Parkinson DiseaseNCT06456684
AV133 Longitudinal Imaging Study in Patients With Early and Prdromal Parkinson's Disease
An observational study of Parkinson Disease, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
A total of 38 patients with early-stage Parkinson's disease and 38 patients with prodromal Parkinson's disease are planned to be enrolled in this study and examined for longitudinal changes in [18F]AV-133 through follow-up, thereby informing the design of future therapeutic trials utilizing [18F]AV-133 as a marker of… Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Fluoro[18F]promethazine
- How many people
- 76 participants
- Where
- 1 siteChina
- Study dates
- 12 Apr 2024to 31 Dec 2026
- 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 30 years and older
- All sexes
- Adult, Older adult
Study population: 38 patients with early-stage Parkinson's disease and 38 patients with prodromal Parkinson's disease
Who may be able to join
- Clinical diagnosis of Parkinson's disease： Men or women aged 30 years or older at the time of diagnosis of Parkinson's disease.
- Patients must have at least two of the following: resting tremor, bradykinesia, tonicity (must have resting tremor or bradykinesia); or asymmetric resting tremor or asymmetric bradykinesia.
- Time to diagnosis of Parkinson's disease at screening was 2 years or less. Hoehn \& Yahr staging stage I or II at baseline. AV133 PET scan suggestive of vesicular monoamine transporter 2 (VMAT2) deficiency.
- Able to provide informed consent. Not yet started on PD medication.
- Clinical diagnosis of Parkinson's disease in the prodromal phase： Subjects confirmed eligible based on existing predictive criteria Olfactory dysfunction confirmed by olfactory testing. Other predictive criteria based on general risk, such as first-degree biological relatives, known Parkinson's disease risk including RBD, or known genetic variants associated with Parkinson's disease risk (LRRK2 or GBA).
- Men or women 60 years or older (or 30 years or older for subjects with SNCA or rare genetic variants such as Parkin or Pink1) AV133 deficiency as determined by visual assessment (screening PET scan) Subjects taking any of the following medications: α-methyldopa, methylphenidate, amphetamine derivatives, or modafinil must be willing and medically able to discontinue the medication for at least 5 half-lives prior to PET imaging.
- Able to provide informed consent. Not yet started on PD medication.
Who cannot join
- Currently taking levodopa, dopamine agonists, MAO-B inhibitors, amantadine, or other anti-Parkinson's disease medications.
- Diagnosed with dementia and related cognitive impairment disorders. Received any of the following medications that may interfere with PET imaging of the dopamine transporter protein within 1 month prior to screening: antipsychotics, metoclopramide, α-methyldopa, methylphenidate, reserpine, modafinil, or amphetamine derivatives.
- Current clinically significant cardiovascular disease or screening ECG abnormalities (including but not limited to QTc > 450 ms) Currently taking medications known to cause QT prolongation; Use of an investigational drug or device within 60 days prior to baseline (dietary supplements taken outside of a clinical trial are not exclusionary, e.g., coenzyme Q10).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Xuan Wu Hospital, Capital Medical University
Beijing, Beijing Municipality, 100053
Chen Biao, M.D., Ph.D, 13501086287, pbchan@hotmail.com
Zhang Hui, Ph.D, 15811176880, zhangxiang229@163.com
About this study
Official title: AV133 Longitudinal Imaging Study in Patients With Early and Prodromal Parkinson's Disease
A total of 38 patients with early-stage Parkinson's disease and 38 patients with prodromal Parkinson's disease are planned to be enrolled in this study and examined for longitudinal changes in [18F]AV-133 through follow-up, thereby informing the design of future therapeutic trials utilizing [18F]AV-133 as a marker of disease progression.
Read the detailed description
This study is a longitudinal study designed to assess the progression of [18F]AV-133 imaging in patients with prodromal and early stages of Parkinson's disease . Approximately 38 patients with early PD and 38 subjects in the prodromal phase will be enrolled in the study. All subjects will undergo imaging assessment with [18F]AV-133 at baseline and every 12 months thereafter, clinical (motor, neuropsychiatric and cognitive) assessment, and biospecimen collection for bioanalysis. The study duration for each subject will be approximately 27 months, including a 60-day screening period and a 24-month follow-up assessment period. Data collection will be performed uniformly for all participants according to the protocol developed.
- Conditions
- Parkinson Disease
- Being tested
- Fluoro[18F]promethazine
- Keywords
- PD, [18F]promethazine
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluoro[18F]promethazineDiagnostic test
It is the first F-18-labeled VMAT2 imaging agent for PET imaging that is currently being used in the clinic internationally. In the brains of Parkinson's disease (PD) patients, the target binding of fluoro[18F]promethazine was significantly reduced compared with that of normal controls, with an 81% reduction in the posterior region of the nucleus accumbens, a 70% reduction in the anterior region of the nucleus accumbens, and a 48% reduction in the caudate nucleus; the radioactivity uptake in the caudate nucleus of PD patients was correlated with the extent of their disease
| Study group | Role | What they receive |
|---|---|---|
| early-stage Parkinson's disease | Not described Receives: Diagnostic Test: Fluoro[18F]promethazine | |
| prodromal Parkinson's disease | Not described Receives: Diagnostic Test: Fluoro[18F]promethazine |
What is being measured
The primary outcome is the main question the study is designed to answer.
to assess the mean rate of change and variability of AV133 imaging results
to assess the mean rate of change and variability of AV133 imaging results from baseline at 12 and 24 months follow-up in patients with prodromal and
Measured: baseline the 12 months and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start12 Apr 2024
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Collaborators
- Michael J. Fox Foundation for Parkinson's Research, XingImaging, LLC, Naming MITRO Pharmaceutical Technology Co., Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06456684
- Sponsor's protocol ID
- 114
- Status last verified
- Feb 2024
- First submitted
- 4 Mar 2024
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AV133 Longitudinal Imaging Study in Patients With Early and Prodromal Parkinson's Disease
- ClinicalTrials.gov ID
- NCT06456684
- Acronym / sponsor ID
- 114
- Conditions
- Parkinson Disease
- Keywords
- PD, [18F]promethazine
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Collaborators
- Michael J. Fox Foundation for Parkinson's Research, XingImaging, LLC, Naming MITRO Pharmaceutical Technology Co., Ltd
- Study start
- 12 Apr 2024 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 13 Jun 2024 (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.
A total of 38 patients with early-stage Parkinson's disease and 38 patients with prodromal Parkinson's disease are planned to be enrolled in this study and examined for longitudinal changes in [18F]AV-133 through follow-up, thereby informing the design of future therapeutic trials utilizing [18F]AV-133 as a marker of disease progression.
Detailed description
This study is a longitudinal study designed to assess the progression of [18F]AV-133 imaging in patients with prodromal and early stages of Parkinson's disease . Approximately 38 patients with early PD and 38 subjects in the prodromal phase will be enrolled in the study. All subjects will undergo imaging assessment with [18F]AV-133 at baseline and every 12 months thereafter, clinical (motor, neuropsychiatric and cognitive) assessment, and biospecimen collection for bioanalysis. The study duration for each subject will be approximately 27 months, including a 60-day screening period and a 24-month follow-up assessment period. Data collection will be performed uniformly for all participants according to the protocol developed.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| early-stage Parkinson's disease | – | Diagnostic Test: Fluoro[18F]promethazine |
| prodromal Parkinson's disease | – | Diagnostic Test: Fluoro[18F]promethazine |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 38 patients with early-stage Parkinson's disease and 38 patients with prodromal Parkinson's disease
Key inclusion criteria (7 listed)
- Clinical diagnosis of Parkinson's disease： Men or women aged 30 years or older at the time of diagnosis of Parkinson's disease.
- Patients must have at least two of the following: resting tremor, bradykinesia, tonicity (must have resting tremor or bradykinesia); or asymmetric resting tremor or asymmetric bradykinesia.
- Time to diagnosis of Parkinson's disease at screening was 2 years or less. Hoehn \& Yahr staging stage I or II at baseline. AV133 PET scan suggestive of vesicular monoamine transporter 2 (VMAT2) deficiency.
- Able to provide informed consent. Not yet started on PD medication.
- Clinical diagnosis of Parkinson's disease in the prodromal phase： Subjects confirmed eligible based on existing predictive criteria Olfactory dysfunction confirmed by olfactory testing. Other predictive criteria based on general risk, such as first-degree biological relatives, known Parkinson's disease risk including RBD, or known genetic variants associated with Parkinson's disease risk (LRRK2 or GBA).
Key exclusion criteria (3 listed)
- Currently taking levodopa, dopamine agonists, MAO-B inhibitors, amantadine, or other anti-Parkinson's disease medications.
- Diagnosed with dementia and related cognitive impairment disorders. Received any of the following medications that may interfere with PET imaging of the dopamine transporter protein within 1 month prior to screening: antipsychotics, metoclopramide, α-methyldopa, methylphenidate, reserpine, modafinil, or amphetamine derivatives.
- Current clinically significant cardiovascular disease or screening ECG abnormalities (including but not limited to QTc > 450 ms) Currently taking medications known to cause QT prolongation; Use of an investigational drug or device within 60 days prior to baseline (dietary supplements taken outside of a clinical trial are not exclusionary, e.g., coenzyme Q10).
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 |
|---|---|---|
| Fluoro[18F]promethazineIt is the first F-18-labeled VMAT2 imaging agent for PET imaging that is currently being used in the clinic internationally. In the brains of Parkinson's disease (PD) patients, the target binding of fluoro[18F]promethazine was significantly reduced compared with that of normal controls, with an 81% reduction in the posterior region of the nucleus accumbens, a 70% reduction in the anterior region of the nucleus accumbens, and a 48% reduction in the caudate nucleus; the radioactivity uptake in the caudate nucleus of PD patients was correlated with the extent of their disease | Diagnostic test | early-stage Parkinson's disease, prodromal Parkinson's disease |
Primary outcome
to assess the mean rate of change and variability of AV133 imaging results
Time frame: baseline the 12 months and 24 months
to assess the mean rate of change and variability of AV133 imaging results from baseline at 12 and 24 months follow-up in patients with prodromal and
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 13 Jun 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by Xuanwu Hospital, Beijing at 1 site in China.
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 7 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 13 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
Contact zhang hui, Doctor (15811176880, zhangxiang229@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to assess the mean rate of change and variability of AV133 imaging results (time frame: baseline the 12 months and 24 months). 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 13 Jun 2024.