Oxiracetam was first developed in 1988 by ICF, a pharmaceutical company in Italy. A number of scientific studies have provided positive results that hint to the effectiveness of Oxiracetam as a brain enhancer and its exceptional safety levels at high dosages taken over a prolonged period. However, no sufficient scientific research has been carried out to prove its efficiency and as such the Food and Drug Administration (FDA) has not approved the use of this nootropic agent for medical purposes within the United States.
In the past few years, there has been increased research into effects of this particular nootropic agent. Public interests have also been on a significant rise in recent years. This might be attributed to the increased proportion of the general public that is entering old age, and who are in need of enhancements in their brain function. An animal-based study was conducted to examine the effects that arise when mice administered with Oxiracetam were under hippocampal protein kinase C and hippocampally-mediated learning performance. The study divided the mice into three classes; the controls, the C57 and the DBA groups. The DBA and C57 were injected on a daily basis for nine days with 50mg/kg of Oxiracetam. A modified version of Morris water maze was then used to examine the DBA and C57 mice with the appropriate fear conditioning task for the last 2 or 5 days respectively, of the nine-day therapy schedule. The Oxiracetam treated mice showed no changes in their motor skills ability to execute the complex learning tasks that included swimming speed and ability to freeze. When Hippocampal PKC action was measured, DBA mice were under Oxiracetam therapy showed a significant rise in their spatial learning as a result of Morris task and in contextual learning as a result of the fear conditioning task. In the C57 mice, no significant enhancements were evident for learning the process and also no alterations were noted in hippocampal PKC activity after administration of Oxiracetam therapy. The results of this study indicated that in DBA mice, learning impairment can be reversed with Oxiracetam. This supports earlier studies that suggested that Oxiracetam works by acting on PKC.
An animal-based study testing the effects of Oxiracetam on memory and learning in healthy animals and animals that had acute cerebral impairment was performed using the pole climbing test. The study gave positive results on both learning and memory. Animal evidence also seems to show that Oxiracetam is reliable and potent in the prevention of amnesia that from a number of anti-glutaminergic and anti-cholinergic compounds. Rats injected with 3-30mg/kg of Oxiracetam were able to achieve almost normal levels of memory formation. It has been shown to improve memory formation in healthy and young rats that have no signs of any cognitive impairment. This implies that it can be used as a nootropic.
Pharmacologists performed human-based studies that comprised of 3 clinical trials, the study subjects were divided into healthy volunteers, mild to moderate dementia patients, and elderly patients suffering from dementia. The healthy volunteers were subjected to a solo rising dose tolerance accompanied by a dose-finding study involving quantitative pharmaco-EGG and also quantitative pharmacopsychology. The mild to moderate dementia patients were subjected to a dose finding study that was administered at three dose levels within three months and then a quantitative pharmaco-EGG. The group comprising of the elderly patients was subjected to a safety and efficacy study that involved rising dosages within a period of 12 weeks with objective and subjective tests. The results indicated that Oxiracetam is safe when administered in single and repeated doses of up to 2,400mg. The healing effect of Oxiracetam can be singled out from the placebo. When compared to Piracetam, Oxiracetam shows higher improvements in memory.
The safety and therapeutic efficiency of Oxiracetam was examined in a double-blind study that considered 40 individuals suffering from organic brain syndrome at old age. The study was also placebo controlled. The patients had memory deficits, lack of drive, and intellectual dysfunction. The patients were randomly allocated to a 4-week therapy with 2×400mg of Oxiracetam capsules or placebo capsules but within the same dosing schedule. The effects in the patients were evaluated within the four weeks. At week one, Oxiracetam group exhibited small but significant enhancements in global symptomatology and improvements had advanced at week 4. The placebo group only indicated improvements in week 4. After carrying out a detailed evaluation using Sandoz clinical assessment geriatric scale, Oxiracetam group was found to have undergone various improvements such as in anxiety, short-term memory, fatigue, and loss of appetite after the four weeks. In the placebo group, no significant improvement was noted in any item. The SCAG scores from the two groups did not achieve statistical significance; however, the Oxiracetam group had a significant overall improvement trend and its tolerance to was acceptable.
Another human study that aimed to examine the behavioral and cognitive effects and the safety of Oxiracetam treatment in a placebo-controlled was performed. The subjects who included patients suffering from multi-infarct dementia (MID) and senile dementia of Alzheimer’s type (SDAT) of mild to moderate stages were studied in a trial that included a follow-up after one year. The sixty subjects who included men and women took part in the double-blind, parallel-group, placebo group and a random trial evaluating the effects of 800 gm of Oxiracetam and placebo over a treatment period of 90 days. Statistical analysis showed significant progress in the Oxiracetam group compared to the placebo group. After the 90 days study, 29 of the original 30 patients under Oxiracetam treatment took part in an open follow-up trial whereby they received 800mg of Oxiracetam for a period adding up to one year. Improvements were again noted in comparison to the baseline using the same tests as in the initial 90-days study. The study concluded that among the current population of individuals suffering from mild to moderate dementia, a dose of 1,600mg per day was also safe for use in a period extending to one year of Oxiracetam therapy.
In another human-based study, the kinetics of Oxiracetam was examined in six elderly women within the age range of 69-96 years who were in an excellent physical state. Oxiracetam was administered in a single oral dose of 800mg and within 1 to 3 hours, the serum levels of the drug had peaked at 25 +/-6 mg/ml and then fell afterwards indicating a half-life of between 3 to 6 hours. Within the next 24 hours, 84% of the drug was found in the urine in an unchanged state. A maintenance regimen that involved 800 b.i.d twice a day at 8 a.m and 2 p.m for a week did not indicate any accumulation of Oxiracetam in the serum. When compared to prior pharmacokinetic data collected from young patients, the results indicated that the rate of clearance of Oxiracetam is lower in the elderly. This may be as a result of the fall in the physiological renal function that is attributed to aging.
Currently, human evidence supporting the effects of Oxiracetam on memory and cognition is to some extent reasonable but the FDA has still not approved the use of this nootropic agent for medical purposes.
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