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Two Michigan universities will test a new drug designed to slow or stop the symptoms of Alzheimer’s disease in patients ages 50-85.
The University of Michigan and Michigan State University are among more than 30 academic medical centers and clinics nationwide conducting clinical trials of the drug troriluzole. The study, called T2 Protect AD, is being coordinated by the Alzheimer’s Disease Cooperative Study, or ADCS, a consortium of institutions that research interventions for the disease.
Dr. Judith Heidebrink, the principal investigator of the study at U-M, said the screening process started this month. Heidebrink said the study targets patients who already have developed mild to moderate dementia.
“There are a lot of trials out there trying to prevent Alzheimer’s disease … and very few for those who have already established dementia,” she said. “We need to really have therapies for folks already showing symptoms, as well as prevent the following generation from showing symptoms.”
To qualify for the study, Heidebrink said patients must score within a certain range when taking memory and thinking tests to establish the severity of their condition and should be in otherwise generally good health. She saidother conditions or medications may affect eligibility.
Dr. Andrea Bozoki, director for cognitive and geriatric neurology at MSU, said her team in East Lansing also has begun recruiting study participants.
Bozoki, who is also an investigator with the ADCS, said the study requires participants to come in for visits every six weeks for a year. In addition, they must have a caregiver who can administer the drug and spend at least 10 hours a week with them.
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According to the Alzheimer’s Association Michigan Great Lakes Chapter, there are more than 180,000 people in the state living with Alzheimer’s.
Dr. Irfan Qureshi, the executive director of neurology at Biohaven — the New Haven, Connecticut-based biotech company sponsoring the study — said that U-M and MSU are particularly important sites because of the large number of Alzheimer’s patients that they serve.
A different kind of drug
Qureshi added that troriluzole is a particularly exciting drug to study because it has a “unique mechanism of action.”
Other medications that have been studied or have gotten “a lot of buzz” in the Alzheimer’s space target a protein called amyloid or another protein called tau, but Qureshi said troriluzole is different, because it targets a neurotransmitter called glutamate.
Glutamate is a chemical that nerve cells use to send signals to other cells.
Qureshi said researchers believe troriluzole will improve symptoms of Alzheimer’s disease, like memory and other cognitive problems, as well as reduce the progression of the disease by normalizing the level of glutamate in the synapse — the space between neurons.
“We think that brain cells communicate with each other through the synapse … and if there’s too much glutamate there, then the neurons don’t communicate properly, and if there’s too much there for too long, they die,” Qureshi said. “In Alzheimer’s disease, (the level of glutamate in the synapse) is probably too high.”
Qureshi said that the U-M and MSU sites were identified as two leading members of the ADCS, which is coordinated nationally by T2 Project Director Dr. Howard Feldman at the University of California San Diego.
“We want to be able to run the study and provide the opportunity for patients to participate who are in Michigan,” Qureshi said.
The Mini-Mental State Examination, which is a scale used to examine the condition of Alzheimer’s disease patients, is part of the inclusion criteria, Qureshi said.
Qureshi said Biohaven is also working on studies with troriluzole that target other diseases and disorders, including the neurodegenerative disease Spinocerebellar ataxia, obsessive compulsive disorder and generalized anxiety disorder.
“Glutamate is probably involved in 90 percent of excitatory transmission or communication between brain cells. So it’s really, really important, and that’s why it has the potential across these different diseases to have a potential benefit,” he said.
“This is an exciting time for research … for investigators, and more importantly, for patients and their families.”
More information about clinical trials can be found on the T2 Protect AD website: www.t2protect.org
Contact Aleanna Siacon: ASiacon@freepress.com. Follow her Twitter: @AleannaSiacon.