Parkinson's DiseaseNCT07081841
AB-1005 Long-Term Follow-up Study
An observational study of Parkinson's Disease and Multiple System Atrophy, Parkinson Variant, run by AskBio Inc at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson's Disease, Multiple System Atrophy, Parkinson Variant
- What is being tested?
- Observation
- How many people
- 132 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 Sep 2025to 30 Mar 2038
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants who have participated in interventional studies of AB-1005.
Who may be able to join
- PD and MSA-P participants that are or were enrolled in an interventional AB-1005 study and provide informed consent
Who cannot join
- There are no exclusion criteria
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Ohio State University
Columbus, Ohio, 43210
University of California San Francisco
San Francisco, California, 94143
About this study
Official title: Long-Term Safety and Efficacy Follow-up of AB-1005 Gene Transfer Study Participants With Parkinson's Disease or Multiple System Atrophy
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.
- Being tested
- Observation
- Medical subject headings
- Parkinson Disease, Multiple System Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
This is an observational study in which safety laboratories and non-invasive routine clinical assessments are conducted to gauge long term safety and efficacy.
| Study group | Role | What they receive |
|---|---|---|
| Participants with PD | Not described Receives: Other: Observation | |
| Participants with MSA-P | Not described Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long term safety and tolerability
Measure of the occurrence of serious and non-serious adverse events
Measured: Up to 10 years post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study start4 Sep 2025
- Primary completion30 Sep 2037 (estimated)
- Study completion30 Mar 2038 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AskBio Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07081841
- Sponsor's protocol ID
- ASK-PD0-CS002
- Status last verified
- Sep 2025
- First submitted
- 9 Jun 2025
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Safety and Efficacy Follow-up of AB-1005 Gene Transfer Study Participants With Parkinson's Disease or Multiple System Atrophy
- ClinicalTrials.gov ID
- NCT07081841
- Acronym / sponsor ID
- ASK-PD0-CS002
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- AskBio IncIndustry (pharma, biotech, devices)
- Study start
- 4 Sep 2025 (actual)
- Primary completion
- 30 Sep 2037 (estimated)
- Study completion
- 30 Mar 2038 (estimated)
- First posted
- 23 Jul 2025 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants with PD | – | Other: Observation |
| Participants with MSA-P | – | Other: Observation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants who have participated in interventional studies of AB-1005.
Key inclusion criteria (1 listed)
- PD and MSA-P participants that are or were enrolled in an interventional AB-1005 study and provide informed consent
Key exclusion criteria (1 listed)
- There are no exclusion criteria
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 |
|---|---|---|
| ObservationThis is an observational study in which safety laboratories and non-invasive routine clinical assessments are conducted to gauge long term safety and efficacy. | Other | Participants with MSA-P, Participants with PD |
Primary outcome
Long term safety and tolerability
Time frame: Up to 10 years post surgery
Measure of the occurrence of serious and non-serious adverse events
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 2 Oct 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease and Multiple System Atrophy, Parkinson Variant, run by AskBio Inc at 2 sites in United States.
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 1 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Long term safety and tolerability (time frame: Up to 10 years post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Oct 2025.