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

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00040378
• Other study ID #: IA0033
• Secondary ID: 5R01AG019241
• Status: Completed
• Phase: N/A
• First received: June 25, 2002
• Last updated: March 12, 2018
• Start date: May 2002
• Est. completion date: August 2016

Study information

• Verified date: March 2018
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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). 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.

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.

Other known NCT identifiers

• NCT00780689

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4246
• Est. completion date: August 2016
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 60 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Drug:
• alphatocopherol
400 IU daily
• Selenium
200mcg daily
• Placebo replacement for vitamin E
1 placebo pill daily
• Placebo replacement for Selenium
1 placebo pill daily

Locations

Country	Name	City	State
Canada	Ottawa General Hospital	Ottawa	Ontario
Puerto Rico	Altamira Family Medicine	San Juan
Puerto Rico	Centro Clinico San Patricio	San Juan
Puerto Rico	Miguel Sosa Padilla, MD/San Juan City Hospital	San Juan
Puerto Rico	San Juan City Hospital - PR, Hematology Oncology Office	San Juan
Puerto Rico	San Juan Dr. I. Gonzalez Martinez/Centro Medico	San Juan
Puerto Rico	VAMC San Juan	San Juan
United States	Abington Memorial Hospital	Abington	Pennsylvania
United States	Bixby Oncology Center	Adrian	Michigan
United States	Stratton Veterans Affairs Medical Center	Albany	New York
United States	Lehigh Valley Hospital	Allentown	Pennsylvania
United States	Bliss Cancer Center/McFarland Clinic/Mary Greely MC	Ames	Iowa
United States	Alaska Regional Hospital	Anchorage	Alaska
United States	Providence Alaska Medical Center	Anchorage	Alaska
United States	Anne Arundel Medical Center	Annapolis	Maryland
United States	Our Lady of Bellefonte Hospital Inc.	Ashland	Kentucky
United States	Cascadia Clinical Trials at St. Joseph Hospital	Bellingham	Washington
United States	St. Luke's Hospital and Health Network	Bethlehem	Pennsylvania
United States	Montana Cancer Consortium CCOP	Billings	Montana
United States	University of Alabama at Birmingham Preventive Medicine	Birmingham	Alabama
United States	Cedar Rapids CCOP	Cedar Rapids	Iowa
United States	University of California, San Diego - Chula Vista	Chula Vista	California
United States	Good Samaritan Hospital	Cincinnati	Ohio
United States	Columbus CCOP	Columbus	Ohio
United States	Bassett Research Institute	Cooperstown	New York
United States	Methodist Hospitals of Dallas	Dallas	Texas
United States	Genesis Medical Center	Davenport	Iowa
United States	Iowa Oncology Research Association	Des Moines	Iowa
United States	Henry Ford Hospital	Detroit	Michigan
United States	Doylestown Hospital	Doylestown	Pennsylvania
United States	Duluth CCOP	Duluth	Minnesota
United States	VAMC New Jersey Health Care System	East Orange	New Jersey
United States	Rocky Mountain CC/Poudre Valley Hospital	Fort Collins	Colorado
United States	Fremont Memorial Hospital	Fremont	Ohio
United States	Glendale Memorial Hospital	Glendale	California
United States	Glens Falls Hospital	Glens Falls	New York
United States	Grand Rapids Clinical Oncology Program CCOP	Grand Rapids	Michigan
United States	Benefis Health Care	Great Falls	Montana
United States	Baptist Medical Center	Jacksonville	Florida
United States	St. John's Regional Medical Center	Joplin	Missouri
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Good Samaritan Health Systems - Cancer Center	Kearney	Nebraska
United States	Thompson Cancer Survival Center	Knoxville	Tennessee
United States	University of California, San Diego	La Jolla	California
United States	University of Kentucky Medical Center	Lexington	Kentucky
United States	Cancer Resource Center	Lincoln	Nebraska
United States	VA Medical Center	Loma Linda	California
United States	VAMC Long Beach	Long Beach	California
United States	Louisville VA Medical Center	Louisville	Kentucky
United States	Marshfield Clinic	Marshfield	Wisconsin
United States	NW Ohio Oncology Center/St. Luke's Hospital	Maumee	Ohio
United States	Baptist Memorial Hospital - Memphis	Memphis	Tennessee
United States	Sinai Samaritan Medical Center	Milwaukee	Wisconsin
United States	Monroe Clinic	Monroe	Michigan
United States	Muskogee Regional Medical Center	Muskogee	Oklahoma
United States	Meharry Medical College	Nashville	Tennessee
United States	Northridge Hospital Medical Center	Northridge	California
United States	Methodist Regional Cancer Center	Oak Ridge	Tennessee
United States	Alegent Health Bergan Mercy Medical Center	Omaha	Nebraska
United States	Alegent Health Immanuel Medical Center	Omaha	Nebraska
United States	Missouri Valley Cancer Cons CCOP/Creighton University	Omaha	Nebraska
United States	St. Charles Hospital	Oregon	Ohio
United States	Warren Hospital	Phillipsburg	New Jersey
United States	Berkshire Hematology Oncology/Bershire Medical Center	Pittsfield	Massachusetts
United States	St. Joseph Mercy Oakland	Pontiac	Michigan
United States	Riverview Medical Center	Red Bank	New Jersey
United States	Washoe Medical Center	Reno	Nevada
United States	Santa Rosa Memorial Hospital Regional CCOP	Santa Rosa	California
United States	Northwest Hospital	Seattle	Washington
United States	Swedish Medical Center	Seattle	Washington
United States	Virginia Mason CCOP	Seattle	Washington
United States	Siouxland Hematology-Oncology Associates	Sioux City	Iowa
United States	Sioux Community Cancer Consortium	Sioux Falls	South Dakota
United States	Cancer Research for the Ozarks	Springfield	Missouri
United States	St. John's Health System	Springfield	Missouri
United States	Flower Hospital	Sylvania	Ohio
United States	Scott & White CCOP	Temple	Texas
United States	St. Vincent Medical Center	Toledo	Ohio
United States	Toledo CCOP	Toledo	Ohio
United States	Toledo Clinic Inc.	Toledo	Ohio
United States	Toledo Hospital	Toledo	Ohio
United States	Stormont-Vail Health Care/Cotton O'Neil Clinic	Topeka	Kansas
United States	LABIOMED (Los Angeles Biomedical) Research Institute at Harbor-UCLA Medical Center	Torrance	California
United States	Munson Medical Center	Traverse City	Michigan
United States	Kaiser Southeast Permanente Medical Group	Tucker	Georgia
United States	Lionel B. Katchem	Upland	California
United States	DC United MBCCOP	Washington	District of Columbia
United States	George Washington University Medical Center	Washington	District of Columbia
United States	Sibley Memorial Hospital	Washington	District of Columbia
United States	Wichita CCOP	Wichita	Kansas
United States	York Cancer Center/Wellspan Health	York	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Frederick Schmitt	National Cancer Institute (NCI), National Institute on Aging (NIA)

Countries where clinical trial is conducted

United States,  Canada,  Puerto Rico, 

References & Publications (11)

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. — View Citation

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. — View Citation

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. — View Citation

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):247 — View Citation

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. — View Citation

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 — View Citation

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/s12603-012-0083-3. — View Citation

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. — View Citation

Markesbery WR, Carney JM. Oxidative alterations in Alzheimer's disease. Brain Pathol. 1999 Jan;9(1):133-46. Review. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	7 to 12 years (depending on enrollment date)

External Links

•   Clinicaltrials.gov SELECT trial record
•   SELECT trial information
•   Southwest Oncology Group