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

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ClinicalTrials.gov Identifier: NCT00040378
Recruitment Status : Completed
First Posted : June 27, 2002
Last Update Posted : March 14, 2018
Sponsor:
Collaborators:
National Institute on Aging (NIA)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Frederick Schmitt, University of Kentucky

Tracking Information
First Submitted Date June 25, 2002
First Posted Date June 27, 2002
Last Update Posted Date March 14, 2018
Actual Study Start Date May 2002
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 12, 2018)
incidence of dementia (including Alzheimer's disease) [ Time Frame: 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
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00040378 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prevention of Alzheimer's Disease by Vitamin E and Selenium (PREADVISE)
Official Title Prevention of Alzheimer's Disease by Vitamin E and Selenium (PREADVISE)
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Participant will be recruited from primary care office visits
Condition Alzheimer Disease
Intervention
  • Drug: alphatocopherol
    400 IU daily
    Other Name: Vitamin E
  • Drug: Selenium
    200mcg daily
  • Drug: Placebo replacement for vitamin E
    1 placebo pill daily
  • Drug: Placebo replacement for Selenium
    1 placebo pill daily
Study Groups/Cohorts
  • Combination therapy
    vitamin E (alphatocopherol) and selenium
    Interventions:
    • Drug: alphatocopherol
    • Drug: Selenium
  • Vitamin E only
    vitamine E (alphatocopherol) and placebo
    Interventions:
    • Drug: alphatocopherol
    • Drug: Placebo replacement for Selenium
  • Selenium only
    selenium and placebo (Placebo replacement for vitamin E)
    Interventions:
    • Drug: Selenium
    • Drug: Placebo replacement for vitamin E
  • Placebo
    placebo (Placebo replacement for vitamin E) and placebo (Placebo replacement for selenium)
    Interventions:
    • Drug: Placebo replacement for vitamin E
    • Drug: Placebo replacement for Selenium
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 12, 2018)
4246
Original Enrollment
 (submitted: June 23, 2005)
10400
Actual Study Completion Date August 2016
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 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.

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.
Sex/Gender
Sexes Eligible for Study: Male
Ages 60 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada,   Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00040378
Other Study ID Numbers IA0033
5R01AG019241 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Frederick Schmitt, University of Kentucky
Study Sponsor Frederick Schmitt
Collaborators
  • National Institute on Aging (NIA)
  • National Cancer Institute (NCI)
Investigators
Principal Investigator: Frederick Schmitt, PhD Sanders-Brown Center on Aging
Principal Investigator: Richard Kryscio, PhD Sanders-Brown Center on Aging
PRS Account University of Kentucky
Verification Date March 2018