Abstract Details

Title Feasibility of an Entirely Remote, Decentralized, Phase 3 Trial of a Light Therapy Device for Parkinson’s Disease

Topic Movement Disorders

Presentation(s) P2 - Poster Session 2 (11:45 AM-12:45 PM)

Poster/Presentation
Number 9-021

Objective

To evaluate the feasibility of an entirely remote, decentralized phase 3 clinical trial of an investigative light therapy device for Parkinson’s disease.

Background

Decentralized trials are increasingly common, but use in device studies remains limited.

Design/Methods

This remote phase 3 trial, reviewed with the FDA, of a non-invasive light device aims to improve circadian function and quality of life in individuals with Parkinson’s disease. Participants were randomized to receive active or control light therapy for one hour every evening for six months. Devices were shipped directly to participants to use at home. All study activities occur remotely with coordinators located centrally and 16 investigators nationally. Participants communicate with coordinators and receive device use reminders through a smartphone application.

Results

From February 2024 to October 2025, 5349 individuals submitted an online pre-screening form, 626 completed a screening visit, and 350 participants were enrolled from 17 states. Individuals who did not meet eligibility criteria or resided in states without licensed investigators were excluded based on a screening questionnaire. Subsequent screen failures were primarily due to low cognition (N=153) and investigator judgement (N=41).

Enrolled participants averaged 67.5 years old with 6.3 years disease duration. To date, participants have completed 80.5% of expected light therapy sessions. As of January 2026, 65 participants have withdrawn due to time commitment (N=17), adverse events (N=14), and life changes (N=7).

Conclusions

Interest in this decentralized phase 3 clinical trial of a promising therapy was robust, and adherence to the study intervention has been high. Retention has been lower than a previous, traditional, site-based clinical trial perhaps due to limited pre-existing relationship with the study team, early operational challenges, and time demands. Decentralized trials hold promise for increasing access to clinical trials and may be especially well suited for geographically dispersed populations with limited mobility.

Authors/Disclosures
Dan Adams, BS (PhotoPharmics, Inc.) PRESENTER	Mr. Adams has received personal compensation for serving as an employee of PhotoPharmics, Inc. Mr. Adams has or had stock in PhotoPharmics, Inc..Mr. Adams has received research support from NIH.
Sarrah Hussain	Ms. Hussain has nothing to disclose.
Christi Alessi Fox, MS	Mrs. Alessi Fox has nothing to disclose.
Melissa Kostrzebski, MBA, MS	The institution of Mrs. Kostrzebski has received research support from Department of Defense. The institution of Mrs. Kostrzebski has received research support from Michael J. Fox Foundation for Parkinson's Research.
Kathryn Murphy, MS	Ms. Murphy has nothing to disclose.
Michelle Porto, Clinical Research Coordinator	Mrs. Porto has nothing to disclose.
Katrina Schmier	Ms. Schmier has nothing to disclose.
Andrew J. McGarry, MD (Cooper University Hospital)	Dr. McGarry has received personal compensation for serving as an employee of Clintrex Research Corporation.
Jamie L. Adams, MD (University of Rochester Medical Center)	Dr. Adams has received personal compensation in the range of $500-$4,999 for serving as a Consultant for AbbVie. Dr. Adams has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Michael J. Fox Foundation. Dr. Adams has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for BioSensics. The institution of Dr. Adams has received research support from NIH/NINDS. The institution of Dr. Adams has received research support from Biogen. The institution of Dr. Adams has received research support from The Michael J. Fox Foundation. The institution of Dr. Adams has received research support from Critical Path Institute. Dr. Adams has received personal compensation in the range of $500-$4,999 for serving as a KINECT-HD Steering Committee Member with Huntington Study Group. Dr. Adams has received personal compensation in the range of $500-$4,999 for serving as a ORCHESTRA-PD Steering Committee Member with Parkinson Study Group.
Pinky H. Agarwal, MD, FAAN (Evergreen Health)	Dr. Agarwal has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Supernus. Dr. Agarwal has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Acadia Pharmaceuticals Inc. Dr. Agarwal has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Amneal. Dr. Agarwal has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Neurocrine. Dr. Agarwal has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Mitsubishi Tanabe Pharma. Dr. Agarwal has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for AbbVie. Dr. Agarwal has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Avion Pharmaceuticals. Dr. Agarwal has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Acadia. Dr. Agarwal has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Supernus. Dr. Agarwal has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Kyowa Kirin. Dr. Agarwal has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Amneal. Dr. Agarwal has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for AbbVie. Dr. Agarwal has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Neurocrine. Dr. Agarwal has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for AskBio. An immediate family member of Dr. Agarwal has stock in ALDEYRA THERAPEUTICS INC. An immediate family member of Dr. Agarwal has stock in Curis Inc. An immediate family member of Dr. Agarwal has stock in Citius Pharmaceuticals. An immediate family member of Dr. Agarwal has stock in Fortress Biotech. An immediate family member of Dr. Agarwal has stock in TG Therapeutics. An immediate family member of Dr. Agarwal has stock in ATYR PHARMA INC . An immediate family member of Dr. Agarwal has stock in CORVUS PHARMACEUTICALS INC . An immediate family member of Dr. Agarwal has stock in LAVA THERAPEUTICS . An immediate family member of Dr. Agarwal has stock in OVID THERAPEUTICS INC . An immediate family member of Dr. Agarwal has stock in TERNS PHARMACEUTICALS INC. An immediate family member of Dr. Agarwal has stock in VIKING THERAPEUTICS INC. Dr. Agarwal has stock in WAVE LIFE SCIENCES LTD. An immediate family member of Dr. Agarwal has stock in ProQr Therapeutics. An immediate family member of Dr. Agarwal has stock in Mind Medicine. An immediate family member of Dr. Agarwal has stock in Lyra Therapeutics. An immediate family member of Dr. Agarwal has stock in Larimer Therapeutics. An immediate family member of Dr. Agarwal has stock in Lantern Pharma. An immediate family member of Dr. Agarwal has stock in Black Diamond Therapeutics. An immediate family member of Dr. Agarwal has stock in Amylyx Pharma. An immediate family member of Dr. Agarwal has stock in Palisade Bio. An immediate family member of Dr. Agarwal has stock in Inozyme Pharma. An immediate family member of Dr. Agarwal has stock in Pyxis Oncology. An immediate family member of Dr. Agarwal has stock in Vertex Pharmaceuticals. An immediate family member of Dr. Agarwal has stock in Vyne Therapeutics. An immediate family member of Dr. Agarwal has stock in Reviva Pharmaceuticals Hld. An immediate family member of Dr. Agarwal has stock in Immuneering Corp. An immediate family member of Dr. Agarwal has stock in Imunon Inc. An immediate family member of Dr. Agarwal has stock in Enlivex Therapeutics. An immediate family member of Dr. Agarwal has stock in Candel Therapeutics. An immediate family member of Dr. Agarwal has stock in Applied Digital Corp. An immediate family member of Dr. Agarwal has stock in Atai Life Sciences. An immediate family member of Dr. Agarwal has stock in Adma Biologics. The institution of Dr. Agarwal has received research support from Biogen . The institution of Dr. Agarwal has received research support from CHDI Foundation. The institution of Dr. Agarwal has received research support from Eli Lilly. The institution of Dr. Agarwal has received research support from MJ Fox. The institution of Dr. Agarwal has received research support from Roche . The institution of Dr. Agarwal has received research support from Supernus. The institution of Dr. Agarwal has received research support from Nova Nordisc. The institution of Dr. Agarwal has received research support from Inhibikase. The institution of Dr. Agarwal has received research support from Intracellular therapeurtics.
Jason L. Aldred, MD, FAAN (Selkirk Neurology)	Dr. Aldred has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Boston Scientific. Dr. Aldred has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Abbvie. Dr. Aldred has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Allergan . Dr. Aldred has received personal compensation in the range of $0-$499 for serving as a Consultant for Quadralynx. Dr. Aldred has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Abbvie. Dr. Aldred has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Boston Scientific. Dr. Aldred has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Medtronic. Dr. Aldred has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Abbvie. Dr. Aldred has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Acorda. Dr. Aldred has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Allergan. Dr. Aldred has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Boston Scientific. Dr. Aldred has received personal compensation in the range of $100,000-$499,999 for serving on a Speakers Bureau for TEVA. Dr. Aldred has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Medtronic. Dr. Aldred has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for US World Meds. Dr. Aldred has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Kyowa Kirin. Dr. Aldred has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Sunovion. Dr. Aldred has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Amneal. Dr. Aldred has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Biogen. Dr. Aldred has received personal compensation in the range of $50,000-$99,999 for serving as an Expert Witness for Arete Neuroscience, PLLC. The institution of Dr. Aldred has received research support from Biogen . The institution of Dr. Aldred has received research support from Abbvie. The institution of Dr. Aldred has received research support from Merz. The institution of Dr. Aldred has received research support from AstraZeneca. The institution of Dr. Aldred has received research support from Neurocrine. The institution of Dr. Aldred has received research support from Aptinyx. The institution of Dr. Aldred has received research support from Cerevance. The institution of Dr. Aldred has received research support from Boston Scientific . The institution of Dr. Aldred has received research support from Parkinson Foundation . The institution of Dr. Aldred has received research support from Roche. The institution of Dr. Aldred has received research support from Sage Therapeutics. The institution of Dr. Aldred has received research support from Annovis. The institution of Dr. Aldred has received research support from Biovie. The institution of Dr. Aldred has received research support from NeuroDerm. The institution of Dr. Aldred has received research support from PhotoPharma. The institution of Dr. Aldred has received research support from Lilly.
Kristin Andruska, MD, PhD (CMDC)	Dr. Andruska has nothing to disclose.
Alexander Baumgartner, MD (University of Colorado)	Dr. Baumgartner has nothing to disclose.
Jill M. Farmer, DO, MPH	Dr. Farmer has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Teva. Dr. Farmer has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Supernus. Dr. Farmer has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Neurocrine. Dr. Farmer has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Acadia. Dr. Farmer has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Abbvie. Dr. Farmer has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Amneal. Dr. Farmer has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Neurology Live. The institution of Dr. Farmer has received research support from Parkinson's Foundation.
Raja Mehanna, MD (University of Texas Health Science Center At Houston-McGovern Medical School)	Dr. Mehanna has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Teva. Dr. Mehanna has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Kyowa Kirin. The institution of Dr. Mehanna has received research support from Cerevel. The institution of Dr. Mehanna has received research support from Neurocrine.
Irene Richard, MD, FAAN	Dr. Richard has received personal compensation in the range of $10,000-$49,999 for serving as an Expert Witness for Katten Muchin Rosenman Law Firm. The institution of Dr. Richard has received research support from Michael J Fox Foundation for Parkinson's Research.
Michael Soileau, MD, FAAN (Texas Movement Disorder Specialists, PLLC)	The institution of Dr. Soileau has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Abbott. The institution of Dr. Soileau has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Abbvie. The institution of Dr. Soileau has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Supernus. The institution of Dr. Soileau has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Amneal Pharmaceuticals. Dr. Soileau has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Abbvie. Dr. Soileau has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Amneal. The institution of Dr. Soileau has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Biogen. The institution of Dr. Soileau has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Merz. The institution of Dr. Soileau has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Teva. The institution of Dr. Soileau has received research support from Abbvie. The institution of Dr. Soileau has received research support from Cerevel. The institution of Dr. Soileau has received research support from Praxis. The institution of Dr. Soileau has received research support from CND Life Sciences. The institution of Dr. Soileau has received research support from Teva. The institution of Dr. Soileau has received research support from Abbott. The institution of Dr. Soileau has received research support from Jazz Pharmaceuticals. The institution of Dr. Soileau has received research support from Scion. Dr. Soileau has received publishing royalties from a publication relating to health care. Dr. Soileau has a non-compensated relationship as a Past President with Texas Neurological Society that is relevant to AAN interests or activities.
Matthew Swan, MD, FAAN	The institution of Dr. Swan has received research support from Biogen. The institution of Dr. Swan has received research support from Sage Therapeutics. The institution of Dr. Swan has received research support from Parkinson's Foundation. The institution of Dr. Swan has received research support from Photopharmics. The institution of Dr. Swan has received research support from Denali Therapeutics. The institution of Dr. Swan has received research support from NOEMA Pharma.
Kara J. Wyant, MD (University of Michigan, Neurology Dept)	Dr. Wyant has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Elsevier. The institution of Dr. Wyant has received research support from NIH-DHHS-US, NeuroNEXT. The institution of Dr. Wyant has received research support from PhotoPharmics, Inc. The institution of Dr. Wyant has received research support from Michael J Fox Foundation. The institution of Dr. Wyant has received research support from UCB BioPharma. Dr. Wyant has received publishing royalties from a publication relating to health care. Dr. Wyant has received publishing royalties from a publication relating to health care. Dr. Wyant has received publishing royalties from a publication relating to health care.
Kent Hendrix (Pentara Corporation)	Kent Hendrix has received personal compensation for serving as an employee of Pentara Corporation. The institution of an immediate family member of Kent Hendrix has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Eisai.
Suzanne Hendrix, PhD (Pentara)	Dr. Hendrix has received personal compensation for serving as an employee of Pentara Corporation. Dr. Hendrix has received personal compensation in the range of $50,000-$99,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Pentara Corporation. Dr. Hendrix has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Pentara Corporation. The institution of Dr. Hendrix has received personal compensation in the range of $0-$499 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Pentara Corporation. Dr. Hendrix has or had stock in Pentara.
E. Ray Dorsey, MD, MBA (University of Rochester)	Dr. Dorsey has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Seelos Therapeutics. Dr. Dorsey has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Eden McCallum, LLP. Dr. Dorsey has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Genentech/Roche. Dr. Dorsey has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biohaven Pharmaceuticals. Dr. Dorsey has received personal compensation in the range of $500-$4,999 for serving as a Consultant for WebMD. Dr. Dorsey has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for BioSensics. Dr. Dorsey has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Mediflix. Dr. Dorsey has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Cerevance. Dr. Dorsey has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Kairos Cinema, LLC. Dr. Dorsey has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Mitsubishi Tanabe Pharma America Inc.. Dr. Dorsey has received personal compensation in the range of $500-$4,999 for serving as a Consultant for HanAll. Dr. Dorsey has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Dorsey has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi. Dr. Dorsey has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Advarra. Dr. Dorsey has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Medrhythms. Dr. Dorsey has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for ANA. Dr. Dorsey has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for HMP ��ɫ��, LLP. Dr. Dorsey has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for ADIVO Associates France. Dr. Dorsey has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for University of Toronto. Dr. Dorsey has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Philadelphia Neurological Society. Dr. Dorsey has stock in Included Health. Dr. Dorsey has stock in Mediflix. Dr. Dorsey has stock in SemCap. Dr. Dorsey has stock in Synapticure. The institution of Dr. Dorsey has received research support from NIH/NINDS. The institution of Dr. Dorsey has received research support from Burroughs Wellcome . The institution of Dr. Dorsey has received research support from Michael J. Fox Foundation - Fox Insight. The institution of Dr. Dorsey has received research support from Michael J. Fox Foundation - Emerald. The institution of Dr. Dorsey has received research support from B. Thomas Golisano Foundation. The institution of Dr. Dorsey has received research support from Emerald Innovations, Inc.. The institution of Dr. Dorsey has received research support from Photopharmics Inc.. The institution of Dr. Dorsey has received research support from Averitas Pharma Inc.. The institution of Dr. Dorsey has received research support from DOD/Army Medical Research Acquisition Activity. The institution of Dr. Dorsey has received research support from NIH/NINDS.

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