[Sign Up Now] to Receive Our FREE Daily SCVTV-SCVNews Digest by E-Mail

SCVNews.com | FDA Facilitates Research on Earlier Stages of Alzheimer’s Disease | 11-17-2016
Inside
Weather
Santa Clarita CA
Sunny
Sunny
79°F
 
Calendar
Today in
S.C.V. History
April 26
1906 - Bobby Batugo, World Champion Mixologist in the 1970s, born in The Philippines [story]


To advance urgently needed research in Alzheimer’s disease, the Food and Drug Administration, or FDA, is engaging with researchers, drug companies, and the public as they design new clinical studies for promising drugs, especially in light of it being National Alzheimer’s Disease Awareness Month.

Alzheimer’s disease is a nightmare haunting many Americans.

More than 5 million Americans have been diagnosed with the disease, which is the sixth leading cause of death in the United States and the most common cause of dementia among people 60 or older. Alzheimer’s is an irreversible, progressive brain disease that slowly destroys memory and thinking skills. It eventually robs sufferers of the ability to perform even the simplest tasks of daily life.

Despite years of intensive efforts by scientists to develop new safe and effective treatments for Alzheimer’s, options remain limited. In the last 20 years, FDA has approved five drugs for the disease—the most recent one in 2003. Although the drugs can provide some benefit, more needs to be done.

A recent development could bring better results: three years ago, FDA scientists released a draft guidance that may help companies conduct clinical trials focused on what could be a more treatable stage of the disease, before the onset of noticeable dementia.

Research has shown that there is a lag of many years between the beginning of changes in a patient’s brain and the onset of Alzheimer’s symptoms. Yet in the past, clinical trials examined Alzheimer’s patients when their symptoms had become clearly apparent, long after the changes in their brains had started. Some researchers have theorized that the greatest benefits will be available if a treatment can be developed for very early in the disease course, when people have the very first symptoms of Alzheimer’s—or even earlier.

For that reason, the development of drugs for the treatment of Alzheimer’s disease has increasingly focused on the stages before the onset of overt dementia. A 2013 FDA draft guidance responded to this development by discussing the design of clinical trials for drugs for Alzheimer’s patients who are still in the very early stages of the disease, when only subtle symptoms are present.

“There may be a window of opportunity to affect the disease before people experience symptoms,” says Eric Bastings, M.D., a neurologist and the deputy director of FDA’s Division of Neurology Products.

FDA’s draft guidance may help researchers design clinical trials for early stage Alzheimer’s therapies. The agency hopes that the guidance will serve as a focus for continued discussions among FDA, sponsors of new drugs, the academic community, and the public.

“Earlier and more precise identification of patients with early changes in the brain who will go on to develop Alzheimer’s is important for the success of these clinical studies,” says Billy Dunn, M.D., a neurologist and the director of FDA’s Division of Neurology Products. “We hope that earlier interventions, before further extensive damage to the brain sets in, will be more successful. We’re very excited about the potential for this research to result in safe and effective treatments for early Alzheimer’s disease.”

FDA’s draft guidance aims to encourage research and discusses FDA’s thinking about conducting new clinical trials at the very early stages of Alzheimer’s disease—in patients with no obvious symptoms, or even no symptoms at all.

One example of how clinical trials are changing is the Anti-Amyloid Treatment in Asymptomatic Alzheimer’s study, a landmark public-private partnership funded in part by the National Institute on Aging. Participants are people ages 65 to 85 who have normal thinking and memory function but might be at risk for developing Alzheimer’s, based on an advanced brain scan. The three-year study is testing whether a new investigational treatment can slow the memory loss caused by Alzheimer’s.

One of the biggest challenges is correctly identifying patients at risk for developing Alzheimer’s. In recent years, researchers have identified biomarkers (measurements, often based on a laboratory test, of a condition or disease) that may indicate a higher risk for developing Alzheimer’s. Some of them are gene mutations.

“In a small proportion of patients, having someone in the family with Alzheimer’s dramatically raises the risk that they, too, will have the disease,” Dunn says.

For most people, however, the risk of Alzheimer’s is not quite as readily identified.

“If we can use biomarkers to better choose who should be in which clinical trials, these biomarkers hopefully will help increase the likelihood that we’ll be able to show the drug effect in clinical trials,” Bastings says.

Prompt detection of the disease may lead to the development of early treatments that could help patients retain their brain function for a long time, even if their underlying Alzheimer’s may not be reversed.

“We’re very excited about increasing our ability to find beneficial treatments for so many people with this devastating disease,” Dunn says.

This article appears on the FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.

Comment On This Story
COMMENT POLICY: We welcome comments from individuals and businesses. All comments are moderated. Comments are subject to rejection if they are vulgar, combative, or in poor taste.
REAL NAMES ONLY: All posters must use their real individual or business name. This applies equally to Twitter account holders who use a nickname.

0 Comments

You can be the first one to leave a comment.

Leave a Comment


SCV NewsBreak
Loading...
Related Content
LOCAL NEWS HEADLINES
Wednesday, Apr 26, 2017
SCV Sheriffs Need Public’s Help in Identifying Two Wanted for Questioning
Santa Clarita Valley Sheriff’s Station needs the public's help in identifying individuals wanted for questioning about a theft that occurred at a Magic Mountain Parkway business.
Tuesday, Apr 25, 2017
Press Conf.: Officials Discuss Spike in Drug Overdoses (Video)
In a press conference held at the Henry Mayo Center on Tuesday, speakers including Henry Mayo Emergency Room Dr. Tracy Lawrence and Cary Quashen, executive director of Behavioral Health and Henry Mayo and director of Action Family Counseling, discuss the recent spike in drug overdoses across the Santa Clarita Valley.
Tuesday, Apr 25, 2017
LASD Looking to Improve Motorcycle Safety
Careless motorists as well as riders get special scrutiny as the Los Angeles County Sheriff’s Department aims to improve motorcycle safety.
Keep Up With Our Facebook

Latest Additions to SCVNews.com
Santa Clarita Valley Sheriff’s Station needs the public's help in identifying individuals wanted for questioning about a theft that occurred at a Magic Mountain Parkway business.
SCV Sheriffs Need Public’s Help in Identifying Two Wanted for Questioning
1906 - Bobby Batugo, World Champion Mixologist in the 1970s, born in The Philippines [story]
In a press conference held at the Henry Mayo Center on Tuesday, speakers including Henry Mayo Emergency Room Dr. Tracy Lawrence and Cary Quashen, executive director of Behavioral Health and Henry Mayo and director of Action Family Counseling, discuss the recent spike in drug overdoses across the Santa Clarita Valley.
Press Conf.: Officials Discuss Spike in Drug Overdoses (Video)
California State University, Northridge will confer honorary doctorates on financial journalist William C. Griffeth and substance-abuse educator Michael Watanabe, president and CEO of Asian American Drug Abuse Program (AADAP).
CSUN Giving Honorary Doctorates to Substance-Abuse Educator, Business News Anchor
Careless motorists as well as riders get special scrutiny as the Los Angeles County Sheriff’s Department aims to improve motorcycle safety.
LASD Looking to Improve Motorcycle Safety
The FDA is warning consumers to beware of products claiming to cure cancer on websites or social media platforms, such as Facebook and Instagram.
FDA Warns Consumers to Beware of Fake Cancer ‘Cures’
The College of the Canyons women’s volleyball program invites boys and girls ages 9-14 to participate in the 2017 COC Volleyball Camp, with two sessions running in July.
COC Athletics to Host 2017 Volleyball Summer Camp
America’s Job Center of California invites residents to connect with new employers, find a new career path or get back into the workforce by attending the Hiring Fest on Friday, April 28, 2017, from 9:00 to 11:00 a.m. at the College of the Canyons University Center, located at 26455 Rockwell Canyon Road.
April 28: Get Hired at the AJCC Hiring Fest
With warmer weather on the way, motorcycle riders will be gearing up and taking to California’s roadways.
CHP, OTS Promoting Motorcycle Safety Throughout May
California Attorney General Xavier Becerra today called out the U.S. Department of Education for abdicating its responsibility to millions of student loan borrowers and their families across the country.
A.G. Becerra Discusses Student Loan Serving Reforms
Senator Scott Wilk, R-Antelope Valley, Monday urged Governor Jerry Brown to reconsider his support of legislation hiking the gas tax and veto Senate Bill 1.
Wilk Urging Governor to Veto Transportation Legislation
The College of the Canyons men’s basketball program invites boys and girls ages 6 to 14 to participate in the 2017 Howard Fisher Cougar Basketball Camp, with two sessions running this summer.
COC Athletic Department to Host 2017 Cougar Basketball Summer Camp
Bridge to Home, SCV homeless service provider, gave a Humanitarian Award to Yaniv Rokah, Director of the internationally acclaimed documentary movie "Queen Mimi" at the Cowboy Breakfast Fundraiser in Newhall on Saturday.
Bridge to Home Gives Humanitarian Award to Film Director
Canyon Country Crime Information and Public Safety Report for the Week of April 10-16, 2017
Crime Blotter: Grand Theft Auto, Aggravated Assault in Canyon Country
1891 - President Benjamin Harrison stops at Saugus Depot, dines at Tolfree's Saugus Eating House [story]
Tonight on SCV NewsBreak, we look back at the 2017 Cowboy Festival. Plus, the first Measure E bonds have been sold. Watch these stories and more on tonight's edition of SCV NewsBreak.
SCV NewsBreak for Monday, April 24, 2017
As part of National Volunteer Week, which runs from April 23 to 29, 2017, the city of Santa Clarita thanks the thousands of volunteers who dedicate their time and energy to the community.
City of Santa Clarita Thanks Volunteers during National Volunteer Week
Join HandsOn Santa Clarita for a night of poker, prizes, a silent auction and great food all while supporting this organization on Friday, May 5 at The Paseo Club.
May 5: Cinco de Mayo Charity Poker Tournament for HandsOn Santa Clarita
Last month (March 2017), Welcome to My Life won an NYICFF (New York Children's Film Festival) Audience Award for children (between 12 and 17 years old).
CalArts Animator Wins NYICFF Audience Award
Laura Zucker announced her plans to leave her position as Executive Director of the Los Angeles County Arts Commission on July 31, 2017.
LA County Arts Commission Exec. Director to Leave Position
The first bonds from Measure E, the Santa Clarita Community College District $230 million general obligation bonds approved by voters in June 2016, were sold on April 12, yielding $50 million to assist in funding a new parking structure at the college’s Valencia campus and two new buildings at its Canyon Country campus.
First Measure E Bonds Sold, Yield $50 Million
Upcoming arts and culture events in the Santa Clarita Valley.
SCV Arts Upcoming Events
Detectives from the Los Angeles County Sheriff’s Department’s Missing Persons Detail are working together with South Pasadena Police Department in seeking the public’s assistance to locate a missing critical child, Andressian, Aramazd Jr.
LASD, SCV Search and Rescue Looking for Missing Boy
As part of National Bike Month, the city of Santa Clarita will host a week of bicycle-focused events and activities leading up to and after the world-class cycling race, Amgen Tour of California, presented by AEG.
City Hosting Free Bike Week Events Leading to Amgen Tour
Agenda for the City Council Committee Development Committee Meeting on April 25 at 4:00 p.m. in the City Hall, Mural Room.
April 25: City Council Development Committee Meeting
The Rotary Club of Santa Clarita and The Newhall Rotary Foundation graciously donated $2,700 to assist with the cost of re-flooring the Val Verde Samuel Dixon Family Health Center.
Rotary Club, Newhall Rotary Foundation Join Efforts to Remodel Val Verde Health Center
Sam Hilliard delivered a game-tying double in the ninth inning, but for the second straight day, the Lake Elsinore Storm won in walk-off fashion, 7-6, in 10 innings on Sunday afternoon at The Diamond.
Jethawks Force Extra Innings, Fall in the 10th
Valencia Crime Information and Public Safety Report for the Week of April 10-16, 2017
Crime Blotter: Grand Theft, Burglary in Valencia
Saugus Crime Information and Public Safety Report for the Week of April 10-16, 2017
Crime Blotter: Assault with a Deadly Weapon, Grand Theft Auto in Saugus
Castaic/ Val Verde Crime Information and Public Safety Report for the Week of April 10-16, 2017
Crime Blotter: Domestic Dispute, Grand Theft Auto in Castaic, Val Verde
1962 - SCV residents vote to connect to State Water Project, creating CLWA [story]
1986 - COC board votes to allow Argentine cliff swallows to nest forever on sides of buildings [story]
1974 - Gov. Ronald Reagan speaks at dedication of COC's first permanent building, the William G. Bonelli Instructional Resource Center [story]
Tonight on SCV NewsBreak, a social media post by a Valencia High School student sparked alarm. Plus, we round-up some great events happening in Santa Clarita this weekend. Watch these stories and more on tonight's edition of SCV NewsBreak.
SCV NewsBreak for Friday, April 21, 2017
The Santa Clarita Public Library has recently named Matthew Hortt as City Librarian. Matthew Hortt will be working with the city of Santa Clarita overseeing programming and operations for the Santa Clarita Public Library’s three branches in Canyon Country, Newhall and Valencia.
Santa Clarita Public Library Welcomes New City Librarian
In an off-market transaction, Colliers International has negotiated the $69.5 million sale of Gateway Village Shopping Center in Santa Clarita.
Valencia L.A. Fitness Shopping Center Sells for $69.5 Mil.