Abstract Details

Title Enhancing Pandemic-Sensitive Recruitment Strategies for a Remote, Randomized Placebo-Controlled Trial for Fracture Prevention in Patients with Neurodegenerative Parkinsonisms

Topic Movement Disorders

Presentation(s) P1 - Poster Session 1 (9:00 AM-5:00 PM)

Poster/Presentation
Number 269

Objective To develop a diversified recruitment model for the ongoing Trial of Parkinson’s and Zoledronic Acid (TOPAZ) during the COVID-19 pandemic.

Background

TOPAZ is a home-based trial examining the efficacy of zoledronate in preventing fractures in people with neurodegenerative parkinsonisms, who have up to 4-fold increased fracture risk.

Design/Methods

Consent is obtained online (). After eligibility is determined by movement disorders specialists using medical records and/or telemedicine, study drug is infused by research nurses at home. Fractures are ascertained by email or telephone. The 2/2020 onset of recruitment coincided with COVID-19 restrictions, with a nearly 7 months pause. To randomize 3,500 participants by 12/2023, we developed multiple methods to recruit potential participants via: 1) 46 Parkinson Study Group (PSG) sites, 2) 11 health care systems with integrated research networks, 3) community outreach organizations (i.e. support groups, social media, newsletters, etc.), 4) outreach by the Parkinson’s Foundation (PF), 5) Fox Trial Finder (FTF), and 6) the 23andMe Parkinson’s disease research program.

Results By 10/1/2021, 2002 had registered on the website, 1333 consented, 992 were eligible per expert diagnostic confirmation, and 632 were randomized, exceeding our goal of 600 for 9/30/21. Registered participants came from the multiple sources: 1) 609 (27.7%) from PSG sites, 2) 529 (24%) from health care systems with integrated research networks, 3) 213 (9.7%) from community outreach, 4) 34 (1.5%) from PF, 5) 16 (0.7%) from FTF and 6) 601 (27.3%) from 23andMe. The largest source of recruitment was PSG. A single study invitation emailed from 23andMe to its 19,733 PD research participants led to nearly the same number of referrals as PSG but in only a few weeks’ time.

Conclusions

Using diverse referral sources to the TOPAZ study website, we are succeeding in achieving enrollment targets for a Parkinson’s trial amidst the challenges of the COVID-19 pandemic.

Authors/Disclosures
Nijee S. Luthra, MD, PhD (UCSF Movement Disorders and Neromodulation Center) PRESENTER	Dr. Luthra has nothing to disclose.
Ethan G. Brown, MD (University of California, San Francisco)	Dr. Brown has received personal compensation in the range of $0-$499 for serving as a Consultant for Rune Labs, Inc. An immediate family member of Dr. Brown has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Novartis. Dr. Brown has received personal compensation in the range of $0-$499 for serving as a Consultant for Guidepoint Inc. An immediate family member of Dr. Brown has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi. Dr. Brown has received personal compensation in the range of $0-$499 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for NEJM Knowledge Plus. Dr. Brown has stock in 153 Therapeutics. The institution of Dr. Brown has received research support from Michael J. Fox Foundation. The institution of Dr. Brown has received research support from NIH.
Samuel Goldman, MD, MPH	Dr. Goldman has received personal compensation in the range of $10,000-$49,999 for serving as an Expert Witness for Littlepage Booth Leckman. The institution of Dr. Goldman has received research support from Michael J Fox Foundation. The institution of Dr. Goldman has received research support from US Department of Defense. The institution of Dr. Goldman has received research support from US Veterans Administration. The institution of Dr. Goldman has received research support from National Institutes of Health. The institution of Dr. Goldman has received research support from Health Resources and Services Administration. The institution of Dr. Goldman has received research support from American Academy of Pediatrics. Dr. Goldman has received personal compensation in the range of $100,000-$499,999 for serving as a Professor with University of California San Francisco. Dr. Goldman has received personal compensation in the range of $100,000-$499,999 for serving as a Staff Physician with San Francisco Veterans Affairs Health Care System.
Jose-Rafael P. Zuzuarregui, MD (UCSF)	Dr. Zuzuarregui has nothing to disclose.
	No disclosure on file
	No disclosure on file
Ian Bledsoe, MD (University of California, San Francisco)	Dr. Bledsoe has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Destum Partners. Dr. Bledsoe has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Abbvie Inc. Dr. Bledsoe has received personal compensation in the range of $0-$499 for serving as a Consultant for Clarity.Co. Dr. Bledsoe has received personal compensation in the range of $0-$499 for serving as a Consultant for GLG. The institution of Dr. Bledsoe has received research support from Dystonia Medical Research Foundation. The institution of Dr. Bledsoe has received research support from NIH. The institution of Dr. Bledsoe has received research support from Michael J Fox Foundation.
Michael Schwarzschild, MD, PhD (Massachusetts General Hospital)	The institution of Dr. Schwarzschild has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Bial Biotech (indirectly, as a service of the Parkinson Study Group service). The institution of Dr. Schwarzschild has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen (indirectly, as a service of the Parkinson Study Group service). The institution of Dr. Schwarzschild has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for UCB (indirectly, as a service of the Parkinson Study Group service). Dr. Schwarzschild has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Eli Lilly. The institution of Dr. Schwarzschild has received research support from NIH. The institution of Dr. Schwarzschild has received research support from Parkinson's Foundation. The institution of Dr. Schwarzschild has received research support from Michael J Fox Foundation. The institution of Dr. Schwarzschild has received research support from Farmer Family Foundation. Dr. Schwarzschild has a non-compensated relationship as a Chair, Executive Committee with the Parkinson Study Group that is relevant to AAN interests or activities.
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.
Alberto J. Espay, MD, FAAN (University of Cincinnati)	Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Tanabe Pharma America (formerly, Neuroderm). Dr. Espay has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Avion. Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Amneal. Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Acadia. Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Acorda. Dr. Espay has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Kyowa Kirin. Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Sunovion. Dr. Espay has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Herantis Pharma. Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Supernus (formerly USWorldMeds). Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Acadia. Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Synaps Dx. Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Bial. Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for NeuroDiagnostics, Inc (SYNAPS Dx). Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Intrance Medical Systems, Inc.. Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Merz. Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Praxis Precision Medicines. Dr. Espay has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Citrus Health. Dr. Espay has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for AskBio. The institution of Dr. Espay has received research support from NIH. The institution of Dr. Espay has received research support from Michael J Fox Foundation for Parkinson's Research. Dr. Espay has received intellectual property interests from a discovery or technology relating to health care. Dr. Espay has received publishing royalties from a publication relating to health care. Dr. Espay has received publishing royalties from a publication relating to health care. Dr. Espay has received publishing royalties from a publication relating to health care.
Irene Litvan, MD, FAAN (UC San Diego Parkinson and Other Movement Disorder Center)	Dr. Litvan has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Aprinoia. Dr. Litvan has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lundbeck. Dr. Litvan has received personal compensation in the range of $10,000-$49,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Frontiers in Neurology. Dr. Litvan has received personal compensation in the range of $50,000-$99,999 for serving as a Chief Editor with Frontiers in Neurology.
Nikolaus McFarland, MD, PhD, FAAN (University of Florida)	Dr. McFarland has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sutter Health. Dr. McFarland has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for ONO Pharmaceuticals. Dr. McFarland has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Ferrer. The institution of Dr. McFarland has received research support from NIH, Michael J. Fox Foundation, Huntington Disease Society for America, CurePSP, and Mission MSA.. Dr. McFarland has received publishing royalties from a publication relating to health care.
Kyle T. Mitchell, MD (Duke University Movement Disorders Center)	Dr. Mitchell has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Boston Scientific. The institution of Dr. Mitchell has received research support from Medtronic. The institution of Dr. Mitchell has received research support from Deep Brain Innovations. The institution of Dr. Mitchell has received research support from National Institutes of Health. The institution of Dr. Mitchell has received research support from National Institute on Aging.
David G. Standaert, MD, PhD, FAAN (Univ of Alabama - Dept of Neurology)	Dr. Standaert has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Abbvie, Inc. Dr. Standaert has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Curium. Dr. Standaert has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alnylam. Dr. Standaert has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biohaven. Dr. Standaert has received personal compensation in the range of $500-$4,999 for serving as a Consultant for CVS/Pharmacy. Dr. Standaert has received personal compensation in the range of $500-$4,999 for serving as a Consultant for HanAll Biopharma. Dr. Standaert has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Eli Lilly. Dr. Standaert has received personal compensation in the range of $500-$4,999 for serving as a Consultant for F. Hoffman LaRoche. Dr. Standaert has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi-Aventis. Dr. Standaert has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Theravance, Inc. Dr. Standaert has received personal compensation in the range of $10,000-$49,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for International Parkinson and Movement Disorder Society. The institution of Dr. Standaert has received research support from Abbvie, Inc. The institution of Dr. Standaert has received research support from American Parkinson Disease Association. The institution of Dr. Standaert has received research support from National Institutes of Health. The institution of Dr. Standaert has received research support from F. Hoffman LaRoche. Dr. Standaert has received publishing royalties from a publication relating to health care. Dr. Standaert has received personal compensation in the range of $500-$4,999 for serving as a Reviewer with National Institutes of Health. Dr. Standaert has a non-compensated relationship as a Chair, Scientific Advisory Board with American Parkinson Disease Association that is relevant to AAN interests or activities.
James Beck, PhD	Dr. Beck has received personal compensation for serving as an employee of Parkinson's Foundation. The institution of Dr. Beck has received research support from NIH, MJFF.
Helen Rowbotham	No disclosure on file
	No disclosure on file
	No disclosure on file
	No disclosure on file
	No disclosure on file
	No disclosure on file
	No disclosure on file
	No disclosure on file
Caroline M. Tanner, MD, PhD, FAAN (University of California San Francisco, Weill Institute for Neurosciences)	Dr. Tanner has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Evidera. Dr. Tanner has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Neurocrine. Dr. Tanner has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Jazz Pharmaceuticals/Cavion. Dr. Tanner has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Bial . Dr. Tanner has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Supernus. Dr. Tanner has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche Genentech. The institution of Dr. Tanner has received research support from Gateway LLC. The institution of Dr. Tanner has received research support from Roche\Genentech. The institution of Dr. Tanner has received research support from Michael J Fox Foundation . The institution of Dr. Tanner has received research support from National Institute of Health . The institution of Dr. Tanner has received research support from Department of Defense. Dr. Tanner has received personal compensation in the range of $500-$4,999 for serving as a Faculty, CME presentation with Medscape /WebND.

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