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High dose vitamin B supplementation does not slow cognitive decline in mild to moderate Alzheimer’s disease

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QUESTION

Question:

Does high dose vitamin B supplementation have an effect on cognitive decline in people with Alzheimer’s disease?

Patients:

409 people with mild to moderate probable Alzheimer’s disease (NINCDS-ADRDA criteria; mean age 76 years; 56% female; 41% multivitamin users; 91% using cholinesterase inhibitors). Exclusions: <50 years old; medically unstable, Mini-Mental State Examination score <14 or >26; vitamin B12 or folate insufficiency (vitamin B12 <175 pg/ml; folate <4.2 ng/ml); renal insufficiency (serum creatine ⩾2.0 mg/dl); daily vitamin supplementation with >400 μg folic acid; used sedatives, anti-Parkinson’s or drugs with anticholinergic effects in the past 2 months; or recent investigational treatment for Alzheimer’s disease. Stable use of cholinesterase inhibitors or memantine was allowed if it had been ongoing for at least 3 months.

Setting:

40 sites across the USA; recruitment: February 2003 to December 2006.

Intervention:

High dose vitamin B supplementation (5 mg folic acid, 1 mg vitamin B12 (cyanocobalamin) and 25 mg vitamin B6 (pyridoxine hydrochloride) per day) or placebo for 18 months.

Outcomes:

Change in cognitive …

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