either AFFITOPE AD02 or placebo. Each patient's participation will last 1 year.

Detailed Description
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AFFITOPE AD02 is a second generation AD immunotherapeutics targeting Aβ. Its active component is a synthetic peptide functionally mimicking the unmodified N-terminus of Aβ.

Official Title
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A Randomized, Controlled, Parallel Group, Double-blind, Multi-center, Phase II Study to Assess the Clinical- and Immunological Activity,as Well as the Safety and Tolerability of Different Doses/Formulations of AFFITOPE AD02 Administered Repeatedly to Patients With Early Alzheimer's Disease

Conditions
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Alzheimer's Disease

Intervention / Treatment
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* Biological: active: AFFITOPE AD02
* Biological: control: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed consent capability Early AD, based on episodic memory deficit and hippocampal atrophy Age from 50 to 80, inclusive MMSE of 20+ Brain magnetic resonance imaging scan consistent with the diagnosis of AD Stable doses of medications (cholinesterase inhibitors and memantine allowed) Caregiver able to attend all visits with patient Exclusion Criteria: Significant neurological disease other than AD Major psychiatric illness Significant systemic illness Autoimmune disease Prior treatment with experimental immunotherapeutics for AD including IVIG Women of childbearing potential without birth control Contraindication for MRI scan

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 |
| --- | --- |
| Active Comparator: A: AFFITOPE AD02<br> | Biological: active: AFFITOPE AD02<br>* vaccination<br>* Other names: AFFITOPE AD02;|
| Active Comparator: B: AFFITOPE AD02<br> | Biological: active: AFFITOPE AD02<br>* vaccination<br>* Other names: AFFITOPE AD02;|
| Active Comparator: C: AFFITOPE AD02<br> | Biological: active: AFFITOPE AD02<br>* vaccination<br>* Other names: AFFITOPE AD02;|
| Active Comparator: D: Placebo control<br> | Biological: control: Placebo<br>* vaccination<br>* Other names: control;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cognitive(ADAS-cog modified) and functional(ADCS-ADL modified) |  | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cognitive(computerised test battery), global(CDR-sb), behavioral(NPI), biomarker (volumetric MRI) |  | 18 months |