We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
ClinicalTrials.gov Menu

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
Information provided by (Responsible Party):
Ken Marek, MD, Institute for Neurodegenerative Disorders

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

Detailed Description:
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.

Layout table for study information
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

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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.

Layout table for eligibility information
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.

Inclusion Criteria:

  1. A PD participant consented to PPMI Clinical, or, a Prodromal participant confirmed eligible to proceed to PPMI Clinical Baseline visit.
  2. Able to provide informed consent.
  3. 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.

Exclusion Criteria:

  1. 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.
  2. Have current clinically significant cardiovascular disease or abnormalities on screening ECG (including but not limited to QTc > 450 msec).
  3. Are currently taking medications that are known to cause QT- prolongation
  4. 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

Layout table for location information
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
Layout table for additonal information
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

Layout table for additional information
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:
Neurodegenerative disorder
At Risk
Loss of Smell
Additional relevant MeSH terms:
Layout table for MeSH terms
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases