Showing posts with label alzheimer's diagnosis. Show all posts

Saturday, August 11, 2018

Should doctors tell patient an Alzheimer's diagnosis:Pros and Cons

Alzheimer's Association

NBC News Washington

Every 67 seconds, an American develops Alzheimer's. Half the time, doctors don't tell. Why would doctors do that? In a key study, the Alzheimer's Association offers a few reasons.

The Alzheimer's Association's Alzheimer's Disease Facts and Figures report found that only 45 percent of people with Alzheimer's disease or their caregivers say they were told the diagnosis by their doctor. In contrast, more than 90 percent of people with the four most common cancers (breast, colorectal, lung and prostate cancer) say they were told the diagnosis.

"These disturbingly low disclosure rates in Alzheimer's disease are reminiscent of rates seen for cancer in the 1950s and 60s, when even mention of the word cancer was taboo," said Beth Kallmyer, MSW, Vice President of Constituent Services for the Alzheimer's Association. "It is of utmost importance to respect people's autonomy, empower them to make their own decisions and acknowledge that people with Alzheimer's have every right to expect truthful discussions with their physicians. When a diagnosis is disclosed, they can better understand the changes they are experiencing, maximize their quality of life, and often play an active role in planning for the future."

Why Not Tell?

Why would doctors not tell their patients about their Alzheimer's diagnosis? Three typical reasons include:

There is still no straghtforward test to diagnose Alzheimer's, though there are tests that can rule it out.
Doctors sometimes fear their patient's negative reaction to that kind of news.
Doctors are concerned they may not be believed. While an Alzheimer's diagosis can change a patient's life, it is based on the doctor's clinical assessment, that is to say, their professional judgement.

Better Late?

The Alzheimer's Facts and Figures report also found that people with Alzheimer's or their caregivers were more likely to say they were told the diagnosis by their doctor after the disease had become more advanced. According to Kallmyer, this is a problem because learning the diagnosis later in the course of the progressive brain disease may mean the person's capacity to participate in decision making about care plans, or legal and financial issues, may be diminished, and their ability to participate in research or fulfill lifelong plans may be limited.

One of the reasons most commonly cited by health care providers for not disclosing an Alzheimer's diagnosis is fear of causing the patient emotional distress. However, according to the new report, "studies that have explored this issue have found that few patients become depressed or have other long-term emotional problems because of the [Alzheimer's] diagnosis."

The Difficult Truth

According to the Alzheimer's Association, telling the person with Alzheimer's the truth about his or her diagnosis should be standard practice. Disclosure can be delivered in a sensitive and supportive manner that avoids unnecessary distress.

"Based on the principles of medical ethics, there is widespread agreement among health care professionals that people have the right to know and understand their diagnosis, including Alzheimer's disease," said William Klunk, M.D., Ph.D., Chair of the Alzheimer's Association Medical and Scientific Advisory Council. "The findings from this report shine a light on the need for more education for medical students and practicing health care providers on how to effectively make and deliver an Alzheimer's diagnosis."

Dr. Klunk is a Distinguished Professor of Psychiatry and Neurology at the University of Pittsburgh School of Medicine in Pittsburgh, PA, where he also is Co-Director of the Alzheimer's Disease Research Center.

Benefits of Disclosing an Alzheimer's Diagnosis

The benefits of promptly and clearly explaining a diagnosis of Alzheimer's have been established in several studies. Benefits include:

Better access to quality medical care and support services
The opportunity for people with Alzheimer's to participate in decisions about their care, including providing informed consent for current and future treatment plans.
Knowing the diagnosis early enables the person with Alzheimer's to get the maximum benefit from available treatments.
An early diagnosis also helps increase chances of participating in clinical drug trials that help advance research and may actually offer treatments that work.

SOURCE:

The Alzheimer's Association
NBC News Washington

Thursday, February 1, 2018

F18 Alzheimer's pet scan benefits

Caregivers, and healthcare professionals,here is some great information

Here is a great dementia resource for caregivers and healthcare professionals,

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The Dementia Caregiver's Little Book of Hope [Kindle Edition]

Lippincott Williams & Wilkins

Today's state-of-the-art in diagnosing Alzheimer's is the F18 PET Scan. See how it changed one man's life. Learn how 87% of patients who received an F18 scan made at least one change in their treatment plan.

Until recently, the hardest part in diagnosing Alzheimer's was the difficulty in "seeing" what was going on in the brain. F18 PET scans changed all that, allowing doctors to "see" how much Alzheimer's plaque, if any, appeared in the brain.

Continued below video...

When the first F18 tests hit the market, they cost a few thousand dollars and were available from only one source. Since then, there has been a rush of activity on the part of pharmaceutical companies to bring better and less expensive F18 tests to market.

The first F18 test to detect brain amyloid deposits (also known as Alzheimer's plaques)was approved by the FDA in 2012. It was called Florbetapir F18 (renamed AMYViD™).

F18 tests approved by the FDA include:

Generic Name	Brand Name
Flutemetamol F18	Vizamyl™
Florbetaben F18	Neuraceq™
Florbetapir F18	AMYViD™

A Closer Look at Florbetapir F18

Seeing the amount of Alzheimer's plaque provides doctors with useful information on treatment and further testing for patients with cognitive impairment, according to the study published online by the journal Alzheimer Disease & Associated Disorders. The journal is published by Lippincott Williams & Wilkins, a part of Wolters Kluwer Health.

Positron emission tomography (PET) scans "light up" the florbetapir F18 biomarker to show amyloid plaques in the brain — a characteristic feature of Alzheimer's disease (AD).

"Amyloid imaging results altered physicians' diagnostic thinking, intended testing and management of patients undergoing evaluation for cognitive decline," according to the study by Dr. Mark Mintun of Avid Pharmaceuticals, Philadelphia, and colleagues.

Is It Alzheimer's? Florbetapir Provides Evidence

The researchers designed a "real-world" study to determine how florbetapir would affect clinical management of patients with cognitive impairment. While a florbetapir PET scan showing amyloid plaques doesn't prove that AD is present, it provides a previously unavailable piece of evidence to support the diagnosis.

The study included 229 patients seen by neurologists or other specialists for evaluation of cognitive decline or impairment of uncertain etiology. Before the florbetapir PET scan, doctors provided a provisional diagnosis, an estimate of their diagnostic confidence, and their plans for further testing and treatment. The goal was to assess the value of florbetapir PET in making the final diagnosis and in providing doctors with useful information for clinical decision making.

The florbetapir PET scans showed amyloid deposits in 113 out of 229 patients. The information provided led doctors to change their diagnosis in 55 percent of cases.

When the provisional diagnosis was AD, imaging results led to a change in diagnosis in 37 percent of cases. When the pre-scan diagnosis was either “indeterminate” or another cause of dementia, the diagnosis changed in over 60 percent of cases. In either direction, the scans increased the physicians' ratings of diagnostic confidence by about 20 percent.

Impact on Treatment and Testing Decisions

Florbetapir PET also provided useful information for treatment decision-making: in 87 percent of patients, the results contributed to at least one change in the treatment plan. The main impact was in deciding whether or not to use medications that are helpful in AD. The scan results also affected decisions on further testing—in many cases, physicians dropped plans to perform additional brain imaging studies or neuropsychological tests.

Alzheimer disease is the most common cause of dementia, but the diagnosis can be challenging to make. The only definitive way to diagnose AD is by autopsy examination of the brain after death. Up to 20 percent of patients diagnosed with AD turn out not to have had AD on autopsy, while up to 40 percent of patients diagnosed with other causes of dementia have evidence of AD at autopsy.

Florbetapir PET is the first FDA-approved imaging that can estimate amyloid deposits in the brain of a living patient. Previous studies have shown that the scans are accurate in identifying patients later shown to have AD at autopsy.

The new results show that florbetapir PET scans can have a significant effect in "real world" clinical evaluation of patients with cognitive impairment. By strengthening the case for or against a diagnosis of AD, this test can have a significant impact on patient management—particularly related to the use of AD medications and the need for further testing. Additional studies will be needed to confirm whether "clinical care that includes amyloid imaging will translate into better outcomes" for patients with cognitive impairment and possible AD.

Monday, December 17, 2012

Amarantus BioScience Licenses LymPro Alzheimer’s Disease Diagnostic Blood Test

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Here is a great dementia resource for caregivers and healthcare professionals,

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The Dementia Caregiver's Little Book of Hope [Kindle Edition

SUNNYVALE, Calif.– Amarantus BioScience, Inc. (OTCQB: AMBS), a biotechnology company discovering and developing treatments for diseases associated with protein misfolding and apoptosis, today announced that it has licensed the LymPro Alzheimer’s Disease Diagnostic Blood Test (LymPro) from Memory Dx, LLC (MDx), formerly known as Provista Life Sciences, Inc. LymPro originated from the University of Leipzig in Germany and has received over $3 million in research grants from the National Institutes of Health (NIH).

LymPro was designed with the purpose of diagnosing Alzheimer’s in its mild to moderate stage, a population of patients currently being tested in numerous clinical studies with amyloid-beta targeting strategies. LymPro works by identifying immune-based biomarkers in the blood of Alzheimer’s patients, diagnosing Alzheimer’s and allowing physicians to definitively differentiate Alzheimer’s disease from other forms of dementia. This patient-specific identification has the potential to become an invaluable tool for Alzheimer’s disease clinical trials, where there has been a well-documented history of patient recruitment errors related to inaccurate diagnosis of Alzheimer’s. LymPro has completed two Phase 1 clinical studies in over 80 patients, showing 98% sensitivity and 96% specificity for Alzheimer’s disease diagnosis. LymPro is ready to move into a Phase 2 validation study. If successful, LymPro can begin generating revenue as a laboratory developed test (“LDT”) within 18 months of study initiation through commercial sales and through sales to companies performing Alzheimer’s disease clinical research.

“We believe LymPro has significant clinical and commercial potential as a diagnostic blood test for Alzheimer’s disease,” said Gerald E. Commissiong, President and CEO of Amarantus. “It is clear that the path forward for treating Alzheimer’s disease is to identify and initiate therapeutic intervention as early as possible. If proven effective, LymPro could provide physicians with a lower-cost, minimally-invasive intervention and reduce the need for costly brain imaging scans. This license expands our diagnostic pipeline and complements our strategic focus on neurodegenerative diseases. While we are not currently developing MANF for Alzheimer’s disease, we believe that the cost-effective definitive identification of earlier-stage patients will create a significant opportunity for Amarantus to evaluate the MANF Program as a disease-modifying treatment in this large, underserved therapeutic indication.”

Under the terms of the agreement, Amarantus has agreed to issue two million shares of restricted common stock to MDx, pay a development milestone upon successful completion of the Phase 2 validation study, as well as pay a nine percent royalty on sales. In addition, Amarantus has agreed to retain MDx to perform the necessary validation study to gain Clinical Laboratory Improvement Amendments (CLIA) certification for LymPro. Together, Amarantus and MDx will expand their relationships with large pharmaceutical companies, and will also seek additional grant funding for the further development of LymPro. Amarantus has the right to assign or sub-license LymPro to a third party of its choosing at any time.

“Amarantus represents an excellent partner for Memory Dx because of its scientific focus on protein misfolding and aggregation, which we believe will continue to be critical in developing disease-modifying treatments for Alzheimer’s,” said William E. Gartner, President and CEO of Memory Dx, LLC. “This agreement with Amarantus is the final step in the transition of Memory Dx from a diagnostic product developer into a contract CLIA lab focused on driving revenues. We look forward to working with Amarantus to advance LymPro and get it into the hands of physicians so we can help address the significant socioeconomic problems caused by Alzheimer’s disease.”

About Alzheimer’s Disease

It is estimated that over 5.4 million people in the United States suffer from Alzheimer’s disease and over 300,000 patients are diagnosed annually, with nearly one in eight older Americans affected by the disease. Alzheimer’s is the sixth leading cause of death in the United States. The estimated cost of unpaid care in the United States is estimated at over $210 billion annually and the total payments for care are estimated at over $200 billion annually, including $140 billion in cost to Medicare and Medicaid. It is estimated that these figures will double by 2050. Amarantus believes the market opportunity for an effective Alzheimer’s disease diagnostic far exceeds $500 million annually.[1]

About Amarantus BioScience, Inc.

Amarantus BioScience, Inc. is a development-stage biotechnology company founded in January 2008. The Company has a focus on developing certain biologics surrounding the intellectual property and proprietary technologies it owns to treat and/or diagnose Parkinson’s disease, Traumatic Brain Injury and other human diseases. The Company owns the intellectual property rights to a therapeutic protein known as Mesencephalic-Astrocyte-derived Neurotrophic Factor (“MANF”) and is developing MANF-based products as treatments for brain disorders. The Company also is a Founding Member of the Coalition for Concussion Treatment (#C4CT), a movement initiated in collaboration with Brewer Sports International seeking to raise awareness of new treatments in development for concussions and nervous-system disorders. For further information please visit www.Amarantus.com.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about the possible benefits of MANF therapeutic applications and/or advantages presented by Amarantus’ PhenoGuard technology, as well as statements about expectations, plans and prospects of the development of Amarantus’ new product candidates. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including the risks that the anticipated benefits of the therapeutic drug candidates or discovery platforms, as well as the risks, uncertainties and assumptions relating to the development of Amarantus’ new product candidates, including those identified under “Risk Factors” in Amarantus’ most recently filed Annual Report on Form 10-K and Quarterly Report on Form 10-Q and in other filings Amarantus periodically makes with the SEC. Actual results may differ materially from those contemplated by these forward-looking statements Amarantus does not undertake to update any of these forward-looking statements to reflect a change in its views or events or circumstances that occur after the date of this presentation.

[1] http://www.alz.org/alzheimers_disease_facts_and_figures.asp

Thursday, June 21, 2012

Amyvid in diagnosing Alzheimer's

Caregivers, and healthcare professionals, here is some great information

Here is a great dementia resource for caregivers and healthcare professinals,

Your residents will love the Amazon Kindle Fire

Here is information on being the best caregiver you can be

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Follow alzheimersideas on twitter

The Dementia Caregiver's Little Book of Hope [Kindle Edition

Lilly

INDIANAPOLIS, /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) and Avid Radiopharmaceuticals, Inc., a wholly owned subsidiary of Lilly announced that Amyvid is available to imaging centers in markets surrounding 16 manufacturing sites located in Atlanta; Charlotte, N.C.; Chicago; Colton, Calif;Columbus, Ohio; Dallas; Fort Lauderdale, Fla.; Hartford, Conn.; Houston; Jacksonville, Fla.; North Wales, Pa.; Orlando, Fla.; Palo Alto, Calif.; Phoenix; Seattle; and St. Louis.

Because Amyvid loses over half of its radioactivity every two hours, it must be distributed directly to imaging centers from the specialized radiopharmacies where it is produced. Patients should speak to their health care provider to determine if Amyvid is an appropriate option for them and to determine if it is available in their area.

"In the roughly two months since the approval of Amyvid, we have been working closely with imaging centers to ensure they are prepared to provide Amyvid to their customers," said Daniel Skovronsky, M.D., Ph.D., president and CEO of Avid, and global brand development leader for Amyvid at Lilly. "We are committed to providing Amyvid to physicians, patients and their families in as many areas as possible as quickly as we can."

To coincide with the availability of Amyvid, Lilly is also announcing the launch of their reader training program. An online training program, developed by Lilly and Avid, is now available at AmyvidTraining.com. The companies also collaborated with the American College of Radiology to present a live, in-person training program, which will be launched on June 11, 2012, in Miami. These reader training programs were developed to provide training for radiologists and nuclear medicine physicians who will be responsible for reading Amyvid scans. Amyvid images should be interpreted only by readers who have successfully completed the Amyvid reader training. Errors may occur in the estimation of plaque density during image interpretation.

Amyvid is the first-and-only radioactive diagnostic agent approved by the U.S. Food and Drug Administration for PET imaging of the brain to estimate beta-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer's Disease and other causes of cognitive decline.(1)

Amyvid works by binding to amyloid plaques, one of the necessary pathological features of Alzheimer's Disease,(2),(3),(4) and is detected using PET scan images of the brain.(1) A negative Amyvid scan indicates sparse to no amyloid plaques are currently present, which is inconsistent with a neuropathological diagnosis of Alzheimer's Disease and reduces the likelihood that a patient's cognitive impairment is due to Alzheimer's Disease.(2),(5) A positive Amyvid scan indicates moderate to frequent amyloid plaques are present; this amount of amyloid plaque is present in patients with Alzheimer's Disease, but may also be present in patients with other types of neurologic conditions and in older people with normal cognition.(1),(4),(6)

It's important to note that Amyvid is an adjunct to other diagnostic evaluations. A positive Amyvid scan does not establish a diagnosis of Alzheimer's Disease or other cognitive disorder. Additionally, the safety and effectiveness of Amyvid have not been established for predicting development of dementia or other neurologic condition, or monitoring responses to therapies.(1)

About Amyvid

Amyvid is a radioactive diagnostic agent, tagged with a radioisotope called fluorine-18. Once Amyvid is injected into a vein, it travels through the bloodstream and into the brain, binding to amyloid plaques. Amyvid produces a positron signal, which is detected by a PET scanner and used to create a brain image. A radiologist, who should have successfully completed Amyvid reader training, then interprets the image to evaluate for the presence or absence of significant amyloid plaques (i.e., moderate to frequent levels of neuritic plaques) in the brain. This information is reported back to the referring physician, who then determines the next steps in the evaluation and management of the patient.

Indications and Usage

Amyvid is indicated for Positron Emission Tomography (PET) imaging of the brain to estimate beta-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer's Disease (AD) and other causes of cognitive decline.

A negative Amyvid scan indicates sparse to no neuritic plaques and is inconsistent with a neuropathological diagnosis of AD at the time of image acquisition; a negative scan result reduces the likelihood that a patient's cognitive impairment is due to AD. A positive Amyvid scan indicates moderate to frequent amyloid neuritic plaques; neuropathological examination has shown this amount of amyloid neuritic plaque is present in patients with AD, but may also be present in patients with other types of neurologic conditions as well as older people with normal cognition. Amyvid is an adjunct to other diagnostic evaluations.

Limitations of Use:

A positive Amyvid scan does not establish a diagnosis of AD or other cognitive disorder. Additionally, the safety and effectiveness of Amyvid have not been established for predicting development of dementia or other neurologic condition, or monitoring responses to therapies.(1)

Amyvid for intravenous use is supplied in 10 mL, 30 mL, or 50 mL multidose vials containing 500-1900 MBq/mL Florbetapir F 18.

Important Safety Information

Warnings and Precautions

Risk for Image Misinterpretation and Other Errors

Errors may occur in the Amyvid estimation of brain neuritic plaque density during image interpretation.

Image interpretation should be performed independently of the patient's clinical information. The use of clinical information in the interpretation of Amyvid images has not been evaluated and may lead to errors. Other errors may be due to extensive brain atrophy that limits the ability to distinguish gray and white matter on the Amyvid scan as well as motion artifacts that distort the image.

Amyvid scan results are indicative of the brain neuritic amyloid plaque content only at the time of image acquisition and a negative scan result does not preclude the development of brain amyloid in the future.

Radiation Risk

Amyvid, similar to other radiopharmaceuticals, contributes to a patient's overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer. Ensure safe handling to protect patients and health care workers from unintentional radiation exposure.

Most Common Adverse Reactions

The most common adverse reactions reported in clinical trials were headache (1.8 percent), musculoskeletal pain (0.8 percent), fatigue (0.6 percent), nausea (0.6 percent), anxiety (0.4 percent), back pain (0.4 percent), blood pressure increased (0.4 percent), claustrophobia (0.4 percent), feeling cold (0.4 percent), insomnia (0.4 percent), neck pain (0.4 percent).

Drug Interactions

Pharmacodynamic drug-drug interaction studies have not been performed in patients to establish the extent, if any, to which concomitant medications may alter Amyvid image results.

For Full Prescribing Information, visit http://pi.lilly.com/us/amyvid-uspi.pdf.

AM HCP ISI 06APR2012

About Eli Lilly and Company

Lilly, a leading innovation-driven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers — through medicines and information — for some of the world's most urgent medical needs. Additional information about Lilly is available at www.lilly.com.

This press release contains certain forward-looking statements about Amyvid™, a radioactive diagnostic agent indicated for brain imaging of beta-amyloid plaques in patients with cognitive impairment who are being evaluated for Alzheimer's Disease and other causes of cognitive decline. This release reflects Lilly's current beliefs; however, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. There is no guarantee that future study results and patient experience will be consistent with study findings to date or that the product will prove to be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly's filings with the United States Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements.

P-LLY

(1) Amyvid Prescribing Information. April 6, 2012.

(2) Hyman BT, Phelps CH, Beach TG, et al. National Institute on Aging—Alzheimer's Association guidelines for the neuropathologic assessment of Alzheimer's disease. Alzheimers Dement. 2012;8:1—13.

(3) Mirra SS, Heyman A, McKeel D, et al; and participating CERAD neuropathologists. The Consortium to Establish a Registry for Alzheimer's Disease (CERAD): part II. standardization of the neuropathologic assessment of Alzheimer's disease. Neurology. 1991;41(4):479—486.

(4) Thies W, Bleiler L; Alzheimer's Association. Alzheimer's Association report: 2012 Alzheimer's disease facts and figures. Alzheimers Dement. 2012;8:131—168.

(5) McKhann GM, Knopman DS, Chertkow H, et al. The diagnosis of dementia due to Alzheimer's disease: recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's Disease. Alzheimers Dement. 2011;7:263—269.

(6) Sperling RA, Aisen PS, Beckett LA, et al. Toward defining the preclinical stages of Alzheimer's disease: recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's Disease. Alzheimers Dement. 2011;7(3):280—292.

Amyvid™ is a trademark of Eli Lilly and Company.

(Logo: http://photos.prnewswire.com/prnh/20031219/LLYLOGO )

SOURCE Eli Lilly and Company

News Provided by Acquire Media

Saturday, May 26, 2012

Brain Scan for Alzheimer's

The Dementia Caregiver's Little Book of Hope [Kindle Edition]

Technology Review

A recently approved plaque-tracking dye can improve doctors' ability to identify Alzheimer's.

by Susan Young

Beginning next month, doctors can use a brain scan to better diagnose Alzheimer's. The U.S. Food and Drug Administration recently approved a fluorescent dye that binds to amyloid plaques, a physical hallmark of the disease, as a diagnostic tool.

Currently, doctors cannot be certain whether or not a patient's brain is riddled with amyloid plaques until after the patient's death. But now, clinicians can use a weakly radioactive dye to search for the presence of plaques in a living patient. The dye binds to the starchy amyloid that builds up in the brains of Alzheimer's patients and can be visualized in a PET scan. The FDA approved the scan as a method for estimating plaque content in the brains of people exhibiting cognitive decline. The presence or absence of plaques in a patient with forgetfulness, confusion, or other signs of neurological trouble could help doctors with their diagnoses.

Although scientists do not know whether or not the plaques are the cause of Alzheimer's, the plaques are strongly correlated with symptoms of dementia. Elderly people with the plaques have a more rapid mental decline than the elderly who don't have the plaques. And even though doctors cannot treat Alzheimer's, diagnostic tools like the plaque-marking dyes will help them identify patients with the disease, as well as those who do not have it but exhibit signs of mental decline due to other problems.

"A positive scan would add more weight to our bedside diagnosis," says Liana Apostolova, an Alzheimer's specialist at the University of California, Los Angeles. She says the technique could be useful in diagnosing patients with unusual forms of the disease and patients whose symptoms may be caused by other conditions, such as drug side effects or depression. "If a patient's cognitive impairment is purely due to depression, then a negative amyloid scan would help ascertain that," Apostolova says.

The new dye and other plaque-marking dyes have been used in clinical research for years, but Eli Lily, whose subsidiary Avid Radiopharmaceuticals produces the diagnostic agent, is the first to bring the technique to the doctor's office. Some experts are still concerned that the clinical use of the dye might be a bit premature, since the presence of the plaques isn't enough to confirm an Alzheimer's diagnosis. In fact, the amyloid deposits are often found in older people with normal mental ability and could be associated with other neurologic conditions. For now, the Avid dye is only approved to be used to rule out Alzheimer's (if no plaques are detected, a doctor can be confident the patient doesn't have the disease).

"I think it puts the clinician in a bind," says Ronald Petersen, director of the Mayo Clinic's Alzheimer's Disease Research Center. If a scan is negative, then a doctor can tell a patient that amyloid is not contributing, but if a scan is positive, what should a clinician do? "The FDA nor the company says anything about the meaning of a positive scan," says Petersen. "The data is not out there."

Petersen and others agree, however, that plaque-detecting diagnostics are critical for Alzheimer's research. The dyes enable researchers to determine which participants carry plaques and thus design better trials for plaque-attacking drugs. Within the trials, plaque tracers can be used to monitor the amount of plaque in a participant's brain during the course of treatment.

The tracers can also help the field elucidate the causes and disease mechanisms of Alzheimer's, which will be key to treating or preventing the disease. Researchers can study people who have amyloid plaques and monitor their cognitive abilities over time. From the pool of cognitively normal elderly with a positive scan, knowing who "develops Alzheimer's disease and who doesn't will help us explore disease susceptibility and resistance, identify all genetic risk factors and the early metabolic changes, so we can then target these specific processes with drugs," Apostolova says. "Diagnoses can be helpful, but we want therapeutics."

More than five million people in the United States have Alzheimer's, and that number is expected to double in coming years, according to the U.S. Department of Health and Human Services. By their early 70s, as many as 30 percent of people have amyloid plaques in the brain, says Michael Weiner, principal investigator of the Alzheimer's Disease Neuroimaging Initiative, which tests imaging techniques as well as biomarkers for Alzheimer's that could be found in the blood or cerebrospinal fluid.

The new dye-based scans "are going to create greater public consciousness of the disease, and that will have a big impact," says Weiner.