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


Phase 3
60 Years
90 Years
Open (Enrolling)
Male
Alzheimer Disease

Thank you

Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Outcome Measure:

Effect on the incidence of dementia (including Alzheimer's disease) over time

Outcome Time Frame:

7 to 12 years (depending on enrollment date)

Safety Issue:

No

Principal Investigator

Frederick Schmitt, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sanders-Brown Center on Aging

Authority:

United States: Federal Government

Study ID:

IA0033

NCT ID:

NCT00040378

Start Date:

May 2002

Completion Date:

August 2014

Related Keywords:

  • Alzheimer Disease
  • Alzheimer Disease
  • Vitamin E
  • Selenium
  • Alzheimer Disease

Name

Location

George Washington University Medical CenterWashington, District of Columbia  20037
Abington Memorial HospitalAbington, Pennsylvania  19001
Henry Ford HospitalDetroit, Michigan  48202
Marshfield ClinicMarshfield, Wisconsin  54449
Cancer Research for the OzarksSpringfield, Missouri  65807
Lehigh Valley HospitalAllentown, Pennsylvania  18103
University of Kansas Medical CenterKansas City, Kansas  66160-7353
Providence Alaska Medical CenterAnchorage, Alaska  99508
Riverview Medical CenterRed Bank, New Jersey  07701
Thompson Cancer Survival CenterKnoxville, Tennessee  37916
Toledo HospitalToledo, Ohio  43606
Warren HospitalPhillipsburg, New Jersey  08865
Sibley Memorial HospitalWashington, District of Columbia  20016
Siouxland Hematology-Oncology AssociatesSioux City, Iowa  51101
Munson Medical CenterTraverse City, Michigan  49684
Good Samaritan HospitalDayton, Ohio  45406
Fremont Memorial HospitalFremont, Ohio  43420
Anne Arundel Medical CenterAnnapolis, Maryland  21401
St. Charles HospitalOregon, Ohio  43616
Alaska Regional HospitalAnchorage, Alaska  99508
St. Joseph Mercy OaklandPontiac, Michigan  48341-2985
Genesis Medical CenterDavenport, Iowa  52804
Northridge Hospital Medical CenterNorthridge, California  91328
St. John's Regional Medical CenterJoplin, Missouri  64804
Muskogee Regional Medical CenterMuskogee, Oklahoma  74401
Doylestown HospitalDoylestown, Pennsylvania  18901
St. John's Health SystemSpringfield, Missouri  65804
Meharry Medical CollegeNashville, Tennessee  37208-3599
Swedish Medical CenterSeattle, Washington  98122-4307
Glens Falls HospitalGlens Falls, New York  12801
Columbus CCOPColumbus, Ohio  43206
University of Alabama at Birmingham Preventive MedicineBirmingham, Alabama  35294-4410
University of California, San Diego - Chula VistaChula Vista, California  91910
Glendale Memorial HospitalGlendale, California  91204
University of California, San DiegoLa Jolla, California  92037-1709
VA Medical CenterLoma Linda, California  92354-3866
VAMC Long BeachLong Beach, California  90822
Santa Rosa Memorial Hospital Regional CCOPSanta Rosa, California  95403
LABIOMED (Los Angeles Biomedical) Research Institute at Harbor-UCLA Medical CenterTorrance, California  90502-2064
Lionel B. KatchemUpland, California  91786
Rocky Mountain CC/Poudre Valley HospitalFort Collins, Colorado  80524
DC United MBCCOPWashington, DC, District of Columbia  20060-0001
Baptist Medical CenterJacksonville, Florida  32207-8560
Kaiser Southeast Permanente Medical GroupTucker, Georgia  30084
Bliss Cancer Center/McFarland Clinic/Mary Greely MCAmes, Iowa  50010
Cedar Rapids CCOPCedar Rapids, Iowa  52403
Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
Stormont-Vail Health Care/Cotton O'Neil ClinicTopeka, Kansas  66606
Wichita CCOPWichita, Kansas  67214-3882
Our Lady of Bellefonte Hospital Inc.Ashland, Kentucky  41101
University of Kentucky Medical CenterLexington, Kentucky  40536-0093
Louisville VA Medical CenterLouisville, Kentucky  40206-1499
Berkshire Hematology Oncology/Bershire Medical CenterPittsfield, Massachusetts  01201
Bixby Oncology CenterAdrian, Michigan  49221
Grand Rapids Clinical Oncology Program CCOPGrand Rapids, Michigan  49503-2560
Monroe ClinicMonroe, Michigan  48162
Duluth CCOPDuluth, Minnesota  55805
Montana Cancer Consortium CCOPBillings, Montana  59101
Benefis Health CareGreat Falls, Montana  59405
Good Samaritan Health Systems - Cancer CenterKearney, Nebraska  68847
Cancer Resource CenterLincoln, Nebraska  68510-4844
Missouri Valley Cancer Cons CCOP/Creighton UniversityOmaha, Nebraska  68131
Alegent Health Immanuel Medical CenterOmaha, Nebraska  68122
Alegent Health Bergan Mercy Medical CenterOmaha, Nebraska  68124
Washoe Medical CenterReno, Nevada  89520
VAMC New Jersey Health Care SystemEast Orange, New Jersey  07018-1095
Stratton Veterans Affairs Medical CenterAlbany, New York  12208
Bassett Research InstituteCooperstown, New York  13326-1394
NW Ohio Oncology Center/St. Luke's HospitalMaumee, Ohio  43537
Flower HospitalSylvania, Ohio  43560-2197
St. Vincent Medical CenterToledo, Ohio  43608
Toledo CCOPToledo, Ohio  43623
Toledo Clinic Inc.Toledo, Ohio  43623
St. Luke's Hospital and Health NetworkBethlehem, Pennsylvania  18015
York Cancer Center/Wellspan HealthYork, Pennsylvania  17403-5049
Sioux Community Cancer ConsortiumSioux Falls, South Dakota  57105
Baptist Memorial Hospital - MemphisMemphis, Tennessee  38120
Methodist Regional Cancer CenterOak Ridge, Tennessee  37830
Methodist Hospitals of DallasDallas, Texas  75203
Scott & White CCOPTemple, Texas  76508
Cascadia Clinical Trials at St. Joseph HospitalBellingham, Washington  98225-1898
Northwest HospitalSeattle, Washington  98133
Virginia Mason CCOPSeattle, Washington  98101
Sinai Samaritan Medical CenterMilwaukee, Wisconsin  53233