Regulators review safety data from Reminyl MCI trials
Regulators in the United States, Canada and Europe are reviewing safety data from two clinical trials testing the Alzheimer drug galantamine (Reminyl) as a treatment for mild cognitive impairment (MCI). The review comes after trial results showed an "imbalance" in the number of deaths among the 2,000 participants: 15 individuals taking galantamine died compared with five deaths among those receiving the placebo.
Neither trial found any statistically significant benefit from galantamine in improving function or preventing progression to Alzheimer's. Johnson and Johnson, co-developer of galantamine along with Shire Pharmaceutical Group, says it does not plan to seek approval of the drug as a treatment for MCI.
"Although the deaths were statistically lopsided toward the galantamine group, the overall number of deaths is quite small in a trial enrolling this many older adults," notes William H. Thies, Ph.D., Alzheimer's Association vice president, medical and scientific affairs. "It will require careful analysis to determine whether the greater number of deaths in the galantamine group was a real effect or a statistical fluke."
"While we wait for the results of this regulatory review, no one whose doctor has prescribed galantamine should stop taking the drug without first discussing the matter with the doctor," Thies cautions.
The review will analyze data from two two-year-long trials testing whether galantamine could prevent MCI from progressing to Alzheimer's disease. Those with MCI have slight but measurable problems with memory or other thinking skills, but little or no decline in ability to carry out daily activities. Many, but not all, individuals with MCI eventually develop Alzheimer's disease.
Galantamine is currently approved to treat mild to moderate Alzheimer's disease. Approval for that indication was based on results of clinical trials lasting six months.
For more information, please see:
- Johnson and Johnson's announcement of the regulatory review
- Johnson and Johnson's synopsis of data and results from the clinical trial GAL-INT-11
- Johnson and Johnson's synopsis of data and results from the clinical trial GAL-INT-18
- Johnson and Johnson's own interim analysis of trial mortality data
- Alzheimer's Association fact sheet on cholinesterase inhibitors, including galantamine and other drugs of this type
- Alzheimer's Association fact sheet on mild cognitive impairment (MCI)