Rhode Island Hospital’s Alzheimer’s Disease and Memory Disorders Center is recruiting participants for a new, national Alzheimer’s disease clinical research study evaluating the potential benefits of an investigational medicine for people with mild to moderate Alzheimer’s.
The Phase 2 study, called T2 Protect AD (Alzheimer’s disease), is evaluating the investigational drug Troriluzole, which may have the potential to protect against, slow down, and eventually improve memory and thinking problems that increase as Alzheimer’s disease progresses. Troriluzole is a drug that modulates glutamate, protecting against neuron loss. Glutamate problems in the brain can lead to brain cell dysfunction and disease, including Alzheimer’s disease.
Troriluzole is related to riluzole, which is used to slightly slow disease progression in patients with amyotrophic lateral sclerosis (ALS), but, unlike its predecessor, it can be taken once a day and has potential for better safety and tolerability.
“We are very excited to be able to participate in this trial. Troriluzole offers an avenue for therapy targeting an Alzheimer's–related disease mechanism that is unlike any other investigational medication we have to offer,” said Jonathan Drake, M.D., the principal investigator for the study site at Rhode Island Hospital. “ It has a proven track record in ALS patients, and has been modified to have fewer side effects. Most importantly, this study will be open to patients with moderate dementia, a population that is currently under-represented in Alzheimer's disease clinical trials.”
Rhode Island Hospital’s Alzheimer’s Disease and Memory Disorders Center is one of more than 30 sites across the U.S. participating in the T2 Protect AD study. Approximately 292 patients will be randomized nationwide on a 1:1 basis to receive 280 mg of troriluzole or placebo, taken orally at bedtime. The duration of treatment will be 48 weeks.
The study is sponsored by New Haven-based Biohaven Pharmaceutical Holding Company Ltd., and is coordinated by the Alzheimer’s Disease Cooperative Study, an Alzheimer’s disease therapeutic research consortium based at the University of California, San Diego.
To participate in T2 Protect AD, candidates must be between age 50 and 85 and diagnosed with mild to moderate Alzheimer’s disease, and already being treated with donepezil (Aricept), rivastigmine (Exelon) or galantamine (Razadyne) for at least three months, with or without memantine (Namenda). Participants must have a study partner who has regular contact with the clinical trial candidate and is able to attend study visits.
For more information about participating in the T2 Protect AD study at Rhode Island Hospital, call 1-844-5MEMORY or email email@example.com.