- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00040378
Prevention of Alzheimer's Disease by Vitamin E and Selenium (PREADVISE)
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Ontario
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Ottawa, Ontario, Canada, K1H 8L6
- Ottawa General Hospital
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San Juan, Puerto Rico, 00919-1811
- San Juan Dr. I. Gonzalez Martinez/Centro Medico
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San Juan, Puerto Rico, 00920
- Altamira Family Medicine
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San Juan, Puerto Rico, 00921
- Centro Clinico San Patricio
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San Juan, Puerto Rico, 00926
- Miguel Sosa Padilla, MD/San Juan City Hospital
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San Juan, Puerto Rico, 00927
- VAMC San Juan
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San Juan, Puerto Rico, 00936-8344
- San Juan City Hospital - PR, Hematology Oncology Office
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Alabama
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Birmingham, Alabama, United States, 35294-4410
- University of Alabama at Birmingham Preventive Medicine
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Alaska
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Anchorage, Alaska, United States, 99508
- Providence Alaska Medical Center
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Anchorage, Alaska, United States, 99508
- Alaska Regional Hospital
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California
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Chula Vista, California, United States, 91910
- University of California, San Diego - Chula Vista
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Glendale, California, United States, 91204
- Glendale Memorial Hospital
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La Jolla, California, United States, 92037-1709
- University of California, San Diego
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Loma Linda, California, United States, 92354-3866
- VA Medical Center
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Long Beach, California, United States, 90822
- VAMC Long Beach
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Northridge, California, United States, 91328
- Northridge Hospital Medical Center
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Santa Rosa, California, United States, 95403
- Santa Rosa Memorial Hospital Regional CCOP
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Torrance, California, United States, 90502-2064
- LABIOMED (Los Angeles Biomedical) Research Institute at Harbor-UCLA Medical Center
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Upland, California, United States, 91786
- Lionel B. Katchem
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Colorado
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Fort Collins, Colorado, United States, 80524
- Rocky Mountain CC/Poudre Valley Hospital
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District of Columbia
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Washington, District of Columbia, United States, 20016
- Sibley Memorial Hospital
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Washington, District of Columbia, United States, 20037
- George Washington University Medical Center
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Washington, District of Columbia, United States, 20060-0001
- DC United MBCCOP
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Florida
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Jacksonville, Florida, United States, 32207-8560
- Baptist Medical Center
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Georgia
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Tucker, Georgia, United States, 30084
- Kaiser Southeast Permanente Medical Group
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Iowa
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Ames, Iowa, United States, 50010
- Bliss Cancer Center/McFarland Clinic/Mary Greely MC
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Cedar Rapids, Iowa, United States, 52403
- Cedar Rapids CCOP
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Davenport, Iowa, United States, 52804
- Genesis Medical Center
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Des Moines, Iowa, United States, 50309-1016
- Iowa Oncology Research Association
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Sioux City, Iowa, United States, 51101
- Siouxland Hematology-Oncology Associates
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Kansas
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Kansas City, Kansas, United States, 66160
- University of Kansas Medical Center
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Topeka, Kansas, United States, 66606
- Stormont-Vail Health Care/Cotton O'Neil Clinic
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Wichita, Kansas, United States, 67214-3882
- Wichita CCOP
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Kentucky
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Ashland, Kentucky, United States, 41101
- Our Lady of Bellefonte Hospital Inc.
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Lexington, Kentucky, United States, 40536-0093
- University of Kentucky Medical Center
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Louisville, Kentucky, United States, 40206-1499
- Louisville VA Medical Center
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Maryland
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Annapolis, Maryland, United States, 21401-2777
- Anne Arundel Medical Center
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Massachusetts
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Pittsfield, Massachusetts, United States, 01201
- Berkshire Hematology Oncology/Bershire Medical Center
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Michigan
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Adrian, Michigan, United States, 49221
- Bixby Oncology Center
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Detroit, Michigan, United States, 48202
- Henry Ford Hospital
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Grand Rapids, Michigan, United States, 49503-2560
- Grand Rapids Clinical Oncology Program CCOP
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Monroe, Michigan, United States, 48162
- Monroe Clinic
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Pontiac, Michigan, United States, 48341
- St. Joseph Mercy Oakland
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Traverse City, Michigan, United States, 49684-2386
- Munson Medical Center
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Minnesota
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Duluth, Minnesota, United States, 55805
- Duluth CCOP
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Missouri
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Joplin, Missouri, United States, 64804
- St. John's Regional Medical Center
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Springfield, Missouri, United States, 65807
- Cancer Research for the Ozarks
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Springfield, Missouri, United States, 65804
- St. John's Health System
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Montana
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Billings, Montana, United States, 59101
- Montana Cancer Consortium CCOP
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Great Falls, Montana, United States, 59405
- Benefis Health Care
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Nebraska
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Kearney, Nebraska, United States, 68847
- Good Samaritan Health Systems - Cancer Center
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Lincoln, Nebraska, United States, 68510-4844
- Cancer Resource Center
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Omaha, Nebraska, United States, 68124
- Alegent Health Bergan Mercy Medical Center
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Omaha, Nebraska, United States, 68122
- Alegent Health Immanuel Medical Center
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Omaha, Nebraska, United States, 68131
- Missouri Valley Cancer Cons CCOP/Creighton University
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Nevada
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Reno, Nevada, United States, 89520
- Washoe Medical Center
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New Jersey
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East Orange, New Jersey, United States, 07018-1095
- VAMC New Jersey Health Care System
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Phillipsburg, New Jersey, United States, 08865
- Warren Hospital
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Red Bank, New Jersey, United States, 07701
- Riverview Medical Center
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New York
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Albany, New York, United States, 12208
- Stratton Veterans Affairs Medical Center
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Cooperstown, New York, United States, 13326-1394
- Bassett Research Institute
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Glens Falls, New York, United States, 12801
- Glens Falls Hospital
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Ohio
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Cincinnati, Ohio, United States, 45220-2489
- Good Samaritan Hospital
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Columbus, Ohio, United States, 43206
- Columbus CCOP
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Fremont, Ohio, United States, 43420
- Fremont Memorial Hospital
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Maumee, Ohio, United States, 43537
- NW Ohio Oncology Center/St. Luke's Hospital
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Oregon, Ohio, United States, 43616
- St. Charles Hospital
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Sylvania, Ohio, United States, 43560-2197
- Flower Hospital
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Toledo, Ohio, United States, 43606
- Toledo Hospital
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Toledo, Ohio, United States, 43608
- St. Vincent Medical Center
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Toledo, Ohio, United States, 43623
- Toledo CCOP
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Toledo, Ohio, United States, 43623
- Toledo Clinic Inc.
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Oklahoma
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Muskogee, Oklahoma, United States, 74401-5075
- Muskogee Regional Medical Center
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Pennsylvania
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Abington, Pennsylvania, United States, 19001-3788
- Abington Memorial Hospital
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Allentown, Pennsylvania, United States, 18103
- LeHigh Valley Hospital
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Bethlehem, Pennsylvania, United States, 18015
- St. Luke's Hospital and Health Network
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Doylestown, Pennsylvania, United States, 18901
- Doylestown Hospital
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York, Pennsylvania, United States, 17403-5049
- York Cancer Center/Wellspan Health
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South Dakota
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Sioux Falls, South Dakota, United States, 57105
- Sioux Community Cancer Consortium
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Tennessee
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Knoxville, Tennessee, United States, 37916
- Thompson Cancer Survival Center
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Memphis, Tennessee, United States, 38120
- Baptist Memorial Hospital - Memphis
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Nashville, Tennessee, United States, 37208-3599
- Meharry Medical College
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Oak Ridge, Tennessee, United States, 37830
- Methodist Regional Cancer Center
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Texas
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Dallas, Texas, United States, 75203
- Methodist Hospitals of Dallas
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Temple, Texas, United States, 76508
- Scott & White CCOP
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Washington
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Bellingham, Washington, United States, 98225-1898
- Cascadia Clinical Trials at St. Joseph Hospital
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Seattle, Washington, United States, 98104
- Swedish Medical Center
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Seattle, Washington, United States, 98101
- Virginia Mason CCOP
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Seattle, Washington, United States, 98133
- Northwest Hospital
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Wisconsin
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Marshfield, Wisconsin, United States, 54449-5703
- Marshfield Clinic
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Milwaukee, Wisconsin, United States, 53233
- Sinai Samaritan Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Combination therapy
vitamin E (alphatocopherol) and selenium
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400 IU daily
Other Names:
200mcg daily
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Vitamin E only
vitamine E (alphatocopherol) and placebo
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400 IU daily
Other Names:
1 placebo pill daily
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Selenium only
selenium and placebo (Placebo replacement for vitamin E)
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200mcg daily
1 placebo pill daily
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Placebo
placebo (Placebo replacement for vitamin E) and placebo (Placebo replacement for selenium)
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1 placebo pill daily
1 placebo pill daily
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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)
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Participants will complete a modified Telephone Interview of Cognitive Status (TIC-S) to evaluate the onset of dementia
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7 to 12 years (depending on enrollment date)
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Collaborators and Investigators
Sponsor
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
General Publications
- 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.
- Sano 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.
- 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.
- Goodman 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurocognitive Disorders
- Neurodegenerative Diseases
- Dementia
- Tauopathies
- Alzheimer Disease
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Protective Agents
- Trace Elements
- Micronutrients
- Antioxidants
- Vitamin E
- Tocopherols
- alpha-Tocopherol
- Vitamins
- Tocotrienols
- Selenium
Other Study ID Numbers
- IA0033
- 5R01AG019241 (U.S. NIH Grant/Contract)
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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