Efficacy of a medical food in mild Alzheimer's disease: A randomized, controlled trial.
OBJECTIVE
To investigate the effect of a medical food on cognitive function in people with mild Alzheimer's disease (AD).


METHODS
A total of 225 drug-naïve AD patients participated in this randomized, double-blind controlled trial. Patients were randomized to active product, Souvenaid, or a control drink, taken once-daily for 12 weeks. Primary outcome measures were the delayed verbal recall task of the Wechsler Memory Scale-revised, and the 13-item modified Alzheimer's Disease Assessment Scale-cognitive subscale at week 12.


RESULTS
At 12 weeks, significant improvement in the delayed verbal recall task was noted in the active group compared with control (P = .021). Modified Alzheimer's Disease Assessment Scale-cognitive subscale and other outcome scores (e.g., Clinician Interview Based Impression of Change plus Caregiver Input, 12-item Neuropsychiatric Inventory, Alzheimer's disease Co-operative Study-Activities of Daily Living, Quality of Life in Alzheimer's Disease) were unchanged. The control group neither deteriorated nor improved. Compliance was excellent (95%) and the product was well tolerated.


CONCLUSIONS
Supplementation with a medical food including phosphatide precursors and cofactors for 12 weeks improved memory (delayed verbal recall) in mild AD patients. This proof-of-concept study justifies further clinical trials.
Scheltens
Philip
P
VU University Medical Center, Amsterdam, The Netherlands. p.scheltens@vumc.nl
Kamphuis
Patrick J G H
PJ
Verhey
Frans R J
FR
Olde Rikkert
Marcel G M
MG
Wurtman
Richard J
RJ
Wilkinson
David
D
Twisk
Jos W R
JW
Kurz
Alexander
A
D000368:Aged; D000369:Aged, 80 and over; D000544:Alzheimer Disease / Q000150:complications*; D016022:Case-Control Studies; D003072:Cognition Disorders / Q000178:diet therapy* / Q000209:etiology*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D055951:Functional Food; D006801:Humans; D008297:Male; D008568:Memory / Q000502:physiology; D008875:Middle Aged; D009483:Neuropsychological Tests; D011569:Psychiatric Status Rating Scales; D013997:Time Factors; D016896:Treatment Outcome