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

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.

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.

Study Overview

• Status: Completed
• Conditions: Parkinson's Disease

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1080
    • Studienzentrum der PROSENEX, AmbulatoriumbetriebsgesmbH an der Confraternität-Privatklinik Josefstadt, Skodagasse 32

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 41 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Only participants of AFF008 will be offered participation in AFF008E.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Affiris AG
• Investigators: Principal Investigator: Dieter Volc, Prim. Dr., Studienzentrum der PROSENEX AmbulatoriumbetriebsgesmbH an der Confraternität-Privatklinik Josefstadt

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: June 21, 2013
• First Submitted That Met QC Criteria: June 21, 2013
• First Posted (Estimate): June 25, 2013

Study Record Updates

• Last Update Posted (Estimate): August 17, 2015
• Last Update Submitted That Met QC Criteria: August 14, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: AFF008E; 2013-001774-20 (EudraCT Number)