Background We conducted a pilot trial to assess the safety and tolerability of Sativex in HD (SAT-HD). Several biomarkers were studied in order to detect putative sub-clinical molecular effects of cannabinoids.
Aims Here we present the results of the CSF analysis, as indicated in the protocol, of all the twenty four patients who underwent the two optional lumbar punctures in the trial [11 women, mean age 47.3 (SD 12.3); CAG 45.9 (3.5); mUHDRS 24 (11.4), fUHDRS 18 (4.6), bUHDRS 15.1 (7.1), NPI 10 (5.5), DB 462.7 (107.4)].
Results (after placebo treatment)
CSF protein concentrations [mean (SD)]: Tau (pg/mL) 202.4 (76.0), p-Tau (pg/mL) 50.2 (15.6) ab-42 (pg/mL) 655.3 (275.9).
CSF monoamine levels: MHPG (ng/mL): 14.5 (3.9), DOPAC × 100(ng/mL):0.3 (0.2) x 100, Tryptophan/10 (ng/mL/10): 621.0 (233.2)/10, 5 HIAA (ng/mL) 27.8 (9.3) and HVA (ng/mL)53.1 (22.1).
CSF endocannabinoid levels: anandamide(pmol/mL): <0.15, palmitoylethanolamide (pmol/mL): 2.8 (0.9), 2-arachidonoyglicerol (pmol/mL): <1.
CSF Brain-derived Neurotrophic Factor (BDNF) (pg/mL): 30.2 (9.5).
Conclusions We did not find any significant differences between the placebo and Sativex treated patients. It is to note that, at the present time, a more comprehensive array of biomarkers would have been preferred. However, some of this results are novel and might serve as reference for future studies.
- Cerebrospinal fluid
- Wet biomarkers
- Lumbar Puncture
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