Thursday, October 31, 2013

FDA: Approval of Alzheimer's Neuroimaging Diagnostic Drug, Vizamyl (flutemetamol F 18 injection)

From the FDA on the 25th of October, quoting the press release:

FDA approves second brain imaging drug to help evaluate patients for Alzheimer’s disease, dementia

The U.S. Food and Drug Administration today approved Vizamyl (flutemetamol F 18 injection), a radioactive diagnostic drug for use with positron emission tomography (PET) imaging of the brain in adults being evaluated for Alzheimer's disease (AD) and dementia.

Dementia is associated with diminishing brain functions such as memory, judgment, language and complex motor skills. The dementia caused by AD is associated with the accumulation in the brain of an abnormal protein called beta amyloid and damage or death of brain cells. However, beta amyloid can also be found in the brain of patients with other dementias and in elderly people without neurologic disease.

Vizamyl works by attaching to beta amyloid and producing a PET image of the brain that is used to evaluate the presence of beta amyloid. A negative Vizamyl scan means that there is little or no beta amyloid accumulation in the brain and the cause of the dementia is probably not due to AD. A positive scan means that there is probably a moderate or greater amount of amyloid in the brain, but it does not establish a diagnosis of AD or other dementia. Vizamyl does not replace other diagnostic tests used in the evaluation of AD and dementia.

“Many Americans are evaluated every year to determine the cause of diminishing neurologic functions, such as memory and judgment, that raise the possibility of Alzheimer’s disease,” said Shaw Chen, M.D., deputy director of the Office of Drug Evaluation IV in the FDA’s Center for Drug Evaluation and Research. “Imaging drugs like Vizamyl provide physicians with important tools to help evaluate patients for AD and dementia.”

Vizamyl is the second diagnostic drug available for visualizing beta amyloid on a PET scan of the brain. In 2012, FDA approved Amyvid (Florbetapir F 18 injection) to help evaluate adults for AD and other causes of cognitive decline.

Vizamyl’s effectiveness was established in two clinical studies comprised of 384 participants with a range of cognitive function. All participants were injected with Vizamyl and were scanned. The images were interpreted by five independent readers masked to all clinical information. A portion of scan results were also confirmed by autopsy.

The study results demonstrate that Vizamyl correctly detects beta amyloid in the brain. The results also confirm that the scans are reproducible and trained readers can accurately interpret the scans. Vizamyl’s safety was established in a total of 761 participants.

Vizamyl is not indicated to predict the development of AD or to check how patients respond to treatment for AD. Vizamyl PET images should be interpreted only by health care professionals who successfully complete training in an image interpretation program. The Vizamyl drug labeling includes information about image interpretation.

Safety risks associated with Vizamyl include hypersensitivity reactions and the risks associated with image misinterpretation and radiation exposure. Common side effects associated with Vizamyl include flushing, headache, increased blood pressure, nausea and dizziness.

Press Release

Sunday, October 27, 2013

Alzheimer's Disease: New Risk Genes Discovered

From Cardiff University News Centre:

New Alzheimer’s risk genes discovered in record study
27 October 2013

"In the largest ever study of its kind, an international collaboration of scientists, jointly led by Cardiff, has uncovered 11 new susceptibility genes linked with Alzheimer’s disease.

"This major breakthrough will significantly advance scientists’ knowledge of Alzheimer’s. It throws open new research avenues and enables a better understanding of the disease’s disordered functional processes."

Read the full press release here.

Tuesday, October 15, 2013

MOOCs: HarvardX "Fundamentals of Clinical Trials"

The HarvardX edX course "Fundamentals of Clinical Trials" started yesterday. Here is some information about the course [click here].

The content for Week One is quite good and presented well by the course faculty.

From the course information page:

[snip]

"This course will provide an introduction to the scientific, statistical, and ethical aspects of clinical trials research. Topics include the design, implementation, and analysis of trials, including first-in-human studies (dose-finding, safety, proof of concept, and Phase I), Phase II, Phase III, and Phase IV studies. All aspects of the development of a study protocol will be addressed, including criteria for the selection of participants, treatments, and endpoints, randomization procedures, sample size determination, data analysis, and study interpretation. The ethical issues that arise at each phase of therapy development will be explored.

"This course contains 12 modules. The modules will be released Monday of each week, with the exception of some holiday weeks. Most students should plan to spend 4 – 6 hours on each module. Students will have until February 14, 2014 to earn a HarvardX certificate."

[snip]

Friday, October 11, 2013

Lewy Body Dementia

Last week, The Dana Foundation offered online this general overview to Lewy Body Dementia:

Lewy Body Dementia: The Under-Recognized but Common Foe
By Meera Balasubramaniam and James E. Galvin
October 02, 2013

Read the article

Tuesday, October 01, 2013

Upcoming Event (Alzheimer's Disease): 7th Canadian Conference on Dementia (This Week, Vancouver, BC)

The conference website homepage is canadianconferenceondementia.com