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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-001774-20 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 15µg AFFITOPE® PD01A | Patients With Parkinson's Disease vaccinated with 4 injections of 15µg AFFITOPE® PD01A adsorbed to adjuvant during AFF008 | ||
| 75µg AFFITOPE® PD01A | Patients With Parkinson's Disease vaccinated with 4 injections of 75µg AFFITOPE® PD01A adsorbed to adjuvant during AFF008 | ||
| Control group | Untreated control group |
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| Measure | Description | Time Frame |
|---|---|---|
| Tolerability and Safety | These will be based on the following parameters:
| 52 weeks |
| 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:
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Inclusion Criteria:
Exclusion Criteria:
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Only participants of AFF008 will be offered participation in AFF008E.
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| Name | Affiliation | Role |
|---|---|---|
| Dieter Volc, Prim. Dr. | Studienzentrum der PROSENEX AmbulatoriumbetriebsgesmbH an der Confraternität-Privatklinik Josefstadt | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Studienzentrum der PROSENEX, AmbulatoriumbetriebsgesmbH an der Confraternität-Privatklinik Josefstadt, Skodagasse 32 | Vienna | 1080 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30741694 | Derived | McFarthing K, Simuni T. Clinical Trial Highlights: Targetting Alpha-Synuclein. J Parkinsons Dis. 2019;9(1):5-16. doi: 10.3233/JPD-189004. No abstract available. |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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Analyzing patients' DNA (isolated out of whole blood) for polymorphisms in genes/regions like REP1 or alpha-synuclein to correlate results with the progression rate of the disease.
| 52 weeks |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |