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.

Condition	Treatment or Intervention	Phase
Alzheimer Disease	Drug: Vitamin E  Drug: Selenium	Phase III

Further Study Details: 

Expected Total Enrollment:  10400

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.

Ages Eligible for Study:  60 Years   -   90 Years,  Genders Eligible for Study:  Male

Accepts Healthy Volunteers

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.

Cecil R. Runyons      1-859-257-1412  Ext. 235    preadvise@lsv.uky.edu

Alabama
      University of Alabama at Birmingham Preventive Medicine, Birmingham,  Alabama,  35294-4410,  United States; Recruiting
Alaska
      Providence Alaska Medical Center, Anchorage,  Alaska,  99508,  United States; Recruiting
      Alaska Regional Hospital, Anchorage,  Alaska,  99508,  United States; Recruiting
California
      VA Medical Center, Loma Linda,  California,  92354-3866,  United States; Recruiting
      Santa Rosa Memorial Hospital Regional CCOP, Santa Rosa,  California,  95403,  United States; Recruiting
      Harbor UCLA Medical Cemter, Torrance,  California,  90502-2064,  United States; Recruiting
      Lionel B. Katchem, Upland,  California,  91786,  United States; Recruiting
      University of California, San Diego - Chula Vista, Chula Vista,  California,  91910,  United States; Recruiting
      Glendale Memorial Hospital, Glendale,  California,  91204,  United States; Recruiting
      University of California, San Diego, La Jolla,  California,  92037-1709,  United States; Recruiting
      VAMC Long Beach, Long Beach,  California,  90822,  United States; Recruiting
      Northridge Hospital Medical Center, Northridge,  California,  91328,  United States; Recruiting
Colorado
      Rocky Mountain CC/Poudre Valley Hospital, Fort Collins,  Colorado,  80524,  United States; Recruiting
District of Columbia
      DC United MBCCOP, Washington, DC,  District of Columbia,  20060-0001,  United States; Recruiting
      George Washington University Medical Center, Washington, DC,  District of Columbia,  20037,  United States; Recruiting
      Sibley Memorial Hospital, Washington, DC,  District of Columbia,  20016,  United States; Recruiting
Florida
      Baptist Medical Center, Jacksonville,  Florida,  32207-8560,  United States; Recruiting
Georgia
      Kaiser Southeast Permanente Medical Group, Tucker,  Georgia,  30084,  United States; Recruiting
Iowa
      Bliss Cancer Center/McFarland Clinic/Mary Greely MC, Ames,  Iowa,  50010,  United States; Recruiting
      Cedar Rapids CCOP, Cedar Rapids,  Iowa,  52403,  United States; Recruiting
      Genesis Medical Center, Davenport,  Iowa,  52804,  United States; Not yet recruiting
      Iowa Oncology Research Association, Des Moines,  Iowa,  50309-1016,  United States; Recruiting
      Siouxland Hematology-Oncology Associates, Sioux City,  Iowa,  51101,  United States; Recruiting
Kansas
      Stormont-Vail Health Care/Cotton O'Neil Clinic, Topeka,  Kansas,  66606,  United States; Recruiting
      Wichita CCOP, Wichita,  Kansas,  67214-3882,  United States; Recruiting
      University of Kansas Medical Center, Kansas City,  Kansas,  66160,  United States; Recruiting
Kentucky
      Louisville VA Medical Center, Louisville,  Kentucky,  40206-1499,  United States; Recruiting
      Our Lady of Bellefonte Hospital Inc., Ashland,  Kentucky,  41101,  United States; Recruiting
      University of Kentucky Medical Center, Lexington,  Kentucky,  40536-0093,  United States; Recruiting
Maryland
      Anne Arundel Medical Center, Annapolis,  Maryland,  21401-2777,  United States; Recruiting
Massachusetts
      Berkshire Hematology Oncology/Bershire Medical Center, Pittsfield,  Massachusetts,  01201,  United States; Recruiting
Michigan
      Bixby Oncology Center, Adrian,  Michigan,  49221,  United States; Recruiting
      Henry Ford Hospital, Detroit,  Michigan,  48202,  United States; Recruiting
      Grand Rapids Clinical Oncology Program CCOP, Grand Rapids,  Michigan,  49503-2560,  United States; Recruiting
      Monroe Clinic, Monroe,  Michigan,  48162,  United States; Recruiting
      St. Joseph Mercy Oakland, Pontiac,  Michigan,  48341,  United States; Recruiting
      Munson Medical Center, Traverse City,  Michigan,  49684-2386,  United States; Recruiting
Minnesota
      Duluth CCOP, Duluth,  Minnesota,  55805,  United States; Recruiting
Mississippi
      Delta Health Center, Mound Bayou,  Mississippi,  38762,  United States; Not yet recruiting
Missouri
      St. John's Regional Medical Center, Joplin,  Missouri,  64804,  United States; Recruiting
      Cancer Research for the Ozarks, Springfield,  Missouri,  65807,  United States; Recruiting
      St. John's Health System, Springfield,  Missouri,  65804,  United States; Recruiting
Montana
      Montana Cancer Consortium CCOP, Billings,  Montana,  59101,  United States; Recruiting
      Benefis Health Care, Great Falls,  Montana,  59405,  United States; Recruiting
Nebraska
      Cancer Resource Center, Lincoln,  Nebraska,  68510-4844,  United States; Recruiting
      Missouri Valley Cancer Cons CCOP/Creighton University, Omaha,  Nebraska,  68131,  United States; Recruiting
      Alegent Health Bergan Mercy Medical Center, Omaha,  Nebraska,  68124,  United States; Recruiting
      Alegent Health Immanuel Medical Center, Omaha,  Nebraska,  68122,  United States; Recruiting
      Good Samaritan Health Systems - Cancer Center, Kearney,  Nebraska,  68847,  United States; Recruiting
Nevada
      Washoe Medical Center, Reno,  Nevada,  89520,  United States; Recruiting
New Jersey
      Riverview Medical Center, Red Bank,  New Jersey,  07701,  United States; Recruiting
      VAMC New Jersey Health Care System, East Orange,  New Jersey,  07018-1095,  United States; Recruiting
      Warren Hospital, Phillipsburg,  New Jersey,  08865,  United States; Recruiting
New York
      Bassett Research Institute, Cooperstown,  New York,  13326-1394,  United States; Recruiting
      Glens Falls Hospital, Glens Falls,  New York,  12801,  United States; Recruiting
      Stratton Veterans Affairs Medical Center, Albany,  New York,  12208,  United States; Recruiting
Ohio
      Good Samaritan Hospital, Cincinnati,  Ohio,  45220-2489,  United States; Recruiting
      Columbus CCOP, Columbus,  Ohio,  43206,  United States; Recruiting
      Fremont Memorial Hospital, Fremont,  Ohio,  43420,  United States; Not yet recruiting
      NW Ohio Oncology Center/St. Luke's Hospital, Maumee,  Ohio,  43537,  United States; Recruiting
      St. Charles Hospital, Oregon,  Ohio,  43616,  United States; Recruiting
      Flower Hospital, Sylvania,  Ohio,  43560-2197,  United States; Recruiting
      St. Vincent Medical Center, Toledo,  Ohio,  43608,  United States; Recruiting
      Toledo CCOP, Toledo,  Ohio,  43623,  United States; Recruiting
      Toledo Clinic Inc., Toledo,  Ohio,  43623,  United States; Recruiting
      Toledo Hospital, Toledo,  Ohio,  43606,  United States; Recruiting
Oklahoma
      Muskogee Regional Medical Center, Muskogee,  Oklahoma,  74401-5075,  United States; Recruiting
Pennsylvania
      Lehigh Valley Hospital, Allentown,  Pennsylvania,  18103,  United States; Recruiting
      Abington Memorial Hospital, Abington,  Pennsylvania,  19001-3788,  United States; Recruiting
      St. Luke's Hospital and Health Network, Bethlehem,  Pennsylvania,  18015,  United States; Recruiting
      Doylestown Hospital, Doylestown,  Pennsylvania,  18901,  United States; Recruiting
      York Cancer Center/Wellspan Health, York,  Pennsylvania,  17403-5049,  United States; Not yet recruiting
South Dakota
      Sioux Community Cancer Consortium, Sioux Falls,  South Dakota,  57105,  United States; Recruiting
Tennessee
      Methodist Regional Cancer Center, Oak Ridge,  Tennessee,  37830,  United States; Recruiting
      Thompson Cancer Survival Center, Knoxville,  Tennessee,  37916,  United States; Recruiting
      Baptist Memorial Hospital - Memphis, Memphis,  Tennessee,  38120,  United States; Recruiting
      Meharry Medical College, Nashville,  Tennessee,  37208-3599,  United States; Not yet recruiting
Texas
      Scott & White CCOP, Temple,  Texas,  76508,  United States; Recruiting
      Methodist Hospitals of Dallas, Dallas,  Texas,  75203,  United States; Recruiting
Washington
      Northwest Hospital, Seattle,  Washington,  98133,  United States; Recruiting
      Cascadia Clinical Trials at St. Joseph Hospital, Bellingham,  Washington,  98225-1898,  United States; Recruiting
      Swedish Medical Center, Seattle,  Washington,  98104,  United States; Recruiting
      Virginia Mason CCOP, Seattle,  Washington,  98101,  United States; Recruiting
Wisconsin
      Marshfield Clinic, Marshfield,  Wisconsin,  54449-5703,  United States; Recruiting
      Sinai Samaritan Medical Center, Milwaukee,  Wisconsin,  53233,  United States; Recruiting
Canada, Ontario
      Ottawa General Hospital, Ottawa,  Ontario,  K1H 8L6,  Canada; Recruiting
Puerto Rico
      Altamira Family Medicine, San Juan,  00920,  Puerto Rico; Recruiting
      Centro Clinico San Patricio, San Juan,  00921,  Puerto Rico; Recruiting
      Miguel Sosa Padilla, MD/San Juan City Hospital, San Juan,  00926,  Puerto Rico; Recruiting
      San Juan City Hospital - PR, Hematology Oncology Office, San Juan,  00936-8344,  Puerto Rico; Recruiting
      San Juan Dr. I. Gonzalez Martinez/Centro Medico, San Juan,  00919-1811,  Puerto Rico; Recruiting
      VAMC San Juan, San Juan,  00927,  Puerto Rico; Recruiting

Study chairs or principal investigators

William Markesbery, MD,  Principal Investigator,  Sanders-Brown Center on Aging   
Frederick Schmitt, PhD,  Principal Investigator,  Sanders-Brown Center on Aging   
Richard Kryscio, PhD,  Principal Investigator,  Sanders-Brown Center on Aging   

Study ID Numbers:  IA0033
Record last reviewed:  November 2004
Last Updated:  November 3, 2004
Record first received:  June 25, 2002
ClinicalTrials.gov Identifier:  NCT00040378
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08