AFF008E: Observational Phase 1b Follow-up Extension Study for Patients With Parkinson's Disease After Immunization With AFFITOPE® PD01A

Study Overview
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Brief Summary
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AFF008E is set-up to assess the long term effects of the 4 PD01A vaccinations that have been applied during AFF008 with regard to safety as well as immunological-, radiological and clinical activity. Accordingly, during AFF008E, no further vaccine dose will be applied. Instead, patients who were participating in AFF008 will be assessed for another 52 weeks at the occasion of 4 quarterly visits. This is offered to patients who received PD01A vaccinations but also to the patients who served as controls in AFF008. Thus, AFF008E will ensure standardized and controlled management of individuals who have received PD01A as part of AFF008, the Phase I study analyzing for the first time in humans this first in class candidate.

Official Title
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AFF008E:Observational Follow-up Extension Study to Evaluate Long-term Safety and Tolerability of Immunization With AFFITOPE® PD01A Applied During AFF008 in Patients With Parkinson's Disease.

Conditions
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Parkinson's Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent signed and dated by the patient Participation in AFF008 Exclusion Criteria: History of questionable compliance to visit schedule; patients not expected to complete the clinical trial Participation in the active treatment phase of another clinical trial except AFF008 within 13 weeks before Visit 1 and for the whole study duration

Ages Eligible for Study
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Minimum Age: 41 Years
Maximum Age: 66 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 15µg AFFITOPE® PD01A<br>Patients With Parkinson's Disease vaccinated with 4 injections of 15µg AFFITOPE® PD01A adsorbed to adjuvant during AFF008 | |
| 75µg AFFITOPE® PD01A<br>Patients With Parkinson's Disease vaccinated with 4 injections of 75µg AFFITOPE® PD01A adsorbed to adjuvant during AFF008 | |
| Control group<br>Untreated control group | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability and Safety | These will be based on the following parameters: Withdrawal criteria (continuation decision) Number of patients who withdraw due to adverse events Reason for withdrawal Occurrence of any serious adverse event possibly, probably or definitely related to the study vaccine at any time during the study. Occurrence of any adverse events possibly, probably or definitely related to the study vaccine | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunological and Clinical Efficacy | Immunological parameters: -Titer of antibodies specific for the immunizing peptide, keyhole limpet hemocyanin (carrier protein), α-Synuclein, β-Synuclein as assessed by Enzyme-Linked Immunosorbent Assay Clinical efficacy variables: Motor symptoms: Movement Disorder Society Unified Parkinson's Disease Rating Scale III Investigator's Global Evaluation scale Non-motor symptoms Parkinson's Disease Quality of Life-39 / Parkinson's Disease Non Motor Symptoms Movement Disorder Society Unified Parkinson's Disease Rating Scale II Cognitive scales Smell identification test Movement Disorder Society Unified Parkinson's Disease Rating Scale Ia (Caregiver-based assessment) Geriatric Depression Scale Biomarker data Change in Dopamine Transporter - Single Photon Emission Computed Tomography signal (compared to AFF008 results) Assessment of change of volume of relevant brain regions (compared to AFF008 results) | 52 weeks |