Abstract Details

Title Impact of Melatonin on Survival in ALS

Topic General Neurology

Presentation(s) P4 - Poster Session 4 (8:00 AM-9:00 AM)

Poster/Presentation
Number 6-004

Objective Determine if melatonin usage is associated with longer survival in ALS

Background Researchers at the University of Pittsburgh in recent publication noted a correlation between ALSFRS-R progression and melatonin usage. The analysis was based on data on 18 subjects from PRO-ACT database that comprises data from 23 clinical trials and 10,723 subjects from 1995-2015 trials. NeuroBANK, a platform for observational studies, contains data from 6,600+ people with ALS, from 2015-2021 studies. As data from observational studies usually lack clinical trials’ selection bias and represents a more heterogeneous population, we decided to analyze data from NeuroBANK to validate the findings.

Design/Methods We pooled data from five largest NeuroBANK-based observational and biomarker studies in ALS and selected records for People with ALS for whom a valid survival end-point date, e.g., date of death, non-invasive ventilation, feeding tube placement, and/or tracheostomy was captured. Survival was defined as the difference between those dates and the date of ALS diagnosis. Cox’s proportional hazards regression was used to determine if differences in survival were significant. Data were controlled for bulbar onset, a known predictor of survival in ALS patients.

Results Of the 1,722 subjects in this data set, 87 used melatonin at least once. Reported melatonin users had a mean survival length of 24.68 months as compared to 22.95 months for subjects with no reported melatonin use. Despite a mean increase of 1.73 months, the results were not significant (p=.21).

Conclusions Melatonin was used by a fraction (5%) of NeuroBANK patients with a known survival end-point date. Other predictors within the subset may help to explain the survival variability within the melatonin group. When and if melatonin use expands to more patients, a larger sample size may give a better estimate of melatonin’s efficacy.

Authors/Disclosures
Alex Berger, BS PRESENTER	Mr. Berger has nothing to disclose.
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Alexander Sherman (Massachusetts General Hospital)	The institution of Mr. Sherman has received research support from The ALS Association. The institution of Mr. Sherman has received research support from NIH. The institution of Mr. Sherman has received research support from FDA. The institution of Mr. Sherman has received research support from Biogen. The institution of Mr. Sherman has received research support from Amylyx Pharmaceuticals. The institution of Mr. Sherman has received research support from Mitsubishi-Tanabe Pharma America. Mr. Sherman has a non-compensated relationship as a Member, Board of Directors with ALD Connect that is relevant to AAN interests or activities.

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