Vote Now
Home | News | Events | Press | Contact  

About UseNewsletterMessage BoardsAction CenterAdvocateWalk to End Alzheimer’sShopDonate

Find your chapter:

search by state

Alzheimer News 1/24/2005
Text Size controlsNormal font sizeMedium font sizeLarge font size

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
    www.jnj.com

  • Johnson and Johnson's synopsis of data and results from the clinical trial GAL-INT-11
    www.clinicalstudyresults.org

  • Johnson and Johnson's synopsis of data and results from the clinical trial GAL-INT-18
    www.clinicalstudyresults.org

  • Johnson and Johnson's own interim analysis of trial mortality data
    www.clinicalstudyresults.org

  • Alzheimer's Association fact sheet on cholinesterase inhibitors, including galantamine and other drugs of this type
    www.alz.org

  • Alzheimer's Association fact sheet on mild cognitive impairment (MCI)
    www.alz.org

 

Join or start a team today.

Find a Walk

Washington Alaska Texas Washington Oregon California Idaho Nevada Arizona Utah Montana Wyoming Colorado New Mexico Oklahoma Kansas Nebraska South Dakota North Dakota Minnesota Iowa Missouri Arkansas Louisiana Mississippi Illinois Wisconsin Michigan Indiana Kentucky Tennessee Alabama Florida Georgia South Carolina North Carolina Virginia West Virginia Ohio Maine Pennsylvania New York Vermont New Hampshire Massachusetts Rhode Island Connecticut New Jersey onClick= Delaware Maryland Hawaii Vermont New Hampshire Massachusetts Rhode Island Connecticut New Jersey Delaware Maryland Washington D.C.
Alzheimer's Association

Our vision is a world without Alzheimer's
Formed in 1980, the Alzheimer's Association is the world's leading voluntary health organization in Alzheimer's care, support and research.