PMID- 18042476
OWN - NLM
STAT- MEDLINE
DCOM- 20080201
LR  - 20221207
IS  - 0149-2918 (Print)
IS  - 0149-2918 (Linking)
VI  - 29
IP  - 10
DP  - 2007 Oct
TI  - Efficacy of multivitamin supplementation containing vitamins B6 and B12 and folic 
      acid as adjunctive treatment with a cholinesterase inhibitor in Alzheimer's 
      disease: a 26-week, randomized, double-blind, placebo-controlled study in 
      Taiwanese patients.
PG  - 2204-14
AB  - BACKGROUND: Elevated serum homocysteine levels have been associated with the 
      development of Alzheimer's dementia (AD). The combined use of a mecobalamin 
      capsule preparation, which contains vitamin B12 0.5 mg with an active methyl 
      base, and an over-the-counter nutritional supplement that contains folic acid 1 
      mg and pyridoxine hyperchloride 5 mg may be effective as a homocysteine-lowering 
      vitamin regimen. OBJECTIVE: The aim of this study was to determine whether oral 
      multivitamin supplementation containing vitamins B6 and B12 and folic acid would 
      improve cognitive function and reduce serum homocysteine levels in patients with 
      mild to moderate AD. METHODS: This randomized, double-blind, placebocontrolled 
      trial was conducted at En Chu Kong Hospital, Taipei, Taiwan. Male and female 
      patients aged >50 years with mild to moderate AD and normal folic acid and 
      vitamin B12 concentrations were enrolled. All patients received treatment with an 
      acetylcholinesterase inhibitor and were randomized to receive add-on mecobalamin 
      (B12) 500 mg + multivitamin supplement, or placebos, PO QD for 26 weeks. The 
      multivitamin contained pyridoxine (B6) 5 mg, folic acid 1 mg, and other vitamins 
      and iron. Serum homocysteine level was measured and cognitive tests were 
      conducted at baseline and after 26 weeks. The primary efficacy outcome was change 
      in cognition, measured as the change in score from baseline to week 26 on the 
      Alzheimer's Disease Assessment Scale 11-item Cognition subscale. Secondary 
      efficacy outcomes included changes in function in performance of activities of 
      daily living (ADLs) and concentrations of homocysteine, B12, and folic acid. 
      Tolerability was assessed by comparing the 2 study groups with respect to 
      physical examination findings, including changes in vital signs, laboratory test 
      abnormalities, concomitant medication use, and compliance of study medication was 
      assessed using an interview with the patient's caregiver, as well as the 
      monitoring of adverse events (AEs) throughout the study. RESULTS: Eighty-nine 
      patients (45 men, 44 women; all Taiwanese; mean [SD] age, 75 [7.3] years) were 
      enrolled and randomized. Overall, there were no significant differences in 
      cognition or ADL function scores between the 2 groups. At week 26, the mean (SD) 
      between-group difference in serum homocysteine concentration versus placebo was 
      -2.25 (2.85) micromol/L (P = 0.008), and the mean serum concentrations of vitamin 
      B12 and folic acid were significantly higher (but within normal range) in the 
      multivitamin group compared with placebo (., +536.9 [694.4] pg/mL [P < 0.001] and 
      +13.84 ng/mL [11.17] [P = 0.012] at 26 weeks, respectively). The 2 most common 
      AEs were muscle pain (11.1% and 6.8%) and insomnia (8.9% and 9.1%) in the 
      multivitamin and placebo groups, respectively. CONCLUSIONS: In this population of 
      patients with mild to moderate AD in Taiwan, a multivitamin supplement containing 
      vitamins B(6) and B(12) and folic acid for 26 weeks decreased homocysteine 
      concentrations. No statistically significant beneficial effects on cognition or 
      ADL function were found between multivitamin and placebo at 26 weeks.
FAU - Sun, Yu
AU  - Sun Y
AD  - Department of Neurology, En Chu Kong Hospital, San-shia, Taipei, Taiwan. 
      sunyu@ms4.hinet.net
FAU - Lu, Chien-Jung
AU  - Lu CJ
FAU - Chien, Kuo-Liong
AU  - Chien KL
FAU - Chen, Sien-Tsong
AU  - Chen ST
FAU - Chen, Rong-Chi
AU  - Chen RC
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Clin Ther
JT  - Clinical therapeutics
JID - 7706726
RN  - 0 (Cholinesterase Inhibitors)
RN  - 0 (Indans)
RN  - 0 (Piperidines)
RN  - 0LVT1QZ0BA (Homocysteine)
RN  - 12001-76-2 (Vitamin B Complex)
RN  - 8059-24-3 (Vitamin B 6)
RN  - 8SSC91326P (Donepezil)
RN  - 935E97BOY8 (Folic Acid)
RN  - P6YC3EG204 (Vitamin B 12)
SB  - IM
MH  - Aged
MH  - Alzheimer Disease/*drug therapy
MH  - Asian People
MH  - Cholinesterase Inhibitors/*therapeutic use
MH  - Donepezil
MH  - Double-Blind Method
MH  - Drug Therapy, Combination
MH  - Female
MH  - Folic Acid/*therapeutic use
MH  - Homocysteine/blood
MH  - Humans
MH  - Indans/*therapeutic use
MH  - Male
MH  - Piperidines/*therapeutic use
MH  - Taiwan
MH  - Vitamin B 12/*therapeutic use
MH  - Vitamin B 6/*therapeutic use
MH  - Vitamin B Complex/*therapeutic use
EDAT- 2007/11/29 09:00
MHDA- 2008/02/02 09:00
CRDT- 2007/11/29 09:00
PHST- 2007/07/16 00:00 [accepted]
PHST- 2007/11/29 09:00 [pubmed]
PHST- 2008/02/02 09:00 [medline]
PHST- 2007/11/29 09:00 [entrez]
AID - S0149-2918(07)00336-0 [pii]
AID - 10.1016/j.clinthera.2007.10.012 [doi]
PST - ppublish
SO  - Clin Ther. 2007 Oct;29(10):2204-14. doi: 10.1016/j.clinthera.2007.10.012.