Ignite Creation Date:
2024-05-05 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00040378
Status:
COMPLETED
Last Update Posted:
2018-03-14
First Post:
2002-06-25
Brief Title:
Prevention of Alzheimers Disease by Vitamin E and Selenium PREADVISE
Sponsor:
Frederick Schmitt
Organization:
University of Kentucky
Study Overview
Official Title:
Prevention of Alzheimers Disease by Vitamin E and Selenium PREADVISE
Status:
COMPLETED
Status Verified Date:
2018-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The Prevention of Alzheimers 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 andor Vitamin E supplements can help to prevent memory loss and dementia such as Alzheimers disease
Detailed Description:
Studies show that increased oxidative stress from excess free radicals may damage brain cells and is linked with Alzheimers 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 Alzheimers 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 applicants medical history and drugs to verify that they have no conditions that would exclude them from this study About 10000 men will take part in this study
The PREADVISE study examinations will be done during the participants 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 participants memory and an update if any of the participants 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 participants 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 doctors 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 Alzheimers disease called Apolipoprotein E ApoE The results of this test will be used for research purposes only
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 Alzheimers 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 applicants medical history and drugs to verify that they have no conditions that would exclude them from this study About 10000 men will take part in this study
The PREADVISE study examinations will be done during the participants 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 participants memory and an update if any of the participants 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 participants 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 doctors 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 Alzheimers disease called Apolipoprotein E ApoE The results of this test will be used for research purposes only
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5R01AG019241 | NIH | None | httpsreporternihgovquickSearch5R01AG019241 |