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Parkinsonism Relat Disord. 2019 Jan 31. pii: S1353-8020(18)30559-5. doi: 10.1016/j.parkreldis.2018.12.025. [Epub ahead of print]

Feasibility and safety of lumbar puncture in the Parkinson's disease research participants: Parkinson's Progression Marker Initiative (PPMI).

Collaborators (144)

Marek K23, Siderowf A24, Seibyl J23, Coffey C25, Tanner C26, Tosun-Turgut D26, Simuni T27, Shaw L24, Trojanowski J24, Singleton A28, Kieburtz K29, Toga A30, Mollenhauer B29, Galasko D31, Poewe W32, Foroud T33, Poston K34, Sherer T35, Chowdhury S35, Frasier M35, Kopil C35, Arnedo V35, Marek K23, Daegele N23, Casaceli C36, Dorsey R36, Wilson R36, Mahes S36, Seibyl J23, Salerno C23, Coffey C25, Caspell-Garcia C25, Toga A30, Crawford K30, Foroud T33, Casalin P37, Malferrari G37, Weisz MG38, Orr-Urtreger A38, Trojanowski J24, Shaw L24, Singleton A28, Foroud T33, Foroud T33, Montine T34, Foroud T33, Russell D23, Tanner C26, Simuni T27, Dahodwala N24, Mollenhauer B29, Galasko D31, Poewe W32, Giladi N38, Factor S39, Hogarth P40, Standaert D41, Hauser R42, Jankovic J43, Saint-Hilaire M44, Richard I45, Shprecher D46, Fernandez H47, Brockmann K48, Rosenthal L49, Barone P50, Espay A51, Rowe D52, Marder K53, Santiago A54, Bressman S55, Hu SC56, Isaacson S57, Corvol JC58, Martinez JR59, Tolosa E60, Tai Y61, Politis M62, Smejdir D23, Rees L23, Williams K25, Kausar F26, Williams K27, Richardson W24, Willeke D29, Peacock S31, Heim B32, Mirelman A38, Sommerfeld B39, Freed A40, Wakeman K40, Blair C41, Guthrie S43, Harrell L42, Hunter C43, Thomas CA44, James R44, Zimmerman G45, Brown V46, Mule J47, Hilt E48, Ribb K49, Ainscough S50, Wethington M51, Ranola M52, Santana HM53, Moreno J54, Raymond D55, Speketer K56, Carvajal L57, Carvalho S58, Croitoru I59, Garrido A60, Payne LM61, Viswanth V63, Severt L63, Facheris M64, Soares H64, Mintun MA65, Cedarbaum J66, Taylor P67, Biglan K68, Vandenbroucke E69, Sheikh ZH69, Bingol B70, Fischer T71, Sardi P71, Forrat R71, Reith A72, Egebjerg J73, Hillert GA73, Saba B74, Min C75, Umek R76, Mather J77, De Santi S78, Post A79, Boess F79, Taylor K79, Grachev I80, Avbersek A81, Muglia P81, Merchant K82, Tauscher J83.

Author information

1
Northwestern University Feinberg School of Medicine, USA. Electronic address: neha.prakash@northwestern.edu.
2
The University of Iowa, USA. Electronic address: chelsea-caspell@uiowa.edu.
3
The University of Iowa, USA. Electronic address: christopher-coffey@uiowa.edu.
4
The University of Pennsylvania, USA. Electronic address: Andrew.siderowf@uphs.upenn.edu.
5
University of California San Francisco, USA. Electronic address: caroline.tanner@ucsf.edu.
6
University of Rochester Medical Center, USA. Electronic address: karl.kieburtz@chet.rochester.edu.
7
Center of Parkinsonism and Movement Disorders Paracelsus-Elena Klinik Kassel and University Medical Center Goettingen, Germany. Electronic address: brit.mollenhauer@med.uni-goettingen.de.
8
University of California San Diego, USA. Electronic address: dgalasko@ucsd.edu.
9
TransThera Consulting, USA. Electronic address: merchant.transthera@gmail.com.
10
Indiana University, USA. Electronic address: tforoud@iu.edu.
11
University of Pittsburgh, USA. Electronic address: lanachahine@pitt.edu.
12
The University of Pennsylvania, USA. Electronic address: daniel.weintraub@uphs.penn.edu.
13
University of Rochester Medical Center, USA. Electronic address: cindy.casaceli@chet.rochester.edu.
14
University of Rochester Medical Center, USA. Electronic address: ray.dorsey@chet.rochester.edu.
15
Clinical Trial Coordination Center, University of Rochester Medical Center, USA. Electronic address: renee.wilson@chet.rochester.edu.
16
Michael J Fox Foundation, USA.
17
Institute for Neurodegenerative Disorders, USA. Electronic address: ndaegele@invicro.com.
18
Michael J Fox Foundation, USA. Electronic address: varnedo@michaeljfox.org.
19
Michael J Fox Foundation, USA. Electronic address: mfrasier@michaeljfox.org.
20
Michael J Fox Foundation, USA. Electronic address: tsherer@michaeljfox.org.
21
Institute for Neurodegenerative Disorders, USA. Electronic address: kmarek@mnimaging.com.
22
Northwestern University Feinberg School of Medicine, USA. Electronic address: tsimuni@nmff.org.
23
Institute for Neurodegenerative Disorders, New Haven, CT, USA.
24
University of Pennsylvania, Philadelphia, PA, USA.
25
University of Iowa, Iowa City, IA, USA.
26
University of California, San Francisco, CA, USA.
27
Northwestern University, Chicago, IL, USA.
28
National Institute on Aging, NIH, Bethesda, MD, USA.
29
Paracelsus-Elena Klinik, Kassel, Germany.
30
Laboratory of Neuroimaging (LONI), University of Southern California, Los Angeles, CA, USA.
31
University of California, San Diego, CA, USA.
32
Innsbruck Medical University, Innsbruck, Austria.
33
Indiana University, Indianapolis, IN, USA.
34
Stanford University, Stanford, CA, USA.
35
The Michael J. Fox Foundation for Parkinson's Research, New York, NY, USA.
36
Clinical Trials Coordination Center, University of Rochester, Rochester, NY, USA.
37
BioRep, Milan, Italy.
38
Tel Aviv Medical Center, Tel Aviv, Israel.
39
Emory University of Medicine, Atlanta, GA, USA.
40
Oregon Health and Science University, Portland, OR, USA.
41
University of Alabama at Birmingham, Birmingham, AL, USA.
42
University of South Florida, Tampa, FL, USA.
43
Baylor College of Medicine, Houston, TX, USA.
44
Boston University, Boston, MA, USA.
45
University of Rochester, Rochester, NY, USA.
46
Banner Research Institute, Sun City, AZ, USA.
47
Cleveland Clinic, Cleveland, OH, USA.
48
University of Tuebingen, Tuebingen, Germany.
49
Johns Hopkins University, Baltimore, MD, USA.
50
University of Salerno, Salerno, Italy.
51
University of Cincinnati, Cincinnati, OH, USA.
52
Macquarie University, Sydney, Australia.
53
Columbia University, New York, NY, USA.
54
The Parkinson's Institute, Sunnyvale, CA, USA.
55
Beth Israel Medical Center, New York, NY, USA.
56
University of Washington, Seattle, WA, USA.
57
Parkinson's Disease and Movement Disorders Center of Boca Raton, Boca Raton, FL, USA.
58
Hospital Pitie-Salpetriere, Paris, France.
59
Hospital Donostia, San Sebastian, Spain.
60
Hospital Clinic de Barcelona, Barcelona, Spain.
61
Imperial College London, London, United Kingdom.
62
King's College London, London, United Kingdom.
63
Allergan, Dublin, Ireland.
64
Abbvie, North Chicago, IL, USA.
65
Avid Radiopharmaceuticals, Inc, Philadelphia, PA, USA.
66
Biogen Idec, Cambridge, MA, USA.
67
BioLegend, Dedham, MA, USA.
68
Eli Lilly and Company, Indianapolis, IN, USA.
69
GE Healthcare, Princeton, NJ, USA.
70
Genentech, San Francisco, CA, USA.
71
Genzyme Sanofi, Cambridge, MA, USA.
72
GlaxoSmithKline, Brentford, United Kingdom.
73
H. Lundbeck A/S, Copenhagen, Denmark.
74
Institut de Recherches Internationales Servier, Neuilly-sur-Seine, France.
75
Merck and Co., Kenilworth, NJ, USA.
76
Meso Scale Diagnostics, Rockville, MD, USA.
77
Pfizer Inc, Cambridge, MA, USA.
78
Piramal Group, Mumbai, India.
79
F. Hoffmann-La Roche Limited, Basel, Switzerland.
80
Teva Pharmaceutical Industries, Petah Tikva, Israel.
81
UCB Pharma, Brussel, Belgium.
82
TransThera Consulting, Portland, OR, USA.
83
Takeda, Osaka, Japan.

Abstract

OBJECTIVE:

To determine the feasibility, safety and tolerability of lumbar punctures (LPs) in research participants with early Parkinson disease (PD), subjects without evidence of dopaminergic deficiency (SWEDDs) and healthy volunteers (HC).

BACKGROUND:

Cerebrospinal fluid (CSF) analysis is becoming an essential part of the biomarkers discovery effort in PD with still limited data on safety and feasibility of serial LPs in PD participants.

DESIGN/METHODS:

Parkinson's Progression Marker Initiative (PPMI) is a longitudinal observation study designed to identify PD progression biomarkers. All PPMI participants undergo LP at baseline, 6, 12 months and yearly thereafter. CSF collection is performed by a trained investigator using predominantly atraumatic needles. Adverse events (AEs) are monitored by phone one week after LP completion. We analyzed safety data from baseline LPs.

RESULTS:

PPMI enrolled 683 participants (423 PD/196 HC/64 SWEDDs) from 23 study sites. CSF was collected at baseline in 97.5% of participants, of whom 5.4% underwent collection under fluoroscopy. 23% participants reported any related AEs, 68% of all AE were mild while 5.6% were severe. The most common AEs were headaches (13%) and low back pain (6.5%) and both occurred more commonly in HC and SWEDDs compared to PD participants. Factors associated with higher incidence of AEs across the cohorts included female gender, younger age and use of traumatic needles with larger diameter. AEs largely did not impact compliance with the future LPs.

CONCLUSIONS:

LPs are safe and feasible in PD research participants. Specific LP techniques (needle type and gauge) may reduce the overall incidence of AEs.

KEYWORDS:

Adverse events; Lumbar puncture; Parkinson's disease; Safety

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