Medical food, supplement tested for dementias

Medical foods and supplements designed to support neural health and function may soon expand treatment options for common forms of dementia based on the results of two studies.

In the first trial, Souvenir II, The VU University Medical Center in Amsterdam, and colleagues studied 259 patients from multiple centers in Europe who had mild Alzheimer’s disease, with mini-mental State Examination (MMSE) score of 25 or greater.

Patients were randomized evenly to receive Souvenaid (125 Ml orally once a day) or a control drink for the first 24 weeks. Souvenaid contains  special formulation of omega-3 and a -6 fatty acids, Choline, Phospolipids, B vitamins, and antioxidants designed to promote the formation and function of synapses.

“Synapse dysfunction is . . . critical to causing symptoms in Alzheimer’s disease. It’s not the amyloid load that causes memory problems — it’s the loss of synapses and the loss of neurons that do so.” In a subsequent 24-week extension period, all patients received souvenaid.

Rates of serious adverse events did not differ between  groups, and there were no new safety signals during the extension period.

At 24 weeks, patients in the souvenaid group had a significantly greater improvement from baseline in z scores for the neuropsychological Test Battery memory domain (P=.023) and marginally better total composite scores (P=.053), as recently published.

In additional results, there was a  significant improvement between 24 and 48 weeks in the z score for the memory domain of the neuropsychological Test Battery among both patients who started and continued on souvenaid and  patients who started on the control drink and switched to souvenaid. The effect size in the study was 0.21, “exactly on the order of the cholinesterase inhibitors.”

Citicoline for vascular MCI

In the second trial, known as IDEALE, a geriatrician with the ambulatory Center for Dementia in Cantanzaro, Italy, and his colleagues enrolled 349 patients in Italy, at least 65 years of age who had evidence of vascular lesions on neuroradiologic imaging, and either an MMSE score of at least 21 or subjective memory complaints.

The patients were assigned in a 3:1 ratio to open-label treatment with citicoline (500 mg twice a day) or a control condition (no treatment).

“Citicoline has number of different properties.” “For example, it inhibits apoptosis associated with cerebral ischemia. And it’s able to inhibit several models of neurodegeneration. It’s able to potentiate neuroplasticity. And it is a natural precursor of phospholipid synthesis.”

Trial results showed a nonsignificant increase in MMSE scores over 6 months in the citicoline group (from 21.5 to 19.6) scores differed significant between groups at 3 months and at 6 months.