What is memantine?

Memantine is a drug by Merz Pharmaceuticals that has been used in Germany for treatment of dementia for more than 10 years.  In May 2002, memantine was approved for treatment of moderately severe to severe Alzheimer's in the European Union, where it is marketed as Ebixa®.

How does memantine work?

Memantine appears to protect the brain’s nerve cells against glutamate, a messenger chemical released in excess amounts by cells damaged by Alzheimer’s disease or certain other neurological disorders.  When glutamate binds to N-methyl-D-aspartate (NMDA) receptors, this attachment permits calcium to flow freely into the cell. Sustained elevation of glutamate leads to chronic overexposure to calcium, which in turn leads to cell degeneration. Memantine may prevent this destructive sequence by filling the NMDA receptor sites.

Can memantine be used with cholinesterase inhibitors? (Aricept®, Exelon®, galantamine)

Memantine’s action in the glutamate system differs from the activity of the cholinesterase inhibitors that are currently approved in the United States for treatment of Alzheimer’s.  Cholinesterase inhibitors temporarily boost levels of acetylcholine, another messenger chemical that becomes deficient in the Alzheimer brain. These differing modes of action raise the possibility that individuals may be able to take memantine and cholinesterase inhibitors simultaneously.

Where is memantine in the drug development process?

Memantine is now under development by Forest Pharmaceuticals for marketing in the United States. There has been speculation about whether memantine’s long track record in Germany might accelerate U.S. approval by the Food and Drug Administration (FDA).  Most experts concur that the original studies on which German approval was based would not meet current U.S. standards for clinical trials. Since those original German studies were conducted, two more recent studies have been completed—one in Latvia and one Phase III trial in the United States. The U.S. Phase III trial tested memantine’s effects in people with moderately severe to severe Alzheimer’s, the stages when individuals develop problems with dressing, bathing, and other daily activities and when behavioral symptoms that often complicate Alzheimer’s tend to become significant. As a result, these are also the stages that cause the greatest caregiver burden and represent the points at which families tend to move relatives with Alzheimer’s from their homes into assisted living arrangements. In the trial, participants who received 10 milligrams of memantine twice a day during the six months of the study showed significantly slower decline in mental function and ability to perform daily self-care activities than enrollees who received a placebo (inactive treatment).

Forest is now conducting additional nationwide multicenter Phase III trials, including one enrolling participants who are simultaneously taking cholinesterase inhibitors.  Although that trial is closed to new participants, two studies remain open—one recruiting individuals with mild to moderate Alzheimer’s and one enrolling participants in moderate to severe stages.

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