Monthly Archives: June 2011

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Cognitive Assessment Battery (CAB) Beta Study
This study is currently recruiting participants.
Verified on May 2011 by CHDI Foundation, Inc.

First Received on February 4, 2011. Last Updated on May 31, 2011 History of Changes
Sponsor: CHDI Foundation, Inc.
Collaborator: Monash University

Information provided by: CHDI Foundation, Inc.
ClinicalTrials.gov Identifier: NCT01290861

Purpose
The overall objective of this study is to identify a 60 minute cognitive battery, for subsequent use in clinical trials, that detects cognitive deficits in early HD and late pre-manifest HD compared to controls, and that has a potential to show drug induced improvements.

Condition
Huntington’s Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cognitive Assessment Battery (CAB)Beta Study

Resource links provided by NLM:

Genetics Home Reference related topics: chorea-acanthocytosis familial paroxysmal nonkinesigenic dyskinesia Huntington disease McLeod neuroacanthocytosis syndrome
MedlinePlus related topics: Huntington’s Disease
U.S. FDA Resources

Further study details as provided by CHDI Foundation, Inc.:

Estimated Enrollment: 270
Study Start Date: February 2011

Groups/Cohorts
pre-manifest HD
early manifest HD
healthy controls

Detailed Description:
Huntington’s disease (HD) is an autosomal dominant genetic disease which typically manifests beginning in adulthood in the form of movement symptoms, cognitive decline, and psychiatric changes. The proposed research is undertaken in collaboration with CHDI Foundation, Inc., a not for profit organization dedicated to finding treatments for HD. CHDI’s goal is to develop or help to develop both symptomatic and disease modifying treatments for HD. To enable future therapeutic trials, CHDI has sponsored several prospective, longitudinal, observational biomarker studies of pre-manifest and early HD with the goal of determining which combination of measures is the most sensitive for detecting changes over the natural progression of pre-manifest and early HD. These and other studies have demonstrated a progressive decline in cognitive function in patients with the huntingtin gene mutation beginning in the pre-manifest period and progressing throughout the course of the disease. These findings support the use of cognitive measures as endpoints in future therapeutic clinical trials. CHDI is committed to the development of a cognitive assessment battery for use in HD therapeutic trials.

There will be paper and pencil and computerized cognitive tests given over a six week period to non-HD control subjects, pre-manifest HD and early manifest HD subjects.

Eligibility

Ages Eligible for Study: 25 Years to 55 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: Yes
Sampling Method: Non-Probability Sample

Study Population
Study participants will be pre-HD, early stage HD and control subjects. The cognitive tests will be given to all participants. (only varied by order of administration) in order to determine what measures will be best at detecting cognitive changes associated with HD.

Criteria
Inclusion Criteria:.

1.For early HD group, subjects eligible are persons who meet the following criteria:

1.Have clinical diagnostic motor features of HD; and
2.Have huntingtin CAG expansion ≥ 36; and
3.Have Stage 1 or Stage 2 HD, defined as UHDRS TFC scores between 7 and 13 inclusive.
2.For the late pre-manifest HD group, subjects eligible are persons who meet the following criteria:

1.Do not have clinical diagnostic motor features of HD; and
2.Have huntingtin CAG expansion ≥ 39; and
3.Have Burden of Pathology scores ≥ 300 .
3.For the healthy control group, subjects eligible are persons who meet the following criteria:

1.Have no known family history of HD; or,
2.Have known family history of HD but have been tested for the huntingtin CAG expansion and are not at genetic risk for HD (CAG 18 or
•Patient appears intoxicated or if an alcohol odour is detected
Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01290861

Locations
United States, California
University of California, San Diego Recruiting
La Jolla, California, United States, 92037
Contact: Jody Goldstein 858-622-5854 jlgoldstein@ucsd.edu
Principal Investigator: Jody Corey-Bloom, MD, PhD
University of California, Los Angeles Recruiting
Los Angeles, California, United States, 90095
Contact: Brian Clemente 310-794-1225 BClemente@mednet.ucla.edu
Principal Investigator: Perlman Susan, MD
University of California, San Francisco Recruiting
San Francisco, California, United States, 94117
Contact: Jonathan Gooblar 415-476-1686 jgooblar@memory.ucsf.edu
Principal Investigator: Michael Geschwind, MD
United States, Florida
University of South Florida Recruiting
Tampa, Florida, United States, 33612
Contact: London Butterfield 813-974-6022 lbutterf@mail.usf.edu
Principal Investigator: Juan Sanchez-Ramos, MD
United States, Illinois
Rush University Recruiting
Chicago, Illinois, United States, 60612
Contact: Jean Jaglin 312-563-2900 ext PRESS 4 jjaglin2@rush.edu
Principal Investigator: Kathleen Shannon, MD
United States, New York
Albany Medical College Recruiting
Albany, New York, United States, 12208
Contact: Mary Eglow 518-262-6651 eglowm@mail.amc.edu
Principal Investigator: Higgins Donald, MD
Columbia University Recruiting
New York, New York, United States, 10032
Contact: Paula Wasserman 212-305-4597 pl2032@columbia.edu
Principal Investigator: Marder Karen, MD
United States, North Carolina
Duke University Recruiting
Durham, North Carolina, United States, 27705
Contact: Peggy Perry-Trice 919-684-0865 peggy.perrytrice@duke.edu
Principal Investigator: Burton Scott, MD
Wake Forest University Baptist Medical Center Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Christine O’Neill 336-716-8611 coneill@wfubmc.edu
Principal Investigator: Frances Walker, MD
United States, Oregon
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239
Contact: April Wilson 503-418-1769 wilsonap@ohsu.edu
Principal Investigator: Penelope Hogarth, MD
Australia
Monash University/Bethlehem Hospital Recruiting
Melbourne, Australia
Contact: Olga Yastrubetskaya 61 3 9816 0636 andrewchurchyard@bigpond.com
Principal Investigator: Andrew Churchyard, MD
Westmead Hospital Recruiting
Sydney, Australia
Contact: David Gunn 61 2 9845 5519 david.gunn@swahs.health.nsw.gov.au
Principal Investigator: Clement Loy, MD
Canada, Ontario
London Health Sciences Center Recruiting
London, Ontario, Canada, N6A 5A5
Contact: Emilija Makaji 519 685-8500 ext 36893 emilija.makaji@lhsc.on.ca
Principal Investigator: Hyson Christopher, MD
Center for Movement Disorders Recruiting
Markham, Ontario, Canada, L6B 1C9
Contact: Alanna Sheinberg 905 472-7082 asheinberg@movementdisorders.ca
Contact: Irita Karmalkar 905 472-7082 ext 229 ikarmalkar@movementdisorders.ca
Principal Investigator: Mark Guttman, MD
United Kingdom
Department of Neuropsychiatry Recruiting
Edgbaston, Birmingham, United Kingdom, B15 2FG
Contact: Shabana Akhtar 44(0)1213012066 Shabana.Akhtar@bsmhft.nhs.uk
Principal Investigator: Hugh Rickards, MD
Plymouth Hospitals NHS Trust Recruiting
Derriford, Plymouth, United Kingdom, PL6 8BX
Contact: Christine Cosby 44 (0)1752 432048 Christine.cosby@phnt.swest.nhs.uk
Contact: Amy Palmer 44 (0) 1752 432048 amy.palmer@phnt.swest.nhs.uk
Principal Investigator: Rupert Noad, MD
University Hospital of Wales Cardiff Recruiting
Cardiff, Wales, United Kingdom
Contact: KA Price +44 7896 762 057 priceka@cf.ac.uk
Principal Investigator: Anne Rosser, MD
Cambridge Center for Brain Repair Recruiting
Cambridge, United Kingdom, CB2 OPY
Contact: Sarah Mason 4401223331160 slm64@cam.ac.uk
Principal Investigator: Barker Roger, MD
University of Manchester Recruiting
Manchester, United Kingdom, M13 9WL
Contact: Ruth Fullam 440 161 701 2541 ruth.fullam@manchester.ac.uk
Principal Investigator: Crauford David, MD

Sponsors and Collaborators
CHDI Foundation, Inc.
Monash University
Investigators
Principal Investigator: Beth Borowsky, Ph.D. CHDI Foundation, Inc.
Principal Investigator: Julie C Stout, Ph.D. Monash University

More Information

Additional Information:
Link to funding agency for the CAB Beta study

No publications provided

Responsible Party: CHDI Foundation, Inc. ( Beth Borowsky, PhD -Director of Translational Medicine )
ClinicalTrials.gov Identifier: NCT01290861 History of Changes
Other Study ID Numbers: CAB Beta
Study First Received: February 4, 2011
Last Updated: May 31, 2011
Health Authority: Australia: Human Research Ethics Committee; United Kingdom: National Health Service; United States: Institutional Review Board

Keywords provided by CHDI Foundation, Inc.:
Huntington’s Disease
Cognitive Battery
Cognitive Testing
Cognition
pre-manifest Huntington’s Disease

Additional relevant MeSH terms:
Huntington Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Dementia
Chorea
Dyskinesias
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on June 28, 2011

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Many Skip Medicare’s Free Preventive Care

Government Urges Patients to Make Use of Free Checkups and Screenings That Are Included in Health Care Reform
By Daniel J. DeNoon
WebMD Health News
 

 

Doctor with senior patient

June 20, 2011 — Only one in six Medicare beneficiaries have so far received any of the preventive care services now free to them due to health care reform.

To save lives — and money — lost to preventable diseases, the Affordable Care Act offers all Medicare beneficiaries a wide range of preventive services. These services are free with no co-pay involved.

“Our job is to make sure every single Medicare beneficiary knows about and takes advantage of these benefits. So we are announcing a multimedia approach to get the word out,” Department of Health and Human Services Secretary Kathleen Sebelius said at a news teleconference.

The new “Share the News, Share the Health” campaign will feature TV, radio, and online ads as well as a “Dear Doctor” letter to all health care professionals who see Medicare patients.

Beginning this year, all Medicare beneficiaries are offered a free annual wellness visit. There’s a wide range of other free services. Many of the most important services are listed on WebMD’s printable checklist.

Services now free to most Medicare beneficiaries include:

  • A one-time “welcome to Medicare” preventive visit
  • A yearly wellness visit
  • Screening for heart disease
  • Breast cancer screening (mammograms)
  • Cervical and vaginal cancer screening
  • Prostate cancer screening
  • Flu, pneumococcal, and hepatitis B vaccines
  • Osteoporosis screening
  • Smoking cessation counseling
  • HIV screening
  • Diabetes screening
  • Medical nutrition counseling for people with diabetes or kidney disease

So far, more than 5 million Americans on Medicare have taken advantage of at least one of these free services. But that’s only one in six Medicare beneficiaries.

“Having a person in Medicare go without a potentially lifesaving test because they do not know it is available at no cost is just as bad as them skipping it because they cannot afford it,” Sebelius said.

A full description of the preventive care benefits can be found at the medicare.gov/share-the-health web site.

SOURCES:

Department of Health and Human Services news conference, June 20, 2011.

Kathleen Sebelius, secretary, Department of Health and Human Services.

News release, Department of Health and Human Services.

Medicare.gov web site.

© 2011 WebMD, LLC. All rights reserved.

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Headline News - FDA Approves New Drug Life-Extending Drug for Metastatic Melanoma

Questions About
Melanoma?

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Skin Cancer Explained

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In its advanced state, it can cause serious illness and even death. Fortunately, melanoma rarely strikes without warning. Learn how to identify melanoma, how it spreads and what treatments are available.
 

What Is Melanoma?

Melanoma is the most serious form of skin cancer. If it is recognized and treated early, it is almost always curable, but if it is not, the cancer can advance and spread to other parts of the body, where it becomes hard to treat and can be fatal. While it is not the most common of the skin cancers, it causes the most deaths. The American Cancer Society estimates that at present, about 120,000 new cases of melanoma in the US are diagnosed in a year. In 2010, about 68,130 of these were invasive melanomas, with about 38,870 in males and 29, 260 in women.

Melanoma originates in melanocytes, the cells which produce the pigment melanin that colors our skin, hair, and eyes. The majority of melanomas are black or brown, but often they can also be skin-colored, pink, red, purple, blue or white.

Read more…

 

Melanoma Drug Approved for Stage III Patients
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The US Food and Drug Administration (FDA) has approved a new drug, peginterferon alfa-2b (also known as Sylatron), to treat stage III melanoma patients – those found to have metastatic disease that has reached the lymph nodes. The drug, injected subcutaneously, is the first adjuvant, or additional, therapy for stage III patients approved since high-dose interferon alfa-2b (IFN alfa-2b) in 1995. This approval follows on the heels of a recent trial in which melanoma patients taking Sylatron remained relapse-free for an average of nine months longer than patients not taking the drug. There was no difference in overall survival. Melanoma, the deadliest form of skin cancer, kills an estimated 8,700 people in the US annually.

 

Learn More about Yervoy (Ipilimumab)
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Medical-Research

On March 25, 2011, the Food and Drug Administration (FDA) approved a breakthrough melanoma treatment called Yervoy (ipilimumab). Not only is this the first melanoma drug to receive FDA approval in 13 years, but it’s the first therapy proven to extend overall survival for advanced stage melanoma patients. According to the best estimates, Yervoy may offer many patients a 2-year survival advantage, with a smaller percentage of patients being virtually cured.“This is a very exciting time in the field of melanoma,” said Perry Robins, MD, President, The Skin Cancer Foundation. “As melanoma incidence continues to rise, we are hopeful that this new therapy will extend life and improve the quality of life for patients with metastatic melanoma.”

Read more…

 

Melanoma Risk Higher for Wealthy Women
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In young white females, higher socioeconomic status is linked with increased melanoma risk, according to new research published online today in Archives of Dermatology. Melanoma is the deadliest form of skin cancer, killing an estimated 8,700 people in the US in 2010.

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Nature or Nurture – Which Is Responsible for Melanoma? PDF Print E-mail
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Marianne Berwick , PHD, MPHCutaneous melanoma is the most lethal form of skin cancer, killing about one person per hour in the US. Its incidence has risen dramatically worldwide during the past five decades, with concomitant increases in mortality. However, mortality has decreased recently in some developed countries, including Australia, Canada, and the US, presumably owing partly to earlier detection and treatment of the disease, when it is usually curable.

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Melanoma and Breast Cancer: A New Warning PDF Print E-mail
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If you’ve had breast cancer or melanoma (the deadliest form of skin cancer), be aware that having either one raises the odds of developing the other, according to a new study published in the Irish Journal of Medical Science.

While earlier studies have noted an association between the two malignancies, this is the first time researchers have explicitly advised doctors to monitor breast cancer patients for signs of melanoma, and vice versa. They also recommend that melanoma patients with a family history of breast cancer have regular mammographies or breast MRIs (magnetic resonance imaging).

Read more…
Stay Safe on Your Getaway: A Study Links Tropical Vacations and Melanoma PDF Print E-mail
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lotionumbrellaIf you’re headed for the sun-baked shores, be warned: A new study shows a link between warm-weather vacations and greater numbers of moles in white women. Since large numbers of moles are a risk factor for melanoma, the deadliest form of skin cancer, the implications are frightening. According to a study in the Journal of Investigative Dermatology, white English women who vacation in hot countries have 74 percent more moles than those who have never vacationed in tropical climates.

Read more…
Treatment Breakthrough for Advanced Melanoma
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IN THE HEADLINES…

news_200wA new treatment for melanoma, the deadliest form of skin cancer, is showing promising results in patients with a particular gene mutation.In a multi-center study just published in the New England Journal of Medicine, patients with terminal metastatic melanoma (advanced melanoma that has spread to distant organs) were treated orally with a drug called PLX4032, which targets a gene mutation associated with an increased risk of melanoma.

e to accept thhat wre arre sick. Wear lots of sunnscxreen outside.

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Parkinson’s Disease May Raise Risk of Melanoma

Study Suggests Link Between Parkinson’s and Development of Melanoma
By Denise Mann
WebMD Health News
 

 

Senior man with serious expression

June 6, 2011 — People with Parkinson’s disease are at increased risk for developing melanoma, a potentially fatal form of skin cancer, a study shows.

The new findings appear in Neurology.

Close to 1 million people in the U.S. have Parkinson’s disease, a progressive neurological disease marked by tremors and difficulty with movement and walking.

The researchers analyzed 12 studies of people with both Parkinson’s disease and melanoma. These studies were conducted from 1965 and 2010, and most had fewer than 10 people with both conditions.

When compared to those without Parkinson’s disease, men with Parkinson’s were twice as likely to develop melanoma. Women with Parkinson’s disease were 1.5 times as likely to be diagnosed with this form of skin cancer. Parkinson’s disease was not associated with an increased risk of other types of skin cancer.

Exactly how the two conditions are linked is not fully understood. Initially, there was some suspicion that a Parkinson’s medication called levodopa may be responsible for this increased risk, but this has not been substantiated. There may be some genetic of environmental risk factor that serves as the common denominator between the two conditions.

“Further research is needed to examine the nature and mechanisms of this relationship in order to advance our understanding about the [causes] of both diseases,” conclude researchers who were led by Honglei Chen, MD, PhD, with the National Institute of Environmental Health Sciences in Research Triangle Park, N.C.

 

Get Annual Skin Exam

This increased risk needs to be placed in its proper perspective, says Roy Alcalay, MD, an assistant professor of neurology at Columbia University Medical Center in New York City and an advisor for the Parkinson’s Disease Foundation.

“Melanoma is an extremely rare cancer, and Parkinson’s disease doubles the risk of what is still a very rare cancer,” he says. “Get your skin checked by a dermatologist each year.”

This advice is important for everyone — not just people with Parkinson’s disease. Other cancer screening tests are also important for people with Parkinson’s disease.

Andrew Feigin, MD, an associate investigator at the Feinstein Institute for Medical Research in Manhasset, N.Y, says the new report stresses the importance of regular skin checks. He conducts studies of Parkinson’s disease, and says that annual dematologic screening exams are often part of the protocol.

“This study doesn’t suggest people with Parkinson’s disease need screening tests more often, but people with Parkinson’s disease should be more careful about sticking to the recommended screening schedule,” he says.

“The message for anyone, especially for those who may have an increased risk for melanoma, is to go and get skin exams,” says Michelle Greene, MD, a dermatologist at Lenox Hill Hospital in New York City

“Know the signs of melanoma,” she says. Suspicious moles may be asymmetrical, have ragged, notched or blurred borders, and changes in color distribution, size, or shape.