title: Down syndrome and dementia: a randomized, controlled trial of antioxidant supplementation.
abstract: Individuals with Down syndrome over age 40 years are at risk for developing dementia of the Alzheimer type and have evidence for chronic oxidative stress. There is a paucity of treatment trials for dementia in Down syndrome in comparison to Alzheimer disease in the general (non-Down syndrome) population. This 2-year randomized, double-blind, placebo-controlled trial assessed whether daily oral antioxidant supplementation (900 IU of alpha-tocopherol, 200 mg of ascorbic acid and 600 mg of alpha-lipoic acid) was effective, safe and tolerable for 53 individuals with Down syndrome and dementia. The outcome measures comprised a battery of neuropsychological assessments administered at baseline and every 6 months. Compared to the placebo group, those individuals receiving the antioxidant supplement showed neither an improvement in cognitive functioning nor a stabilization of cognitive decline. Mean plasma levels of alpha-tocopherol increased ~2-fold in the treatment group and were consistently higher than the placebo group over the treatment period. Pill counts indicated good compliance with the regimen. No serious adverse events attributed to the treatment were noted. We conclude that antioxidant supplementation is safe, though ineffective as a treatment for dementia in individuals with Down syndrome and Alzheimer type dementia. Our findings are similar to studies of antioxidant supplementation in Alzheimer disease in the general population. The feasibility of carrying out a clinical trial for dementia in Down syndrome is demonstrated.
authors: Department of Pediatrics, School of Medicine, University of California, Irvine (UCI), Orange, California, USA. itlott@uci.edu
authors: Ira T
authors: IT
authors: Lott
authors: Eric
authors: E
authors: Doran
authors: Vinh Q
authors: VQ
authors: Nguyen
authors: Anne
authors: A
authors: Tournay
authors: Elizabeth
authors: E
authors: Head
authors: Daniel L
authors: DL
authors: Gillen
mesh_terms: D000544:Alzheimer Disease / Q000150:complications / Q000188:drug therapy*; D000975:Antioxidants / Q000627:therapeutic use*; D001205:Ascorbic Acid / Q000627:therapeutic use*; D004314:Down Syndrome / Q000150:complications / Q000188:drug therapy*; D004338:Drug Combinations; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D008063:Thioctic Acid / Q000627:therapeutic use*; D016896:Treatment Outcome; D024502:alpha-Tocopherol / Q000627:therapeutic use*
chemical_list: D000975:Antioxidants; D004338:Drug Combinations; D008063:Thioctic Acid; D024502:alpha-Tocopherol; D001205:Ascorbic Acid