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Sponsors and Collaborators: |
National Institute on Aging (NIA) National Cancer Institute (NCI) |
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Information provided by: | National Institute on Aging (NIA) |
ClinicalTrials.gov Identifier: | NCT00040378 |
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.
Condition | Intervention | Phase |
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Alzheimer Disease |
Drug: alphatocopherol Drug: Selenium Drug: Placebo replacement for vitamin E Drug: Placebo replacement for Selenium |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Factorial Assignment, Efficacy Study |
Official Title: | Prevention of Alzheimer's Disease by Vitamin E and Selenium (PREADVISE) |
Estimated Enrollment: | 10400 |
Study Start Date: | May 2002 |
Estimated Study Completion Date: | August 2012 |
Estimated Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
vitamin E and selenium
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Drug: alphatocopherol
400 IU daily
Drug: Selenium
200mcg daily
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2: Experimental
vitamine E and placebo
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Drug: alphatocopherol
400 IU daily
Drug: Placebo replacement for Selenium
1 placebo pill daily
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3: Experimental
selenium and placebo
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Drug: Selenium
200mcg daily
Drug: Placebo replacement for vitamin E
1 placebo pill daily
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4: Placebo Comparator
placebo and placebo
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Drug: Placebo replacement for vitamin E
1 placebo pill daily
Drug: Placebo replacement for Selenium
1 placebo pill daily
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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.
Ages Eligible for Study: | 60 Years to 90 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
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):
Principal Investigator: | William Markesbery, MD | Sanders-Brown Center on Aging |
Principal Investigator: | Frederick Schmitt, PhD | Sanders-Brown Center on Aging |
Principal Investigator: | Richard Kryscio, PhD | Sanders-Brown Center on Aging |
Responsible Party: | University of Kentucky ( William R. Markesbery, MD ) |
Study ID Numbers: | IA0033 |
Study First Received: | June 25, 2002 |
Last Updated: | October 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00040378 |
Health Authority: | United States: Federal Government |
Alzheimer Disease Vitamin E Selenium |
Tocopherol acetate Alzheimer Disease Central Nervous System Diseases Brain Diseases Neurodegenerative Diseases Cognition Disorders Alpha-Tocopherol Tocopherols |
Selenium Vitamin E Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Alzheimer disease Tocotrienols Dementia Delirium |
Antioxidants Molecular Mechanisms of Pharmacological Action Vitamins Growth Substances Physiological Effects of Drugs Nervous System Diseases |
Trace Elements Micronutrients Tauopathies Protective Agents Pharmacologic Actions |