application) There is evidence from a multicenter clinical trial that vitamin E slows the rate of clinical deterioration in individuals with moderately severe Alzheimer s disease (AD). The AD Cooperative Study (ADCS) is now mounting a large study to test the effects of vitamin E in persons at the earliest stage of cognitive deterioration. Older individuals with Down syndrome (DS) are at very high risk for AD. Most individuals with DS develop functional decline and show neuropathological evidence of AD by the sixth decade. The applicants propose an international multicenter randomized double-blind study to determine whether vitamin E supplementation will slow the rate of cognitive/functional decline in individuals with DS. Subjects with DS who are at least 50 years of age will be randomized into two treatment groups: vitamin E 2000 IU plus a multivitamin per day or placebo plus multivitamin. The multivitamin contains vitamin E 15 IU. The treatment period will be three years with evaluation visits every six months. The primary outcome measure will be a three year change score on a cognitive/functional measure that was derived for this purpose from the DYSPRAXIA Scale for Adults with Down Syndrome. Secondary outcome measures will include additional cognitive tests as well as informant-based measures of function and behavior.

National Institute of Health (NIH)
National Institute on Aging (NIA)
Research Project (R01)
Project #
Application #
Study Section
Special Emphasis Panel (ZAG1-BJS-3 (M2))
Program Officer
Ryan, Laurie M
Project Start
Project End
Budget Start
Budget End
Support Year
Fiscal Year
Total Cost
Indirect Cost
Institute for Basic Research in Dev Disabil
Staten Island
United States
Zip Code
Chen, Yun-Fei; Ni, Xiao; Fleisher, Adam S et al. (2018) A simulation study comparing slope model with mixed-model repeated measure to assess cognitive data in clinical trials of Alzheimer's disease. Alzheimers Dement (N Y) 4:46-53
Insel, Philip S; Mattsson, Niklas; Mackin, R Scott et al. (2016) Accelerating rates of cognitive decline and imaging markers associated with ?-amyloid pathology. Neurology 86:1887-96
Risacher, Shannon L; McDonald, Brenna C; Tallman, Eileen F et al. (2016) Association Between Anticholinergic Medication Use and Cognition, Brain Metabolism, and Brain Atrophy in Cognitively Normal Older Adults. JAMA Neurol 73:721-32
Insel, Philip S; Donohue, Michael C; Mackin, R Scott et al. (2016) Cognitive and functional changes associated with A? pathology and the progression to mild cognitive impairment. Neurobiol Aging 48:172-181
Reiman, Eric M; Langbaum, Jessica B; Tariot, Pierre N et al. (2016) CAP--advancing the evaluation of preclinical Alzheimer disease treatments. Nat Rev Neurol 12:56-61
Insel, Philip S; Mattsson, Niklas; Donohue, Michael C et al. (2015) The transitional association between ?-amyloid pathology and regional brain atrophy. Alzheimers Dement 11:1171-9
Henley, David B; Dowsett, Sherie A; Chen, Yun-Fei et al. (2015) Alzheimer's disease progression by geographical region in a clinical trial setting. Alzheimers Res Ther 7:43
Hampel, Harald; Schneider, Lon S; Giacobini, Ezio et al. (2015) Advances in the therapy of Alzheimer's disease: targeting amyloid beta and tau and perspectives for the future. Expert Rev Neurother 15:83-105
Grill, Joshua D; Raman, Rema; Ernstrom, Karin et al. (2015) Comparing recruitment, retention, and safety reporting among geographic regions in multinational Alzheimer's disease clinical trials. Alzheimers Res Ther 7:39
Hampel, Harald; Lista, Simone; Teipel, Stefan J et al. (2014) Perspective on future role of biological markers in clinical therapy trials of Alzheimer's disease: a long-range point of view beyond 2020. Biochem Pharmacol 88:426-49

Showing the most recent 10 out of 22 publications