Amyotrophic Lateral Sclerosis Clinical Trial
Official title:
The Study of Tamoxifen Treatment in Patients With Motor Neuron Disease
The aim of this study is to survey the effect of Tamoxifen in motor neuron disease (MND) patients, amyotrophic lateral sclerosis (ALS) with regular riluzole usage. TDP-43 is related to ALS. Increased the ubiquitinated or phosphorylated TDP-43 can cause animal model of ALS, and TDP43 can be degraded either by proteasome or autophagy pathway system. Autophagy pathway can be activated by mTOR inhibition, resulting in ameliorating TDP-43 accumulation and rescue in motor function in animal model. Tamoxifen had shown ability of enhance both proteasome and autophagy pathway, therefore the investigators assume that Tamoxifen probably can ameliorate TDP-43 accumulation and inclusion body formation in ALS.
The investigators will assess the ALSFR-s in ALS patients at start, 1, 3, 6 and 12 months and
correlate the score to the neurological outcome of the patients with and without tamoxifen
treatment at dose of 40mg daily for one year.
The study will be able to prove the investigators hypothesis: Tamoxifen, a protease and
autophagy enhancer, has synergic effect with riluzole in ALS patients to slowing the
progression of neurological dysfunction, and respiratory insufficiency.
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