Clinical trial NCT00040378: Prevention of Alzheimer's Disease by Vitamin E and Selenium (PREADVISE)
Official title: Prevention of Alzheimer's Disease by Vitamin E and Selenium (PREADVISE)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alzheimer Disease
Keywords: Alzheimer Disease
Vitamin E
Selenium
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
name: National Cancer Institute (NCI)
First posted: 2002-06-27
Enrollment: 4246
Sex: MALE
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participant will be recruited from primary care office visits

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.

Detailed description: Studies show that increased oxidative stress (from excess free radicals) may damage brain cells and is linked with Alzheimer's disease (AD). Many studies show increased oxidation of brain lipids (fats), proteins, carbohydrates (sugars) and DNA in AD. Although the causes of AD are not known, it is believed that oxidative stress is part of what damages brain cells in AD and probably other brain diseases. Animal and tissue culture studies of vitamin E and selenium suggest that they can protect brain cells from damage. This research study is being done to see how safe and effective vitamin E and selenium may be in preventing AD and other brain illnesses. These illnesses are more common in people over the age of 60 to 65. A potential benefit of participating in the PREADVISE study is that early detection of memory changes can lead to early diagnosis and treatment. Also, some participants may decrease their risk of getting AD if the supplements are effective. The findings of this study may also help in the research and understanding of AD.

Only participants who are taking part in the SELECT study (a study that looks at the use of vitamin E and selenium for preventing prostate cancer) may apply to participate in the PREADVISE study about how useful vitamin E and selenium might be for preventing memory changes with age (including Alzheimer's disease and other disease that can affect the brain). African American and Hispanic men who are age 60 or older may take part. Men of other ethnic groups aged 62 or older may take part. The SELECT doctors or staff will review the applicant's medical history and drugs to verify that they have no conditions that would exclude them from this study. About 10,000 men will take part in this study.

The PREADVISE study examinations will be done during the participant's annual SELECT visit at the clinic where the SELECT studies are being conducted. There will be one study visit for each year the participants are in SELECT (7 to 12 visits). Each visit for PREADVISE will consist of a brief screening of the participant's memory, and an update (if any) of the participant's family history of dementia and medications. If memory changes are suggested by the brief memory screen, the participant will be asked to take a longer memory screen to further evaluate the potential for memory changes. If the longer memory screen also suggests problems with the participant's memory, the participant will be asked to see his family doctor or a PREADVISE doctor for a more complete medical exam to find the possible causes of the memory change. Results of the doctor's medical exam, with the consent of the participant, will be sent to the PREADVISE doctors for their review to help with the diagnosis. Results of the memory checks will not be given to the participants. However, if the participant does have a medical workup for memory changes, this information will be given to the family doctor after the medical workup is completed. A portion of the blood sample that was taken when the participant entered SELECT might be analyzed and tested for a genetic risk factor associated with Alzheimer's disease, called Apolipoprotein E (ApoE). The results of this test will be used for research purposes only.

Eligibility criteria: Inclusion Criteria:

* Participating in SELECT Prevention study;
* 62 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.

Exclusion Criteria:

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.

Primary outcomes:
measure: incidence of dementia (including Alzheimer's disease)
timeFrame: 7 to 12 years (depending on enrollment date)
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham Preventive Medicine
state: Alabama
city: Anchorage
country: United States
facility: Alaska Regional Hospital
state: Alaska
city: Anchorage
country: United States
facility: Providence Alaska Medical Center
state: Alaska
city: Chula Vista
country: United States
facility: University of California, San Diego - Chula Vista
state: California
city: Glendale
country: United States
facility: Glendale Memorial Hospital
state: California
city: La Jolla
country: United States
facility: University of California, San Diego
state: California
city: Loma Linda
country: United States
facility: VA Medical Center
state: California
city: Long Beach
country: United States
facility: VAMC Long Beach
state: California
city: Northridge
country: United States
facility: Northridge Hospital Medical Center
state: California
city: Santa Rosa
country: United States
facility: Santa Rosa Memorial Hospital Regional CCOP
state: California
city: Torrance
country: United States
facility: LABIOMED (Los Angeles Biomedical) Research Institute at Harbor-UCLA Medical Center
state: California
city: Upland
country: United States
facility: Lionel B. Katchem
state: California
city: Fort Collins
country: United States
facility: Rocky Mountain CC/Poudre Valley Hospital
state: Colorado
city: Washington
country: United States
facility: Sibley Memorial Hospital
state: District of Columbia
city: Washington
country: United States
facility: George Washington University Medical Center
state: District of Columbia
city: Washington
country: United States
facility: DC United MBCCOP
state: District of Columbia
city: Jacksonville
country: United States
facility: Baptist Medical Center
state: Florida
city: Tucker
country: United States
facility: Kaiser Southeast Permanente Medical Group
state: Georgia
city: Ames
country: United States
facility: Bliss Cancer Center/McFarland Clinic/Mary Greely MC
state: Iowa
city: Cedar Rapids
country: United States
facility: Cedar Rapids CCOP
state: Iowa
city: Davenport
country: United States
facility: Genesis Medical Center
state: Iowa
city: Des Moines
country: United States
facility: Iowa Oncology Research Association
state: Iowa
city: Sioux City
country: United States
facility: Siouxland Hematology-Oncology Associates
state: Iowa
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Topeka
country: United States
facility: Stormont-Vail Health Care/Cotton O'Neil Clinic
state: Kansas
city: Wichita
country: United States
facility: Wichita CCOP
state: Kansas
city: Ashland
country: United States
facility: Our Lady of Bellefonte Hospital Inc.
state: Kentucky
city: Lexington
country: United States
facility: University of Kentucky Medical Center
state: Kentucky
city: Louisville
country: United States
facility: Louisville VA Medical Center
state: Kentucky
city: Annapolis
country: United States
facility: Anne Arundel Medical Center
state: Maryland
city: Pittsfield
country: United States
facility: Berkshire Hematology Oncology/Bershire Medical Center
state: Massachusetts
city: Adrian
country: United States
facility: Bixby Oncology Center
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Grand Rapids
country: United States
facility: Grand Rapids Clinical Oncology Program CCOP
state: Michigan
city: Monroe
country: United States
facility: Monroe Clinic
state: Michigan
city: Pontiac
country: United States
facility: St. Joseph Mercy Oakland
state: Michigan
city: Traverse City
country: United States
facility: Munson Medical Center
state: Michigan
city: Duluth
country: United States
facility: Duluth CCOP
state: Minnesota
city: Joplin
country: United States
facility: St. John's Regional Medical Center
state: Missouri
city: Springfield
country: United States
facility: St. John's Health System
state: Missouri
city: Springfield
country: United States
facility: Cancer Research for the Ozarks
state: Missouri
city: Billings
country: United States
facility: Montana Cancer Consortium CCOP
state: Montana
city: Great Falls
country: United States
facility: Benefis Health Care
state: Montana
city: Kearney
country: United States
facility: Good Samaritan Health Systems - Cancer Center
state: Nebraska
city: Lincoln
country: United States
facility: Cancer Resource Center
state: Nebraska
city: Omaha
country: United States
facility: Alegent Health Immanuel Medical Center
state: Nebraska
city: Omaha
country: United States
facility: Alegent Health Bergan Mercy Medical Center
state: Nebraska
city: Omaha
country: United States
facility: Missouri Valley Cancer Cons CCOP/Creighton University
state: Nebraska
city: Reno
country: United States
facility: Washoe Medical Center
state: Nevada
city: East Orange
country: United States
facility: VAMC New Jersey Health Care System
state: New Jersey
city: Phillipsburg
country: United States
facility: Warren Hospital
state: New Jersey
city: Red Bank
country: United States
facility: Riverview Medical Center
state: New Jersey
city: Albany
country: United States
facility: Stratton Veterans Affairs Medical Center
state: New York
city: Cooperstown
country: United States
facility: Bassett Research Institute
state: New York
city: Glens Falls
country: United States
facility: Glens Falls Hospital
state: New York
city: Cincinnati
country: United States
facility: Good Samaritan Hospital
state: Ohio
city: Columbus
country: United States
facility: Columbus CCOP
state: Ohio
city: Fremont
country: United States
facility: Fremont Memorial Hospital
state: Ohio
city: Maumee
country: United States
facility: NW Ohio Oncology Center/St. Luke's Hospital
state: Ohio
city: Oregon
country: United States
facility: St. Charles Hospital
state: Ohio
city: Sylvania
country: United States
facility: Flower Hospital
state: Ohio
city: Toledo
country: United States
facility: Toledo Hospital
state: Ohio
city: Toledo
country: United States
facility: St. Vincent Medical Center
state: Ohio
city: Toledo
country: United States
facility: Toledo CCOP
state: Ohio
city: Toledo
country: United States
facility: Toledo Clinic Inc.
state: Ohio
city: Muskogee
country: United States
facility: Muskogee Regional Medical Center
state: Oklahoma
city: Abington
country: United States
facility: Abington Memorial Hospital
state: Pennsylvania
city: Allentown
country: United States
facility: Lehigh Valley Hospital
state: Pennsylvania
city: Bethlehem
country: United States
facility: St. Luke's Hospital and Health Network
state: Pennsylvania
city: Doylestown
country: United States
facility: Doylestown Hospital
state: Pennsylvania
city: York
country: United States
facility: York Cancer Center/Wellspan Health
state: Pennsylvania
city: Sioux Falls
country: United States
facility: Sioux Community Cancer Consortium
state: South Dakota
city: Knoxville
country: United States
facility: Thompson Cancer Survival Center
state: Tennessee
city: Memphis
country: United States
facility: Baptist Memorial Hospital - Memphis
state: Tennessee
city: Nashville
country: United States
facility: Meharry Medical College
state: Tennessee
city: Oak Ridge
country: United States
facility: Methodist Regional Cancer Center
state: Tennessee
city: Dallas
country: United States
facility: Methodist Hospitals of Dallas
state: Texas
city: Temple
country: United States
facility: Scott & White CCOP
state: Texas
city: Bellingham
country: United States
facility: Cascadia Clinical Trials at St. Joseph Hospital
state: Washington
city: Seattle
country: United States
facility: Virginia Mason CCOP
state: Washington
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Seattle
country: United States
facility: Northwest Hospital
state: Washington
city: Marshfield
country: United States
facility: Marshfield Clinic
state: Wisconsin
city: Milwaukee
country: United States
facility: Sinai Samaritan Medical Center
state: Wisconsin
city: Ottawa
country: Canada
facility: Ottawa General Hospital
state: Ontario
city: San Juan
country: Puerto Rico
facility: San Juan Dr. I. Gonzalez Martinez/Centro Medico
city: San Juan
country: Puerto Rico
facility: Altamira Family Medicine
city: San Juan
country: Puerto Rico
facility: Centro Clinico San Patricio
city: San Juan
country: Puerto Rico
facility: Miguel Sosa Padilla, MD/San Juan City Hospital
city: San Juan
country: Puerto Rico
facility: VAMC San Juan
city: San Juan
country: Puerto Rico
facility: San Juan City Hospital - PR, Hematology Oncology Office
Study officials:
affiliation: Sanders-Brown Center on Aging
name: Frederick Schmitt, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sanders-Brown Center on Aging
name: Richard Kryscio, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Markesbery 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.
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citation: Mathews 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.
citation: Kryscio 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.
citation: Abner 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.
citation: Caban-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.
citation: Ding 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.
citation: Abner 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.
citation: Kryscio 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.
citation: Ding 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.