Early Longitudinal Imaging in Parkinson's Progression Markers Initiative Using [¹⁸F] AV-133 and DaTscan™
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| ClinicalTrials.gov Identifier: NCT04507139 |
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Recruitment Status :
Recruiting
First Posted : August 11, 2020
Last Update Posted : April 18, 2023
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Sponsor:
Michael J. Fox Foundation for Parkinson's Research
Information provided by (Responsible Party):
Ken Marek, MD, Institute for Neurodegenerative Disorders
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Brief Summary:
Directly examine whether early (6-month) imaging with DaTscan and [¹⁸F] AV-133 will provide an early signal of disease progression in recently diagnosed untreated PD patients.
| Condition or disease |
|---|
| Parkinson Disease |
The study is a longitudinal, multi-center study to assess progression of DaTscan and [18F] AV-133 imaging in PD and Prodromal patients. Participants will be followed for up to 24 months. Approximately 50 early PD participants and 100 Prodromal participants will be recruited from up to 15 sites. Participants will be comprehensively assessed at baseline and follow up according to the Schedule of Activities for the respective cohort. Participants will undergo imaging assessments with DaTscan and [18F] AV-133 and clinical (motor, neuropsychiatric and cognitive) assessments. Data will be collected by each site under uniformly established protocols and data will be stored and analyzed at designated core facilities.
| Study Type : | Observational |
| Estimated Enrollment : | 50 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Other |
| Official Title: | Early Longitudinal Imaging in Parkinson's Progression Markers Initiative Using [¹⁸F] AV-133 and DaTscan™ (PPMI Early Imaging) |
| Actual Study Start Date : | September 10, 2020 |
| Estimated Primary Completion Date : | June 2023 |
| Estimated Study Completion Date : | June 2023 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Parkinson disease
Primary Outcome Measures :
- Mean Rate of Change [ Time Frame: 24 months ]The mean rates of change and the variability around the mean of imaging outcomes in early and Prodromal PD patients, and where appropriate the comparison of these rates between PD patient subsets at study intervals ranging from 6 months to 24 months. Specific examples of outcomes include dopamine transporter striatal uptake and vesicular monoamine transporter type-2 uptake. PD patient subsets may be defined by baseline assessments, genetic mutation, progression milestones and/or rate of clinical, imaging, or biomic change.
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| Ages Eligible for Study: | 30 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Approximately 50 early PD and 100 prodromal participants will be recruited from up to 15 sites internationally.
Criteria
Inclusion Criteria:
- A PD participant consented to PPMI Clinical, or, a Prodromal participant confirmed eligible to proceed to PPMI Clinical Baseline visit.
- Able to provide informed consent.
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Women may not be pregnant, lactating or planning pregnancy during the study.
- Includes a negative serum pregnancy test prior to Baseline 18F-AV-133 injection.
- Includes a negative urine pregnancy test prior to injection of 18F-AV-133 on day of Baseline PET scan.
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Women participating in the study must be of non-childbearing potential or be using a highly effective method of birth control 14 days prior to until at least 24 hours after the last injection of 18F-AV-133.
- Non-childbearing potential is defined as a female that must be either postmenopausal (no menses for at least 12 months prior to Screening) or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy).
- Highly effective method of birth control is defined as practicing at least one of the following: A birth control method that results in a less than 1% per year failure rate when used consistently and correctly, such as oral contraceptives for at least 3 months prior to injection, an intrauterine device (IUD) for at least 2 months prior to injection, or barrier methods, e.g., diaphragm or combination condom and spermicide. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) is not acceptable.
Exclusion Criteria:
- Received any of the following medications that might interfere with 18F- AV-133 PET imaging: tetrabenazine (TBZ) or methylphenidate, reserpine, or amphetamine derivative, within 1 month prior to the Baseline 18F-AV-133 injection.
- Have current clinically significant cardiovascular disease or abnormalities on screening ECG (including but not limited to QTc > 450 msec).
- Are currently taking medications that are known to cause QT- prolongation
- Any other medical or psychiatric condition or lab abnormality, which in the opinion of the investigator might preclude participation.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04507139
Locations
| United States, Connecticut | |
| Institute For Neurodegenerative Disorders | Recruiting |
| New Haven, Connecticut, United States, 06510 | |
| Contact: Cheryl Winakor 203-401-4398 cwinakor@invicro.com | |
| Principal Investigator: David Russell, MD | |
| United States, Massachusetts | |
| Boston University Medical Center | Recruiting |
| Boston, Massachusetts, United States, 02118 | |
| Contact: Raymond James 617-638-7745 rcjames@bu.edu | |
| Principal Investigator: Marie Saint-Hilaire | |
| United States, Pennsylvania | |
| University of Pennsylvania | Recruiting |
| Philadelphia, Pennsylvania, United States, 19107 | |
| Contact: Ashwini Ramachandran 215-829-6952 ashwini.ramachandran@pennmedicine.upenn.edu | |
| Principal Investigator: Nabila Dahodwala | |
Sponsors and Collaborators
Michael J. Fox Foundation for Parkinson's Research
| Responsible Party: | Ken Marek, MD, Protocol Principal Investigator, Institute for Neurodegenerative Disorders |
| ClinicalTrials.gov Identifier: | NCT04507139 |
| Other Study ID Numbers: |
PPMI-004 |
| First Posted: | August 11, 2020 Key Record Dates |
| Last Update Posted: | April 18, 2023 |
| Last Verified: | April 2023 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Ken Marek, MD, Institute for Neurodegenerative Disorders:
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Parkinson Bio-markers Neurodegenerative disorder Imaging |
Prodromal Genetics At Risk Loss of Smell |
Additional relevant MeSH terms:
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Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Movement Disorders Synucleinopathies Neurodegenerative Diseases |