DSP-1083 Implantation for Parkinson's Disease
This study is testing a new treatment called DSP-1083 for people with Parkinson's disease. DSP-1083 involves implanting special cells into the brain. The main goal is to see how safe DSP-1083 is and if people can tolerate it, as well as to observe any clinical improvements. Some participants will receive the DSP-1083 implants, while others will have a "sham surgery" (a procedure that mimics surgery but without the actual implant) for comparison. You might be able to join if you are between 40 and 72 years old and have had Parkinson's disease for at least 4 years. This study is currently recruiting in the United States.
- Study design
- This is a multicenter study planning to enroll 25 participants. It compares DSP-1083 implantation with a sham surgery.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for safety outcomes for up to 104 weeks (about 2 years) after treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Multicenter Study to Evaluate Safety, Tolerability, and Clinical Responses of DSP-1083 Into Subjects With Parkinson's Disease
At a glance
Conditions
NCT06753331
Where you'd take part
This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
New York Presbyterian Hospital-Columbia University Medical Center
New York, New Yorkstudy coordinator listed
Recruiting
University of Kentucky Medical Center
Lexington, Kentuckystudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
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Exclusion
What this trial measures
- Incidence and severity of Adverse Events.Up to 104 weeks
- Incidence of Serious Adverse Events (SAE).Up to 104 weeks
- Incidence and severity of Adverse Events of Special Interest (AESI).Up to 104 weeks
- Incidence and severity of Adverse Events leading to study discontinuation.Up to 104 weeks
- Change from baseline in cognition and neuropsychiatric status as assessed by Montreal Cognitive Assessment (MoCA).Up to 104 weeks
The MoCA is a widely used, sensitive, validated screening test for detecting mild cognitive impairment and can also predict the presence of cognitive deterioration (ie, progression from mild cognitive impairment to dementia) in PD patients.
- Change from baseline in cognition and neuropsychiatric status as assessed by Mattis Dementia Rating Scale (MDRS).Up to 104 weeks
The MDRS has been utilized for early detection of dementia, differential diagnosis between Alzheimer's disease and other dementias. The 144-point scale is an aggregate score of 5 subscales: attention, initiation/perseveration (I/P), construction, conceptualization, and memory.The total score ranges from 0 to 144, with lower scores indicating greater cognitive impairment.
- Change from baseline in Head Magnetic Resonance Imaging (MRI) (graft expansion/rejection) neuroimaging parameters.Up to 104 weeks
Safety MRIs - are conducted to assess the safety of DSP-1083 including rejection, abnormal growth, and formation of mass lesions, which could indicate teratoma formation
- Change from baseline in Fluorodopa (F-DOPA) uptake (graft function) neuroimaging parameters.Up to 104 weeks
PET scans using F-DOPA will be performed at Screening and then post-surgery to follow the course of graft development and to provide a measure of dopaminergic nerve terminals in the striatum.
- Frequency of subjects with suicidal ideation or suicidal behavior using the Columbia Suicide Severity Scale (C-SSRS).Up to 104 weeks
- Observed values and change from baseline in clinical laboratory tests.Up to 104 weeks
Laboratory results at each time point will be summarized using descriptive statistics (mean, standard deviation (SD), median, minimum, and maximum) by treatment group.
- Observed values and change from baseline in Heart Rate (HR).Up to 104 weeks
12-lead ECG parameters ventricular HR at each time point will be summarized by treatment group. All ECG diagnostic findings will be summarized on the basis of incidence rates by treatment group.
- Observed values and change from baseline in QT interval.Up to 104 weeks
12-lead ECG parameters QT interval at each time point will be summarized by treatment group. All ECG diagnostic findings will be summarized on the basis of incidence rates by treatment group.
- Observed values and change from baseline in PR interval.Up to 104 weeks
12-lead ECG parameters PR interval at each time point will be summarized by treatment group. All ECG diagnostic findings will be summarized on the basis of incidence rates by treatment group.
- Observed values and change from baseline in QRS duration.Up to 104 weeks
12-lead ECG parameters QRS duration at each time point will be summarized by treatment group. All ECG diagnostic findings will be summarized on the basis of incidence rates by treatment group.
- Observed values and change from baseline in RR interval.Up to 104 weeks
12-lead ECG parameters RR interval at each time point will be summarized by treatment group. All ECG diagnostic findings will be summarized on the basis of incidence rates by treatment group.
- Observed values and change from baseline in QTcF interval.Up to 104 weeks
12-lead ECG parameters QTcF interval at each time point will be summarized by treatment group. All ECG diagnostic findings will be summarized on the basis of incidence rates by treatment group.
- Observed values and change from baseline in body temperature.Up to 104 weeks
Vital signs parameter body temperature will be summarized using descriptive statistics at each time point by treatment group.
- Observed values and change from baseline in respiratory rate.Up to 104 weeks
Vital signs parameter supine respiratory rate will be summarized using descriptive statistics at each time point by treatment group.
- Observed values and change from baseline in pulse rate.Up to 104 weeks
Vital signs parameter supine and standing pulse will be summarized using descriptive statistics at each time point by treatment group.
- Observed values and change from baseline in Systolic Blood Pressure.Up to 104 weeks
Vital signs parameter Systolic Blood Pressure will be summarized using descriptive statistics at each time point by treatment group.
- Observed values and change from baseline in Diastolic Blood Pressure.Up to 104 weeks
Vital signs parameter Diastolic Blood Pressure will be summarized using descriptive statistics at each time point by treatment group.