An Exploratory Study of the Potential for Rational Immune System Manipulation to Prevent Emergence of Synucleinopathy Manifestations in Persons With REM Sleep Behavior Disorder (RBD)
Part of paid clinical trials in Los Angeles, California.
- Sponsor
- Yale University
- Study ID
- NCT06996652
- Phase
- PHASE2
- Status
- Recruiting
Conditions
- REM Sleep Behavior Disorder
Eligibility Criteria
- Sex
- ALL
- Age
- 50 Years - 80 Years
- Healthy Volunteers
- Not accepted
Interventions
- Adalimumab — DRUG40 mg self-administered subcutaneously using a pre-filled syringe (PFS) every 2 weeks for up to 2 years
- Placebo — DRUG40 mg matching placebo self-administered subcutaneously using a pre-filled syringe (PFS) every 2 weeks for up to 2 years
Study Details
This is a phase 2 study to assess the ability of adalimumab as compared to placebo to reduce or prevent progression of synuclein-related neurodegeneration in persons with idiopathic REM Sleep Behavior Disorder (RBD). The Primary Endpoint will be change from baseline in expression of the Parkinson Disease Related Pattern (PDRP) will be assessed using change in 18-flurodeoxyglucose (FDG) Positron Emission Tomography (PET) imaging.
Key Dates
- First listed
- May 30, 2025
- Start date
- Aug 17, 2026
- Status verified
- Aug 2026
- Primary completion
- Aug 1, 2029
- Completion
- Jan 1, 2030
Study Design
- Enrollment
- 108 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- PREVENTION
Arms
- Experimental: AdalimumabParticipants in this arm will receive Adalimumab every 2 weeks for up to 2 years
- Placebo Comparator: PlaceboParticipants in this arm will receive matching placebo every 2 weeks for up to 2 years
Primary Outcome Measure
Change in Parkinson Disease Related Pattern (PDRP) expression [ Time Frame: Baseline and Week 96 ]
Central Contacts
- Erika Renkl475-254-9169
- Kathy Gerich
Locations (18)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Cedars Sinai Medical Center | Los Angeles | California | 90048 | Michele Tagliati, MD (PRINCIPAL_INVESTIGATOR) Yvette Bordelon, MD, PhD (SUB_INVESTIGATOR) Elliot Hogg, MD (SUB_INVESTIGATOR) Camille Malatt, MD (SUB_INVESTIGATOR) Echo E Tan, MD (SUB_INVESTIGATOR) |
| University of Colorado Anschutz | Aurora | Colorado | 80045 | Jeanne Feuerstein, MD (PRINCIPAL_INVESTIGATOR) Amy Amara, MD, PhD (SUB_INVESTIGATOR) Alexander Baumgartner, MD (SUB_INVESTIGATOR) |
| Yale Medicine | North Haven | Connecticut | 06473 | Veronica Santini, MD, MA (PRINCIPAL_INVESTIGATOR) Hae-Young Hawong, DO, PhD (SUB_INVESTIGATOR) |
| Parkinson's Disease & Movement Disorders Center of Boca Raton | Boca Raton | Florida | 33486 | Stuart Isaacson, MD (PRINCIPAL_INVESTIGATOR) Richard Dewey III, MD (SUB_INVESTIGATOR) Sagari Bette, MD (SUB_INVESTIGATOR) Jonathan Isaacson, MD (SUB_INVESTIGATOR) |
| Emory University School of Medicine | Atlanta | Georgia | 30329 | Lynne Marie Trotti, MD, MSc (PRINCIPAL_INVESTIGATOR) Kendall Nichols, MD (SUB_INVESTIGATOR) |
| Johns Hopkins University | Baltimore | Maryland | 21287 | Kelly Mills, MD (PRINCIPAL_INVESTIGATOR) Emile Moukheiber, MD (SUB_INVESTIGATOR) |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | Lan Luo, MD, MS (PRINCIPAL_INVESTIGATOR) Monica Makhija, MD (SUB_INVESTIGATOR) |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | Aleksandar Videnovic, MD, MSc (PRINCIPAL_INVESTIGATOR) |
| University of Minnesota | Minneapolis | Minnesota | 55414 | Michael Howell, MD (PRINCIPAL_INVESTIGATOR) |
| Washington University | St Louis | Missouri | 63110 | Scott Norris, MD (PRINCIPAL_INVESTIGATOR) Joel S. Perlmutter, MD (PRINCIPAL_INVESTIGATOR) |
| Cleveland Clinic Lou Ruvo Center for Brain Health - Las Vegas | Las Vegas | Nevada | 89106 | Zoltan Mari, MD (PRINCIPAL_INVESTIGATOR) |
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | Stephen Lee, MD, PhD (PRINCIPAL_INVESTIGATOR) Mary Feldman, DO (SUB_INVESTIGATOR) Glen Greenough, MD (SUB_INVESTIGATOR) Marc Seltzer, MD (SUB_INVESTIGATOR) |
| Weill Medical College of Cornell University | New York | New York | 10021 | Harini Sarva, MD (PRINCIPAL_INVESTIGATOR) Moath Hamed, MD (SUB_INVESTIGATOR) Natalie Hellmers, NP (SUB_INVESTIGATOR) Andrea Yoo, MD (SUB_INVESTIGATOR) |
| Oregon Health & Science University | Portland | Oregon | 97239 | Delaram Safarpour, MD (PRINCIPAL_INVESTIGATOR) Matthew Brodsky, MD (SUB_INVESTIGATOR) Joseph Quinn, MD (SUB_INVESTIGATOR) |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19107 | Nabila Dahodwala, MD, MS (PRINCIPAL_INVESTIGATOR) Gavin Villacorta, CRNP (SUB_INVESTIGATOR) |
| Medical University of South Carolina | Charleston | South Carolina | 29403 | Christine Cooper, MD (PRINCIPAL_INVESTIGATOR) Chrstine Dziwis, MD (SUB_INVESTIGATOR) |
| University of Texas Houston Medical Center | Houston | Texas | 77030 | Mya C Schiess, MD (PRINCIPAL_INVESTIGATOR) Chiamaka Onuigbo, MD (SUB_INVESTIGATOR) Sudha S Tallavajhula, MD (SUB_INVESTIGATOR) Emily Tharp, MD (SUB_INVESTIGATOR) |
| University of Texas Health Science Center- San Antonio | San Antonio | Texas | 78229 | Okeanis Vaou, MD (PRINCIPAL_INVESTIGATOR) Cynthia Cornejo, PA-C (SUB_INVESTIGATOR) |
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