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P S Aisen
Dr P S Aisen, University of California, San Diego, CA, USA; paisen@ucsd.edu
QUESTION
Do high-dose vitamin B supplements reduce rate of cognitive decline in patients with Alzheimer disease (AD)?
METHODS
Design:
randomised placebo controlled trial. Clinicaltrials.gov NCT00056225.
Allocation:
{concealed}.*
Blinding:
blinded (patients, caregivers, clinicians, and psychometrists).
Follow-up period:
every 3 months up to 18 months.
Setting:
40 centres in the USA.
Patients:
409 patients >50 years of age (mean age 76 y, 56% women), who had probable AD, scored 14–26 on the Mini-Mental State Examination (MMSE), and were medically stable. Exclusion criteria were vitamin B12 concentrations <129 pmol/l (175 pg/ml), folate concentrations <9.5 nmol/l (4.2 ng/ml), renal insufficiency (serum creatinine ⩾176.8 µmol/l [2.0 …
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