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

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Alzheimer Disease	Drug: alphatocopherol Drug: Selenium Drug: Placebo replacement for vitamin E Drug: Placebo replacement for Selenium

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 Design

Study Type:

Observational

Actual Enrollment :

4246 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

May 1, 2002

Actual Primary Completion Date :

Jan 1, 2014

Actual Study Completion Date :

Aug 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Combination therapy vitamin E (alphatocopherol) and selenium	Drug: alphatocopherol 400 IU daily Other Names: Vitamin E Drug: Selenium 200mcg daily
Vitamin E only vitamine E (alphatocopherol) and placebo	Drug: alphatocopherol 400 IU daily Other Names: Vitamin E Drug: Placebo replacement for Selenium 1 placebo pill daily
Selenium only selenium and placebo (Placebo replacement for vitamin E)	Drug: Selenium 200mcg daily Drug: Placebo replacement for vitamin E 1 placebo pill daily
Placebo placebo (Placebo replacement for vitamin E) and placebo (Placebo replacement for selenium)	Drug: Placebo replacement for vitamin E 1 placebo pill daily Drug: Placebo replacement for Selenium 1 placebo pill daily

Outcome Measures

Primary Outcome Measures

incidence of dementia (including Alzheimer's disease) [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years to 90 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham Preventive Medicine	Birmingham	Alabama	United States	35294-4410
2	Alaska Regional Hospital	Anchorage	Alaska	United States	99508
3	Providence Alaska Medical Center	Anchorage	Alaska	United States	99508
4	University of California, San Diego - Chula Vista	Chula Vista	California	United States	91910
5	Glendale Memorial Hospital	Glendale	California	United States	91204
6	University of California, San Diego	La Jolla	California	United States	92037-1709
7	VA Medical Center	Loma Linda	California	United States	92354-3866
8	VAMC Long Beach	Long Beach	California	United States	90822
9	Northridge Hospital Medical Center	Northridge	California	United States	91328
10	Santa Rosa Memorial Hospital Regional CCOP	Santa Rosa	California	United States	95403
11	LABIOMED (Los Angeles Biomedical) Research Institute at Harbor-UCLA Medical Center	Torrance	California	United States	90502-2064
12	Lionel B. Katchem	Upland	California	United States	91786
13	Rocky Mountain CC/Poudre Valley Hospital	Fort Collins	Colorado	United States	80524
14	Sibley Memorial Hospital	Washington	District of Columbia	United States	20016
15	George Washington University Medical Center	Washington	District of Columbia	United States	20037
16	DC United MBCCOP	Washington	District of Columbia	United States	20060-0001
17	Baptist Medical Center	Jacksonville	Florida	United States	32207-8560
18	Kaiser Southeast Permanente Medical Group	Tucker	Georgia	United States	30084
19	Bliss Cancer Center/McFarland Clinic/Mary Greely MC	Ames	Iowa	United States	50010
20	Cedar Rapids CCOP	Cedar Rapids	Iowa	United States	52403
21	Genesis Medical Center	Davenport	Iowa	United States	52804
22	Iowa Oncology Research Association	Des Moines	Iowa	United States	50309-1016
23	Siouxland Hematology-Oncology Associates	Sioux City	Iowa	United States	51101
24	University of Kansas Medical Center	Kansas City	Kansas	United States	66160
25	Stormont-Vail Health Care/Cotton O'Neil Clinic	Topeka	Kansas	United States	66606
26	Wichita CCOP	Wichita	Kansas	United States	67214-3882
27	Our Lady of Bellefonte Hospital Inc.	Ashland	Kentucky	United States	41101
28	University of Kentucky Medical Center	Lexington	Kentucky	United States	40536-0093
29	Louisville VA Medical Center	Louisville	Kentucky	United States	40206-1499
30	Anne Arundel Medical Center	Annapolis	Maryland	United States	21401-2777
31	Berkshire Hematology Oncology/Bershire Medical Center	Pittsfield	Massachusetts	United States	01201
32	Bixby Oncology Center	Adrian	Michigan	United States	49221
33	Henry Ford Hospital	Detroit	Michigan	United States	48202
34	Grand Rapids Clinical Oncology Program CCOP	Grand Rapids	Michigan	United States	49503-2560
35	Monroe Clinic	Monroe	Michigan	United States	48162
36	St. Joseph Mercy Oakland	Pontiac	Michigan	United States	48341
37	Munson Medical Center	Traverse City	Michigan	United States	49684-2386
38	Duluth CCOP	Duluth	Minnesota	United States	55805
39	St. John's Regional Medical Center	Joplin	Missouri	United States	64804
40	St. John's Health System	Springfield	Missouri	United States	65804
41	Cancer Research for the Ozarks	Springfield	Missouri	United States	65807
42	Montana Cancer Consortium CCOP	Billings	Montana	United States	59101
43	Benefis Health Care	Great Falls	Montana	United States	59405
44	Good Samaritan Health Systems - Cancer Center	Kearney	Nebraska	United States	68847
45	Cancer Resource Center	Lincoln	Nebraska	United States	68510-4844
46	Alegent Health Immanuel Medical Center	Omaha	Nebraska	United States	68122
47	Alegent Health Bergan Mercy Medical Center	Omaha	Nebraska	United States	68124
48	Missouri Valley Cancer Cons CCOP/Creighton University	Omaha	Nebraska	United States	68131
49	Washoe Medical Center	Reno	Nevada	United States	89520
50	VAMC New Jersey Health Care System	East Orange	New Jersey	United States	07018-1095
51	Warren Hospital	Phillipsburg	New Jersey	United States	08865
52	Riverview Medical Center	Red Bank	New Jersey	United States	07701
53	Stratton Veterans Affairs Medical Center	Albany	New York	United States	12208
54	Bassett Research Institute	Cooperstown	New York	United States	13326-1394
55	Glens Falls Hospital	Glens Falls	New York	United States	12801
56	Good Samaritan Hospital	Cincinnati	Ohio	United States	45220-2489
57	Columbus CCOP	Columbus	Ohio	United States	43206
58	Fremont Memorial Hospital	Fremont	Ohio	United States	43420
59	NW Ohio Oncology Center/St. Luke's Hospital	Maumee	Ohio	United States	43537
60	St. Charles Hospital	Oregon	Ohio	United States	43616
61	Flower Hospital	Sylvania	Ohio	United States	43560-2197
62	Toledo Hospital	Toledo	Ohio	United States	43606
63	St. Vincent Medical Center	Toledo	Ohio	United States	43608
64	Toledo CCOP	Toledo	Ohio	United States	43623
65	Toledo Clinic Inc.	Toledo	Ohio	United States	43623
66	Muskogee Regional Medical Center	Muskogee	Oklahoma	United States	74401-5075
67	Abington Memorial Hospital	Abington	Pennsylvania	United States	19001-3788
68	Lehigh Valley Hospital	Allentown	Pennsylvania	United States	18103
69	St. Luke's Hospital and Health Network	Bethlehem	Pennsylvania	United States	18015
70	Doylestown Hospital	Doylestown	Pennsylvania	United States	18901
71	York Cancer Center/Wellspan Health	York	Pennsylvania	United States	17403-5049
72	Sioux Community Cancer Consortium	Sioux Falls	South Dakota	United States	57105
73	Thompson Cancer Survival Center	Knoxville	Tennessee	United States	37916
74	Baptist Memorial Hospital - Memphis	Memphis	Tennessee	United States	38120
75	Meharry Medical College	Nashville	Tennessee	United States	37208-3599
76	Methodist Regional Cancer Center	Oak Ridge	Tennessee	United States	37830
77	Methodist Hospitals of Dallas	Dallas	Texas	United States	75203
78	Scott & White CCOP	Temple	Texas	United States	76508
79	Cascadia Clinical Trials at St. Joseph Hospital	Bellingham	Washington	United States	98225-1898
80	Virginia Mason CCOP	Seattle	Washington	United States	98101
81	Swedish Medical Center	Seattle	Washington	United States	98104
82	Northwest Hospital	Seattle	Washington	United States	98133
83	Marshfield Clinic	Marshfield	Wisconsin	United States	54449-5703
84	Sinai Samaritan Medical Center	Milwaukee	Wisconsin	United States	53233
85	Ottawa General Hospital	Ottawa	Ontario	Canada	K1H 8L6
86	San Juan Dr. I. Gonzalez Martinez/Centro Medico	San Juan		Puerto Rico	00919-1811
87	Altamira Family Medicine	San Juan		Puerto Rico	00920
88	Centro Clinico San Patricio	San Juan		Puerto Rico	00921
89	Miguel Sosa Padilla, MD/San Juan City Hospital	San Juan		Puerto Rico	00926
90	VAMC San Juan	San Juan		Puerto Rico	00927
91	San Juan City Hospital - PR, Hematology Oncology Office	San Juan		Puerto Rico	00936-8344