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Feasibility and Safety of Lumbar Punctures in the Parkinson Progression Marker Initiative (PPMI)

Samuel Frank, Boston, MA, Shirley Lasch, New Haven, CT, Chelsea Caspell, Iowa City, IA, Liz Uribe, Iowa City, IA, Danna Jennings, New Haven, CT, Kenneth Marek, New Haven, CT, Investigators of Parkinson Progression Markers Initiative, New Haven, CT
 
2013-03-19
AAN: San Diego, CA
Download Presentation: PPMI-LP-Poster-FINAL.pdf
 
Abstract:
OBJECTIVE: To determine the feasibility, safety and tolerability of lumbar punctures (LPs) in early Parkinson disease (PD), healthy volunteer (HV) and SWEDD participants in PPMI. BACKGROUND: The discovery of biomarkers in PD may require the sampling of cerebrospinal fluid (CSF), similar to recent findings in Alzheimer's disease. PPMI is a longitudinal observation study to identify PD progression biomarkers. DESIGN/METHODS: All subjects enrolled in PPMI are required to undergo LP at baseline, 6, 12 months and yearly. Preferred study LP technique is: acquisition of 15 mls CSF using a 24 gauge Sprotte needle in the L4-5 interspace in the seated position. The small gauge needle requires aspiration of CSF. Subjects were instructed to remain horizontal for at least 30 minutes following the procedure. Adverse events were monitored by phone one week after LP completion. RESULTS: PPMI has acquired baseline data for 495 subjects (298 PD/155 HV/42 SWEDDs) from 23 study sites. There was no difference in mean (SD) age 61.1 (10.4) or weight 81.0 (16.7) kg. CSF was collected at baseline in 96.6% of subjects, 2.7% required collection under fluoroscopy. Mean volume collected was 17.4 (18.7) cc. Total related adverse event rate for the PD/HV/SWEDD groups were 9.4%, 22.6% and 11.9%, respectively. Headache occurred in 5.4%, 11.6% and 9.5%. There was a higher rate of AEs when the LP was performed at L4-5 (vs. L3-4 or L2-3, p=0.0339) and in the seated position (p=0.0003). CONCLUSIONS: Obtaining CSF in a cohort of newly diagnosed PD and HV subjects is safe and feasible. Specific LP techniques (gauge and type of needle, subject position and level of insertion) may reduce the overall incidence of adverse events. Supported by: Michael J Fox Foundation for Parkinson's Research, GE Healthcare, Pfizer, Roche, Genentech, Merck, Abbott, Biogen Idec, Covance, Glaxo-Smith Kline, Avid Radiopharmaceuticals, Elan Corporation, plc., F. Hoffman-La Roche Ltd and Eli Lily.
Category - Movement Disorders: Parkinson?s disease