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Alzheimer DiseaseNCT00040378

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

An observational study of Alzheimer Disease, run by Frederick Schmitt at 91 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 60 to 90 years, men onlyHealthy volunteers can take part
Conditions the study is for
Alzheimer Disease
What is being tested?
alphatocopherol and Selenium
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
4,246 participants
Where
91 sitesin 3 countries
Study dates
May 2002to Aug 2016
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 90 years
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Participant will be recruited from primary care office visits

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

91 sites in 3 countries.

91 sites in 3 countries

United States84 sites

  • Abington Memorial Hospital

    Abington, Pennsylvania, 19001-3788

  • Bixby Oncology Center

    Adrian, Michigan, 49221

  • Stratton Veterans Affairs Medical Center

    Albany, New York, 12208

  • Lehigh Valley Hospital

    Allentown, Pennsylvania, 18103

  • Bliss Cancer Center/McFarland Clinic/Mary Greely MC

    Ames, Iowa, 50010

  • Alaska Regional Hospital

    Anchorage, Alaska, 99508

  • Providence Alaska Medical Center

    Anchorage, Alaska, 99508

  • Anne Arundel Medical Center

    Annapolis, Maryland, 21401-2777

  • Our Lady of Bellefonte Hospital Inc.

    Ashland, Kentucky, 41101

  • Cascadia Clinical Trials at St. Joseph Hospital

    Bellingham, Washington, 98225-1898

  • St. Luke's Hospital and Health Network

    Bethlehem, Pennsylvania, 18015

  • Montana Cancer Consortium CCOP

    Billings, Montana, 59101

  • University of Alabama at Birmingham Preventive Medicine

    Birmingham, Alabama, 35294-4410

  • Cedar Rapids CCOP

    Cedar Rapids, Iowa, 52403

  • University of California, San Diego - Chula Vista

    Chula Vista, California, 91910

  • Good Samaritan Hospital

    Cincinnati, Ohio, 45220-2489

  • Columbus CCOP

    Columbus, Ohio, 43206

  • Bassett Research Institute

    Cooperstown, New York, 13326-1394

  • Methodist Hospitals of Dallas

    Dallas, Texas, 75203

  • Genesis Medical Center

    Davenport, Iowa, 52804

  • Iowa Oncology Research Association

    Des Moines, Iowa, 50309-1016

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Doylestown Hospital

    Doylestown, Pennsylvania, 18901

  • Duluth CCOP

    Duluth, Minnesota, 55805

  • VAMC New Jersey Health Care System

    East Orange, New Jersey, 07018-1095

  • Rocky Mountain CC/Poudre Valley Hospital

    Fort Collins, Colorado, 80524

  • Fremont Memorial Hospital

    Fremont, Ohio, 43420

  • Glendale Memorial Hospital

    Glendale, California, 91204

  • Glens Falls Hospital

    Glens Falls, New York, 12801

  • Grand Rapids Clinical Oncology Program CCOP

    Grand Rapids, Michigan, 49503-2560

  • Benefis Health Care

    Great Falls, Montana, 59405

  • Baptist Medical Center

    Jacksonville, Florida, 32207-8560

  • St. John's Regional Medical Center

    Joplin, Missouri, 64804

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • Good Samaritan Health Systems - Cancer Center

    Kearney, Nebraska, 68847

  • Thompson Cancer Survival Center

    Knoxville, Tennessee, 37916

  • University of California, San Diego

    La Jolla, California, 92037-1709

  • University of Kentucky Medical Center

    Lexington, Kentucky, 40536-0093

  • Cancer Resource Center

    Lincoln, Nebraska, 68510-4844

  • VA Medical Center

    Loma Linda, California, 92354-3866

  • VAMC Long Beach

    Long Beach, California, 90822

  • Louisville VA Medical Center

    Louisville, Kentucky, 40206-1499

  • Marshfield Clinic

    Marshfield, Wisconsin, 54449-5703

  • NW Ohio Oncology Center/St. Luke's Hospital

    Maumee, Ohio, 43537

  • Baptist Memorial Hospital - Memphis

    Memphis, Tennessee, 38120

  • Sinai Samaritan Medical Center

    Milwaukee, Wisconsin, 53233

  • Monroe Clinic

    Monroe, Michigan, 48162

  • Muskogee Regional Medical Center

    Muskogee, Oklahoma, 74401-5075

  • Meharry Medical College

    Nashville, Tennessee, 37208-3599

  • Northridge Hospital Medical Center

    Northridge, California, 91328

  • Methodist Regional Cancer Center

    Oak Ridge, Tennessee, 37830

  • Alegent Health Immanuel Medical Center

    Omaha, Nebraska, 68122

  • Alegent Health Bergan Mercy Medical Center

    Omaha, Nebraska, 68124

  • Missouri Valley Cancer Cons CCOP/Creighton University

    Omaha, Nebraska, 68131

  • St. Charles Hospital

    Oregon, Ohio, 43616

  • Warren Hospital

    Phillipsburg, New Jersey, 08865

  • Berkshire Hematology Oncology/Bershire Medical Center

    Pittsfield, Massachusetts, 01201

  • St. Joseph Mercy Oakland

    Pontiac, Michigan, 48341

  • Riverview Medical Center

    Red Bank, New Jersey, 07701

  • Washoe Medical Center

    Reno, Nevada, 89520

  • Santa Rosa Memorial Hospital Regional CCOP

    Santa Rosa, California, 95403

  • Virginia Mason CCOP

    Seattle, Washington, 98101

  • Swedish Medical Center

    Seattle, Washington, 98104

  • Northwest Hospital

    Seattle, Washington, 98133

  • Siouxland Hematology-Oncology Associates

    Sioux City, Iowa, 51101

  • Sioux Community Cancer Consortium

    Sioux Falls, South Dakota, 57105

  • St. John's Health System

    Springfield, Missouri, 65804

  • Cancer Research for the Ozarks

    Springfield, Missouri, 65807

  • Flower Hospital

    Sylvania, Ohio, 43560-2197

  • Scott & White CCOP

    Temple, Texas, 76508

  • Toledo Hospital

    Toledo, Ohio, 43606

  • St. Vincent Medical Center

    Toledo, Ohio, 43608

  • Toledo CCOP

    Toledo, Ohio, 43623

  • Toledo Clinic Inc.

    Toledo, Ohio, 43623

  • Stormont-Vail Health Care/Cotton O'Neil Clinic

    Topeka, Kansas, 66606

  • LABIOMED (Los Angeles Biomedical) Research Institute at Harbor-UCLA Medical Center

    Torrance, California, 90502-2064

  • Munson Medical Center

    Traverse City, Michigan, 49684-2386

  • Kaiser Southeast Permanente Medical Group

    Tucker, Georgia, 30084

  • Lionel B. Katchem

    Upland, California, 91786

  • Sibley Memorial Hospital

    Washington D.C., District of Columbia, 20016

  • George Washington University Medical Center

    Washington D.C., District of Columbia, 20037

  • DC United MBCCOP

    Washington D.C., District of Columbia, 20060-0001

  • Wichita CCOP

    Wichita, Kansas, 67214-3882

  • York Cancer Center/Wellspan Health

    York, Pennsylvania, 17403-5049

Other trials in United States

Puerto Rico6 sites

  • San Juan Dr. I. Gonzalez Martinez/Centro Medico

    San Juan, 00919-1811

  • Altamira Family Medicine

    San Juan, 00920

  • Centro Clinico San Patricio

    San Juan, 00921

  • Miguel Sosa Padilla, MD/San Juan City Hospital

    San Juan, 00926

  • VAMC San Juan

    San Juan, 00927

  • San Juan City Hospital - PR, Hematology Oncology Office

    San Juan, 00936-8344

Other trials in Puerto Rico

Canada1 site

  • Ottawa General Hospital

    Ottawa, Ontario, K1H 8L6

Other trials in Canada

About this study

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.

Read the 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.

Being tested
alphatocopherol, Selenium, Placebo replacement for vitamin E, Placebo replacement for Selenium
Keywords
Alzheimer Disease, Vitamin E, Selenium
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • alphatocopherolDrug

    Also called Vitamin E

    400 IU daily

  • SeleniumDrug

    200mcg daily

  • Placebo replacement for vitamin EDrug

    1 placebo pill daily

  • Placebo replacement for SeleniumDrug

    1 placebo pill daily

Study groups in NCT00040378
Study groupRoleWhat they receive
Combination therapyvitamin E (alphatocopherol) and selenium
Receives: Drug: alphatocopherol; Drug: Selenium
Vitamin E onlyvitamine E (alphatocopherol) and placebo
Receives: Drug: alphatocopherol; Drug: Placebo replacement for Selenium
Selenium onlyselenium and placebo (Placebo replacement for vitamin E)
Receives: Drug: Selenium; Drug: Placebo replacement for vitamin E
Placeboplacebo (Placebo replacement for vitamin E) and placebo (Placebo replacement for selenium)
Receives: Drug: Placebo replacement for vitamin E; Drug: Placebo replacement for Selenium

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. incidence of dementia (including Alzheimer's disease)

    Participants will complete a modified Telephone Interview of Cognitive Status (TIC-S) to evaluate the onset of dementia

    Measured: 7 to 12 years (depending on enrollment date)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jun 2002 (estimated)
  2. Study startMay 2002
  3. Primary completionJan 2014
  4. Study completionAug 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
4,246 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00040378
Sponsor's protocol ID
IA0033
Other IDs
5R01AG019241
Status last verified
Mar 2018
First submitted
25 Jun 2002
Last updated
14 Mar 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • Lovell MA, Ehmann WD, Butler SM, Markesbery WR. Elevated thiobarbituric acid-reactive substances and antioxidant enzyme activity in the brain in Alzheimer's disease. Neurology. 1995 Aug;45(8):1594-601. doi: 10.1212/wnl.45.8.1594.

    PubMed 7644059

  • Sano M, Ernesto C, Thomas RG, Klauber MR, Schafer K, Grundman M, Woodbury P, Growdon J, Cotman CW, Pfeiffer E, Schneider LS, Thal LJ. A controlled trial of selegiline, alpha-tocopherol, or both as treatment for Alzheimer's disease. The Alzheimer's Disease Cooperative Study. N Engl J Med. 1997 Apr 24;336(17):1216-22. doi: 10.1056/NEJM199704243361704.

    PubMed 9110909

  • Markesbery WR, Carney JM. Oxidative alterations in Alzheimer's disease. Brain Pathol. 1999 Jan;9(1):133-46. doi: 10.1111/j.1750-3639.1999.tb00215.x.

    PubMed 9989456

  • Goodman PJ, Tangen CM, Darke AK, Arnold KB, Hartline J, Yee M, Anderson K, Caban-Holt A, Christen WG, Cassano PA, Lance P, Klein EA, Crowley JJ, Minasian LM, Meyskens FL. Opportunities and challenges in incorporating ancillary studies into a cancer prevention randomized clinical trial. Trials. 2016 Aug 12;17:400. doi: 10.1186/s13063-016-1524-9.

    PubMed 27519183

  • Mathews M, Abner E, Caban-Holt A, Dennis BC, Kryscio R, Schmitt F. Quality of education and memory test performance in older men: the New York University Paragraph Recall Test normative data. Curr Alzheimer Res. 2013 Sep;10(7):776-83. doi: 10.2174/15672050113109990140.

    PubMed 23906000

  • Kryscio RJ, Abner EL, Schmitt FA, Goodman PJ, Mendiondo M, Caban-Holt A, Dennis BC, Mathews M, Klein EA, Crowley JJ; SELECT Investigators. A randomized controlled Alzheimer's disease prevention trial's evolution into an exposure trial: the PREADViSE Trial. J Nutr Health Aging. 2013 Jan;17(1):72-5. doi: 10.1007/s12603-013-0004-0.

    PubMed 23299383

  • Abner EL, Dennis BC, Mathews MJ, Mendiondo MS, Caban-Holt A, Kryscio RJ, Schmitt FA; PREADViSE Investigators; Crowley JJ; SELECT Investigators. Practice effects in a longitudinal, multi-center Alzheimer's disease prevention clinical trial. Trials. 2012 Nov 20;13:217. doi: 10.1186/1745-6215-13-217.

    PubMed 23171483

  • Caban-Holt A, Abner E, Kryscio RJ, Crowley JJ, Schmitt FA. Age-expanded normative data for the Ruff 2&7 Selective Attention Test: evaluating cognition in older males. Clin Neuropsychol. 2012;26(5):751-68. doi: 10.1080/13854046.2012.690451. Epub 2012 May 31.

    PubMed 22651854

  • Ding X, Kryscio RJ, Turner J, Jicha GA, Cooper G, Caban-Holt A, Schmitt FA, Abner EL. Self-Reported Sleep Apnea and Dementia Risk: Findings from the Prevention of Alzheimer's Disease with Vitamin E and Selenium Trial. J Am Geriatr Soc. 2016 Dec;64(12):2472-2478. doi: 10.1111/jgs.14393. Epub 2016 Nov 1.

    PubMed 27801937

  • Abner EL, Kryscio RJ, Caban-Holt AM, Schmitt FA. Baseline subjective memory complaints associate with increased risk of incident dementia: the PREADVISE trial. J Prev Alzheimers Dis. 2015 Mar;2(1):11-16. doi: 10.14283/jpad.2015.37.

    PubMed 26180776

  • Kryscio RJ, Abner EL, Caban-Holt A, Lovell M, Goodman P, Darke AK, Yee M, Crowley J, Schmitt FA. Association of Antioxidant Supplement Use and Dementia in the Prevention of Alzheimer's Disease by Vitamin E and Selenium Trial (PREADViSE). JAMA Neurol. 2017 May 1;74(5):567-573. doi: 10.1001/jamaneurol.2016.5778.

    PubMed 28319243

  • Ding X, Abner EL, Schmitt FA, Crowley J, Goodman P, Kryscio RJ. Mental Component Score (MCS) from Health-Related Quality of Life Predicts Incidence of Dementia in U.S. Males. J Prev Alzheimers Dis. 2021;8(2):169-174. doi: 10.14283/jpad.2020.50.

    PubMed 33569563

Questions about this trial

What is this clinical trial studying?

An observational study of Alzheimer Disease, run by Frederick Schmitt at 91 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 91 sites in United States, Puerto Rico, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

incidence of dementia (including Alzheimer's disease) (time frame: 7 to 12 years (depending on enrollment date)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00040378, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2018.

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