Medical Food for Alzheimer’s Patients - Axona

About Axona

Axona is a prescription medical food intended for the clinical dietary management of the metabolic processes associated with mild to moderate Alzheimer's disease. The human brain relies almost exclusively on glucose as a source of energy. Research shows that, in Alzheimer's disease patients, there is a dramatic drop in the brain's ability to metabolize glucose.

Axona addresses energy deficiencies in the brain by providing an alternative source of energy. In clinical trials, patients taking Axona experienced cognitive improvement in 45 days.

Axona has demonstrated safety and effectiveness in clinical trials. Axona is available by prescription only and its use must be supervised by a physician.

Axona Benefits

The results of clinical studies involving patients with mild to moderate Alzheimer's disease supported the positive role of Axona as a therapy that is compatible with drugs used to treat Alzheimer's disease.

Clinical studies demonstrated that Alzheimer's disease patients taking Axona:

• Experienced cognitive improvement by day 45
• Maintained cognitive benefits over the course of the study
• Experienced few side effects
• Could also take commonly prescribed Alzheimer's medications

Clinical Trial

Axona has been studied in clinical trials involving patients with mild to moderate Alzheimer's disease as well as healthy elderly volunteers. A study was conducted on 20 patients diagnosed with Alzheimer's disease or mild cognitive impairment. The results showed a positive response with improvement in paragraph recall (a primary measure of cognition).

Axona was evaluated in a double-blind, randomized, placebo-controlled study performed at multiple US clinical centers with 152 patients with mild to moderate Alzheimer's disease over a period of 90 days. Approximately 80% of those participating were receiving another type of Alzheimer's therapy. The results showed a significant improvement in cognitive function in certain patients taking Axona while a decline was demonstrated in the placebo group. The results also showed that cognitive benefits could be maintained over a period of time in the patients receiving Axona.

Axona Dozing

Axona is supplied as a powder, and is available in convenient individual packets of 40 grams per packet. It is recommended that patients take one packet of Axona once a day shortly after breakfast. The contents of each packet of Axona should be added to 4 to 8 ounces (118 to 236 milliliters) of water or other liquids, and shaken or blended until fully mixed.

For those who are unable to tolerate a full dose of Axona, talk to your doctor about starting at a lower dose for a period of time. If you are able to tolerate half the dose (about 2 1/2 Tbsp) of Axona, you may be able to gradually increase to the full dose level (about 5 Tbsp).

In clinical trials, the current formulation of Axona was studied only when it was mixed with water. However, additional studies indicate that Axona is a highly stable product and may be mixed with other foods and liquids, such as:

• Ice cream
• Pudding
• Meal replacement drinks
• Oatmeal
• Milk
• Fruit juice
• Chocolate syrup

In clinical studies, certain patients experienced improved results when they followed the dosing regimen exactly. Therefore, to take full advantage of your opportunity to achieve the best results, it is important to take Axona exactly as prescribed by your doctor.

About Medical Foods

Accera markets Axona as a medical food, available only by prescription.  Medical foods do not require the same U.S. Food and Drug Administration (FDA) review and approval as drugs.  Without the lengthy FDA review, if no data from placebo-controlled trials is published in peer-reviewed journals, it can be difficult to assess how effective a medical food is.

Medical foods were defined in 1988 by Congress as a special category of products that are designed for dietary management of a condition or disease that has specific nutritional requirements that have been verified by medical evaluation. Producers of medical foods are required to show that their products meet the specific nutritional needs of a particular condition using testing that includes clinical trials. Because they are not classified as drugs, they do not need the official approval of the Food and Drug Administration (FDA), as prescription medications do.

Medical foods are subject to some FDA oversight and regulation, which can include monitoring manufacturing processes and quality assurance programs, and analyzing ingredients for safety.  The agency does not necessarily conduct inspections for all medical foods, though.  In addition, food ingredients must be “Generally Recognized as Safe” (GRAS) to be exempt from pre-market review and approval. 

Why did Accera choose to market Axona as a medical food rather than as an FDA-approved drug?  Probably, because developing a potential drug, conducting clinical trials and going through FDA review is a lengthy and expensive process, while marketing as medical food offers much faster access to the market.

Research Limitations

Limited studies, funded by the manufacturers of the product, confirmed that memory and cognition improved for people with mild to moderate Alzheimer's disease. However, more studies are needed to determine its safety and effectiveness.

Axona is marketed as a medical food. Medical foods are dietary supplements that help manage a disease or condition that causes nutritional deficiencies. The Alzheimer's Association, however, disputes the notion that Alzheimer's disease causes nutritional deficiencies and requires a medical food. Medical foods are given only under the supervision of a doctor. The Food and Drug Administration (FDA) doesn't approve medical foods, nor does it test medical foods for safety or effectiveness.

Until more is known, the Alzheimer's Association doesn't recommend the use of medical foods, including Axona, for the treatment of Alzheimer's disease.

Side Effects

Side effects included diarrhea, heartburn, and flatulence. Axona contains milk and soy products. The company notes that it should be used with caution in people who are hypersensitive to palm or coconut oil, those at risk for ketoacidosis, or those with a history of metabolic syndrome, gastrointestinal inflammation, and/or renal problems. There were no significant interactions noted with commonly used Alzheimer’s drugs, including donepezil (Aricept) or memantine (Namenda).

Sources and Additional Information:

http://www.about-axona.com/

http://www.mayoclinic.com/health/axona/an01992

http://www.tangledneuron.info/the_tangled_neuron/2009/06/axona-a-different-approach-to-alzheimers.html

http://www.emaxhealth.com/1275/91/34426/axona-medical-food-alzheimers-disease.html

Sage as Alternative Treatment to Alzheimer's

A popular Chinese sage herb has been shown to contain similar active ingredients to compounds used in Western medicine to treat Alzheimer's disease.

Sage Clinical Effects

Clinical, animal and laboratory studies have shown that sage can help both the symptoms of Alzheimer's disease and contain the pathological mechanisms underlying this neurodegenerative condition.

Old memories
Sage contains cholinesterase inhibitor compounds that give it the ability to act in a similar way to drugs currently used to alleviate some of the effects of Alzheimer's disease. Cholinesterase inhibitors slow the breakdown of the neurotransmitter, acetylcholine, thereby improving interconnectivity between different parts of the brain. By so doing they enhance cognition and memory – functions that deteriorate in Alzheimer's patients.

Two helpful acids
More importantly, compounds in sage such as carnosic acid and rosmarinic acid both help to combat the pathological processes that underlie Alzheimer's disease. Both of these compounds are strong antioxidants; carnosic acid is particularly useful as it crosses the blood-brain barrier to counteract free radical damage to the brain.

Carnosic acid
Sage also enhances the production of glutathione, one of the most important of the body's own antioxidants. Furthermore, it helps to improve circulation to the brain by dilating the middle cerebral arteries. This is a very important function as a declining blood supply to the brain exacerbates the impaired neurological function caused by other pathological processes associated with neurodegenerative diseases.

Beats beta-amyloid
Sage also counters the damaging effects of beta-amyloid, the protein that clogs up the neural pathways in the brain and is the root cause of Alzheimer's disease.

Medicinal Plant Research Centre Research

It has taken 400 years but scientists have finally demonstrated what herbalists have long believed: sage is a tonic for the brain. Oil derived from the herb improved the memory of healthy young adults given a list of words to recall.

The Medicinal Plant Research Centre at Newcastle and Northumbria universities (both in UK) tested a group of 44 adults aged between 18 and 37. Some were given capsules containing sage oil while others received a placebo capsule of sunflower oil.

Those who took the sage oil performed consistently better, remembering more words than those who had the placebo.

Herbalists have been recommending sage since the 16th century. In 1597 John Gerard wrote: 'It is singularly good for the head and brain and quickeneth the nerves and memory.' Part of a 1652 description of sage by Nicholas Culpepper reads: 'It also heals the memory, warming and quickening the senses.' 

Other Applications for Sage

These uses have been tested in humans or animals. Safety and effectiveness have not always been proven. Some of these conditions are potentially serious, and should be evaluated by a qualified healthcare provider.

Cognitive improvement (Grade: A)
Sage has long been suggested to improve memory. Several trials provide evidence for the use of sage. Additional study is needed to confirm these findings and determine the best dose.

Mood enhancement (Grade: A)
Sage has long been suggested to improve mood. Several trials provide evidence for the use of sage. Additional study is needed to confirm these findings and determine the best dose.

Acute pharyngitis (Grade: B)
Sage mouthwashes and gargles have been approved for use against sore throat in Germany by the German Commission E for many years. Additional study is needed comparing sage to standard therapies.

Herpes (Grade: B)
Early evidence suggests that sage extracts may be useful in the treatment of herpes skin manifestations.

Menopausal symptoms (Grade: B)
Sage has been tested against menopausal symptoms with promising results.

Lung cancer prevention (Grade: C)
Sage used daily as a spice in foods has been associated with a lower risk of lung cancer in the Mediterranean diet.

Dosing

Adults (over 18 years old)

Doses of 25-50 microliters of the essential oil have been taken by mouth one to three times daily. Single daily doses of 60 drops of an ethanolic extract of S.officinalis were used in a clinical study with benefit. 120 milligrams of sage extract and 60 milligrams of alfalfa extract (Medicago sativa) have been used daily for up to three months to alleviate symptoms of menopause. Dried sage leaf, 300 or 600 milligrams, in single daily doses have been used. A 15% spray containing 140 microliters of S. officinalis extract per dose has been applied to the skin six to nine times daily for three days.

Children (under 18 years old)

There is no proven effective dose for sage in children. However, secondary sources note that children have safely eaten sage as a spice in foods for many centuries.

Safety

Allergies

Avoid in individuals with a known allergy or hypersensitivity to sage species, their constituents, or to members of the Lamiaceae family. Systemic allergic reactions relating to cross sensitivity have been noted.

Dust from sage plants may contain airborne microorganisms that may induce allergic reactions in farm workers and herb processors.

Sage powder should not be used for asthma. Although some formulations of sage have been reported to be useful in asthma, sage powder is not appropriate for use in asthmatic patients since it can cause bronchial reactions.

Side Effects and Warnings

Sage (Salvia officinalis) is uncontrolled in the United States. This means all parts of the plant and its extracts are legal to cultivate, buy, possess, and distribute (sell, trade, or give) without a license or prescription. If sold as a supplement, sales must conform to U.S. supplement laws. If sold for consumption as a food or drug, the U.S. Food and Drug Administration (FDA) regulate sales. Sage is approved for food use as a spice or seasoning in the United States and appears on the FDA's list of substances Generally Recognized as Safe (GRAS).

Skin rash may occur in some patients who are exposed to the leaves.

Sage is likely safe when included in the preparation of foods as a spice for upset stomach, due to a long history of use around the world. Sage is also likely safe when used in moderate amounts as a cream applied to the skin for herpes infections.

Certain medicinal preparations or high doses of sage have been documented to induce seizures. Large amounts or prolonged use of sage leaf or ingestion of sage oil may cause restlessness, vomiting, dizziness, rapid heart beats, tremors, seizures, and kidney damage.

Some patients may exhibit increases in blood pressure during sage essential oil therapy.

When using a 15% spray containing sage extract for three days, minor dry pharynx or mild burning of the throat have been reported in some patients. Other side effects may include: cheilitis (cracking and drying of the lips), stomatitis (mouth sores), dry mouth, and local irritation.

A plant preparation that is not sterile and not free of particles should not be used in the eye since these preparations may damage the cornea.

Sage powder should not be used for asthma, since sage powder can cause asthmatic attacks.

Pregnancy & Breastfeeding

Due to a lack of available scientific evidence, women should avoid sage supplementation during pregnancy and breastfeeding. Hormonal effects are possible and could be dangerous.

Interactions

Interactions with Drugs

Sage essential oil and tinctures may increase the effects of drugs used in the treatment of Alzheimer's disease.

Sage extracts may have antimicrobial effects.

Sage may lower blood sugar levels. Caution is advised when using medications that may also lower blood sugar. Patients taking drugs for diabetes by mouth or insulin should be monitored closely by a qualified healthcare professional, including a pharmacist. Medication adjustments may be necessary.

Sage may have anti-inflammatory activity. Use cautiously with anti-inflammatory medications, due to possible additive effects.

Sage may have antioxidant activity.

Use cautiously with benzodiazepines or drugs broken down by the liver. Sage may increase sedation.

Sage essential oil and tinctures can induce seizures and may enhance the ability of some drugs to induce seizures.

Sage essential oil may have estrogenic activity. Extracts of the leaves of sage may abolish hot flashes and night sweating in some menopausal women.

Use cautiously with thyroid hormones, due to possible additive effects.

Interactions with Herbs & Dietary Supplements

Sage may increase the effects of alfalfa (Medicago sativa) on the reduction of menopausal symptoms, including hot flashes, insomnia, nocturnal sweating, dizziness, headaches, and palpitations.

Sage essential oil and tinctures may increase the anticholinergic effects of drugs used in the treatment of Alzheimer's disease.

Sage extracts may have antimicrobial effects.

Some species of sage may cause convulsions. Theoretically, this might interfere with anticonvulsant drug therapy.

Sage may have anti-inflammatory activity. Caution is advised when taking other anti-inflammatory herbs or supplements, due to possible additive effects.

Based on laboratory studies, sage may have antioxidant activity.

Sage may interact with therapies that are broken down by the liver.

Sage may lower blood sugar levels. Caution is advised when using herbs or supplements that may also lower blood sugar. Blood glucose levels may require monitoring, and doses may need adjustment.

Sage essential oil may have estrogenic activity. In addition, extracts of the leaves of sage may abolish hot flashes and night sweating in some menopausal women. Caution is advised in patients taking phytoestrogens.

Sage may increase the amount of drowsiness caused by some herbs or supplements.

Sage may induce a significant increase in thyroid stimulating hormone and interact with other herbs and supplements that affect the thyroid.

Sources and Additional Information:

http://www.medicinal-herbs-and-spices.com/sage-benefits.html

http://www.medicalnewstoday.com/articles/4212.php

http://www.nutraingredients.com/Research/Sage-alternative-treatment-to-Alzheimer-s-drug

http://www.wellness.com/reference/food/sage-salvia-officinalis-salvia-lavandulaefolia-salvia-lavandulifolia/

http://www.aromamd.net/edu_alzheimers_dementia.pdf