Vitamins and antioxidant combine against dementia

Looking for partners: Andrew McCaddon of Cobalz

With an estimated 400 million people at risk for developing dementia, and 20 million people worldwide already affected, a simple, a natural remedy such as a vitamin would be a welcome answer. That's the approach being taken by Cobalz Ltd. of Chester, UK.

The company recently was granted a European patent for a sophisticated form of B vitamins used with a powerful antioxidant to treat and possibly prevent dementia. Clinical trials are scheduled to start in the United States in the first quarter of 2006, run under licence by a Louisiana-based company, and Cobalz also is looking for partners in other countries to license the treatment and conduct clinical trials.

The idea for the treatment originated in 1990, when Dr Andrew McCaddon, a scientific advisor to Cobalz, was training as a family doctor. McCaddon noticed that a patient with early-onset Alzheimer's had low vitamin B12 and folate levels. He also discovered that half of the patient's family - six people - who had early-onset Alzheimer's also had the same deficiencies.

So McCaddon began to look for the problem in his other patients with signs of dementia or Alzheimer's, and discovered they did. He gave them supplements of vitamin B12 and folate, a type of B vitamin. "Not much happened," said McCaddon, who practises medicine in Wrexham, Wales.

McCaddon began examining the stresses on the body that come with aging. High levels of homocysteine, an amino acid that can damage blood vessels, are a known risk factor for stroke, dementia and Alzheimer's. He found another phenomenon linked to dementia: oxidative stress, which can occur when the body produces too many free radicals. Free radicals form when oxygen interacts with certain molecules.

In healthy individuals, antioxidants typically keep free radicals in check. But in dementia, the free radicals damage an enzyme that breaks down homocysteine.

McCaddon discovered that by adding a powerful antioxidant called N-acetylcysteine (NAC) to the B12 and folate treatments, homocysteine levels declined. The clinical trials set to start in the United States are to confirm that this unique combination of NAC, B12 and folate can slow or arrest dementia during its early stages.

Pan American Laboratories (PamLab) of Covington, Louisiana, has licensed the treatment from Cobalz to run the clinical trials, which will be double-blinded and conducted at three locations: in Texas, Canada and Italy. One of the reasons is that the US fortifies food with vitamins, which may affect the results, while Italy and Canada do not.

McCaddon says the PamLab hopes to recruit 150 patients with elevated levels of homocysteine and mild cognitive impairment, meaning they are a bit forgetful but do not yet have dementia. Half of the patients will get an over-the-counter vitamin, and the other half will get the combination treatment. The treatment will be for 48 weeks, and patients will receive various neuropsychological tests, scans and blood tests before, during and after treatment.

"The primary goal of the trial is to get a radiological measure of the disease progression," says McCaddon. "We hope the treatment will delay the onset of dementia."