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About
This is a randomized, placebo-controlled, parallel group, patient-blind, single-center phase I clinical trial of repeated once every 4 weeks administration by subcutaneous injection of AFFITOPE® PD01A, adsorbed to aluminium oxide in 30 patients with PD-GBA over a treatment period of 8 weeks. Patients will be randomized in a 2:1 ratio to two different treatment groups: A) 75 µg AFFITOPE® PD01A, adsorbed to aluminium oxide and B) placebo (= 1 mg aluminium oxide).
Over a study duration of 52 weeks, each patient will receive 3 injections of AFFITOPE® PD01A or placebo during the participation in the clinical trial. Patients will either receive 75 µg AFFITOPE® PD01A adsorbed to 1 mg aluminium oxide or placebo (=1mg aluminium oxide). The treatment group consists of 20 PDGBA patients, the placebo group of 10 PDGBA patients. Male and female patients aged 40 to 80 years can participate in the trial.
AFF010 is part of the project MULTISYN funded by the European Commission (FP7-HEALTH-2013-INNOVATION-1 project; N° HEALTH-F4-2013-602646).
Sex
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Inclusion criteria
Exclusion criteria
Pregnant women
Sexually active women of childbearing potential who are not using a medically accepted birth control method
Participation in another clinical trial within 3 months before Visit 1
History of questionable compliance to visit schedule; patients not expected to complete the clinical trial
Presence or history of allergy to components of the vaccine if considered relevant by the investigator
Contraindication for MRI imaging such as metallic implants (e.g. endoprosthesis, stents, cardiac pacemakers) which are not MR compatible at 3.0 Tesla with the given MR protocol, other foreign metal bodies (e.g. bullets, metal splinters, e.g.) or claustrophobia
Missing agreement to be informed about incident findings and consultation of a neuroradiologist
Contraindication for PET, that is, pregnancy and breast feeding.
Ongoing participation in other interventional studies or clinical trials using radiotracers
Dementia according to Diagnostic and Statistical Manual (DSM) IV criteria
History and/or presence of autoimmune disease, if considered relevant by the investigator
Recent (≤3 years since last specific treatment) history of cancer (Exceptions: non-melanoma skin cancer, intraepithelial cervical neoplasia)
Active infectious disease (e.g., Hepatitis B, C)
Presence and/or history of Immunodeficiency (e.g., HIV)
Significant systemic illness (e.g., chronic renal failure, chronic liver disease, poorly controlled diabetes, poorly controlled congestive heart failure, other deficiencies), if considered relevant by the investigator
History of significant psychiatric illness such as schizophrenia, bipolar affective disorder or psychotic depression
Parkinson-like disease secondary to drug therapy side effects (e.g., due to exposure to medications that deplete dopamine [reserpine, tetrabenazine] or block dopamine receptors [neuroleptics, antiemetics])
Parkinson-plus syndromes (e.g., multiple system atrophy (MSA), progressive supranuclear palsy (PSP)), Dementia with Lewy Bodies (DLB)
Heredodegenerative disorders other than PDGBA, evidence for other genetic forms of PD (e.g. LRRK2, Parkin gene mutations)
Alcoholism or substance abuse within the past year (alcohol or drug intoxication)
Prior and/or current treatment with experimental immunotherapeutics including Intravenous Immunoglobulin (IVIG)
Prior and/or current treatment with immune modulating drugs:
Change in dose of standard treatments for PD within 3 months prior to Visit 1
Change in dose of previous and current medications which the patient is taking because of consisting illnesses according medical history (except PD therapies, these will be recorded separately) within the last 30 days prior to Visit 1, if clinically relevant
Treatment with deep brain stimulation
Venous status rendering it impossible to place an i.v. access
Primary purpose
Allocation
Interventional model
Masking
0 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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