Early Longitudinal Imaging in Parkinson's Progression Markers Initiative Using [¹⁸F] AV-133 and DaTscan™
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04507139|
Recruitment Status : Recruiting
First Posted : August 11, 2020
Last Update Posted : April 18, 2023
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|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|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|
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|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|
- 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.
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.
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.
- 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.
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
|United States, Connecticut|
|Institute For Neurodegenerative Disorders||Recruiting|
|New Haven, Connecticut, United States, 06510|
|Contact: Cheryl Winakor 203-401-4398 firstname.lastname@example.org|
|Principal Investigator: David Russell, MD|
|United States, Massachusetts|
|Boston University Medical Center||Recruiting|
|Boston, Massachusetts, United States, 02118|
|Contact: Raymond James 617-638-7745 email@example.com|
|Principal Investigator: Marie Saint-Hilaire|
|United States, Pennsylvania|
|University of Pennsylvania||Recruiting|
|Philadelphia, Pennsylvania, United States, 19107|
|Contact: Ashwini Ramachandran 215-829-6952 firstname.lastname@example.org|
|Principal Investigator: Nabila Dahodwala|
|Responsible Party:||Ken Marek, MD, Protocol Principal Investigator, Institute for Neurodegenerative Disorders|
|Other Study ID Numbers:||
|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|
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