Alzheimer’s drug clinical trial in N.J. has openings for patients
A brief set of questions – including some involving drawing – is one of the first steps in diagnosing Alzheimer’s disease. Star-Ledger file photo
A Princeton research company is looking for people with mild-to-moderate Alzheimer’s disease to participate in a clinical trial of a potential new medication.
Calling Alzheimer’s “the plague of the current century,” psychiatrist and study researcher Jeffrey Apter said the drug being tested seems to promote the growth of nerve cells, as well as inhibit cell death.
That makes the trial drug a potential improvement over the current drugs prescribed for the progressive disease: Aricet, Excelon and Namenda.
“The drugs that are on the market don’t help to prevent progression,” Apter said. “They just offer a temporary panacea for the symptoms.”
The neuroprotective agent under study – called T-817MA for now –
has already made it through Phase 2 trials, which are using to determine the optimal effective and safe dosage. The latest round, for which Princeton Medical Institute is seeking participants, is Phase 3 of the U.S. Food and Drug Administration’s protocol for new drugs.
“We don’t know exactly how this new drug works,” he said, but added, “it appears to be safe and well-tolerated.”
Participants in the study must have mild-to-moderate Alzheimer’s, and must already be on one of the existing medications for it. They do not have to stop that medication in order to join the study. They should be between the ages of 55 and 85.
In addition, they must have a caregiver who spends at least 10 hours a week with them who is able to meet with researchers as well, in order to report observations about the patient.
This is a classic “double blind” clinical trial: Half the participants will receive the investigational drug, while the other half will receive a fake pill. Neither the patients nor the researchers will know who is in which group – a time-honored way to prevent bias from coloring one’s perception of the drug’s effects.
After six months, though, drug companies often let the placebo group that received the fake pill have access to the medicine under study, said Apter.
Those who join the clinical trial get free medication as well as blood work, MRIs and CT scans. They remain in the overall care of their regular physician, with whom the researchers share testing results.
Participation is free, and research subjects can be modestly compensated for their travel costs, Apter said.
The Princeton company is one of 20 sites nationally participating in the NOBLE clinical trial, and the only one in New Jersey. Anyone interesting in learning more about the study can contact the firm at (609) 921-6050, or through its website, www.princetonmedicalinstitute.com or Facebook page.
“We cannot guarantee any results,” Apter said. “We try not to give them false expectations.”
Kathleen O’Brien may be reached at kobrien@njadvancemedia.com, or at (732) 902-4557. Follow her on Twitter @OBrienLedger. Find NJ.com on Facebook.
