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Friday, May 29, 2015

Imaging Dementia — Evidence for Amyloid


Dear Readers,

In a truly exciting development, the Centers for Medicare & Medicaid Services (CMS) has approved a four-year, $100 million study called Imaging Dementia—Evidence for Amyloid Scanning 'IDEAS'. The goal of the study is to better understand whether getting an amyloid PET scan can affect the diagnosis, management, and care of individuals whose cognitive symptoms cannot be diagnosed with current techniques. There will be approximately 18,500 patients enrolled from over 200 imaging centers around the country. CMS will reimburse for one amyloid scan for each cognitively impaired person taking part in a clinical trial, if that trial collects data about how the scan subsequently affected the patient’s health outcomes. As readers of this blog will recall, amyloid PET scans, though FDA approved, are not currently covered by any insurance.

The participants in the IDEAS study will be Medicare beneficiaries aged 65 and older. Before a patient gets a scan, the clinician will complete a case report form with the diagnosis and treatment plan. Patients will then undergo amyloid PET imaging and three months after the referral, the clinician will submit a second, updated report that details any change in diagnosis and/or treatment plan resulting from the amyloid PET scan. Participants will learn the results of the amyloid scan.

Perhaps the greatest impact of the IDEAS study will be on patients with the syndrome called Mild Cognitive Impairment (MCI), which presents with symptoms of memory loss and can result from multiple causes, including AD, about half of the time. In a patient with MCI, where the amyloid scan is negative, a diagnosis of AD is essentially ruled out. This type of information will help clinicians tailor diagnostic work-ups and treatment plans more clearly with a better sense of the patient's amyloid status in hand.


Thanks for reading,


Michael Rafii, MD, PhD
Director, Memory Disorders Clinic
Medical Core Director
Alzheimer’s Disease Cooperative Study
University of California San Diego
 
Author: Michael Rafii MD,PhD at 1:59 PM 0 Comments

Tuesday, May 05, 2015

Aducanumab’s Extraordinary Results


Dear Readers,

At the recent AD/PD meeting held in March, results were presented from an AD clinical trial that for the first time clearly showed a drug could significantly reduce beta-amyloid in the brain while also slowing cognitive decline. The drug, aducanumab, is yet another anti-amyloid antibody that was tested in 166 patients with prodromal or mild dementia due to AD. An Alzheimer’s diagnosis was confirmed using amyloid PET scans. Participants were given either 3 mg/kg or 10 mg/kg of the immunotherapy by monthly intravenous infusion. The researchers reported results on two measures: CDR (Clinical Dementia Rating) scale and MMSE (Mini Mental State Exam). Both scales are used to objectively measure memory and cognitive function. On the CDR scale, patients on placebo declined by an average of 2.04 points at one year, compared with 0.59 for the 10 mg/kg , which was statistically significant. On the MMSE scale, patients taking placebo declined an average of 3.14 points at one year compared with a decline of 0.75 points in the 3 mg/kg dose, and 0.58 points in the 10 mg/kg, both of which are statistically significant.

Partway into the trial, Biogen followed a recommendation of its data safety-monitoring board and added a third cohort of 6 mg/kg because the highest dose was showing more ARIA-E (Amyloid-Related Imaging Abnormalities (ARIA)) on brain MRI, a closely watched side effect of anti-amyloid therapy. The ARIA-E side effect was seen more often in patients with ApoE4, a gene variant associated with AD. On the highest dose (10 mg/kg), 55 percent of ApoE4 carriers developed ARIA-E versus 17 percent for non- ApoE4 carriers. The study also showed patients on the drug had headaches more frequently; 22 percent for those receiving aducanumab versus 5 percent on placebo.

So, what do these results mean? First, they lend further support to the idea that clinical trials for AD should utilize Amyloid PET to confirm the patient population. Second, it furthers the idea that earlier treatment with anti-amyloid therapies is likely critical for efficacy. And finally, it sets the stage for a large phase III study to confirm the findings and make dose adjustments to get maximal efficacy with minimal adverse effects. As readers might recall, all three of these features are integrated into the ADCS’ Anti-Amyloid for Asymptomatic Alzheimer’s (A4) clinical trial.

Thanks for reading,


Michael Rafii, MD, PhD
Director, Memory Disorders Clinic
Medical Core Director
Alzheimer’s Disease Cooperative Study
University of California San Diego
 
Author: Michael Rafii MD,PhD at 3:00 PM 0 Comments

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The Alzheimer's Disease Cooperative Study (ADCS) was formed in 1991 as a cooperative agreement between the National Institute on Aging (NIA) and the University of California, San Diego. The ADCS is a major initiative for Alzheimer's disease (AD) clinical studies in the Federal government, addressing treatments for both cognitive and behavioral symptoms. This is part of the NIA Division of Neuroscience's effort to facilitate the discovery, development and testing of new drugs for the treatment of AD and also is part of the Alzheimer's Disease Prevention Initiative.

The ADCS was developed in response to a perceived need to advance research in the development of drugs that might be useful for treating patients with Alzheimer's disease (AD), particularly drugs that might not be developed by industry.