A Study to Evaluate the Effects of ACI-7104.056 in Patients With Early Stages of Parkinson's Disease (NCT06015841) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Study to Evaluate the Effects of ACI-7104.056 in Patients With Early Stages of Parkinson's Disease
Germany, Spain150 participantsStarted 2023-07-24
Plain-language 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.
Who can participate
Age range40 Years – 75 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.
✕
What they're measuring
1
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)
Timeframe: From Screening (ICF signature) to Week 100
2
Number of participants with abnormal MRI results
Timeframe: From Baseline to Week 100
3
Number of participants with clinically significant changes in physical and neurological examination results
Timeframe: From Baseline to Week 74
4
Number of participants reporting suicidal ideation or behavior using Columbia-Suicide Severity Rating Scale (C-SSRS)
Timeframe: From Baseline to Week 100
5
Measurement of levels of specific antibodies against a-synuclein present in serum generated by ACI-7104.056
. 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.