Parkinson DiseasePhase 2VacSYnNCT06015841
A Study to Evaluate the Effects of ACI-7104.056 in Patients With Early Stages of Parkinson's Disease
A Phase 2 study testing ACI-7104.056 at Dose A, ACI-7104.056 at Dose B (optional) and ACI-7104.056 at Dose C (optional) in people with Parkinson Disease and Parkinson Disease 6, Early-Onset, run by AC Immune SA at 12 sites in 3 countries.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, immunogenicity, and pharmacodynamic effects of ACI-7104.056 in patients with early stages of Parkinson's disease. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Parkinson Disease, Parkinson Disease 6, Early-Onset
- What is being tested?
- ACI-7104.056 at Dose A, ACI-7104.056 at Dose B (optional) and ACI-7104.056 at Dose C (optional)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 12 sitesin 3 countries
- Study dates
- 24 Jul 2023to Jun 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of clinically established early PD using the modified Movement Disorder Society criteria, after excluding any other known or suspected cause of PD. The presence of motor symptoms should not be of more than 2 years at screening.
- Monotherapy treatment with L-Dopa at 300 mg per day, with a stable dose prior to baseline for 3 months. The participant has a reasonably low likelihood of requiring dose adjustment within the next 6 to 12 months after enrolment. Any exception to this rule has to be previously agreed with the Sponsor medical monitor.
- Male or female.
- Aged ≥40 to ≤75 years.
- Body weight range of ≥45 kg to ≤110 kg (99 to 242 lbs) and a body mass index of ≥18 to ≤34 kg/m2.
- Modified Hoehn-Yahr (H\&Y) Stage I to II.
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- A centrally read screening brain DaT-SPECT consistent with PD.
- Participants can understand the informed consent form, are able and willing to provide documented informed consent, and can be expected to comply with the study protocol according to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use and local regulations.
- Female participants must be postmenopausal for at least 1 year and/or surgically sterilized, or, if they are female of childbearing potential or not postmenopausal, they must have a negative blood pregnancy test at screening and be willing to use highly effective methods of contraception from the screening visit until the end of the safety follow-up period (approximately 108 weeks). Male participants in the trial with female partners of childbearing potential are required to use barrier methods of contraception (condoms with spermicide) in addition to contraceptive measures used by female partners during the whole study duration. Men must refrain from donating sperm during this same period. The female partners of male participants should use a highly effective method of contraception with a failure rate of less than 1% per year from screening until the end of the safety follow-up period (approximately 108 weeks). The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the participant. Periodic abstinence (eg, calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.
- Participants having completed study Part 1 and having received all 6 administrations of the study treatment as per protocol.
- Participants can understand the informed consent form, are able and willing to provide documented informed consent, and are expected to comply with the study protocol according to ICH requirements and local regulations.
- Inclusion criterion 9 from study Part 1 regarding prevention of pregnancy/contraception must continue to apply.
Who cannot join
- Medical history indicating a Parkinsonian syndrome other than idiopathic PD, including but not limited to, progressive supranuclear palsy, multiple system atrophy, drug induced parkinsonism, essential tremor, vascular parkinsonism, primary dystonia.
- Known carriers of certain familial PD gene mutations (PRKN, PINK1, DJ1, LRRK2).
- History of PD-related freezing episodes or falls.
- History of brain surgery or any neurosurgical procedures.
- Reside in a nursing home or assisted care facility.
- A history of cancer within 5 years of baseline with the exception of fully excised non melanoma skin cancers or nonmetastatic prostate cancer that has been stable for at least 6 months, or cervical intraepithelial neoplasia stage I uterine cancer.
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- History of and/or screening brain MRI scan indicative of, clinically significant abnormality including but not limited to prior hemorrhage or infarct >1 cm3 or >3 lacunar infarcts.
- Diagnosis of a significant central nervous system disease other than PD (including but not limited to Huntington's disease, normal pressure hydrocephalus, cerebrovascular disease including stroke, fronto-temporal dementia, Alzheimer's disease, dementia with Lewy bodies, multiple sclerosis, brain tumor); history of repeated head injury; history of epilepsy or seizure disorder other than febrile seizures as a child.
- Presence of psychiatric symptoms (eg, confusion, hallucination, delusion, excitation, delirium, abnormal behavior at screening and baseline). Note: mild depression, depressive mood, or mild anxiety arising in the context of PD are not exclusionary.
- Clinically significant concomitant disease or condition within 6 months prior to screening, or as specified below, that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the study participant:
- Autoimmune disease (except well controlled conditions as specified in the study protocol with decision making on a case per case basis).
- Any active infectious disease and/or any febrile illness (including noninfectious) within 1 week prior to first dose administration.
- Any current psychiatric diagnosis that may interfere with the participant's ability to perform the study.
- Female participants who are pregnant or breastfeeding or intending to become pregnant during the study.
- Myocardial infarction within 12 months of baseline.
- Known history or documentation of uncontrolled hypotension or bradycardia on more than 1 occasion within 3 months prior to baseline and known history or documentation of uncontrolled hypertension on more than 1 occasion within 3 months prior to baseline (up to Principal Investigator's discretion). Resting pulse rate >100 or <45 bpm. A QT interval corrected using Fridericia's formula measurement of 450 ms for males or 470 ms for females at screening or a family history of long QT-syndrome. Intermittent second or third degree atrioventricular (AV) heart block or AV dissociation or any other clinically significant cardiovascular disease.
- Clinically significant abnormalities in laboratory test results at the screening visit (specified in more detail in a separate document), positive result for acute or chronic infectious Hepatitis B virus (HBV; [ie, Hepatitis B surface antigen (HBsAg) positive test]), for Hepatitis C virus (HCV), or for Human Immunodeficiency Virus (HIV) 1 or 2. Successfully treated participants with HCV (undetectable HCV RNA) are eligible for enrolment. Participants who are immune due to HBV natural infection or HBV vaccination are eligible.
- Use of any of the following: monoamine oxidase (MAO)-B inhibitors, catechol-O-methyl transferase (COMT) inhibitors (eg, entacapone, opicapone, tolcapone), amantadine, adenosine A2a antagonists or anticholinergics, or dopaminergic medication (both ergot and nonergot [pramipexole, ropinirole, rotigotine] dopamine agonists) for more than a total of 90 days or within 90 days of baseline.
- Antiepileptic medication (eg, valproate) for nonseizure-related treatment that has not remained stable for at least 60 days prior to baseline.
- Antidepressant use that has not remained stable for at least 2 months prior to baseline.
- Use of any of the following medications within 90 days prior to baseline: metoclopramide, alpha methyldopa, flunarizine, amoxapine, amphetamine derivatives, reserpine, bupropion, buspirone, cocaine, cannabis, mazindol, methamphetamine, methylphenidate, phentermine, phenylpropanolamine, and modafinil. Exceptional use of norephedrine is allowed (eg, treatment for a cold).
- Previous participation in a clinical trial using an active immunotherapy against PD, unless there is firm evidence that the participant received placebo only and the placebo formulation is not expected to induce any specific immune response.
- Previous treatment with any investigational and/or marketed passive immunotherapy against PD within 6 months before screening or 5 half-lives, whichever is longer, unless there is firm evidence that the participant received placebo only (in the case of any IMP administered within the frame of a clinical trial participation).
- Participation in previous clinical trials for PD and/or for neurological disorders using any small molecule drug with a washout <30 days or <5 half lives of the drug, whichever is longer before screening, unless there is firm evidence that the participant received placebo only.
- Concomitant participation in any other clinical trial using experimental or approved medications or therapies (eg, device, stem cell). This does not include noninterventional devices for disease tracking or imaging studies.
- Immunomodulating and immunosuppressant drugs including oral corticosteroids within 30 days prior to baseline.
- Allergy to any of the components of the study treatment.
- Any contraindications to obtaining a brain MRI or DaT-SPECT, getting a lumbar puncture or receiving IM injections.
- Current, or history of, alcohol or drug (including cannabis) abuse or other dependence (except nicotine dependence) within 12 months before screening.
- Participants with known hypersensitivity to the study treatment or placebo components.
- Participants who previously received a vaccination (ie, influenza treatment and COVID 19) within the last 4 weeks prior to randomization or standard-of-care immunizations within the last 2 weeks prior to randomization.
- Participants being treated with any anticoagulants or antiplatelet drugs, except aspirin at doses of 100 mg daily or lower.
- Exclusion criteria for the study Part 1 and Part 2 are applicable and should be reassessed for Extension of study Part 1 relative to the rescreening period, with the following exceptions:
- Exclusion criterion 3: in addition to the history of PD-related freezing episodes or falls, history or presence of severe dyskinesias should be excluded.
- Exclusion criteria 6, 9, 10e, 10f, 10k, and 10p should be evaluated based on time windows anchored to Visit 16 instead of baseline and Visit 15 instead of screening.
- Exclusion criterion 10g: the testing for HBV, HCV, and/or HIV can be repeated if considered clinically relevant by the investigator.
- Exclusion criteria 10h, 10i, and 10j are not applicable for study Part 1 Extension.
- Exclusion criterion 12 does not refer to treatment with ACI-7104.056 within study Part 1.
- Exclusion criterion 13 should be evaluated prior to the first booster dose administration in study Part 1 Extension instead of randomization.
Trial locations and contacts
12 sites in 3 countries.
12 sites in 3 countries
Spain6 sites
Hospital De La Santa Creu I Sant Pau
Barcelona
Hospital Universitari Vall D Hebron
Barcelona
Policlinica Gipuzkoa
Donostia / San Sebastian
Hospital Universitario De La Princesa
Madrid
Hospital Universitario Puerta De Hierro De Majadahonda
Majadahonda
Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcón
Germany3 sites
Katholisches Klinikum Bochum GmbH
Bochum
Paracelsus-Kliniken Deutschland GmbH & Co. KGaA
Kassel
University Medical Centre Schleswig-Holstein
Kiel
United Kingdom3 sites
King's College Hospital NHS Foundation Trust
London
Re:Cognition Health Limited
London
Northern Care Alliance NHS Foundation Trust
Salford
About this study
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
The purpose of this study is to evaluate the safety, tolerability, immunogenicity, and pharmacodynamic effects of ACI-7104.056 in patients with early stages of Parkinson's disease.
Read the detailed description
This is a Phase 2, 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 in study Part 1 and 2. One cohort from study Part 1 may enter an extension phase including a rescreening period of up to 4 weeks, a 52-week double-blind treatment period, and a 26-week post-treatment follow-up period.
Study Part 1 may include up to 3 cohorts, each consisting of up to 32 participants (up to 24 under the active treatment and up to 8 under placebo; 3:1 active treatment/placebo ratio). One of the cohorts from study Part 1 may be further expanded into study Part 2 to reach an overall total of up to 150 participants in the study. If a cohort is further expanded beyond 32 participants into study Part 2, the active treatment/placebo ratio will be adjusted to reach a 2:1 ratio in this cohort.
The route of administration of the study treatment and placebo will be by intramuscular injections.
- Being tested
- Placebo, ACI-7104.056 at Dose A, ACI-7104.056 at Dose B (optional), ACI-7104.056 at Dose C (optional)
- Keywords
- Early Parkinson's disease
- Medical subject headings
- Parkinson Disease, Parkinson Disease 6, Autosomal Recessive Early-Onset
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboBiological
The placebo is a solution matching the study treatment formulation.
ACI-7104.056 at Dose ABiological
The study treatment (ACI-7104.056) consists of an adjuvanted protein peptide conjugate vaccine.
ACI-7104.056 at Dose B (optional)Biological
The study treatment (ACI-7104.056) consists of an adjuvanted protein peptide conjugate vaccine.
ACI-7104.056 at Dose C (optional)Biological
The study treatment (ACI-7104.056) consists of an adjuvanted protein peptide conjugate vaccine.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Early PD subjects receive placebo at pre-defined time points over 74 weeks in study Part 1 and 2 and additionally over 52 weeks in the extension phase (applicable only to 1 cohort in study Part 1). Receives: Biological: Placebo |
| ACI-7104.056 at Dose A | Experimental | Early PD subjects receive dose A of ACI-7104.056 at pre-defined time points over 74 weeks in study Part 1 and 2 and additionally over 52 weeks in the extension phase (applicable only to 1 cohort in study Part 1). Receives: Biological: ACI-7104.056 at Dose A |
| ACI-7104.056 at Dose B (optional) | Experimental | Early PD subjects receive dose B of ACI-7104.056 at pre-defined time points over 74 weeks. This arm is optional. Receives: Biological: ACI-7104.056 at Dose B (optional) |
| ACI-7104.056 at Dose C (optional) | Experimental | Early PD subjects receive dose C of ACI-7104.056 at pre-defined time points over 74 weeks. This arm is optional. Receives: Biological: ACI-7104.056 at Dose C (optional) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: From Screening (ICF signature) to Week 100 in study part 1 and 2, and from Rescreening (ICF signature) to Week 78 in the extension phase
Number of participants with abnormal MRI results
Measured: From Baseline to Week 100 in study part 1 and 2, and from Baseline to Week 78 in the extension phase
Number of participants with clinically significant changes in physical and neurological examination results
Measured: From Baseline to Week 100 in study part 1 and 2, and from Baseline to Week 78 in the extension phase
Number of participants reporting suicidal ideation or behavior using Columbia-Suicide Severity Rating Scale (C-SSRS)
Measured: From Baseline to Week 100 in study part 1 and 2, and from Baseline to Week 78 in the extension phase
Measurement of levels of specific antibodies against a-synuclein present in serum generated by ACI-7104.056
Measured: From Baseline to Week 100 in study part 1 and 2, and from Baseline to Week 78 in the extension phase
Secondary outcomes (3)
Measures of alpha-synuclein (a-syn) related biofluid biomarkers
Measured: From Baseline to Week 100 in study part 1 and 2, and from Baseline to Week 78 in the extension phase
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
Measured: From Baseline to Week 100 in study part 1 and 2, and from Baseline to Week 78 in the extension phase
Change from baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III
Measured: From Baseline to Week 100 in study part 1 and 2, and from Baseline to Week 78 in the extension phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2023
- Study start24 Jul 2023
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AC Immune SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ICON Clinical Research
- Responsible party
- Sponsor
- Investigators
- Daniela Berg, Prof., Study chair, Klinik für Neurologie, UKSH Campus Kiel, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06015841
- Sponsor's protocol ID
- ACI-7104-PD-2103
- Other IDs
- 2022-500292-31-00, 1006102
- Acronym
- VacSYn
- Status last verified
- Sep 2026
- First submitted
- 4 Aug 2023
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 32562684
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06015841
- Acronym / sponsor ID
- VacSYn / ACI-7104-PD-2103
- Keywords
- Early Parkinson's disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- AC Immune SAIndustry (pharma, biotech, devices)
- Collaborators
- ICON Clinical Research
- Study start
- 24 Jul 2023 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 29 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety, tolerability, immunogenicity, and pharmacodynamic effects of ACI-7104.056 in patients with early stages of Parkinson's disease.
Detailed description
This is a Phase 2, 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 in study Part 1 and 2. One cohort from study Part 1 may enter an extension phase including a rescreening period of up to 4 weeks, a 52-week double-blind treatment period, and a 26-week post-treatment follow-up period.
Study Part 1 may include up to 3 cohorts, each consisting of up to 32 participants (up to 24 under the active treatment and up to 8 under placebo; 3:1 active treatment/placebo ratio). One of the cohorts from study Part 1 may be further expanded into study Part 2 to reach an overall total of up to 150 participants in the study. If a cohort is further expanded beyond 32 participants into study Part 2, the active treatment/placebo ratio will be adjusted to reach a 2:1 ratio in this cohort.
The route of administration of the study treatment and placebo will be by intramuscular injections.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Biological: PlaceboEarly PD subjects receive placebo at pre-defined time points over 74 weeks in study Part 1 and 2 and additionally over 52 weeks in the extension phase (applicable only to 1 cohort in study Part 1). |
| ACI-7104.056 at Dose A | Experimental | Biological: ACI-7104.056 at Dose AEarly PD subjects receive dose A of ACI-7104.056 at pre-defined time points over 74 weeks in study Part 1 and 2 and additionally over 52 weeks in the extension phase (applicable only to 1 cohort in study Part 1). |
| ACI-7104.056 at Dose B (optional) | Experimental | Biological: ACI-7104.056 at Dose B (optional)Early PD subjects receive dose B of ACI-7104.056 at pre-defined time points over 74 weeks. This arm is optional. |
| ACI-7104.056 at Dose C (optional) | Experimental | Biological: ACI-7104.056 at Dose C (optional)Early PD subjects receive dose C of ACI-7104.056 at pre-defined time points over 74 weeks. This arm is optional. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Confirmed diagnosis of clinically established early PD using the modified Movement Disorder Society criteria, after excluding any other known or suspected cause of PD. The presence of motor symptoms should not be of more than 2 years at screening.
- Monotherapy treatment with L-Dopa at 300 mg per day, with a stable dose prior to baseline for 3 months. The participant has a reasonably low likelihood of requiring dose adjustment within the next 6 to 12 months after enrolment. Any exception to this rule has to be previously agreed with the Sponsor medical monitor.
- Male or female.
- Aged ≥40 to ≤75 years.
- Body weight range of ≥45 kg to ≤110 kg (99 to 242 lbs) and a body mass index of ≥18 to ≤34 kg/m2.
Key exclusion criteria (39 listed)
- Medical history indicating a Parkinsonian syndrome other than idiopathic PD, including but not limited to, progressive supranuclear palsy, multiple system atrophy, drug induced parkinsonism, essential tremor, vascular parkinsonism, primary dystonia.
- Known carriers of certain familial PD gene mutations (PRKN, PINK1, DJ1, LRRK2).
- History of PD-related freezing episodes or falls.
- History of brain surgery or any neurosurgical procedures.
- Reside in a nursing home or assisted care facility.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboThe placebo is a solution matching the study treatment formulation. | Biological | Placebo |
| ACI-7104.056 at Dose AThe study treatment (ACI-7104.056) consists of an adjuvanted protein peptide conjugate vaccine. | Biological | ACI-7104.056 at Dose A |
| ACI-7104.056 at Dose B (optional)The study treatment (ACI-7104.056) consists of an adjuvanted protein peptide conjugate vaccine. | Biological | ACI-7104.056 at Dose B (optional) |
| ACI-7104.056 at Dose C (optional)The study treatment (ACI-7104.056) consists of an adjuvanted protein peptide conjugate vaccine. | Biological | ACI-7104.056 at Dose C (optional) |
Primary outcome
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 in study part 1 and 2, and from Rescreening (ICF signature) to Week 78 in the extension phase
Number of participants with abnormal MRI results
Time frame: From Baseline to Week 100 in study part 1 and 2, and from Baseline to Week 78 in the extension phase
Number of participants with clinically significant changes in physical and neurological examination results
Time frame: From Baseline to Week 100 in study part 1 and 2, and from Baseline to Week 78 in the extension phase
Number of participants reporting suicidal ideation or behavior using Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: From Baseline to Week 100 in study part 1 and 2, and from Baseline to Week 78 in the extension phase
Measurement of levels of specific antibodies against a-synuclein present in serum generated by ACI-7104.056
Time frame: From Baseline to Week 100 in study part 1 and 2, and from Baseline to Week 78 in the extension phase
3 secondary outcomes
Measures of alpha-synuclein (a-syn) related biofluid biomarkers
Time frame: From Baseline to Week 100 in study part 1 and 2, and from Baseline to Week 78 in the extension phase
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 in study part 1 and 2, and from Baseline to Week 78 in the extension phase
Change from baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III
Time frame: From Baseline to Week 100 in study part 1 and 2, and from Baseline to Week 78 in the extension phase
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Results publication: PubMed 32562684Volc 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniela Berg, Prof. study chair
Klinik für Neurologie, UKSH Campus Kiel, Germany
12 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ACI-7104.056 at Dose A, ACI-7104.056 at Dose B (optional) and ACI-7104.056 at Dose C (optional) in people with Parkinson Disease and Parkinson Disease 6, Early-Onset, run by AC Immune SA at 12 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 39 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Spain, Germany, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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) (time frame: From Screening (ICF signature) to Week 100 in study part 1 and 2, and from Rescreening (ICF signature) to Week 78 in the extension phase). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06015841, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.