ClinicalTrials.gov record NCT07081841
AB-1005 Long-Term Follow-up Study
Long-Term Safety and Efficacy Follow-up of AB-1005 Gene Transfer Study Participants With Parkinson's Disease or Multiple System Atrophy
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This is an observational follow-up for people who took part in prior interventional AB-1005 studies. It uses safety labs and routine non-invasive clinical assessments to track long-term safety, tolerability, and how long any effects last. Safety monitoring is planned for up to 10 years after surgery.
What it is studying. Whether AB-1005-treated participants have any long-term safety issues, how well the treatment is tolerated, and how long effects persist after prior gene transfer.
What the researchers hope to learn. To gather long-term safety data on AB-1005 by recording serious and non-serious adverse events, tolerability, and duration of effects after prior treatment.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
This is an observational, long term, follow-up study for participants with Parkinson's disease (PD) or Multiple System Atrophy-Parkinsonian subtype (MSA-P) who participated in prior interventional studies with AB-1005. It is intended to better understand the long-term safety of AB-1005, how well tolerated it is and how long lasting the effects are.
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Other
- Observation
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
Inclusion criteria
- PD and MSA-P participants that are or were enrolled in an interventional AB-1005 study and provide informed consent
Exclusion criteria
- There are no exclusion criteria
Study description and what participation involves
The registry record has no detailed description beyond the summary above.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This observational follow-up involves periodic clinic visits with non-invasive routine clinical assessments and safety laboratory tests to monitor long-term safety and tolerability of AB-1005. Follow-up may continue for up to 10 years post surgery as noted in the record. The study does not assign any new investigational treatments; it collects safety and clinical data only.
How the study is structured. A prospective observational cohort: people previously treated with AB-1005 are followed over time. The study uses safety laboratory tests and non-invasive routine clinical assessments, with groups for Parkinson's disease and MSA-P participants and follow-up for up to 10 years post surgery.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
- The registry says participants are enrolled by invitation. Who decides who is invited, and how?
- The listed sites are in United States. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on multiple system atrophy
Important dates
- Study start
- Sep 4, 2025
- Primary completion
- Sep 30, 2037 (estimated)
- Study completion
- Mar 30, 2038 (estimated)
- Target enrollment
- 132 participants (estimated)
- Last updated on registry
- Oct 2, 2025
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- AskBio Inc
Participating sites (2)
- University of California San Francisco
San Francisco, California, 94143 · United States
- Ohio State University
Columbus, Ohio, 43210 · United States
Terms used on this page · explanations by MedicalUpdates.ai
- follow-up
- The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.
- interventional
- A study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
- informed consent
- The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
- exclusion criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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