The Parkinson's Progression Markers Initiative (PPMI)

Who is this study for? Patients with Parkinson's disease
What treatments are being studied? DaTscan
Status: Unknown status
Location: See all (34) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This is a observational, multi-center study to assess progression of clinical features, imaging and biologic biomarkers in Parkinson disease (PD) patients compared to healthy controls (HC) and in PD patient subtypes. The primary objective of this study is to identify clinical, imaging and biologic markers of PD progression for use in clinical trials of disease-modifying therapies.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 30
Healthy Volunteers: No
View:

• Parkinson Disease (PD) Subjects:

• A diagnosis of Parkinson disease for 2 years or less at Screening.

• Confirmation from imaging core that screening DAT scan is consistent with dopamine transporter deficit, or if applicable a VMAT-2 PET scan consistent with vesicular monoamine transporter deficit.

• Not expected to require PD medication with at least 6 months from Baseline.

• Male or female age 30 years or older at time of PD diagnosis.

• Healthy Control (HC) Subjects:

• • Male or female age 30 years or older at Screening.

• Hyposmia:

• Male or female age 60 years or older

• Confirmation from olfactory core that olfaction as determined by UPSIT is at or below the 10th percentile by age and gender

• REM Behavior Disorder (RBD):

• Male or female age 60 years or older

• Confirmation from sleep core that subject's Polysomnography (PSG) meets criteria for RBD

• LRRK2:

• Male or female age 60 years or older

• Written confirmation or documentation from testing facility that the individual is LRRK2 mutation positive 4.2.7.2. Confirmation from imaging core that screening dopamine transporter SPECT scan is read as eligible (see below). About 80 subjects will have a range of DAT deficit similar to subjects with early PD (mild to moderate DAT deficit). About 20 subjects will be selected with no DAT deficit or minimal DAT deficit similar in age, gender, and risk profile to those with mild to moderate DAT deficit. 4.2.7.3. Ability to provide written informed consent in accordance with Good Clinical Practice (GCP), International Conference on Harmonization (ICH), and local regulations. 4.2.7.4. Willing and able to comply with scheduled visits, required study procedures and laboratory tests. 4.2.7.5. Women may not be pregnant, lactating or planning pregnancy during the course of the study. Includes a negative urine pregnancy test on day of screening scan prior to injection (DaTSCAN).

Locations
United States
Alabama
University of Alabama at Birmingham
Birmingham
Arizona
Banner Research Institute
Sun City
California
University of California San Diego
La Jolla
University of California, San Francisco
San Francisco
The Parkinson's Institute
Sunnyvale
Connecticut
Institute For Neurodegenerative Disorders
New Haven
Florida
Parkinson's Disease& Movement Disorder Center of Boca Raton
Boca Raton
University of South Florida
Tampa
Georgia
Emory University School of Medicine
Atlanta
Illinois
Northwestern University
Chicago
Massachusetts
Boston University
Boston
Maryland
John Hopkins University
Baltimore
New York
Beth Israel Medical Center
New York
Columbia University Medical Center
New York
University of Rochester
Rochester
Ohio
University of Cincinnati/Cincinnati Children's Hospital
Cincinnati
Cleveland Clinic
Cleveland
Oregon
Oregon Health &Science University
Portland
Pennsylvania
University of Pennsylvania
Philadelphia
Texas
Baylor College of Medicine
Houston
Washington
Univ of Washington and VA Puget Sound Health Care System
Seattle
Other Locations
Australia
Macquarie University
Sydney
Austria
Innsbruck Medical University
Innsbruck
France
Hospital Pitie-Salpetriere
Paris
Germany
Paracelsus-Elena Klinik
Kassel
University of Tuebingen
Tuebingen
Greece
Foundation for Biomedical Research of the Academy of Athens
Athens
Israel
Tel Aviv Sourasky Medical Center
Tel Aviv
Italy
Universita Federico II
Napoli
University of Salerno
Salerno
Norway
St. Olavs Hospital
Trondheim
Spain
Hospital Clinic de Barcelona
Barcelona
Hospital Donostia
San Sebastian
United Kingdom
Imperial College London
London
Time Frame
Start Date: June 2010
Completion Date: December 2022
Participants
Target number of participants: 1100
Treatments
Experimental: Datscan SPECT Imaging
Subjects will b injected with 3-5 mCi of dopamine transporter. Within a 4 hour (+/- 30 minutes) window following the injection, subjects will undergo SPECT imaging on the camera.
Authors
ivka Sachdev, Machetanz Gerrit, Naomi Lubar, Maria De Arriba Sanchez, Irene Richards, Hwai Yin OOI, Kelly Tehan, Milan Zimmerman, Helga Holzmann, Clar Elana, Anwar Ahmed, Stuart Isaacson, Penelope Hogarth, Marie H. Saint-Hilaire, Sara Dhanani, Victor Sung, Cindy Zadikoff, Deborah Burke, Nisha Chhabria, Kimberly Peters, Caroline Tanner, Ilia Itin, Matthew Stern, Charles Adler, Grace Liang, David Brooks, nabila Dahodwala, David G. Standaert, David Russell, Holly Shill, Nicholas Weisman, Douglas Galasko, Jennifer Madonia, Stephanie Lessig, Rizwan Akhtar, Anna Hohler, Veronica Hicks, Karen Marder, Danna L Jennings, Jill Ostrem, Stewart A Factor, Maya Katz, Anthony Mosley, Liana Rosenthal, Ted Dawson, Andrew Duker, Alberto Espay, Amy Amara, Irene Litvan, David Shprecher, Michael Gostkowski, Joseph Jankovic, Joan Miravite, Zoltan Mari, Hubert H. Fernandez, Carolyn Orr, Nijee Luthra, Susan Bressman, James Tetrud, Gretchen Todd, Maria Teresa Pellecchia, Thomas Tropea, Marta San Luciano, Melanie Brandabur, Lindsey Neimand, David Coughlin, Alfonso Mauro, Lama Chahine, Bernadette Pinter, Bjorg Waro, Daniela Berg, Brit Mollenhauer, Isabel Wurster, Florence Cormier-Dequaire, Benjamin Roben, Alexis Brice, Dominic Rowe, Kathrin Brockmann, Robert Hauser, Graziella Mangone, Sabine Spielberger, Walter Maetzler, Jenny Vaughan, Jens Ebentheuer, Karin Srulijes, Sophie Molloy, Eva Reiter, Sweta Bajaj, Autilia Cozzolino, Massimo Squillante, Shu-Ching Hu, Ana Fernandez, Javier Ruiz Martinez, Rachel Saunders-Pullman, Alicia Garrido, Mario Werkmann, Cristina Simonet, Maria Jose Marti, Katherine Leaver, Giampiero Volpe, Enza Maria Valente, Samual Frank, Alison Ansbach, Joyce Gibbons, Jim Leverenz, Alex Iranzo, Nicola Pavese, Atbin Djamshidian, Philipp Mahlknecht, Jean-Christophe Corvol, Marina Peball, Marina Picillo, Joohi Shahed, Eduardo Tolosa, Jan O. Aasly, Paolo Barone, Beatrice Heim, Yen Tai, Nir Giladi, Maria Stamelou, Anat Mirelman, Aleksandar Videnovic, Christos Koros, Leonidas Stefanis, Klaus Seppi, Werner Poewe, Tanya Simuni
Sponsors
Leads: Ken Marek, MD
Collaborators: Institute for Neurodegenerative Disorders

This content was sourced from clinicaltrials.gov

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