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

Phase 3
60 Years
90 Years
Open (Enrolling)
Alzheimer Disease

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Trial Information

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

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.

Inclusion Criteria:

- Participating in SELECT Prevention study;

- 62 years or older if other ethnic origin, or 60 years or older if African-American or

- 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Outcome Measure:

Effect on the incidence of dementia (including Alzheimer's disease) over time

Outcome Time Frame:

7 to 12 years (depending on enrollment date)

Safety Issue:


Principal Investigator

Frederick Schmitt, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sanders-Brown Center on Aging


United States: Federal Government

Study ID:




Start Date:

May 2002

Completion Date:

August 2014

Related Keywords:

  • Alzheimer Disease
  • Alzheimer Disease
  • Vitamin E
  • Selenium
  • Alzheimer Disease



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