Up to modern times, the serine/threonine kinase glycogen synthase kinase-3 (GSK-3) inhibitor was first discovered and examined in the regulation of glycogen synthesis as noted by Michael Membrino, President of the Neuro-Endoceuticals.
On the other hand, there is enough evidence to support the clinical trial to be carried out based on the results of the small scale study that have indicated the preliminary evidence. The attempt was pilot, double-blind, placebo-controlled, randomized, escalating dose trial to examine the effectiveness and safety of the tideglusib, which is known to be the inhibitor of the glycogen synthase kinase-3, in a patient with Alzheimer’s disease. Additionally, GSK-3 believes in operating in a broad arrange of cellular processes.
In the study, about thirty mid-moderate patients with AD cholinesterase inhibitor treatment were prescribed ever-increasing prescriptions (400, 600, 800, 1,000 mg) of tideglusib or placebo (ratio 2:1), for a period of 4, 4, 6, and 6, weeks.
The study was conducted primarily to examine the safety and efficacy of tideglusib with an absolute condition for drug escalation (Ser et al., 2013). Mini-Mental Status Examination (MMSE), AD Assessment Scale-cognitive subscale (ADAS-cog+), word fluency, Geriatric Depression Scale (GDS), and a final Global Clinical Assessment (GCA) were measured as secondary objectives. Throughout the exercise, treatment was well tolerated. Episodes of adverse events were as frequent in active and placebo groups, excluding for some moderate, asymptomatic, and fully rescindable increases (>2.5 × ULN) of serum transaminases in 6 positive cases (p = 0.001) (Ser et al., 2013).
The results indicated that using tideglusib in MMSE, ADAS-cog, GDS, and GCA showed positive event that was concurrent without large data difference in the small sample. On the other hand, MMSE was significantly higher in the active group (p = 0.05) (Ser et al., 2013). Additionally, patients escalated up to 1000 mg/day had a positive response with 1.68 points in the MMSE and 4.72 points in the ADAS-cog+ when measured against placebo (Ser et al., 2013). In this case, it is clear that the pilot study provided a valuable safety and efficacy of the use of tideglusib in a patient with AD, and is currently being accepted in the clinical trial. Furthermore, the trend and escalation in the doses and small population used, makes this study to provide sufficient evidence to support the efficiency and safety of tideglusib in treating of patient with AD.