Preclinical toxicological evaluation of adjunct dementia medicinal supplement (PMCV002) in Wistar rats: from bench to clinical trial series

Abstract

BACKGROUND: Considering unmet clinical needs in the dementia therapeutics world, PCMCV002 was developed as a cheap and easily accessible adjunct therapy option. It is a combination of amino acids, vitamins, and essential nutrients formulated in a best-fit complex medicinal food supplement as an adjunct therapy to the already established dementia therapies. AIM: The aim of this study is to evaluate the sub-acute preclinical toxicity profile of PCMCV002 in Wistar rats. MATERIALS/METHOD: PMCV002, ketamine, Photoelectric colorimeter model AE 11D (Erma Inc. Japan), Hematology analyzer (Sysmex USA), hematocrit, centrifuge, spectrophotometer, weighing balance, cotton wool, scissors, animal cages, plastic containers, plain and heparinized plastic bottles. The study involved hematology, hepatorenal and electrolytes changes and histological evaluation 28 days postdosing daily with PCMCV002 using OECD test Guideline 407 (2008). CONCLUSIONS: The findings following a 28-day administration of PMCV002 revealed that it is relatively nontoxic in rats, as no obvious harmful effects were noted on hematological and biochemical indices. The histo-architecture of the brain, heart, liver, and kidneys following a 28-day administration of PCMCV002 to the test rats did not show any significant pathologic changes. All these indicate a quite safe medicinal product, coupled with maximum tolerable dose as high as 5000 mg/kg.