Abstract Details

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

Topic Movement Disorders

Presentation(s) P03 - (-)

Poster/Presentation
Number 068

Objective

Background 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 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 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 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.

Authors/Disclosures
Samuel A. Frank, MD, FAAN (Beth Israel Deaconess Medical Center/Harvard Medical School) PRESENTER	Dr. Frank has received personal compensation in the range of $500-$4,999 for serving as a Consultant for uniQure. Dr. Frank has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Teva. Dr. Frank has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche. The institution of Dr. Frank has received research support from Huntington's Disease Society of America. The institution of Dr. Frank has received research support from Roche/Genentech. The institution of Dr. Frank has received research support from CHDI Foundation. The institution of Dr. Frank has received research support from Huntington Study Group. The institution of Dr. Frank has received research support from Cerevel.
	No disclosure on file
Christopher Coffey, PhD, FAAN (University of Iowa)	Dr. Coffey has received personal compensation in the range of $5,000-$9,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for American Heart Association. The institution of Dr. Coffey has received research support from NIH. The institution of Dr. Coffey has received research support from Michael J Fox Foundation.
	No disclosure on file
Danna L. Jennings, MD (Denali Therapeutics)	Dr. Jennings has received personal compensation for serving as an employee of Denali Therapeutics . Dr. Jennings has received stock or an ownership interest from Denali Therapeutics.
Judith Haas, MD	No disclosure on file
Kenneth L. Marek, MD (IND)	Dr. Marek has received personal compensation for serving as an employee of IND. Dr. Marek has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for invicro. Dr. Marek has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Roche. Dr. Marek has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Sanofi. Dr. Marek has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biohaven. Dr. Marek has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for takeda. Dr. Marek has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Denali. Dr. Marek has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Koneksa. Dr. Marek has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Xingimaging. Dr. Marek has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Neuron23. Dr. Marek has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Lilly. Dr. Marek has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biohaven. Dr. Marek has received research support from Michael J Fox Foundation.
	No disclosure on file

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