Phase I clinical trial of safety of L-serine for ALS patients
@article{Levine2017PhaseIC, title={Phase I clinical trial of safety of L-serine for ALS patients}, author={Todd D. Levine and Robert G. Miller and Walter G Bradley and D. Moore and David S. Saperstein and Lynne E Flynn and Jonathan S. Katz and Dallas A. Forshew and James S Metcalf and Sandra Anne Banack and Paul Alan Cox}, journal={Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration}, year={2017}, volume={18}, pages={107 - 111} }
Abstract We performed a randomized, double-blind phase I clinical trial for six months on the effects of oral L-serine in patients with ALS. The protocol called for enrollment of patients with a diagnosis of probable or definite ALS, age 18–85 years, disease duration of less than three years and forced vital capacity (FVC) ≥ 60%. Patients were randomly assigned to four different oral twice-daily dose regimens (0.5, 2.5, 7.5, or 15 g/dose). Blood, urine and CSF samples, ALS Functional Rating…
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References
SHOWING 1-10 OF 20 REFERENCES
Efficacy of minocycline in patients with amyotrophic lateral sclerosis: a phase III randomised trial
- Medicine, PsychologyThe Lancet Neurology
- 2007
The ALSFRSr predicts survival time in an ALS clinic population
- Medicine, PsychologyNeurology
- 2005
In an ALS clinic population, the total Amyotrophic Lateral Sclerosis Functional Rating Scale–revised score at baseline is a strong predictor of death or tracheostomy independently of forced vital capacity and after adjustment for age at baseline, sex, and symptom duration.
Use of respiratory function tests to predict survival in amyotrophic lateral sclerosis
- MedicineAmyotrophic lateral sclerosis : official publication of the World Federation of Neurology Research Group on Motor Neuron Diseases
- 2010
It is shown that measurements of FVC in the supine position are worth including in the assessment of respiratory function in ALS, and a normal supine FVC was highly predictive for two-year survival and had superior sensitivity over seated FVC.
Oral L-serine supplementation reduces production of neurotoxic deoxysphingolipids in mice and humans with hereditary sensory autonomic neuropathy type 1.
- BiologyThe Journal of clinical investigation
- 2011
Observations support the hypothesis that an altered substrate selectivity of the mutant SPT is key to the pathophysiology of HSAN1 and raise the prospect of l-serine supplementation as a first treatment option for this disorder.
Cyanobacterial neurotoxin BMAA in ALS and Alzheimer’s disease
- BiologyActa neurologica Scandinavica
- 2009
Objective – The aim of this study was to screen for and quantify the neurotoxic amino acid β‐N‐methylamino‐l‐alanine (BMAA) in a cohort of autopsy specimens taken from Alzheimer’s disease (AD),…
Is exposure to cyanobacteria an environmental risk factor for amyotrophic lateral sclerosis and other neurodegenerative diseases?
- BiologyAmyotrophic lateral sclerosis & frontotemporal degeneration
- 2013
Methods that may be used to assess exposure to cyanobacteria, and hence potentially to BMAA, are described, namely an epidemiologic questionnaire and direct and indirect methods for estimating the cyanobacterial load in ecosystems.
Dietary exposure to an environmental toxin triggers neurofibrillary tangles and amyloid deposits in the brain
- BiologyProceedings of the Royal Society B: Biological Sciences
- 2016
It is found that while chronic exposure to the environmental toxin BMAA can trigger neurodegeneration in vulnerable individuals, increasing the amount of l-serine in the diet can reduce the risk.
Cerebral uptake and protein incorporation of cyanobacterial toxin &bgr;-N-methylamino-L-alanine
- BiologyNeuroreport
- 2013
The time-dependent association of [14C]-L-BMAA in the protein-bound fraction suggests that BMAA may be trapped in new proteins by protein synthesis-dependent processes.
The ALSFRS-R: a revised ALS functional rating scale that incorporates assessments of respiratory function
- PsychologyJournal of the Neurological Sciences
- 1999