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Alzheimers Disease

Patient Engagement in Alzheimer's and Mild Cognitive Impairment Clinical Trials

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  • 02 Aug

Considering the large number of individuals affected by Alzheimer's disease (AD) or Mild Cognitive Impairment (MCI), you might expect fast enrollment into clinical trials. The reality is quite different. Sponsors of clinical trials face several obstacles: 1) Patients are underdiagnosed. 2) Patients have a limited knowledge of clinical trials and some misconceptions. 3) AD/MCI clinical trials are complex, prohibiting participation.

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Biomarkers for Alzheimer's Disease – Where are we now and Where are we going?

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  • 04 Oct

Last July, the Alzheimer's disease community gathered in Toronto for the Alzheimer's Association International Conference (AAIC) to share the latest advances in AD research and clinical trials.

Dementia is a global health issue as it affects over 45 million people worldwide and is recognized as a public health priority by the World Health Organization (WHO). Alzheimer's disease (AD) is a fatal degenerative brain disease and is the most common cause of dementia, accounting for an estimated 60 to 80% of cases1.

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Elizabeth Thiele

Patient Recruitment and Retention for Healthier Studies

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  • 18 Aug

Finding patients to participate in clinical trials and keeping them engaged for the duration are two of the greatest challenges in the clinical development process. Yet, as our President and CEO John Hubbard sees it, "Every major challenge is also an opportunity to improve the clinical development process." To overcome such hurdles, we as an industry must become more efficient in conducting clinical trials while simultaneously keeping a keen focus on the patient.

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CSF biomarkers & Alzheimer's Disease

CSF Biomarkers and the advancement of Alzheimer's Disease Trials

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  • 03 Aug

The Importance of Early Diagnosis for AD Last month, scientists, clinicians, drug sponsors, and regulators gathered in our nation's capital at the annual Alzheimer's Association International Conference (AAIC) to share recent advances in AD research and clinical drug development.

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Escalating Role of Medical Imaging in AD Clinical Trials

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  • 30 Jan

Alzheimer's disease is one of the most important health challenges facing aging populations worldwide. Disease modifying therapies are desperately needed and many potential treatments are currently being tested in clinical trials. The role and impact of medical imaging in AD trials continues to grow, especially as clinicians and scientists seek to define and treat AD at the earliest stages of disease.

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Brain scan

Biomarkers Help with Early Detection of Alzheimer’s Disease

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  • 18 Dec

I recently returned from the 6th Annual Clinical Trials in Alzheimer's Disease (CTAD) conference in San Diego. At the meeting, I had a chance to catch up on some of the latest scientific advances for the detection and treatment of AD. A recurring theme for improving the diagnosis and prognosis of AD is the increased use of biomarker data. Imaging biomarkers enable earlier detection of the disease state, more accurate patient classification and can provide a better understanding of the mechanisms which contribute to AD.

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Important Alzheimer’s Research on Display at CTAD 2013

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  • 28 Oct
Next month, I will be attending the 6th annual Clinical Trials Conference on Alzheimer's Disease (CTAD) conference along with fellow members of the BioClinica Central Nervous System therapeutic team including Luc Bracoud, Joël Schaerer and Florent Roche. At the meeting, we will be presenting volumetric MRI data from the first prospective, randomized, controlled trial in subjects with pre-dementia AD using entry criteria based upon clinical phenotypic features and CSF biomarker criteria
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Molecular imaging tracers and Alzheimer’s presentation at DIA 2013.

Molecular Imaging Tracers: Alzheimer’s Disease and Beyond

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  • 17 Jul

I recently attended the 49th annual Drug Information Association (DIA) conference in Boston and had the good fortune to attend individual sessions as well as explore the exhibition hall. With an interest in medical imaging and an eye for hot topics, I spotted a session entitled “Molecular Imaging: Utilizing it as an Effective Drug Development Tool.”  This session, featuring three speakers, focused on the uses of molecular imaging agents in both preclinical and clinical settings.

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MRI to Monitor Safety of Therapeutic Compounds to Treat Alzheimers

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  • 01 Jul
Detecting cerebral microhemorrhage and vasogenic edema (VE) has become a major challenge in monitoring the safety of new therapeutic compounds intended to treat Alzheimer's Disease by reducing β-amyloid in the brain. Following the publication of the phase II multiple ascending dose trial of bapineuzumab in mild to moderate Alzheimer's disease by Salloway et al. (Neurology, 73:2061-2070, 2009) and the latest recommendations by the FDA, the following considerations have to be taken into account...
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MRI Sequences used in AD Clinical Trials

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  • 25 May

It’s always an important question to start with: which MRI sequences should I use in my AD clinical trial? During the latest ADNI meeting in April, it was reminded that the following base MRI sequences were used in the ADNI II/GO protocols:

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Information Brief at Alzheimer's Association Gala in Washington, DC

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  • 20 May
Following on the theme of Alzheimer’s disease, there is a great summary paper from last month on the facts and figures (1) of this disease. Much of this was used as the information brief at the Alzheimer’s Association Gala in Washington, DC. Some of the facts are quite surprising, e.g. it is estimated that 5.4 million Americans have AD. Every 69 seconds someone in America develops Alzheimer’s disease. Total payments in 2011 for health care, long term care and hospital services for people age 65 years and older with AD and other dementias are estimated at $183 million.
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Subject Retention in Clinical Trials Discussion at ADNI Meeting

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  • 16 May
Having just come back from the Alzheimer’s Disease Neuroimaging Initiative 2 (ADNI 2) face-to-face meeting, the challenge of subject retention in clinical trials was raised. ADNI 1 has finished its 5 years of funding and ADNI 2 has received the majority of funding (although still $10M short, if anyone wishes to contribute) for another 5 years. As an aside, this is in no small part because of the enthusiasm of the scientists involved which is spearheaded by Dr. Michael Weiner.
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Alzheimer's Disease Neuroimaging Initiative: ADNI Clinical Trials

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  • 14 Apr
Last week was a highpoint for the ADNI group with the presentation of the Nancy and Ronald Reagan award at the national Alzheimer’s Disease Gala in Washington DC, and the face to face meeting of the ADNI researchers and private partners in LA preceding the American Academy of Neurology meeting in Hawaii. I had the privilege of attending the first two with my colleague Dr. Chahin Pachai. He then went on to Hawaii (Note to self – next time get Chahin to write a blog and I’ll go to Hawaii)!
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Lilly's Amyvid Gets FDA Advisory Panel Approval for Alzheimer's

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  • 21 Jan
Following my recent blog post on PET imaging and Alzheimer’s disease, the FDA Advisory Panel recommended the approval of the Lilly compound “Amyvid”. Lilly bought AVID Radiopharmaceuticals last year. This is the first compound of its kind to be given this level of approval...
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PET Neurochemical Classification

The Use of Biomarkers and PET in Early Alzheimer’s Disease Diagnosis

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  • 27 Jul
Alzheimer’s disease (AD) is the most common form of dementia and is incurable, degenerative and irreversible. It affects around 4.5 million people in the United States, a number that is expected to exceed 12 million by 2050. Neuropsychological tests, such as the mini-mental state examination (MMSE), are commonly used to diagnose patients. However, cognitive impairment may be due to another disease, not Alzheimer’s. There remains an unmet need to be able to differentiate between different forms of dementia.
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Bioclinica is organized into three business segments so that we can provide expert service and multifaceted technologies. Our Medical Imaging & Biomarkers segment includes an Imaging Core Lab, a Cardiovascular Safety division, and a Molecular Marker Laboratory. Our eHealth segment comprises eClinical Solutions, Randomization & Trial Supply Management, Safety & Regulatory Solutions, and Financial Lifecycle Solutions. Under the Global Clinical Research segment, we offer a network of research sites, patient recruitment, and a Post-Approval Research division.

Great advice from our Dir. Cardiovascular Imaging on quality imaging acquisitions & assessments in clin trials.
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