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A growing number of herbal remedies, dietary supplements and "medical foods" are promoted as memory enhancers or treatments to delay or prevent Alzheimer’s disease and related disorders. Claims about the safety and effectiveness of these products, however, are based largely on testimonials, tradition and a rather small body of scientific research. The rigorous scientific research required by the U.S. Food and Drug Administration (FDA) for the approval of a prescription drug is not required by law for the marketing of dietary supplements or "medical foods."
Axona’s development was preceded by development of the chemically similar Ketasyn (AC-1202). Ketasyn was tested in a Phase II clinical study enrolling 152 volunteers with mild to moderate Alzheimer’s. Most participants were also taking FDA-approved Alzheimer's drugs. The manufacturer of Axona reports that study participants who took Ketasyn performed better on tests of memory and overall function than those who received a placebo (a look-alike, inactive treatment).
The chief goal of Phase II clinical studies is to provide information about the safety and best dose of an experimental treatment. Phase II trials are generally too small to confirm that a treatment works. To demonstrate effectiveness under the prescription drug approval framework, the FDA requires drug developers to follow Phase II studies with larger Phase III trials enrolling several hundred to thousands of volunteers.
The manufacturer of Ketasyn decided not to conduct Phase III studies to confirm its effectiveness. The company chose instead to use Ketasyn as the basis of Axona and promote Axona as a “medical food.” Medical foods do not require Phase III studies or any other clinical testing. The Alzheimer’s Association Medical and Scientific Advisory Council has expressed concern that there is not enough evidence to assess the potential benefit of medical foods for Alzheimer’s disease. For more information, please see the Medical and Scientific Advisory Council statement about medical foods.
Some people with Alzheimer’s and their caregivers have turned to coconut oil as a less expensive, over-the-counter source of caprylic acid. A few people have reported that coconut oil helped the person with Alzheimer’s, but there’s never been any clinical testing of coconut oil for Alzheimer’s, and there’s no scientific evidence that it helps.
A growing number of herbal remedies, dietary supplements and "medical foods" are promoted as memory enhancers or treatments to delay or prevent Alzheimer’s disease and related disorders. Claims about the safety and effectiveness of these products, however, are based largely on testimonials, tradition and a rather small body of scientific research. The rigorous scientific research required by the U.S. Food and Drug Administration (FDA) for the approval of a prescription drug is not required by law for the marketing of dietary supplements or "medical foods."
- Caprylic acid and coconut oil
- Concerns
- Coenzyme Q10
- Coral calcium
- Ginkgo biloba
- Huperzine A
- Omega-3 fatty acids
- Phosphatidylserine
- Tramiprosate
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Effectiveness and safety are unknown. The rigorous scientific
research required by the U.S. Food and Drug Administration (FDA) for the
approval of a prescription drug is not required by law for the
marketing of dietary supplements. The maker of a dietary supplement is
not required to provide the FDA with the evidence on which it bases its
claims for safety and effectiveness.
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Purity is unknown. The FDA has no authority over supplement
production. It is a manufacturer’s responsibility to develop and enforce
its own guidelines for ensuring that its products are safe and contain
the ingredients listed on the label in the specified amounts.
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Bad reactions are not routinely monitored. Manufacturers are
not required to report to the FDA any problems that consumers experience
after taking their products. The agency does provide voluntary
reporting channels for manufacturers, health care professionals, and
consumers, and will issue warnings about product when there is cause for
concern.
- Dietary supplements can have serious interactions with prescribed medications. No one should take a supplement without first consulting a physician.
Axona’s development was preceded by development of the chemically similar Ketasyn (AC-1202). Ketasyn was tested in a Phase II clinical study enrolling 152 volunteers with mild to moderate Alzheimer’s. Most participants were also taking FDA-approved Alzheimer's drugs. The manufacturer of Axona reports that study participants who took Ketasyn performed better on tests of memory and overall function than those who received a placebo (a look-alike, inactive treatment).
The chief goal of Phase II clinical studies is to provide information about the safety and best dose of an experimental treatment. Phase II trials are generally too small to confirm that a treatment works. To demonstrate effectiveness under the prescription drug approval framework, the FDA requires drug developers to follow Phase II studies with larger Phase III trials enrolling several hundred to thousands of volunteers.
The manufacturer of Ketasyn decided not to conduct Phase III studies to confirm its effectiveness. The company chose instead to use Ketasyn as the basis of Axona and promote Axona as a “medical food.” Medical foods do not require Phase III studies or any other clinical testing. The Alzheimer’s Association Medical and Scientific Advisory Council has expressed concern that there is not enough evidence to assess the potential benefit of medical foods for Alzheimer’s disease. For more information, please see the Medical and Scientific Advisory Council statement about medical foods.
Some people with Alzheimer’s and their caregivers have turned to coconut oil as a less expensive, over-the-counter source of caprylic acid. A few people have reported that coconut oil helped the person with Alzheimer’s, but there’s never been any clinical testing of coconut oil for Alzheimer’s, and there’s no scientific evidence that it helps.
