By Julie Steenhuysen Julie Steenhuysen – Mon Mar 16, 1:53 pm ET
CHICAGO (Reuters) – A new test can accurately detect Alzheimer's disease in its earliest stages , before dementia symptoms surface and widespread damage occurs, U.S. researchers said on Monday.
The test, which measures proteins in spinal fluid that can point to Alzheimer's, was 87 percent accurate at predicting which patients with early memory problems and other symptoms of cognitive impairment would eventually be diagnosed with Alzheimer's, they said.
"With this test, we can reliably detect and track the progression of Alzheimer's disease," said Leslie Shaw of the University of Pennsylvania School of Medicine, whose study appears in the Annals of Neurology.
Such tests, which look for so-called biomarkers of disease, can help researchers better focus trials of Alzheimer's treatments, Shaw said....
...They found people with low concentrations of amyloid beta42 were more likely to develop Alzheimer's disease, presumably because the protein was accumulating in plaques in the brain .
They also found people with high levels of tau in their spinal fluid were more likely to develop the disease.
...The test also ruled out the disease in 95.2 percent of the volunteers...
-New 12-month study broadens Phase 3 clinical program to further evaluate the benefits of Dimebon in Alzheimer's Disease--
NEW YORK and SAN FRANCISCO, April 15 /PRNewswire-FirstCall/ -- Pfizer (NYSE: PFE - News) and Medivation, Inc. (Nasdaq: MDVN - News) today announced the initiation of a 12-month, Phase 3 clinical trial of the investigational drug Dimebon. The study, known as CONCERT, is designed to evaluate the safety and efficacy of Dimebon when added to ongoing treatment with donepezil HCI tablets, the leading Alzheimer's disease (AD) medication worldwide, in patients with mild-to-moderate AD.
The CONCERT study is part of a broad, Phase 3 clinical development program for Dimebon. The study builds on data from a small-scale safety and tolerability trial of Dimebon added to donepezil, which found the combination to be well tolerated. CONCERT is designed to complement previous and ongoing studies by further evaluating the efficacy of Dimebon. The Phase 3 program also includes the confirmatory 6-month CONNECTION study, which is designed to evaluate the safety and efficacy of Dimebon monotherapy in patients with mild-to-moderate AD and builds on results of the first pivotal trial of Dimebon in AD.
"Due to the complexity of Alzheimer's disease, the condition often requires combination treatment to help relieve symptoms and slow disease progression," said Bengt Winblad, professor of geriatrics, Karolinska Institute. "The CONCERT trial will explore the potential additive effects of Dimebon to ongoing donepezil therapy, two drugs thought to have different mechanisms of action. We believe this trial may serve to demonstrate the potential of Dimebon in AD."
Dimebon is an investigational compound currently in Phase 3 development for the treatment of Alzheimer's disease (AD) and in clinical development for Huntington's disease (HD). In preclinical models of AD and HD explored thus far, Dimebon has been shown to inhibit brain cell death, potentially by stabilizing and improving mitochondrial function in a way that prevents neuron death and dysfunction. The Dimebon mechanism is thought to be distinct from currently available AD medications.
Design of the CONCERT Study
The international, randomized, double-blind, placebo-controlled study will enroll approximately 1,050 patients with mild-to-moderate AD at approximately 100 sites in the United States, Australia, New Zealand and Western Europe. Patients on a stable dose of donepezil will be randomized to one of three treatment groups: Dimebon 20 mg three times per day, Dimebon 5 mg three times per day or placebo. Patients must be on treatment with donepezil for at least six months and at a stable dose of 10 mg daily for at least four months prior to enrollment in the study.
The primary endpoints are the Alzheimer's Disease Assessment Scale - cognitive subscale (ADAS-cog) and the Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) - a measure of self-care and daily function.
For more information on the CONCERT study, please visit www.concertstudy.com or call 877-888-6386.
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