Prevention of Alzheimer's Disease by Vitamin E and Selenium (PREADVISE)
2 other identifiers
observational
4,246
3 countries
91
Brief Summary
The Prevention of Alzheimer's Disease by Vitamin E and Selenium (PREADVISE) prevention trial is an important addition to the Selenium and Vitamin E Cancer Prevention Trial (SELECT). As a prevention trial, PREADVISE is trying to find out if taking selenium and/or Vitamin E supplements can help to prevent memory loss and dementia such as Alzheimer's disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2002
Longer than P75 for all trials
91 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2002
CompletedFirst Submitted
Initial submission to the registry
June 25, 2002
CompletedFirst Posted
Study publicly available on registry
June 27, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedMarch 14, 2018
March 1, 2018
11.7 years
June 25, 2002
March 12, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
incidence of dementia (including Alzheimer's disease)
Participants will complete a modified Telephone Interview of Cognitive Status (TIC-S) to evaluate the onset of dementia
7 to 12 years (depending on enrollment date)
Study Arms (4)
Combination therapy
vitamin E (alphatocopherol) and selenium
Vitamin E only
vitamine E (alphatocopherol) and placebo
Selenium only
selenium and placebo (Placebo replacement for vitamin E)
Placebo
placebo (Placebo replacement for vitamin E) and placebo (Placebo replacement for selenium)
Interventions
Eligibility Criteria
Participant will be recruited from primary care office visits
You may qualify if:
- Participating in SELECT Prevention study;
- years or older if other ethnic origin, or 60 years or older if African-American or Hispanic;
- General good health with no neurological or psychiatric illness.
You may not qualify if:
- The SELECT doctors or staff will review the PREADVISE applicants' medical history and drugs to verify that they have no condition(s) that would exclude them from this study. The participant must not have any of the following neurological conditions based on self report (were told by a physician):
- Alzheimer's disease, or any other form of dementia such as Pick's disease, dementia with Lewy bodies, frontotemporal dementia, vascular dementia, significant cognitive and motor impairment from a stroke or corticobasal degeneration;
- Huntington's disease, epilepsy, Parkinson's disease, brain tumor, multiple sclerosis, manic-depressive disorder, or schizophrenia;
- The participant must not have had a head injury with prolonged loss of consciousness (over 30 minutes) within the past five years;
- The participant must not have a current alcohol or substance abuse diagnosis, or must have been treatment free for the past 24 months;
- The participant must not have had a diagnosis of depression or anxiety disorder in the past 4 months and must not currently be under treatment for depression or anxiety disorder. \[A participant who was previously diagnosed with depression or anxiety disorder but completed treatment more than four months ago is eligible.\];
- The participant must not currently use of any of the following medications: Aricept, Cognex, Exelon, Reminyl, or Hydergine;
- The participant must not have blindness, deafness, language difficulties or any other disability that may prevent completion of the memory screen.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Frederick Schmittlead
- National Institute on Aging (NIA)collaborator
- National Cancer Institute (NCI)collaborator
Study Sites (91)
University of Alabama at Birmingham Preventive Medicine
Birmingham, Alabama, 35294-4410, United States
Alaska Regional Hospital
Anchorage, Alaska, 99508, United States
Providence Alaska Medical Center
Anchorage, Alaska, 99508, United States
University of California, San Diego - Chula Vista
Chula Vista, California, 91910, United States
Glendale Memorial Hospital
Glendale, California, 91204, United States
University of California, San Diego
La Jolla, California, 92037-1709, United States
VA Medical Center
Loma Linda, California, 92354-3866, United States
VAMC Long Beach
Long Beach, California, 90822, United States
Northridge Hospital Medical Center
Northridge, California, 91328, United States
Santa Rosa Memorial Hospital Regional CCOP
Santa Rosa, California, 95403, United States
LABIOMED (Los Angeles Biomedical) Research Institute at Harbor-UCLA Medical Center
Torrance, California, 90502-2064, United States
Lionel B. Katchem
Upland, California, 91786, United States
Rocky Mountain CC/Poudre Valley Hospital
Fort Collins, Colorado, 80524, United States
Sibley Memorial Hospital
Washington D.C., District of Columbia, 20016, United States
George Washington University Medical Center
Washington D.C., District of Columbia, 20037, United States
DC United MBCCOP
Washington D.C., District of Columbia, 20060-0001, United States
Baptist Medical Center
Jacksonville, Florida, 32207-8560, United States
Kaiser Southeast Permanente Medical Group
Tucker, Georgia, 30084, United States
Bliss Cancer Center/McFarland Clinic/Mary Greely MC
Ames, Iowa, 50010, United States
Cedar Rapids CCOP
Cedar Rapids, Iowa, 52403, United States
Genesis Medical Center
Davenport, Iowa, 52804, United States
Iowa Oncology Research Association
Des Moines, Iowa, 50309-1016, United States
Siouxland Hematology-Oncology Associates
Sioux City, Iowa, 51101, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Stormont-Vail Health Care/Cotton O'Neil Clinic
Topeka, Kansas, 66606, United States
Wichita CCOP
Wichita, Kansas, 67214-3882, United States
Our Lady of Bellefonte Hospital Inc.
Ashland, Kentucky, 41101, United States
University of Kentucky Medical Center
Lexington, Kentucky, 40536-0093, United States
Louisville VA Medical Center
Louisville, Kentucky, 40206-1499, United States
Anne Arundel Medical Center
Annapolis, Maryland, 21401-2777, United States
Berkshire Hematology Oncology/Bershire Medical Center
Pittsfield, Massachusetts, 01201, United States
Bixby Oncology Center
Adrian, Michigan, 49221, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Grand Rapids Clinical Oncology Program CCOP
Grand Rapids, Michigan, 49503-2560, United States
Monroe Clinic
Monroe, Michigan, 48162, United States
St. Joseph Mercy Oakland
Pontiac, Michigan, 48341, United States
Munson Medical Center
Traverse City, Michigan, 49684-2386, United States
Duluth CCOP
Duluth, Minnesota, 55805, United States
St. John's Regional Medical Center
Joplin, Missouri, 64804, United States
St. John's Health System
Springfield, Missouri, 65804, United States
Cancer Research for the Ozarks
Springfield, Missouri, 65807, United States
Montana Cancer Consortium CCOP
Billings, Montana, 59101, United States
Benefis Health Care
Great Falls, Montana, 59405, United States
Good Samaritan Health Systems - Cancer Center
Kearney, Nebraska, 68847, United States
Cancer Resource Center
Lincoln, Nebraska, 68510-4844, United States
Alegent Health Immanuel Medical Center
Omaha, Nebraska, 68122, United States
Alegent Health Bergan Mercy Medical Center
Omaha, Nebraska, 68124, United States
Missouri Valley Cancer Cons CCOP/Creighton University
Omaha, Nebraska, 68131, United States
Washoe Medical Center
Reno, Nevada, 89520, United States
VAMC New Jersey Health Care System
East Orange, New Jersey, 07018-1095, United States
Warren Hospital
Phillipsburg, New Jersey, 08865, United States
Riverview Medical Center
Red Bank, New Jersey, 07701, United States
Stratton Veterans Affairs Medical Center
Albany, New York, 12208, United States
Bassett Research Institute
Cooperstown, New York, 13326-1394, United States
Glens Falls Hospital
Glens Falls, New York, 12801, United States
Good Samaritan Hospital
Cincinnati, Ohio, 45220-2489, United States
Columbus CCOP
Columbus, Ohio, 43206, United States
Fremont Memorial Hospital
Fremont, Ohio, 43420, United States
NW Ohio Oncology Center/St. Luke's Hospital
Maumee, Ohio, 43537, United States
St. Charles Hospital
Oregon, Ohio, 43616, United States
Flower Hospital
Sylvania, Ohio, 43560-2197, United States
Toledo Hospital
Toledo, Ohio, 43606, United States
St. Vincent Medical Center
Toledo, Ohio, 43608, United States
Toledo CCOP
Toledo, Ohio, 43623, United States
Toledo Clinic Inc.
Toledo, Ohio, 43623, United States
Muskogee Regional Medical Center
Muskogee, Oklahoma, 74401-5075, United States
Abington Memorial Hospital
Abington, Pennsylvania, 19001-3788, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, 18103, United States
St. Luke's Hospital and Health Network
Bethlehem, Pennsylvania, 18015, United States
Doylestown Hospital
Doylestown, Pennsylvania, 18901, United States
York Cancer Center/Wellspan Health
York, Pennsylvania, 17403-5049, United States
Sioux Community Cancer Consortium
Sioux Falls, South Dakota, 57105, United States
Thompson Cancer Survival Center
Knoxville, Tennessee, 37916, United States
Baptist Memorial Hospital - Memphis
Memphis, Tennessee, 38120, United States
Meharry Medical College
Nashville, Tennessee, 37208-3599, United States
Methodist Regional Cancer Center
Oak Ridge, Tennessee, 37830, United States
Methodist Hospitals of Dallas
Dallas, Texas, 75203, United States
Scott & White CCOP
Temple, Texas, 76508, United States
Cascadia Clinical Trials at St. Joseph Hospital
Bellingham, Washington, 98225-1898, United States
Virginia Mason CCOP
Seattle, Washington, 98101, United States
Swedish Medical Center
Seattle, Washington, 98104, United States
Northwest Hospital
Seattle, Washington, 98133, United States
Marshfield Clinic
Marshfield, Wisconsin, 54449-5703, United States
Sinai Samaritan Medical Center
Milwaukee, Wisconsin, 53233, United States
Ottawa General Hospital
Ottawa, Ontario, K1H 8L6, Canada
San Juan Dr. I. Gonzalez Martinez/Centro Medico
San Juan, 00919-1811, Puerto Rico
Altamira Family Medicine
San Juan, 00920, Puerto Rico
Centro Clinico San Patricio
San Juan, 00921, Puerto Rico
Miguel Sosa Padilla, MD/San Juan City Hospital
San Juan, 00926, Puerto Rico
VAMC San Juan
San Juan, 00927, Puerto Rico
San Juan City Hospital - PR, Hematology Oncology Office
San Juan, 00936-8344, Puerto Rico
Related Publications (12)
Lovell MA, Ehmann WD, Butler SM, Markesbery WR. Elevated thiobarbituric acid-reactive substances and antioxidant enzyme activity in the brain in Alzheimer's disease. Neurology. 1995 Aug;45(8):1594-601. doi: 10.1212/wnl.45.8.1594.
PMID: 7644059BACKGROUNDSano M, Ernesto C, Thomas RG, Klauber MR, Schafer K, Grundman M, Woodbury P, Growdon J, Cotman CW, Pfeiffer E, Schneider LS, Thal LJ. A controlled trial of selegiline, alpha-tocopherol, or both as treatment for Alzheimer's disease. The Alzheimer's Disease Cooperative Study. N Engl J Med. 1997 Apr 24;336(17):1216-22. doi: 10.1056/NEJM199704243361704.
PMID: 9110909BACKGROUNDMarkesbery WR, Carney JM. Oxidative alterations in Alzheimer's disease. Brain Pathol. 1999 Jan;9(1):133-46. doi: 10.1111/j.1750-3639.1999.tb00215.x.
PMID: 9989456BACKGROUNDGoodman PJ, Tangen CM, Darke AK, Arnold KB, Hartline J, Yee M, Anderson K, Caban-Holt A, Christen WG, Cassano PA, Lance P, Klein EA, Crowley JJ, Minasian LM, Meyskens FL. Opportunities and challenges in incorporating ancillary studies into a cancer prevention randomized clinical trial. Trials. 2016 Aug 12;17:400. doi: 10.1186/s13063-016-1524-9.
PMID: 27519183BACKGROUNDMathews M, Abner E, Caban-Holt A, Dennis BC, Kryscio R, Schmitt F. Quality of education and memory test performance in older men: the New York University Paragraph Recall Test normative data. Curr Alzheimer Res. 2013 Sep;10(7):776-83. doi: 10.2174/15672050113109990140.
PMID: 23906000BACKGROUNDKryscio RJ, Abner EL, Schmitt FA, Goodman PJ, Mendiondo M, Caban-Holt A, Dennis BC, Mathews M, Klein EA, Crowley JJ; SELECT Investigators. A randomized controlled Alzheimer's disease prevention trial's evolution into an exposure trial: the PREADViSE Trial. J Nutr Health Aging. 2013 Jan;17(1):72-5. doi: 10.1007/s12603-012-0083-3.
PMID: 23299383BACKGROUNDAbner EL, Dennis BC, Mathews MJ, Mendiondo MS, Caban-Holt A, Kryscio RJ, Schmitt FA; PREADViSE Investigators; Crowley JJ; SELECT Investigators. Practice effects in a longitudinal, multi-center Alzheimer's disease prevention clinical trial. Trials. 2012 Nov 20;13:217. doi: 10.1186/1745-6215-13-217.
PMID: 23171483BACKGROUNDCaban-Holt A, Abner E, Kryscio RJ, Crowley JJ, Schmitt FA. Age-expanded normative data for the Ruff 2&7 Selective Attention Test: evaluating cognition in older males. Clin Neuropsychol. 2012;26(5):751-68. doi: 10.1080/13854046.2012.690451. Epub 2012 May 31.
PMID: 22651854BACKGROUNDDing X, Kryscio RJ, Turner J, Jicha GA, Cooper G, Caban-Holt A, Schmitt FA, Abner EL. Self-Reported Sleep Apnea and Dementia Risk: Findings from the Prevention of Alzheimer's Disease with Vitamin E and Selenium Trial. J Am Geriatr Soc. 2016 Dec;64(12):2472-2478. doi: 10.1111/jgs.14393. Epub 2016 Nov 1.
PMID: 27801937RESULTAbner EL, Kryscio RJ, Caban-Holt AM, Schmitt FA. Baseline subjective memory complaints associate with increased risk of incident dementia: the PREADVISE trial. J Prev Alzheimers Dis. 2015 Mar;2(1):11-16. doi: 10.14283/jpad.2015.37.
PMID: 26180776RESULTKryscio RJ, Abner EL, Caban-Holt A, Lovell M, Goodman P, Darke AK, Yee M, Crowley J, Schmitt FA. Association of Antioxidant Supplement Use and Dementia in the Prevention of Alzheimer's Disease by Vitamin E and Selenium Trial (PREADViSE). JAMA Neurol. 2017 May 1;74(5):567-573. doi: 10.1001/jamaneurol.2016.5778.
PMID: 28319243RESULTDing X, Abner EL, Schmitt FA, Crowley J, Goodman P, Kryscio RJ. Mental Component Score (MCS) from Health-Related Quality of Life Predicts Incidence of Dementia in U.S. Males. J Prev Alzheimers Dis. 2021;8(2):169-174. doi: 10.14283/jpad.2020.50.
PMID: 33569563DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Frederick Schmitt, PhD
Sanders-Brown Center on Aging
- PRINCIPAL INVESTIGATOR
Richard Kryscio, PhD
Sanders-Brown Center on Aging
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 25, 2002
First Posted
June 27, 2002
Study Start
May 1, 2002
Primary Completion
January 1, 2014
Study Completion
August 1, 2016
Last Updated
March 14, 2018
Record last verified: 2018-03