Lancet Neurology: Safety and immunogenicity of α-synaptic nuclear protein active immunotherapy PD01A in patients with Parkinson's disease: a randomized, single-blind, Phase 1 trial

α-synth nucleoprotein is a soluble protein expressed before and around synapses in the central nervous system, and strong evidence supports the role of α-synactal nucleoprotein pathology as a driver of neuron dysfunction in Parkinson's disease.
PD01A is a specific α immunotherapy for oligopolymer-synaptic nuclear proteins.
phase 1 study assessed the safety and tolerance of PD01A immunotherapy in patients with Parkinson's disease.
: We conducted the first human random phase 1 study of PD01A immunity, followed by three consecutive study extensions.
patients recruited at a private clinic in Vienna, Austria, required patients aged 45-65 who were clinically diagnosed with Parkinson's disease (since diagnosis≤4 years, Hoehn and Yahr Phase 1-2), and imaging results (dopamine transporter monophoton emission CT and MRI) were consistent with Parkinson's disease diagnosis and a stable dose of Parkinson's drugs for at least three months.
patients were randomly assigned (1:1) to receive 4 subsute immunizations using computer-generated sequences of different sizes, of which 15 or 75 μg PD01A was injected into the upper arm, initially for 52 weeks, followed by 39 weeks.
, the patient was randomly assigned (1:1) to receive 15 μg or 75?g of the first enhanced immunity again, and followed for 24 weeks.
all patients were immunized for a second 75 sg and followed up for 52 weeks.
patients were concealed from dose distribution.
(safety) analysis includes all patients treated.
: Between 14 February 2012 and 6 February 2013, 32 patients were recruited, 24 of whom were considered eligible and randomly assigned to receive 4 PD01A initiation immunizations.
patient was diagnosed with multisyscular atrophy and withdrawn, and two patients withdrew their consents during the study.
21 (87%) of the 24 patients received all six immunizations and completed 221-259 weeks of the study (two patients in the 15 μg dose group and one patient in the 75?g dose group stopped taking the drug).
all patients experienced at least one adverse event, but most patients were not considered to be related to the study treatment (except for a brief local injection site reaction, only one patient was affected).
a series of MRI tests also ruled out the inflammatory process.
adverse events associated with systemic therapy were fatigue (n=4), headache (n=3), myalgia (n=3), muscle stiffness (n=2) and tremor (n=2).
the geometry of the immunopeptide PD01 antibody increased from 1:46 at the baseline to 1:3580 in the 12th week and from 1:76 to 1:2462 in the 75?g dose group at 12 weeks.
antibody titration returned to baseline levels after 2 years, but recovered rapidly after intensive immunity from week 116, reaching the geometric group average titration of 1:20218.
, our results on the ongoing α-synaptic nuclear protein-specific antibody response suggest that PD01A immunity may be a promising strategy for long-term treatment of Parkinson's disease.
Volc, Dieter et al. Safety and immunogenicity of the α-synuclein active immunotherapeutic PD01A in patients with Parkinson's disease: a randomised, single-blinded, phase 1 trial. The Lancet Neurology, Volume 19, Issue 7, 591 - 600 Network Source: Web Copyright Notice: All text, images and audio and video materials on this website that indicate "Source: Met Medical" or "Source: MedSci Original" are owned by Mays Medical, are not authorized, may not be reproduced by any media, website or individual, and shall be reproduced with the words "Source: Mays Medicine".
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