Purpose

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

Eligibility

Eligible Ages
Over 30 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Enrolled in PPMI 2.0 Clinical protocol. 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.

Study Design

Phase
Study Type
Observational
Observational Model
Case-Only
Time Perspective
Other

Recruiting Locations

Boston University Medical Center
Boston, Massachusetts 02118
Contact:
Raymond James
617-638-7745
rcjames@bu.edu

More Details

Status
Recruiting
Sponsor
Michael J. Fox Foundation for Parkinson's Research

Study Contact

Detailed Description

A multi-center study to assess progression of DaTscan and [¹⁸F] AV-133 imaging in PD patients. Participants will be followed for at least 18 months. Approximately 50 PD participants will be recruited from up to 5 sites. All participants will be comprehensively assessed at baseline and every six months thereafter. Participants will undergo imaging assessments with DaTscan and [¹⁸F] AV-133, clinical (motor, neuropsychiatric and cognitive) assessments, as well as biospecimen collection for biomic analysis. Data will be collected by each site under uniformly established protocols and data will be stored and analyzed at designated core facilities.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.