Flutemetamol for Alzheimer's, Results of Phase 3 Studies

The ability to detect or exclude significant amyloid deposits in the brain, along with other diagnostic tests, may help physicians make a more accurate assessment of patients with suspected Alzheimer’s disease and other cognitive disorders.

Alzheimer's Reading Room

GE Healthcare (GE) today announced the preliminary results of two Phase 3 studies of its investigational PET amyloid imaging agent, [18F]flutemetamol, where both studies met their primary endpoints.

One study, in terminally ill patients who agreed to undergo brain autopsy, showed strong concordance between flutemetamol PET images and Alzheimer’s disease-associated beta amyloid brain pathology.

The other study, in young healthy volunteers under age 40, had results concordant with the known lack of brain amyloid in this population.

Full results of these studies will be presented in the coming months. [18F]Flutemetamol is a GE Healthcare PET imaging agent in development for the detection of beta amyloid.

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“The ability to detect or exclude significant amyloid deposits in the brain, along with other diagnostic tests, may help physicians make a more accurate assessment of patients with suspected Alzheimer’s disease and other cognitive disorders. The results from these studies are quite encouraging in demonstrating the potential of flutemetamol in that regard,” said Carl Sadowsky, MD, Clinical Professor of Neurology at Nova Southeastern University Ft. Lauderdale, FL. “We need an accurate diagnosis and better treatment, as accurate diagnosis has the potential to enable better patient management, and may also save cost.”

The accumulation of beta amyloid in the brain is believed to play a role leading up to the degeneration of neurons in Alzheimer’s disease (AD) and is one of several pathological characteristics implicated in the development of AD. Currently, AD is confirmed by histopathological identification of core features, including beta amyloid plaques, in post-mortem brain samples.[i] Targeted amyloid imaging agents are being studied to determine their ability to help physicians detect amyloid deposition in living humans.

“Flutemetamol may well prove to be a clinically valuable component of a broader diagnostic workup that neurologists use when assessing patients with cognitive impairments, who may have AD,” said Jonathan Allis, MI PET Segment Leader, GE Healthcare Medical Diagnostics. “These studies support our application for regulatory approval of [18F]flutemetamol, and we intend to file later this year.”

[18F]Flutemetamol is one component of a broad portfolio of diagnostic solutions that GE Healthcare is currently developing in the Alzheimer’s field. GE Healthcare is taking a comprehensive approach to understanding AD through its ongoing research to uncover the causes, risks and physical effects of the disease. For example, the company is partnering with pharma to identify a biosignature, or a biological indicator, which may help physicians diagnose Alzheimer’s disease prior to the onset of clinical symptoms.

GE Healthcare offers a broad portfolio of imaging resources, which support accurate visualization of the signs of neurodegenerative diseases via state-of-the-art scanners, including MRI, PET and CT which deliver clear visualization of the brain; an expanding portfolio of imaging agents are being developed to enhance visual evidence of disease and innovative software applications which can aid physicians in image interpretation and determination of disease management. More specifically, our portfolio today includes cyclotrons and chemistry systems to manufacture PET imaging agents; PET and MR scanners to scan patients; and image analysis software to interpret the results.


GE Healthcare has also been a key contributor to the Alzheimer’s Disease Neuroimaging Initiative (ADNI) since its inception. GE Healthcare also plays a key role in PredictAD, an EU-funded research project to develop solutions to enable earlier diagnosis of AD, and Coalition Against Major Diseases (CAMD).

Additionally, the combination of our different business offerings positions us well to offer an integrated global diagnostics solution for the next generation of therapies. To that end, we are working with potential partners in the pharmaceutical industry to understand their strategic needs. and design solutions accordingly, which may support market entry via conduct of pivotal trials, provision of complex technologies, and (potentially) expedited time to market.

ABOUT GE

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About GE Healthcare

GE Healthcare provides transformational medical technologies and services that are shaping a new age of patient care. Our broad expertise in medical imaging and information technologies, medical diagnostics, patient monitoring systems, drug discovery, biopharmaceutical manufacturing technologies, performance improvement and performance solutions services help our customers to deliver better care to more people around the world at a lower cost. In addition, we partner with healthcare leaders, striving to leverage the global policy change necessary to implement a successful shift to sustainable healthcare systems.

For more information about GE Healthcare, visit our website at www.gehealthcare.com.

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Original content Bob DeMarco, the Alzheimer's Reading Room

Researchers clear up Alzheimer's plaques in mice

I think we tend to ignore research when we see the word mice. But, this is where medical research often starts. I find this research interesting and promising. If you would like to read more follow the link in the clip.

Blocking a common immune system response cleared up plaques associated with Alzheimer’s Disease and enabled treated mice to recover some lost memory, Yale University researchers report Friday in the journal Nature Medicine.

clipped from www.physorg.com Researchers hope the new approach may one day overcome one of the biggest obstacles to development of new dementia medications – the difficulty in finding drugs that can safely cross the blood-brain barrier. The results of the research surprised the scientists working in the lab of Richard Flavell, senior author of the paper, chairman of the Department of Immunobiology at Yale and investigator with the Howard Hughes Medical Institute. Flavell’s team originally thought that blocking the immune system molecule TGF-â(or transforming growth factor), might actually increase the buildup of amyloid plaques associated with Alzheimer’s Disease the team found that as much as 90 percent of the plaques were eliminated from the brains of mice genetically engineered to block TGF-â in the peripheral immune cells. It was like a vacuum cleaner had removed the plaques," Flavell said.

Clinical Trial: Effect of LY450139 on the Long Term Progression of Alzheimer's Disease

This study will use several different tests to measure the effect of LY450139 on both A-Beta amyloid and amyloid plaques for some patients. The build up of amyloid plaques will be measured by a new brain scan that can take a picture of amyloid plaques in the brain.

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Purpose

Alzheimer's disease (AD) is a fatal degenerative disease of the brain for which there is no cure. AD causes brain cells to die. AD is thought to be caused by an excess of A-Beta amyloid, a sticky protein in the brain that forms amyloid plaques. At autopsy, AD patients are required to have these amyloid plaques in the brain in order to have a definitive diagnosis of AD. Inhibiting the enzyme gamma-secretase inhibits the production of A-Beta amyloid as measured in blood and spinal fluid in humans tested thus far and in blood, spinal fluid and brain in animals tested thus far. This study will use several different tests to measure the effect of LY450139 on both A-Beta amyloid and amyloid plaques for some patients. The build up of amyloid plaques will be measured by a new brain scan that can take a picture of amyloid plaques in the brain. Other tests will attempt to measure the overall function of the brain and brain size in some patients. In this trial, patients who initially receive placebo (inactive sugar pill) will at a certain point in the study be switched over to active drug, LY450139. In other words, all patients will eventually receive active drug. Each patient's participation will last approximately two years. Patients taking approved AD medications may participate in this study and continue taking these medications during the study. All patients who complete this study will have the option to continue receiving LY450139 by participating in an open label study.

Eligibility
Ages Eligible for Study: 55 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

* Meets criteria for mild to moderate AD with Mini-Mental State Examination score of 16 through 26 at visit 1
* Modified Hachinski Ischemia Scale score of less than or equal to 4
* Geriatric Depression Scale score of less than or equal to 6
* A magnetic resonance imaging (MRI) or computerized tomography (CT)scan in the last 2 years with no findings inconsistent with a diagnosis of Alzheimer's disease
* If female must be without menstruation for at least 12 consecutive months or have had both ovaries removed.

Exclusion Criteria:

* Is not capable of swallowing whole oral medication
* Has serious or unstable illnesses
* Does not have a reliable caregiver
* Chronic alcohol or drug abuse within the past 5 years
* Has ever had active vaccination for AD


Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00594568

Contacts
Contact: There may be multiple sites in this clinical trial 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559


Locations and More Information

The 36-Hour Day: A Family Guide to Caring for People with Alzheimer Disease and Memory Loss in Later Life