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Four Alzheimer's Clinical Trials Address a Variety of Treatment Targets - Amyloid, Tau, Synapse Formation
Date:7/29/2008

search has shown that specific combinations of certain nutrients interact to enhance brain cell outgrowth, synapse formation, and neurotransmitter release and also improved cognitive function in several pre-clinical models. This specific combination of nutrients showed also reduced amyloid production and toxicity in the pre-clinical models.

At ICAD 2008, Philip Scheltens, MD, Ph.D., of the Alzheimer Center of the VU University Medical Centre, Amsterdam, the Netherlands reported the results of a randomised, double-blind, controlled 12-week trial, sponsored by Danone Research, to assess the safety and effect of Souvenaid(TM) on memory and cognitive performance in people with mild Alzheimer's (MMSE 20-26, mean=23.9) who had never taken any Alzheimer's drugs.

Two hundred twelve (212) people with mild Alzheimer's were recruited for the trial at 28 sites mainly in the Netherlands, Germany, and Belgium, with a single site in the U.S.; 106 were assigned to Souvenaid(TM), a 125 ml (125 kcal) once-a-day drink, and 106 to control in the 12-week study. Primary outcome measures were a delayed verbal memory task derived from the Wechsler Memory Scale-revised and the 13-item modified ADAS-cog. Secondary outcomes included the MMSE, 23-item Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL), 12-item Neuropsychiatric Inventory (NPI), Clinician's Interview Based Impression of Change plus Caregiver Input (CIBIC-plus) and Quality of Life in Alzheimer's Disease (QOL-AD). A separate analysis was performed on a pre-specified subgroup of very mild Alzheimer's (MMSE>23). In an optional, double-blind, 12-week extension phase, patients continued to receive the same study product (85 percent of the week 12 completers continued into the extension phase).

The investigators found a statistically significant benefit in mild Alzheimer's patients on the delayed verbal memory task in the Souvenaid(TM) group, and also a significant effect in the
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SOURCE Alzheimer's Association
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