Smart Drug Update:

The Case for Piracetam
in Down’s Syndrome

One of the current focal points for the emergence of smart drugs into popular consciousness and mainstream use is the application of piracetam to Down’s syndrome (DS). This application has generated lots of controversy within DS circles for several reasons: 1) piracetam is not FDA approved, 2) US physicians are generally unfamiliar with its use, and 3) major establishment DS organizations have a policy that DS is fundamentally untreatable.

US physicians and scientists associated with these DS organizations are actively discouraging piracetam’s use. Allegations of elevated seizure risks and possible long-term side effects from piractam are being made. However, the complete lack of such effects during more than two decades of worldwide clinical experience with piracetam suggest that political and ideological considerations are the sole basis of these anti-piracetam policy positions. Indeed, the increasing use of piracetam and targetted nutritional intervention (TNI) is putting these matters to the test. This article will specifically focus on the use of piracetam in DS-related conditions [see v2n10, v3n4, v4n10, v5n1 for previous articles].

A Brief History

Piracetam’s earliest use in Down’s syndrome (DS) was in Spain and Portugal in 1974 in a comparative study (using historic case controls) of Dromia (a 5-hydroxytryptophan-containing product) and Noostan (a brand of piracetam) in 26 children from age 3 months to 12 years of age [Fialmo, 1976]. This study was obscurely published, not indexed in any computer database, and remained largely unknown in the US.

In the early 90s, Dixie Tafoya, the mother of a child with DS, read Smart Drugs & Nutrients and realized that piracetam’s beneficial effects on various learning disabilities might address some of her daughter’s developmental problems [see SDN v3n4]. Piracetam’s almost complete lack of toxicity [Reynolds, 1996; Dukes, 1996] coupled with its ability to 1) enhance the higher (telencephalic) functions of the brain, 2) enhance interhemispheric communication through the corpus calosum, 3) enhance memory and learning in both animals and humans, and 4) prevent memory loss and learning difficulties induced by drugs, stress and trauma [reviewed by Vernon and Sorkin, 1991] made it seem an ideal prospect for DS therapy. Her daughter responded dramatically, and piracetam use has been spreading through the DS community ever since.

In 1995, Dr. Fialmo’s study of Dromia and piracetam was rediscovered in the US. It showed universal benefits in motor development, mental development, speech, affective social (emotional) development, scholastic achievement, and EEG changes indicating improved hemispheric synchronization (see Figure 1). The gains in speech were especially dramatic.

Toxicity and Pharmacology

One of piracetam’s most unique and conspicuous features is its extremely low toxicity. The classical measure of drug toxicity, the LD-50 (the dose causing death for 50% of test animals), is not applicable; standard dosing methods (oral, intravenous injection, intraperitoneal injection) cannot deliver enough piracetam to kill laboratory animals. Doses of greater than 20 g/day have been given to people suffering from myoclonic seizure disorders, without serious side effects [Karacostas et al., 1993]. The recommended dose of piracetam for infants with myoclonic seizures is 10-20 g/day (approximately 1-2 rounded tablespoons), a phenomenally high dose by normal drug standards.

Piracetam is absorbed rapidly and completely following oral intake, and it is excreted predominantly unchanged in the urine. Peak plasma levels are reached in less than an hour. However, brain concentrations rise more slowly. It may take days for piracetam to reach peak levels... (end of full-text presentation)

Begin Summary of Remaining Contents...

Section: Piracetam and Seizures: “Allegations of increased seizure risk from piracetam have been made by a few US physicians associated with establishment DS organizations. This is of special concern due to a higher-than-normal incidence of seizures...”

Section: Membrane Fluidization: “One of the effects common to many anti-seizure medications and therapies is fluidization of brain membranes. Membrane fluidity is influenced by many factors, some of which are cholesterol content, fatty acid profile, and degree of lipid peroxidation. The higher the cholesterol...”

Section: Piracetam and Hypoxia: “Hypoxia is a condition of low oxygen levels in the tissues. Hypoxia can be caused by lack of oxygen in the air (hypobaric or high-altitude conditions), decreased oxygen-carrying capacity of the blood (anemia or carbon monoxide...”

Section: Piracetam and Heart Disease: “Although piracetam has obvious theoretical applications to the hypoxic conditions typical of heart disease, Russian doctors and scientists appear to be the only researchers pursuing this application.”

Section: Piracetam and Inflammation: “The regulation of biological responses to oxygen free radicals, whether due to low or high oxygen levels, is mediated by tissue hormones called prostaglandins. These powerful hormones are created by the interaction...”

Section: Piracetam and Heart Surgery: “The high incidence of heart defects in DS infants has raised questions about how concurrent piracetam use may affect surgical risks. The standard response of US cardiovascular surgeons...”

Section: Learning Disabilities: “Piracetam’s ability to enhance learning abilities may be directly related to its effect on membrane fluidity. In rat studies, 300 mg/kg of piracetam administered once daily enhanced brain fluidity...”

Section: Piracetam and Language Skills: “Piracetam has a specific language-enhancing effect. This effect has been observed in studies of adults and children with learning disabilities, and it has recently been confirmed in a double-blind, placebo-controlled study of aphasic infants...”

Section: Summary: “Piracetam offers the potential of addressing a host of DS-related conditions without imposing any significant toxicity. It has been demonstrated to augment cognitive, learning and memory abilities, to decrease oxidative...”

Section: References: Thirty references are provided.