xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06015841</url>
    </required_header>
    <id_info>
      <org_study_id>ACI-7104-PD-2103</org_study_id>
      <secondary_id>2022-500292-31-00</secondary_id>
      <secondary_id>1006102</secondary_id>
      <nct_id>NCT06015841</nct_id>
    </id_info>
    <brief_title>A Study to Evaluate the Effects of ACI-7104.056 Vaccination in Patients With Early Stages of Parkinson's Disease</brief_title>
    <acronym>VacSYn</acronym>
    <official_title>An Adaptive, Phase 2, Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Safety, Tolerability, Immunogenicity, and Pharmacodynamic Effects of ACI-7104.056 in Patients With Early Stages of Parkinson's Disease</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>AC Immune SA</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>ICON Clinical Research</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>AC Immune SA</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this study is to evaluate the safety, tolerability, immunogenicity, and&#xD;
        pharmacodynamic effects of ACI-7104.056 vaccination in patients with early stages of&#xD;
        Parkinson's disease.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a prospective, multicenter, placebo-controlled, double-blind, randomized study with&#xD;
        adaptive features, comprising a screening period of up to 8 weeks, a 74-week double-blind&#xD;
        treatment period, and a 26-week post-treatment follow-up period.&#xD;
  &#xD;
        Up to 3 cohorts will include 16 subjects each (12 under the study vaccine and 4 under&#xD;
        placebo; 3:1 active treatment/placebo ratio). One of the initial potential 3 cohorts (Cohorts&#xD;
        2 and 3 are optional) may be expanded in order to reach an overall total of up to 150&#xD;
        subjects in the study. In case a cohort is expanded, the randomization ratio will be adjusted&#xD;
        to achieve an active treatment/placebo ratio of 2:1 in this cohort.&#xD;
  &#xD;
        The route of administration of the study vaccine and placebo will be by intramuscular&#xD;
        injections.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 24, 2023</start_date>
    <completion_date type="Anticipated">January 2028</completion_date>
    <primary_completion_date type="Anticipated">January 2028</primary_completion_date>
    <phase>Phase 2</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Sequential Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Number of participants with Adverse Events (AEs) assessed by intensity (mild, moderate or severe) and causal relationship (unrelated, or unlikely, possibly, probably or definitely related)</measure>
      <time_frame>From Screening (ICF signature) to Week 100</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of participants with abnormal MRI results</measure>
      <time_frame>From Baseline to Week 100</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of participants with clinically significant changes in physical and neurological examination results</measure>
      <time_frame>From Baseline to Week 74</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of participants reporting suicidal ideation or behavior using Columbia-Suicide Severity Rating Scale (C-SSRS)</measure>
      <time_frame>From Baseline to Week 100</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Measurement of levels of specific antibodies against a-synuclein present in serum generated by ACI-7104.056</measure>
      <time_frame>From Baseline to Week 100</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Measures of alpha-synuclein (a-syn) related biofluid biomarkers</measure>
      <time_frame>From Baseline to Week 100</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Measurement of levels of dopamine transporter proteins in specific brain regions, notably substantia nigra, by Dopamine Transporter-Single Photon Emission Computerized Tomography (DaT-SPECT) imaging</measure>
      <time_frame>From Baseline to Week 100</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III</measure>
      <time_frame>From Baseline to Week 100</time_frame>
    </secondary_outcome>
    <other_outcome>
      <measure>Change in motor and nonmotor functions using the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)</measure>
      <time_frame>From Baseline to Week 100</time_frame>
    </other_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">150</enrollment>
    <condition>Parkinson Disease</condition>
    <condition>Parkinson Disease 6, Early-Onset</condition>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Early PD subjects receive placebo at pre-defined time points over 74 weeks.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>ACI-7104.056 at Dose A</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Early PD subjects receive dose A of ACI-7104.056 at pre-defined time points over 74 weeks.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>ACI-7104.056 at Dose B (optional)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Early PD subjects receive dose B of ACI-7104.056 at pre-defined time points over 74 weeks. This arm is optional.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>ACI-7104.056 at Dose C (optional)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Early PD subjects receive dose C of ACI-7104.056 at pre-defined time points over 74 weeks. This arm is optional.</description>
    </arm_group>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>The placebo is a solution matching the study vaccine formulation.</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>ACI-7104.056 at Dose A</intervention_name>
      <description>The study vaccine (ACI-7104.056) consists of an adjuvanted protein peptide conjugate vaccine.</description>
      <arm_group_label>ACI-7104.056 at Dose A</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>ACI-7104.056 at Dose B (optional)</intervention_name>
      <description>The study vaccine (ACI-7104.056) consists of an adjuvanted protein peptide conjugate vaccine.</description>
      <arm_group_label>ACI-7104.056 at Dose B (optional)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>ACI-7104.056 at Dose C (optional)</intervention_name>
      <description>The study vaccine (ACI-7104.056) consists of an adjuvanted protein peptide conjugate vaccine.</description>
      <arm_group_label>ACI-7104.056 at Dose C (optional)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion criteria:&#xD;
  &#xD;
            1. Confirmed diagnosis of clinically established early PD using the modified Movement&#xD;
               Disorder Society criteria, after excluding any other known or suspected cause of PD.&#xD;
               The presence of motor symptoms should not be of more than 2 years at screening.&#xD;
  &#xD;
            2. Monotherapy treatment with L-Dopa at 300 mg per day, with a stable dose prior to&#xD;
               baseline for 3 months. The subject has a reasonably low likelihood of requiring dose&#xD;
               adjustment within the next 6 to 12 months after enrolment. Any exception to this rule&#xD;
               has to be previously agreed with the Sponsor medical monitor.&#xD;
  &#xD;
            3. Male or female.&#xD;
  &#xD;
            4. Aged ≥40 to ≤75 years.&#xD;
  &#xD;
            5. Body weight range of ≥45 kg to ≤110 kg (99 to 242 lbs) and a body mass index of ≥18 to&#xD;
               ≤34 kg/m2.&#xD;
  &#xD;
            6. Modified Hoehn-Yahr (H&amp;Y) Stage I to II.&#xD;
  &#xD;
            7. A centrally read screening brain DaT-SPECT consistent with PD.&#xD;
  &#xD;
            8. Subjects can understand the informed consent form, are able and willing to provide&#xD;
               written informed consent, and can be expected to comply with the study protocol&#xD;
               according to the International Council for Harmonisation of Technical Requirements for&#xD;
               Pharmaceuticals for Human Use and local regulations.&#xD;
  &#xD;
            9. Female participants must be postmenopausal for at least 1 year and/or surgically&#xD;
               sterilized, or, if they are female of childbearing potential or not postmenopausal,&#xD;
               they must have a negative blood pregnancy test at screening and be willing to use&#xD;
               highly effective methods of contraception from the screening visit until the end of&#xD;
               the safety follow-up period (approximately 108 weeks). Male participants in the trial&#xD;
               with female partners of childbearing potential are required to use barrier methods of&#xD;
               contraception (condoms with spermicide) in addition to contraceptive measures used by&#xD;
               female partners during the whole study duration. Men must refrain from donating sperm&#xD;
               during this same period. The female partners should use a highly effective method of&#xD;
               contraception with a failure rate of less than 1% per year from screening until the&#xD;
               end of the safety follow-up period (approximately 108 weeks). The reliability of&#xD;
               sexual abstinence should be evaluated in relation to the duration of the clinical&#xD;
               trial and the preferred and usual lifestyle of the subject. Periodic abstinence (eg,&#xD;
               calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not&#xD;
               acceptable methods of contraception.&#xD;
  &#xD;
          Exclusion criteria:&#xD;
  &#xD;
            1. Medical history indicating a Parkinsonian syndrome other than idiopathic PD, including&#xD;
               but not limited to, progressive supranuclear palsy, multiple system atrophy, drug&#xD;
               induced parkinsonism, essential tremor, vascular parkinsonism, primary dystonia.&#xD;
  &#xD;
            2. Known carriers of certain familial PD gene mutations (PRKN, PINK1, DJ1, LRRK2).&#xD;
  &#xD;
            3. History of PD-related freezing episodes or falls.&#xD;
  &#xD;
            4. History of brain surgery or any neurosurgical procedures.&#xD;
  &#xD;
            5. Reside in a nursing home or assisted care facility.&#xD;
  &#xD;
            6. A history of cancer within 5 years of baseline with the exception of fully excised non&#xD;
               melanoma skin cancers or nonmetastatic prostate cancer that has been stable for at&#xD;
               least 6 months, or cervical intraepithelial neoplasia stage I uterine cancer.&#xD;
  &#xD;
            7. History of and/or screening brain MRI scan indicative of, clinically significant&#xD;
               abnormality including but not limited to prior hemorrhage or infarct &gt;1 cm3 or &gt;3&#xD;
               lacunar infarcts.&#xD;
  &#xD;
            8. Diagnosis of a significant central nervous system disease other than PD (including but&#xD;
               not limited to Huntington's disease, normal pressure hydrocephalus, cerebrovascular&#xD;
               disease including stroke, fronto-temporal dementia, Alzheimer's disease, dementia with&#xD;
               Lewy bodies, multiple sclerosis, brain tumor); history of repeated head injury;&#xD;
               history of epilepsy or seizure disorder other than febrile seizures as a child.&#xD;
  &#xD;
            9. Presence of psychiatric symptoms (eg, confusion, hallucination, delusion, excitation,&#xD;
               delirium, abnormal behavior at screening and baseline). Note: mild depression,&#xD;
               depressive mood, or mild anxiety arising in the context of PD are not exclusionary.&#xD;
  &#xD;
           10. Clinically significant concomitant disease or condition within 6 months prior to&#xD;
               screening, or as specified below, that could interfere with the conduct of the study,&#xD;
               or that would, in the opinion of the investigator, pose an unacceptable risk to the&#xD;
               study participant:&#xD;
  &#xD;
                 1. Autoimmune disease (except well controlled conditions as specified in the study&#xD;
                    protocol with decision making on a case per case basis).&#xD;
  &#xD;
                 2. Any active infectious disease and/or any febrile illness (including&#xD;
                    noninfectious) within 1 week prior to first dose administration.&#xD;
  &#xD;
                 3. Any current psychiatric diagnosis that may interfere with the participant's&#xD;
                    ability to perform the study.&#xD;
  &#xD;
                 4. Women who are pregnant or breastfeeding or intending to become pregnant during&#xD;
                    the study.&#xD;
  &#xD;
                 5. Myocardial infarction within 12 months of baseline.&#xD;
  &#xD;
                 6. Known history or documentation of uncontrolled hypotension or bradycardia on more&#xD;
                    than 1 occasion within 3 months prior to baseline and known history or&#xD;
                    documentation of uncontrolled hypertension on more than 1 occasion within 3&#xD;
                    months prior to baseline (up to Principal Investigator's discretion). Resting&#xD;
                    pulse rate &gt;100 or &lt;45 bpm. A QT interval corrected using Fridericia's formula&#xD;
                    measurement of 450 ms for males or 470 ms for females at screening or a family&#xD;
                    history of long QT-syndrome. Intermittent second or third degree atrioventricular&#xD;
                    (AV) heart block or AV dissociation or any other clinically significant&#xD;
                    cardiovascular disease.&#xD;
  &#xD;
                 7. Clinically significant abnormalities in laboratory test results at the screening&#xD;
                    visit (specified in more detail in a separate document), positive result for&#xD;
                    acute or chronic infectious Hepatitis B virus (HBV; [ie, Hepatitis B surface&#xD;
                    antigen (HBsAg) positive test]), for Hepatitis C virus (HCV), or for Human&#xD;
                    Immunodeficiency Virus (HIV) 1 or 2. Successfully treated subjects with HCV&#xD;
                    (undetectable HCV RNA) are eligible for enrolment. Participants who are immune&#xD;
                    due to HBV natural infection or HBV vaccination are eligible.&#xD;
  &#xD;
                 8. Use of any of the following: monoamine oxidase (MAO)-B inhibitors,&#xD;
                    catechol-O-methyl transferase (COMT) inhibitors (eg, entacapone, opicapone,&#xD;
                    tolcapone), amantadine, adenosine A2a antagonists or anticholinergics, or&#xD;
                    dopaminergic medication (both ergot and nonergot [pramipexole, ropinirole,&#xD;
                    rotigotine] dopamine agonists) for more than a total of 90 days or within 90 days&#xD;
                    of baseline.&#xD;
  &#xD;
                 9. Antiepileptic medication (eg, valproate) for nonseizure-related treatment that&#xD;
                    has not remained stable for at least 60 days prior to baseline.&#xD;
  &#xD;
                10. Antidepressant use that has not remained stable for at least 2 months prior to&#xD;
                    baseline.&#xD;
  &#xD;
                11. Use of any of the following medications within 90 days prior to baseline:&#xD;
                    metoclopramide, alpha methyldopa, flunarizine, amoxapine, amphetamine&#xD;
                    derivatives, reserpine, bupropion, buspirone, cocaine, cannabis, mazindol,&#xD;
                    methamphetamine, methylphenidate, phentermine, phenylpropanolamine, and&#xD;
                    modafinil. Exceptional use of norephedrine is allowed (eg, treatment for a cold).&#xD;
  &#xD;
                12. Previous participation in a clinical trial using an active immunotherapy against&#xD;
                    PD, unless there is firm evidence that the subject received placebo only and the&#xD;
                    placebo formulation is not expected to induce any specific immune response.&#xD;
  &#xD;
                13. Previous treatment with any investigational and/or marketed passive immunotherapy&#xD;
                    against PD within 6 months before screening or 5 half-lives, whichever is longer,&#xD;
                    unless there is firm evidence that the subject received placebo only (in the case&#xD;
                    of any investigational product administered within the frame of a clinical trial&#xD;
                    participation).&#xD;
  &#xD;
                14. Participation in previous clinical trials for PD and/or for neurological&#xD;
                    disorders using any small molecule drug with a washout &lt;30 days or &lt;5 half lives&#xD;
                    of the drug, whichever is longer before screening, unless there is firm evidence&#xD;
                    that the subject received placebo only.&#xD;
  &#xD;
                15. Concomitant participation in any other clinical trial using experimental or&#xD;
                    approved medications or therapies (eg, device, stem cell). This does not include&#xD;
                    noninterventional devices for disease tracking or imaging studies.&#xD;
  &#xD;
                16. Immunomodulating and immunosuppressant drugs including oral corticosteroids&#xD;
                    within 30 days prior to baseline.&#xD;
  &#xD;
                17. Allergy to any of the components of the study vaccine.&#xD;
  &#xD;
                18. Any contraindications to obtaining a brain MRI or DaT-SPECT, getting a lumbar&#xD;
                    puncture or receiving IM injections.&#xD;
  &#xD;
           11. Current, or history of, alcohol or drug (including cannabis) abuse or other dependence&#xD;
               (except nicotine dependence) within 12 months before screening.&#xD;
  &#xD;
           12. Subjects with known hypersensitivity to the study vaccine or placebo components.&#xD;
  &#xD;
           13. Subjects who previously received a vaccination (ie, influenza vaccine and COVID 19)&#xD;
               within the last 4 weeks prior to randomization or standard-of-care immunizations&#xD;
               within the last 2 weeks prior to randomization.&#xD;
  &#xD;
           14. Subjects being treated with any anticoagulants or antiplatelet drugs, except aspirin&#xD;
               at doses of 100 mg daily or lower.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>40 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Daniela Berg, Prof.</last_name>
      <role>Study Chair</role>
      <affiliation>Klinik für Neurologie, UKSH Campus Kiel, Germany</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Olivier Sol</last_name>
      <phone>+41 21 345 91 21</phone>
      <email>clinicaltrials@acimmune.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Tanja Touilloux</last_name>
      <phone>+41 21 345 91 21</phone>
      <email>clinicaltrials@acimmune.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Katholisches Klinikum Bochum GmbH</name>
        <address>
          <city>Bochum</city>
          <country>Germany</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Paracelsus-Kliniken Deutschland GmbH &amp; Co. KGaA</name>
        <address>
          <city>Kassel</city>
          <country>Germany</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>University Medical Centre Schleswig-Holstein</name>
        <address>
          <city>Kiel</city>
          <country>Germany</country>
        </address>
      </facility>
      <status>Active, not recruiting</status>
    </location>
    <location>
      <facility>
        <name>Hospital De La Santa Creu I Sant Pau</name>
        <address>
          <city>Barcelona</city>
          <country>Spain</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Hospital Universitari Vall D Hebron</name>
        <address>
          <city>Barcelona</city>
          <country>Spain</country>
        </address>
      </facility>
      <status>Active, not recruiting</status>
    </location>
    <location>
      <facility>
        <name>Policlinica Gipuzkoa</name>
        <address>
          <city>Donostia</city>
          <country>Spain</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Hospital Universitario De La Princesa</name>
        <address>
          <city>Madrid</city>
          <country>Spain</country>
        </address>
      </facility>
      <status>Active, not recruiting</status>
    </location>
    <location>
      <facility>
        <name>Hospital Universitario Puerta De Hierro De Majadahonda</name>
        <address>
          <city>Majadahonda</city>
          <country>Spain</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Hospital Universitario Quironsalud Madrid</name>
        <address>
          <city>Pozuelo De Alarcón</city>
          <country>Spain</country>
        </address>
      </facility>
      <status>Active, not recruiting</status>
    </location>
    <location_countries>
      <country>Germany</country>
      <country>Spain</country>
    </location_countries>
    <results_reference>
      <citation>Volc D, Poewe W, Kutzelnigg A, Luhrs P, Thun-Hohenstein C, Schneeberger A, Galabova G, Majbour N, Vaikath N, El-Agnaf O, Winter D, Mihailovska E, Mairhofer A, Schwenke C, Staffler G, Medori R. Safety and immunogenicity of the alpha-synuclein active immunotherapeutic PD01A in patients with Parkinson's disease: a randomised, single-blinded, phase 1 trial. Lancet Neurol. 2020 Jul;19(7):591-600. doi: 10.1016/S1474-4422(20)30136-8.</citation>
      <PMID>32562684</PMID>
    </results_reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 4, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 29, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 29, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Early Parkinson's disease</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Parkinson Disease</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06015841
  org study id: ACI-7104-PD-2103
  secondary id: 2022-500292-31-00
  secondary id: 1006102
  nct id: NCT06015841
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study is to evaluate the safety, tolerability, immunogenicity, and
        pharmacodynamic effects of ACI-7104.056 vaccination in patients with early stages of
        Parkinson's disease.
  This is a prospective, multicenter, placebo-controlled, double-blind, randomized study with
        adaptive features, comprising a screening period of up to 8 weeks, a 74-week double-blind
        treatment period, and a 26-week post-treatment follow-up period.
  
        Up to 3 cohorts will include 16 subjects each (12 under the study vaccine and 4 under
        placebo; 3:1 active treatment/placebo ratio). One of the initial potential 3 cohorts (Cohorts
        2 and 3 are optional) may be expanded in order to reach an overall total of up to 150
        subjects in the study. In case a cohort is expanded, the randomization ratio will be adjusted
        to achieve an active treatment/placebo ratio of 2:1 in this cohort.
  
        The route of administration of the study vaccine and placebo will be by intramuscular
        injections.
  allocation: Randomized
  intervention model: Sequential Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Number of participants with Adverse Events (AEs) assessed by intensity (mild, moderate or severe) and causal relationship (unrelated, or unlikely, possibly, probably or definitely related)
  time frame: From Screening (ICF signature) to Week 100
  measure: Number of participants with abnormal MRI results
  time frame: From Baseline to Week 100
  measure: Number of participants with clinically significant changes in physical and neurological examination results
  time frame: From Baseline to Week 74
  measure: Number of participants reporting suicidal ideation or behavior using Columbia-Suicide Severity Rating Scale (C-SSRS)
  time frame: From Baseline to Week 100
  measure: Measurement of levels of specific antibodies against a-synuclein present in serum generated by ACI-7104.056
  time frame: From Baseline to Week 100
  measure: Measures of alpha-synuclein (a-syn) related biofluid biomarkers
  time frame: From Baseline to Week 100
  measure: Measurement of levels of dopamine transporter proteins in specific brain regions, notably substantia nigra, by Dopamine Transporter-Single Photon Emission Computerized Tomography (DaT-SPECT) imaging
  time frame: From Baseline to Week 100
  measure: Change from baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III
  time frame: From Baseline to Week 100
  measure: Change in motor and nonmotor functions using the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
  time frame: From Baseline to Week 100
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: Early PD subjects receive placebo at pre-defined time points over 74 weeks.
  arm group label: ACI-7104.056 at Dose A
  arm group type: Experimental
  description: Early PD subjects receive dose A of ACI-7104.056 at pre-defined time points over 74 weeks.
  arm group label: ACI-7104.056 at Dose B (optional)
  arm group type: Experimental
  description: Early PD subjects receive dose B of ACI-7104.056 at pre-defined time points over 74 weeks. This arm is optional.
  arm group label: ACI-7104.056 at Dose C (optional)
  arm group type: Experimental
  description: Early PD subjects receive dose C of ACI-7104.056 at pre-defined time points over 74 weeks. This arm is optional.
  intervention type: Biological
  intervention name: Placebo
  description: The placebo is a solution matching the study vaccine formulation.
  arm group label: Placebo
  intervention type: Biological
  intervention name: ACI-7104.056 at Dose A
  description: The study vaccine (ACI-7104.056) consists of an adjuvanted protein peptide conjugate vaccine.
  arm group label: ACI-7104.056 at Dose A
  intervention type: Biological
  intervention name: ACI-7104.056 at Dose B (optional)
  description: The study vaccine (ACI-7104.056) consists of an adjuvanted protein peptide conjugate vaccine.
  arm group label: ACI-7104.056 at Dose B (optional)
  intervention type: Biological
  intervention name: ACI-7104.056 at Dose C (optional)
  description: The study vaccine (ACI-7104.056) consists of an adjuvanted protein peptide conjugate vaccine.
  arm group label: ACI-7104.056 at Dose C (optional)
  criteria: 
  gender: All
  minimum age: 40 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Daniela Berg, Prof.
  role: Study Chair
  affiliation: Klinik für Neurologie, UKSH Campus Kiel, Germany
  last name: Olivier Sol
  phone: +41 21 345 91 21
  email: clinicaltrials@acimmune.com
  last name: Tanja Touilloux
  phone: +41 21 345 91 21
  email: clinicaltrials@acimmune.com
  facility: 
  status: Not yet recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Active, not recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Active, not recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Active, not recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Active, not recruiting
  country: Germany
  country: Spain
  citation: Volc D, Poewe W, Kutzelnigg A, Luhrs P, Thun-Hohenstein C, Schneeberger A, Galabova G, Majbour N, Vaikath N, El-Agnaf O, Winter D, Mihailovska E, Mairhofer A, Schwenke C, Staffler G, Medori R. Safety and immunogenicity of the alpha-synuclein active immunotherapeutic PD01A in patients with Parkinson's disease: a randomised, single-blinded, phase 1 trial. Lancet Neurol. 2020 Jul;19(7):591-600. doi: 10.1016/S1474-4422(20)30136-8.
  PMID: 32562684
  responsible party type: Sponsor
  mesh term: Parkinson Disease
  sharing ipd: Undecided