A Study to Evaluate the Effects of ACI-7104.056 in Patients With Early Stages of Parkinson's Disease

NCT06015841 | Active Not Recruiting Phase 2 DMC

• 3 other identifiers: ACI-7104-PD-21032022-500292-31-001006102
• Study Type: interventional
• Target: 150
• Locations: 3 countries
• Sites: 12

Brief 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.

Conditions

Parkinson Disease; Parkinson Disease 6, Early-Onset

Keywords

Early Parkinson's disease

Outcome Measures

Primary Outcomes (5)

• 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)

  From Screening (ICF signature) to Week 100

• Number of participants with abnormal MRI results

  From Baseline to Week 100

• Number of participants with clinically significant changes in physical and neurological examination results

  From Baseline to Week 74

• Number of participants reporting suicidal ideation or behavior using Columbia-Suicide Severity Rating Scale (C-SSRS)

  From Baseline to Week 100

• Measurement of levels of specific antibodies against a-synuclein present in serum generated by ACI-7104.056

  From Baseline to Week 100

Secondary Outcomes (3)

• Measures of alpha-synuclein (a-syn) related biofluid biomarkers

  From Baseline to Week 100

• 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

  From Baseline to Week 100

• Change from baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III

  From Baseline to Week 100

Other Outcomes (1)

• Change in motor and nonmotor functions using the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)

  From Baseline to Week 100

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Early PD subjects receive placebo at pre-defined time points over 74 weeks.

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.

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.

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.

Biological: ACI-7104.056 at Dose C (optional)

Interventions

Placebo BIOLOGICAL

The placebo is a solution matching the study treatment formulation.

Placebo

ACI-7104.056 at Dose A BIOLOGICAL

The study treatment (ACI-7104.056) consists of an adjuvanted protein peptide conjugate vaccine.

ACI-7104.056 at Dose A

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 B (optional)

ACI-7104.056 at Dose C (optional) BIOLOGICAL

The study treatment (ACI-7104.056) consists of an adjuvanted protein peptide conjugate vaccine.

ACI-7104.056 at Dose C (optional)

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 subject 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.
• A centrally read screening brain DaT-SPECT consistent with PD.
• Subjects can understand the informed consent form, are able and willing to provide written 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 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 subject. Periodic abstinence (eg, calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.

You may not qualify if:

• 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.
• 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.
• 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.
• Women 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.

Sponsors & Collaborators

• AC Immune SA: lead
• ICON Clinical Research: collaborator

Study Sites (12)

Katholisches Klinikum Bochum GmbH

Bochum, Germany

Location

Paracelsus-Kliniken Deutschland GmbH & Co. KGaA

Kassel, Germany

Location

University Medical Centre Schleswig-Holstein

Kiel, Germany

Location

Hospital De La Santa Creu I Sant Pau

Barcelona, Spain

Location

Hospital Universitari Vall D Hebron

Barcelona, Spain

Location

Policlinica Gipuzkoa

Donostia / San Sebastian, Spain

Location

Hospital Universitario De La Princesa

Madrid, Spain

Location

Hospital Universitario Puerta De Hierro De Majadahonda

Majadahonda, Spain

Location

Hospital Universitario Quironsalud Madrid

Pozuelo de Alarcón, Spain

Location

King's College Hospital NHS Foundation Trust

London, United Kingdom

Location

Re:Cognition Health Limited

London, United Kingdom

Location

Northern Care Alliance NHS Foundation Trust

Salford, United Kingdom

Location

Related Publications (1)

• 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 RESULT

MeSH Terms

Conditions

Parkinson Disease; Parkinson Disease 6, Autosomal Recessive Early-Onset

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Daniela Berg, Prof.

  Klinik für Neurologie, UKSH Campus Kiel, Germany

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2023
• First Posted: August 29, 2023
• Study Start: July 24, 2023
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: November 21, 2025

Record last verified: 2025-11

Locations

ES (6); GB (3); DE (3)