Clinical Research Highlights
Slowing Brain Deterioration:
The NOBLE Study by Gale Smith
Photo: Robert Seale
The NOBLE study was initiated in March 2014 by the Alzheimer’s Disease Cooperative Study (ADCS). It is a phase II clinical trial of T-817MA, a neurotropic agent with an undisclosed mechanism of action. NOBLE will compare the neuroprotective profile of T-817MA at once a day dosing to placebo in 450 patients with mild to moderate Alzheimer’s disease. Patients must have been taking donepezil (“Aricept”) or rivastigmine (“Exelon”), single or combined with memantine (“NamendaTM”), for at least four months before enrollment
Previous studies in preclinical models have shown this investigational drug may work by protecting brain cells, which would result in improved memory and cognition,” said Joseph C. Masdeu, M.D., Ph.D., the
in the trial, for symptom management. Study
Graham Family Distinguished Chair for Neurological Sciences and the
participants will be randomized to T-817MA
principal investigator of this study at Houston Methodist. “Our goal
or placebo.
is to find out if this drug is a viable option for our patients.
T-817MA is a neuroprotective drug that acts on amyloid-induced neurotoxicity and memory deficits. Positron emission tomography (PET) has shown through the use of biomarkers that abnormal amounts of beta amyloid are evident in the brain as many as 20 years before
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Of more than five million Americans living with Alzheimer’s disease, almost two-thirds are women. American women are twice as likely to die of Alzheimer’s disease as they are from breast cancer. According to the Alzheimer’s Association, someone develops Alzheimer’s disease every 67 seconds. In 2013, 15.5 million caregivers provided an estimated 17.7 billion hours of unpaid care valued at more than $220 billion.
initial symptoms develop. In previous studies,
The NOBLE study is sponsored by Toyama Chemical Co., Ltd., FUJIFILM Group.
T-817MA has been shown to mitigate
Approximately 50 sites nationwide are offering this study to patients with mild to
amyloid-induced learning deficits in
moderate Alzheimer’s disease. Houston Methodist is the only study location in Texas.
experimental Alzheimer’s disease models.
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