Prevention of Alzheimer's Disease by Vitamin E and Selenium (PREADVISE)
- Conditions
- Alzheimer Disease
- Interventions
- Drug: alphatocopherolDrug: Placebo replacement for SeleniumDrug: Placebo replacement for vitamin E
- Registration Number
- NCT00040378
- Lead Sponsor
- Frederick Schmitt
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 4246
- 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.
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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Combination therapy alphatocopherol vitamin E (alphatocopherol) and selenium Vitamin E only alphatocopherol vitamine E (alphatocopherol) and placebo Vitamin E only Placebo replacement for Selenium vitamine E (alphatocopherol) and placebo Selenium only Placebo replacement for vitamin E selenium and placebo (Placebo replacement for vitamin E) Placebo Placebo replacement for vitamin E placebo (Placebo replacement for vitamin E) and placebo (Placebo replacement for selenium) Placebo Placebo replacement for Selenium placebo (Placebo replacement for vitamin E) and placebo (Placebo replacement for selenium) Combination therapy Selenium vitamin E (alphatocopherol) and selenium Selenium only Selenium selenium and placebo (Placebo replacement for vitamin E)
- Primary Outcome Measures
Name Time Method incidence of dementia (including Alzheimer's disease) 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (91)
Duluth CCOP
🇺🇸Duluth, Minnesota, United States
NW Ohio Oncology Center/St. Luke's Hospital
🇺🇸Maumee, Ohio, United States
Marshfield Clinic
🇺🇸Marshfield, Wisconsin, United States
Virginia Mason CCOP
🇺🇸Seattle, Washington, United States
Northwest Hospital
🇺🇸Seattle, Washington, United States
Good Samaritan Hospital
🇺🇸Cincinnati, Ohio, United States
Stormont-Vail Health Care/Cotton O'Neil Clinic
🇺🇸Topeka, Kansas, United States
Wichita CCOP
🇺🇸Wichita, Kansas, United States
Columbus CCOP
🇺🇸Columbus, Ohio, United States
VAMC San Juan
🇵🇷San Juan, Puerto Rico
San Juan City Hospital - PR, Hematology Oncology Office
🇵🇷San Juan, Puerto Rico
University of Alabama at Birmingham Preventive Medicine
🇺🇸Birmingham, Alabama, United States
Glendale Memorial Hospital
🇺🇸Glendale, California, United States
University of California, San Diego
🇺🇸La Jolla, California, United States
University of California, San Diego - Chula Vista
🇺🇸Chula Vista, California, United States
Alaska Regional Hospital
🇺🇸Anchorage, Alaska, United States
Providence Alaska Medical Center
🇺🇸Anchorage, Alaska, United States
VA Medical Center
🇺🇸Loma Linda, California, United States
Northridge Hospital Medical Center
🇺🇸Northridge, California, United States
VAMC Long Beach
🇺🇸Long Beach, California, United States
Santa Rosa Memorial Hospital Regional CCOP
🇺🇸Santa Rosa, California, United States
Lionel B. Katchem
🇺🇸Upland, California, United States
LABIOMED (Los Angeles Biomedical) Research Institute at Harbor-UCLA Medical Center
🇺🇸Torrance, California, United States
Rocky Mountain CC/Poudre Valley Hospital
🇺🇸Fort Collins, Colorado, United States
George Washington University Medical Center
🇺🇸Washington, District of Columbia, United States
DC United MBCCOP
🇺🇸Washington, District of Columbia, United States
Sibley Memorial Hospital
🇺🇸Washington, District of Columbia, United States
Baptist Medical Center
🇺🇸Jacksonville, Florida, United States
Bliss Cancer Center/McFarland Clinic/Mary Greely MC
🇺🇸Ames, Iowa, United States
Kaiser Southeast Permanente Medical Group
🇺🇸Tucker, Georgia, United States
Cedar Rapids CCOP
🇺🇸Cedar Rapids, Iowa, United States
Genesis Medical Center
🇺🇸Davenport, Iowa, United States
Our Lady of Bellefonte Hospital Inc.
🇺🇸Ashland, Kentucky, United States
Iowa Oncology Research Association
🇺🇸Des Moines, Iowa, United States
Siouxland Hematology-Oncology Associates
🇺🇸Sioux City, Iowa, United States
University of Kentucky Medical Center
🇺🇸Lexington, Kentucky, United States
Anne Arundel Medical Center
🇺🇸Annapolis, Maryland, United States
Louisville VA Medical Center
🇺🇸Louisville, Kentucky, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Bixby Oncology Center
🇺🇸Adrian, Michigan, United States
Berkshire Hematology Oncology/Bershire Medical Center
🇺🇸Pittsfield, Massachusetts, United States
Grand Rapids Clinical Oncology Program CCOP
🇺🇸Grand Rapids, Michigan, United States
St. Joseph Mercy Oakland
🇺🇸Pontiac, Michigan, United States
Monroe Clinic
🇺🇸Monroe, Michigan, United States
St. John's Regional Medical Center
🇺🇸Joplin, Missouri, United States
Munson Medical Center
🇺🇸Traverse City, Michigan, United States
Montana Cancer Consortium CCOP
🇺🇸Billings, Montana, United States
St. John's Health System
🇺🇸Springfield, Missouri, United States
Cancer Research for the Ozarks
🇺🇸Springfield, Missouri, United States
Cancer Resource Center
🇺🇸Lincoln, Nebraska, United States
Good Samaritan Health Systems - Cancer Center
🇺🇸Kearney, Nebraska, United States
Alegent Health Bergan Mercy Medical Center
🇺🇸Omaha, Nebraska, United States
Alegent Health Immanuel Medical Center
🇺🇸Omaha, Nebraska, United States
Washoe Medical Center
🇺🇸Reno, Nevada, United States
Missouri Valley Cancer Cons CCOP/Creighton University
🇺🇸Omaha, Nebraska, United States
VAMC New Jersey Health Care System
🇺🇸East Orange, New Jersey, United States
Warren Hospital
🇺🇸Phillipsburg, New Jersey, United States
Bassett Research Institute
🇺🇸Cooperstown, New York, United States
Riverview Medical Center
🇺🇸Red Bank, New Jersey, United States
Stratton Veterans Affairs Medical Center
🇺🇸Albany, New York, United States
Glens Falls Hospital
🇺🇸Glens Falls, New York, United States
Toledo Hospital
🇺🇸Toledo, Ohio, United States
St. Vincent Medical Center
🇺🇸Toledo, Ohio, United States
Fremont Memorial Hospital
🇺🇸Fremont, Ohio, United States
St. Charles Hospital
🇺🇸Oregon, Ohio, United States
Flower Hospital
🇺🇸Sylvania, Ohio, United States
Toledo Clinic Inc.
🇺🇸Toledo, Ohio, United States
Toledo CCOP
🇺🇸Toledo, Ohio, United States
Muskogee Regional Medical Center
🇺🇸Muskogee, Oklahoma, United States
St. Luke's Hospital and Health Network
🇺🇸Bethlehem, Pennsylvania, United States
Lehigh Valley Hospital
🇺🇸Allentown, Pennsylvania, United States
Abington Memorial Hospital
🇺🇸Abington, Pennsylvania, United States
Doylestown Hospital
🇺🇸Doylestown, Pennsylvania, United States
York Cancer Center/Wellspan Health
🇺🇸York, Pennsylvania, United States
Thompson Cancer Survival Center
🇺🇸Knoxville, Tennessee, United States
Baptist Memorial Hospital - Memphis
🇺🇸Memphis, Tennessee, United States
Sioux Community Cancer Consortium
🇺🇸Sioux Falls, South Dakota, United States
Methodist Hospitals of Dallas
🇺🇸Dallas, Texas, United States
Cascadia Clinical Trials at St. Joseph Hospital
🇺🇸Bellingham, Washington, United States
Scott & White CCOP
🇺🇸Temple, Texas, United States
Sinai Samaritan Medical Center
🇺🇸Milwaukee, Wisconsin, United States
Ottawa General Hospital
🇨🇦Ottawa, Ontario, Canada
San Juan Dr. I. Gonzalez Martinez/Centro Medico
🇵🇷San Juan, Puerto Rico
Altamira Family Medicine
🇵🇷San Juan, Puerto Rico
Centro Clinico San Patricio
🇵🇷San Juan, Puerto Rico
Methodist Regional Cancer Center
🇺🇸Oak Ridge, Tennessee, United States
Miguel Sosa Padilla, MD/San Juan City Hospital
🇵🇷San Juan, Puerto Rico
Benefis Health Care
🇺🇸Great Falls, Montana, United States
Swedish Medical Center
🇺🇸Seattle, Washington, United States
Meharry Medical College
🇺🇸Nashville, Tennessee, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States