Johnnie B. Byrd, Sr. Alzheimer's Center & Research Institute

Fundraising efforts for the Johnnie B. Byrd, Sr. Alzheimer's Center and Research Institute's are taking off. 

The Fraternal Order of Eagles chose the Institute as their charity of the year and raised $120,000 so far for the non-profit organization.

Visit the Johnnie B. Byrd, Sr. Alzheimer's Center & Research Institute website.

Clinical Trial: Omega 3 Fatty Acid, Slowing the Progression of Alzheimer's Disease

Preliminary studies have shown a reduced risk of Alzheimer's disease (AD) in people consuming increased amounts of fish in their diets. Many of the health benefits of fish are attributed to the abundance of omega 3 fatty acids. Docosahexaenoic Acid (DHA) is the most abundant omega 3 fatty acid in the brain. Data from several animal models supports the hypothesis that DHA may be an effective treatment for AD by means of anti-amyloid, antioxidant, and neuroprotectant mechanisms.

This study is currently recruiting patients.

Personal Note: I have been feeding my mother fish and giving her Omega 3 Oil daily for a couple of years. I believe it is beneficial.

For a complete description of the trial including eligibility requirements go to the Clinical Trials Page

Official Title: A Randomized Double-Blind Placebo-Controlled Trial Of The Effects Of Docosahexaenoic Acid (DHA) In Slowing The Progression Of Alzheimer’s Disease

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Further study details as provided by National Institute on Aging (NIA)

Primary Outcome Measures:
Changes in rate of cognitive and functional decline measured by ADAS-Cog and CDR-SOB

Preliminary studies have shown a reduced risk of Alzheimer's disease (AD) in people consuming increased amounts of fish in their diets. Many of the health benefits of fish are attributed to the abundance of omega 3 fatty acids. Docosahexaenoic Acid (DHA) is the most abundant omega 3 fatty acid in the brain. Data from several animal models supports the hypothesis that DHA may be an effective treatment for AD by means of anti-amyloid, antioxidant, and neuroprotectant mechanisms.

In this study, 400 individuals with mild to moderate AD will participate at approximately 53 study sites throughout the US for 18 months. Participants will be randomized so that 60% will receive approximately 2 grams of DHA, divided into 4 capsules, 2 capsules taken twice a day, while 40% receive an identical placebo.

Potential participants will go to their study site for a screening visit, where eligibility is determined, and if accepted, for a baseline visit where cognitive status, behavioral status, functional status, and global severity of dementia will be assessed. Vital signs and biomarker labs will also be obtained. Subsequent visits will occur every three months for medication checks and, every 6 months, further assessments, physical exams, and labs.

Some participants will also take part in MRI (magnetic resonance imaging) and/or CSF (cerebrospinal fluid) sub-studies. For the MRI sub-study, scans will be done prior to beginning the study medication, and again after 18 months. Likewise, for the CSF sub-study, a lumbar puncture will be done prior to beginning the study medication, and again after 18 months.

Enrollment is restricted to individuals who consume no more than 200 mg of DHA per day, which is almost 300% of the average daily intake in an American diet. Individuals who take fish oil or omega 3 fatty acid supplements are also not eligible. Each visit will include completion of a very brief food frequency questionnaire to monitor dietary DHA levels.

Risk Evaluation and Education for Alzheimer's Disease

By Bob DeMarco
Alzheimer's Reading Room

REVEAL, the Risk Evaluation and Education for Alzheimer's Disease Study is a multi-center funded research project.

The goal of REVEAL is to provide healthy adults with genetic susceptibility testing and information about their chances to develop Alzheimer's disease.

Please Note: If you know someone that is related to a person suffering from Alzheimer's disease please make them aware of this new and important study.

Newest Estimate of Worldwide Prevalence of Alzheimer’s Disease 26.6 Million

The latest worldwide estimate of Alzheimer’s disease prevalence shows that 26.6 million people were living with the disease in 2006, according to research reported today at the 2nd Alzheimer’s Association International Conference on Prevention of Dementia in Washington, D.C.

The researchers predict that global prevalence of Alzheimer’s will quadruple by 2050 to more than 100 million, at which time 1 in 85 persons worldwide will be living with the disease. More than 40 percent of those cases will be in late stage Alzheimer’s requiring a high level of attention equivalent to nursing home care.

Read more of this study and its findings.

The National Public Health Road Map to Maintaining Cognitive Health (Road Map)

Download the The Healthy Brain Initiative

A National Public Health Road Map to Maintaining Cognitive Health.

CDC and Alzheimer's Association Release the First Ever Brain Health "Road Map"

The Road Map highlights the importance of maintaining and improving cognitive health to the overall health of the nation.

The Road Map is both a call to action and a guide for implementing a coordinated approach to raising the public’s awareness about cognitive health and increasing the nation’s commitment to understanding both the risks for cognitive decline and ways of maintaining brain health.

Myriad Genetics Presents Mathematical Comparison of Disease Modification Trial Designs at Alzheimer's Conference (MYGN)

Current Flurizan™ Phase 3 Study Design May Demonstrate Disease Modification (Alzheimer's)

"We are excited about this persuasive mathematical comparison of clinical trial designs," said Adrian Hobden, PhD, President of Myriad Pharmaceuticals, Inc. "We believe that this mathematical proof, coupled with the Flurizan trial design may strengthen the Company's position with the FDA in favor of a disease modification label for Flurizan."

Myriad Genetics Presents Mathematical Comparison of Disease Modification Trial Designs at Alzheimer's Conference


Salt Lake City, UT, Jun 11, 2007—Myriad Genetics, Inc. (NASDAQ: MYGN) (www.myriad.com) announced today that it presented a mathematical comparison of a "Staggered Start" and a "Randomized Withdrawal" clinical trial design with a "Natural History Staggered Start" clinical trial design at the Alzheimer's Association Prevention Conference held June 9 - 12, 2007, in Washington, D.C. The analysis demonstrates that the "Natural History Staggered Start" trial design currently being used in the Flurizan Phase 3 study can provide the same level of disease modification support as the cross-over trial designs, which are challenged by ethical concerns, dropout bias and complications.

A disease modifying therapy for Alzheimer's disease (AD) is one that has an impact on the underlying pathology of the disease and thus slows the rate of a patient's decline over the course of long-term treatment. In contrast, the currently available AD medicines are believed to treat the symptoms of AD without impacting the underlying disease process or providing long lasting benefit. The development of robust methods to demonstrate disease modification in AD clinical trials has been a controversial issue in the field, and to date, there have been no studies that provide convincing evidence of disease modification in AD. Two clinical trial designs that could provide evidence for disease modification were originally proposed for AD studies over 10 years ago by Paul Leber, then the head of the Division of Neuropharmacological Drug Products of the FDA. These designs have come to be known as the "Randomized Withdrawal" and "Staggered Start" designs and are based on measuring clinical outcomes in a cross-over type study.

In the randomized withdrawal design, patients are withdrawn from therapy after a defined period to determine whether the long-lasting benefit to the patient is maintained, demonstrating disease modification, or if the patient drops back to the level of patients on placebo for the duration of the study. In a staggered start design, one group of patients receives the active study drug for the entire study period, while a second group initially receives placebo and then later is given the active drug. If the second group fails to "catch up" in the level of performance of the first group, this is taken to be evidence for a disease modifying effect of the drug. Unfortunately, these designs are difficult to implement and have rarely been used in clinical trials as they are complicated by very long study durations, leading to high dropout rates that introduce biased results, as well as presenting ethical concerns unacceptable to patients and their families.

A team of biostatisticians and mathematicians at Myriad, led by Suzanne Hendrix, Ph.D., Sasha Gutin, Ph.D., and Scott Horton, has proposed an alternative strategy designated the "Natural History Staggered Start" analysis, that compares the slopes of decline of drug treated patients with those of patients receiving placebo and corrects for the severity of disease at baseline. The mathematical analysis presented at the Alzheimer's Association AD Prevention Conference demonstrates that this trial analysis methodology is mathematically equivalent to the "Staggered Start" and "Randomized Withdrawal" designs and provides the same level of evidence of a disease-modifying drug effect in a clinical trial that is not subject to the above-mentioned complications, bias and ethical challenges of the previous designs.

"We are excited about this persuasive mathematical comparison of clinical trial designs," said Adrian Hobden, PhD, President of Myriad Pharmaceuticals, Inc. "We believe that this mathematical proof, coupled with the Flurizan trial design may strengthen the Company's position with the FDA in favor of a disease modification label for Flurizan."

About Flurizan™
Myriad has two Phase 3 trials of Flurizan ongoing in patients with mild Alzheimer's disease. In each study, participants are taking 800 mg of Flurizan or placebo twice daily, and participants enrolled will have taken the study drug for 18 months. Flurizan is the first in a new class of drug candidates known as Selective Amyloid beta-42 Lowering Agents (SALAs). Flurizan lowered levels of Abeta42 in cellular assays and animal models. Abeta42 is the primary constituent of senile plaque that accumulates in the brain of patients with Alzheimer's disease. It is thought to be the key initiator of Alzheimer's disease, since Abeta42 has the greatest tendency to aggregate, cause neuronal damage and initiate amyloid deposits in the brain. Most genetic mutations that cause early-onset Alzheimer's disease appear to do so by increasing production of Abeta42. Myriad believes that Flurizan is the most advanced drug candidate that modifies the production of Abeta42 to be evaluated in a clinical trial for the treatment of Alzheimer's disease.

About Myriad
Myriad Genetics, Inc. is a biopharmaceutical company focused on the development and marketing of novel healthcare products. The Company develops and markets molecular diagnostic products, and is developing and intends to market therapeutic products. Myriad's news and other information are available on the Company's Web site at www.myriad.com. Flurizan is a trademark of Myriad Genetics, Inc. in the United States and other countries.

This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include whether the Flurizan Phase 3 study design may demonstrate disease modification; the Company's use of the Natural History Staggered Start trial design and trial analysis methodology in its Flurizan Phase 3 clinical trials; the ability of the Natural History Staggered Start trial design and trial analysis methodology to provide the same level of disease modification support as the cross-over trial designs; the ability of the Natural History Staggered Start trial design and trial analysis methodology to demonstrate that this trial analysis methodology is mathematically equivalent to the "Staggered Start" and "Randomized Withdrawal" designs and provides the same level of evidence of a disease modifying drug effect in a clinical trial that is not subject to the complications, bias and ethical challenges of previous designs; the excitement of the Company about this persuasive mathematical comparison of clinical trial designs and the Company's belief that this mathematical proof, coupled with the Flurizan trial design, may strengthen the Company's position with the FDA in favor of a disease modification label for Flurizan; the successful completion of the ongoing Flurizan Phase 3 trials; and whether the Flurizan Phase 3 trials results will demonstrate or support a claim of disease modification. These forward-looking statements are based on management's current expectation and are subject to certain risks and uncertainties that could cause actual results to differ materially from those set forth or implied by forward-looking statements. These include, but are not limited to, uncertainties as to the extent of future government regulation of Myriad Genetics' business; uncertainties as to whether Myriad Genetics and its collaborators will be successful in developing, and obtaining regulatory approval for, and commercial acceptance of, therapeutic compounds; the risk that markets will not exist for therapeutic compounds that Myriad Genetics develops or if such markets exist, that Myriad Genetics will not be able to sell compounds, which it develops, at acceptable prices; and the risk that the Company will not be able to sustain revenue growth for its predictive medicine business and products. These and other risks are discussed under the heading "Risk Factors" contained in Item 1A in our Annual Report on Form 10-K for the year ended June 30, 2006, which has been filed with the Securities and Exchange Commission, as well as any updates to those risk factors filed from time to time in our Quarterly Reports on Form 10-Q or Current Reports on Form 8-K. All information in this press release is as of the date of this release, and Myriad undertakes no duty to update this information unless required by law.

Contact:
William A. Hockett
EVP, Corporate Communications
(801) 584-3600




myriad genetics
"staggered start"
Alzheimer's Association Prevention Conference
disease modification
Flurizan Phase 3