Prevention of Alzheimer's Disease by Vitamin E and Selenium (PREADVISE)
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Observational

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.
    

Intervention name(s): alphatocopherol; Selenium; Placebo replacement for vitamin E; Placebo replacement for Selenium
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 400 IU daily; 200mcg daily; 1 placebo pill daily; 1 placebo pill daily
Other intervention name(s): Vitamin E
Intervention MeSH terms: Vitamins; Vitamin E; Tocopherols; Tocotrienols; alpha-Tocopherol; Selenium
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Participant will be recruited from primary care office visits
      
Keywords: Alzheimer Disease; Vitamin E; Selenium