A recent study finds that galantamine has a much lower mortality rate among patients with mild to moderately severe Alzheimer’s disease compared to placebo. The findings were presented at the American College of Neuropsychopharmacology 51st Annual Meeting in Hollywood, and come from a study sponsored by Fla. Janssen Research & Development, LLC.

Galantamine not only reduced mortality rates, but also slowed down declines in cognitive impairment over a 24-month period, compared to those who were given placebo.

The double-blind, placebo-controlled, randomized clinical study evaluated the effectiveness and safety of treating Alzheimer’s patients with galantamine over a 2 year period. 2,051 people between the ages 45 and 92 participated, of whom 1,023 were in the placebo group and 1,028 were in the galantamine group. 127 sites in 13 different countries were involved in this study.

Galantamine is an acetylcholinesterase inhibitor, it is believed to increase the concentration of the neurotransmitter acetylcholine by inhibiting an enzyme called cholinesterase, which is detrimental to the neurotransmitter.

The target outcome of the trial was to observe the rate of mortality and number of serious adverse events that occurred over the two years.

The human study was terminated early because mortality rates were evidently significantly superior in the galantamine group.

The study’s primary safety endpoint was mortality rates or death over a 24-month period. The secondary safety endpoint was the existence of adverse events linked to galantamine, including serious adverse events over 24 months.

Below are some data on the human trial:

  • 54% of patients in the Galantamine group reported at least one TEAE (treatment emergent adverse event), compared to 49% in the placebo group
  • The most common TEAEs in the Galantamine group were nausea and/or vomiting
  • The adverse events in the two groups were very similar.
  • Mortality was much higher in the placebo group than the galantamine group

Alzheimer’s disease is not a normal part of aging. It is a degenerative brain disease; the most common form of dementia, which progressively destroys the patient’s cognitive and functional abilities, including memory and the ability to carry out normal daily activities, such as eating and washing.

According to the CDC (Centers for disease control and prevention), approximately five million Americans live with Alzheimer’s disease. It is the sixth leading cause of death in the USA.

Dementia (including Alzheimer’s) affects over 35 million people worldwide. As lifespans globally increase, experts say the incidence of Alzheimer’s and other dementias will also increase, and probably more than double over the next couple of decades – possibly to 65 million by 2030 and 115 million by 2050.

Alzheimer’s disease is believed to cost the world economy about 1% of its GDP (global GDP) – a burden of at least $600 billion.

In patients with Alzheimer’s disease, acetylcholine production goes down. Acetylcholine is a neurotransmitter. This drop in acetylcholine production occurs because neurons (in the brain) degenerate. Studies have shown a link between acetylcholine loss and amyloid density plaques, the hallmark sign of the disease.

Galantamine helps raise acetylcholine levels.

Although Alzheimer’s disease is incurable, certain medications and lifestyle changes can help slow down its rate of progression, studies have shown. Scientists from the University of California showed that people with active lifestyles tend to have a slower progression of Alzheimer’s symptoms.

Galantamine is sold by Janssen Pharmaceuticals Inc. in the USA, under the brand names Razadyne and Razadyne ER.

Written by Joseph Nordqvist