Prevention of Alzheimer's Disease by Vitamin E and Selenium (PREADVISE)

March 12, 2018 updated by: Frederick Schmitt
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.

Study Overview

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.

Study Type

Observational

Enrollment (Actual)

4246

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • Ottawa General Hospital
      • San Juan, Puerto Rico, 00919-1811
        • San Juan Dr. I. Gonzalez Martinez/Centro Medico
      • San Juan, Puerto Rico, 00920
        • Altamira Family Medicine
      • San Juan, Puerto Rico, 00921
        • Centro Clinico San Patricio
      • San Juan, Puerto Rico, 00926
        • Miguel Sosa Padilla, MD/San Juan City Hospital
      • San Juan, Puerto Rico, 00927
        • VAMC San Juan
      • San Juan, Puerto Rico, 00936-8344
        • San Juan City Hospital - PR, Hematology Oncology Office
    • Alabama
      • Birmingham, Alabama, United States, 35294-4410
        • University of Alabama at Birmingham Preventive Medicine
    • Alaska
      • Anchorage, Alaska, United States, 99508
        • Providence Alaska Medical Center
      • Anchorage, Alaska, United States, 99508
        • Alaska Regional Hospital
    • California
      • Chula Vista, California, United States, 91910
        • University of California, San Diego - Chula Vista
      • Glendale, California, United States, 91204
        • Glendale Memorial Hospital
      • La Jolla, California, United States, 92037-1709
        • University of California, San Diego
      • Loma Linda, California, United States, 92354-3866
        • VA Medical Center
      • Long Beach, California, United States, 90822
        • VAMC Long Beach
      • Northridge, California, United States, 91328
        • Northridge Hospital Medical Center
      • Santa Rosa, California, United States, 95403
        • Santa Rosa Memorial Hospital Regional CCOP
      • Torrance, California, United States, 90502-2064
        • LABIOMED (Los Angeles Biomedical) Research Institute at Harbor-UCLA Medical Center
      • Upland, California, United States, 91786
        • Lionel B. Katchem
    • Colorado
      • Fort Collins, Colorado, United States, 80524
        • Rocky Mountain CC/Poudre Valley Hospital
    • District of Columbia
      • Washington, District of Columbia, United States, 20016
        • Sibley Memorial Hospital
      • Washington, District of Columbia, United States, 20037
        • George Washington University Medical Center
      • Washington, District of Columbia, United States, 20060-0001
        • DC United MBCCOP
    • Florida
      • Jacksonville, Florida, United States, 32207-8560
        • Baptist Medical Center
    • Georgia
      • Tucker, Georgia, United States, 30084
        • Kaiser Southeast Permanente Medical Group
    • Iowa
      • Ames, Iowa, United States, 50010
        • Bliss Cancer Center/McFarland Clinic/Mary Greely MC
      • Cedar Rapids, Iowa, United States, 52403
        • Cedar Rapids CCOP
      • Davenport, Iowa, United States, 52804
        • Genesis Medical Center
      • Des Moines, Iowa, United States, 50309-1016
        • Iowa Oncology Research Association
      • Sioux City, Iowa, United States, 51101
        • Siouxland Hematology-Oncology Associates
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center
      • Topeka, Kansas, United States, 66606
        • Stormont-Vail Health Care/Cotton O'Neil Clinic
      • Wichita, Kansas, United States, 67214-3882
        • Wichita CCOP
    • Kentucky
      • Ashland, Kentucky, United States, 41101
        • Our Lady of Bellefonte Hospital Inc.
      • Lexington, Kentucky, United States, 40536-0093
        • University of Kentucky Medical Center
      • Louisville, Kentucky, United States, 40206-1499
        • Louisville VA Medical Center
    • Maryland
      • Annapolis, Maryland, United States, 21401-2777
        • Anne Arundel Medical Center
    • Massachusetts
      • Pittsfield, Massachusetts, United States, 01201
        • Berkshire Hematology Oncology/Bershire Medical Center
    • Michigan
      • Adrian, Michigan, United States, 49221
        • Bixby Oncology Center
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
      • Grand Rapids, Michigan, United States, 49503-2560
        • Grand Rapids Clinical Oncology Program CCOP
      • Monroe, Michigan, United States, 48162
        • Monroe Clinic
      • Pontiac, Michigan, United States, 48341
        • St. Joseph Mercy Oakland
      • Traverse City, Michigan, United States, 49684-2386
        • Munson Medical Center
    • Minnesota
      • Duluth, Minnesota, United States, 55805
        • Duluth CCOP
    • Missouri
      • Joplin, Missouri, United States, 64804
        • St. John's Regional Medical Center
      • Springfield, Missouri, United States, 65807
        • Cancer Research for the Ozarks
      • Springfield, Missouri, United States, 65804
        • St. John's Health System
    • Montana
      • Billings, Montana, United States, 59101
        • Montana Cancer Consortium CCOP
      • Great Falls, Montana, United States, 59405
        • Benefis Health Care
    • Nebraska
      • Kearney, Nebraska, United States, 68847
        • Good Samaritan Health Systems - Cancer Center
      • Lincoln, Nebraska, United States, 68510-4844
        • Cancer Resource Center
      • Omaha, Nebraska, United States, 68124
        • Alegent Health Bergan Mercy Medical Center
      • Omaha, Nebraska, United States, 68122
        • Alegent Health Immanuel Medical Center
      • Omaha, Nebraska, United States, 68131
        • Missouri Valley Cancer Cons CCOP/Creighton University
    • Nevada
      • Reno, Nevada, United States, 89520
        • Washoe Medical Center
    • New Jersey
      • East Orange, New Jersey, United States, 07018-1095
        • VAMC New Jersey Health Care System
      • Phillipsburg, New Jersey, United States, 08865
        • Warren Hospital
      • Red Bank, New Jersey, United States, 07701
        • Riverview Medical Center
    • New York
      • Albany, New York, United States, 12208
        • Stratton Veterans Affairs Medical Center
      • Cooperstown, New York, United States, 13326-1394
        • Bassett Research Institute
      • Glens Falls, New York, United States, 12801
        • Glens Falls Hospital
    • Ohio
      • Cincinnati, Ohio, United States, 45220-2489
        • Good Samaritan Hospital
      • Columbus, Ohio, United States, 43206
        • Columbus CCOP
      • Fremont, Ohio, United States, 43420
        • Fremont Memorial Hospital
      • Maumee, Ohio, United States, 43537
        • NW Ohio Oncology Center/St. Luke's Hospital
      • Oregon, Ohio, United States, 43616
        • St. Charles Hospital
      • Sylvania, Ohio, United States, 43560-2197
        • Flower Hospital
      • Toledo, Ohio, United States, 43606
        • Toledo Hospital
      • Toledo, Ohio, United States, 43608
        • St. Vincent Medical Center
      • Toledo, Ohio, United States, 43623
        • Toledo CCOP
      • Toledo, Ohio, United States, 43623
        • Toledo Clinic Inc.
    • Oklahoma
      • Muskogee, Oklahoma, United States, 74401-5075
        • Muskogee Regional Medical Center
    • Pennsylvania
      • Abington, Pennsylvania, United States, 19001-3788
        • Abington Memorial Hospital
      • Allentown, Pennsylvania, United States, 18103
        • LeHigh Valley Hospital
      • Bethlehem, Pennsylvania, United States, 18015
        • St. Luke's Hospital and Health Network
      • Doylestown, Pennsylvania, United States, 18901
        • Doylestown Hospital
      • York, Pennsylvania, United States, 17403-5049
        • York Cancer Center/Wellspan Health
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Sioux Community Cancer Consortium
    • Tennessee
      • Knoxville, Tennessee, United States, 37916
        • Thompson Cancer Survival Center
      • Memphis, Tennessee, United States, 38120
        • Baptist Memorial Hospital - Memphis
      • Nashville, Tennessee, United States, 37208-3599
        • Meharry Medical College
      • Oak Ridge, Tennessee, United States, 37830
        • Methodist Regional Cancer Center
    • Texas
      • Dallas, Texas, United States, 75203
        • Methodist Hospitals of Dallas
      • Temple, Texas, United States, 76508
        • Scott & White CCOP
    • Washington
      • Bellingham, Washington, United States, 98225-1898
        • Cascadia Clinical Trials at St. Joseph Hospital
      • Seattle, Washington, United States, 98104
        • Swedish Medical Center
      • Seattle, Washington, United States, 98101
        • Virginia Mason CCOP
      • Seattle, Washington, United States, 98133
        • Northwest Hospital
    • Wisconsin
      • Marshfield, Wisconsin, United States, 54449-5703
        • Marshfield Clinic
      • Milwaukee, Wisconsin, United States, 53233
        • Sinai Samaritan Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Probability Sample

Study Population

Participant will be recruited from primary care office visits

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Combination therapy
vitamin E (alphatocopherol) and selenium
400 IU daily
Other Names:
  • Vitamin E
200mcg daily
Vitamin E only
vitamine E (alphatocopherol) and placebo
400 IU daily
Other Names:
  • Vitamin E
1 placebo pill daily
Selenium only
selenium and placebo (Placebo replacement for vitamin E)
200mcg daily
1 placebo pill daily
Placebo
placebo (Placebo replacement for vitamin E) and placebo (Placebo replacement for selenium)
1 placebo pill daily
1 placebo pill daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of dementia (including Alzheimer's disease)
Time Frame: 7 to 12 years (depending on enrollment date)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Frederick Schmitt, PhD, Sanders-Brown Center on Aging
  • Principal Investigator: Richard Kryscio, PhD, Sanders-Brown Center on Aging

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2002

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

June 25, 2002

First Submitted That Met QC Criteria

June 26, 2002

First Posted (Estimate)

June 27, 2002

Study Record Updates

Last Update Posted (Actual)

March 14, 2018

Last Update Submitted That Met QC Criteria

March 12, 2018

Last Verified

March 1, 2018

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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