Early Longitudinal Imaging in Parkinson's Progression Markers Initiative Using [¹⁸F] AV-133 and DaTscan™

NCT04507139 | Active Not Recruiting

• 1 other identifier: PPMI-004
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 3

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.

Conditions

Parkinson Disease

Keywords

Parkinson; Bio-markers; Neurodegenerative disorder; Imaging; Prodromal; Genetics; At Risk; Loss of Smell

Outcome Measures

Primary Outcomes (1)

• Mean Rate of Change

  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.

  24 months

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Approximately 50 early PD and 100 prodromal participants will be recruited from up to 15 sites internationally.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Michael J. Fox Foundation for Parkinson's Research: lead

Study Sites (3)

Institute For Neurodegenerative Disorders

New Haven, Connecticut, 06510, United States

Location

Boston University Medical Center

Boston, Massachusetts, 02118, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Parkinson Disease; Neurodegenerative Diseases; Anosmia

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Olfaction Disorders; Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Protocol Principal Investigator

Study Record Dates

• First Submitted: August 3, 2020
• First Posted: August 11, 2020
• Study Start: September 10, 2020
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: October 31, 2024

Record last verified: 2024-10

Locations

US (3)