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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00687102
Other study ID # IA0132
Secondary ID 1R13AG020218-01
Status Completed
Phase Phase 3
First received
Last updated
Start date October 2001
Est. completion date March 2008

Study information

Verified date August 2018
Source Wake Forest University Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to assess the effects of tamoxifen and raloxifene on cognitive aging in selected cognitively-healthy women.


Description:

Recent reports indicate that hormone therapy (HT) may have a protective effect on the aging brain. Although previous studies have examined the effects of HT on age-related cognitive changes, there is little information on the effect of a new class of estrogenic agents, selective estrogen receptor modulators (SERMs), on cognitive aging. The two most commonly prescribed SERMs are tamoxifen, for treatment and prevention of breast cancer, and raloxifene, for maintaining bone density. In the face of potential widespread use of SERMs in healthy women, information on the effects of these agents on memory and other cognitive functions is essential.

The principal goals of Co-STAR are to compare the effects of tamoxifen and raloxifene

- on age-associated declines in measures of verbal and nonverbal memory in women over age 65

- other cognitive abilities and mood

- with those resulting from more common forms of HT, specifically ET (conjugated equine estrogen) and ET plus progesterone

Co-STAR results will be compared to results from the Women's Health Initiative Study of Cognitive Aging (WHISCA), a study involving 6-year longitudinal assessment of cognitive outcomes in 2969 women randomly assigned to receive active treatment (Premarin or Premarin plus medroxyprogesterone acetate) or placebo. A comparison of the Co-STAR treatment groups with the group of WHISCA participants receiving placebo will provide insights into the effects of SERMs relative to no treatment. A comparison of the Co-STAR treatment groups with WHISCA treatment groups receiving ET or ET plus progesterone will provide insights into the effects of SERMs relative to common HT treatments.

Co-STAR participants will be recruited from The National Cancer Institute's (NCI) Study of Tamoxifen and Raloxifene (STAR) NCT00003906, a multi-center, 5-year, randomized clinical trial among 22,000 women at increased risk for breast cancer, to compare the effects of tamoxifen and raloxifene on risk for breast cancer.


Other known NCT identifiers
  • NCT00571857

Recruitment information / eligibility

Status Completed
Enrollment 1498
Est. completion date March 2008
Est. primary completion date March 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 65 Years and older
Eligibility Inclusion Criteria:

- Women enrolled in STAR trial at a site participating in Co-STAR

- 65 years of age or older

- Have been randomized into STAR but have not started taking the study drug OR enrolled in STAR for a minimum of one year

- Have not been diagnosed with dementia

- Have signed a separate consent document for the Co-STAR Study

- Previous diagnoses of chronic neurologic disease (Parkinson's disease, stroke, epilepsy, multiple sclerosis), history of head injury, depression, alcohol addiction, drug addiction, and other neurologic or psychiatric conditions will be recorded but will not serve as exclusion factors for this study

Exclusion Criteria:

- Not enrolled in the STAR Trial

- Younger than 65 years of age

- Diagnosed with dementia

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
tamoxifen
oral tamoxifen plus placebo daily for 5 years
raloxifene
oral raloxifene plus placebo daily for 5 years

Locations

Country Name City State
Canada Tom Baker Cancer Centre Calgary Alberta
Canada Women's Breast Health Centre Ottawa Ontario
Canada Thunder Bay Regional Health Sciences Centre, Regional Cancer Care Clinical Trials Thunder Bay Ontario
Canada North York General Hospital Toronto Ontario
Canada Women's College Hospital Toronto Ontario
Canada UBC-Vancouver Hospital & Health Science Center Vancouver British Columbia
Canada CancerCare Manitoba Winnepeg Manitoba
United States Don and Sybil Harrington Cancer Center Amarillo Texas
United States Genesys Hurley Cancer Institute Ann Arbor Michigan
United States Genesys Regional Medical Center Ann Arbor Michigan
United States Oakwood Healthcare System Ann Arbor Michigan
United States Saint Joseph Mercy Hospital Ann Arbor Michigan
United States St. John Hospital and Medical Center Ann Arbor Michigan
United States The Harry and Jeanette Weinberg Cancer Institute at Franklin Square Baltimore Maryland
United States Battle Creek Health Systems Battle Creek Michigan
United States Kaiser Permanente Ohio Bedford Ohio
United States Montana Cancer Consortium Billings Montana
United States Boston Medical Center Boston Massachusetts
United States Olympic Hematology and Oncology Associates Bremerton Washington
United States Roswell Park/Western New York STAR Consortium Buffalo New York
United States Naval Hospital Camp Pendleton Camp Pendleton California
United States Roper Hospital Charleston South Carolina
United States Blumenthal Cancer Center Charlotte North Carolina
United States Presbyterian Hospital Charlotte North Carolina
United States Rush-Presbyterian-St. Luke's Medical Center Chicago Illinois
United States Ireland Cancer Center at Case Western Reserve University Cleveland Ohio
United States Penrose Cancer Center Colorado Springs Colorado
United States Ellis Fischel Cancer Center Columbia Missouri
United States Palmetto Richland Memorial Hospital Columbia South Carolina
United States CCOP Columbus Columbus Ohio
United States Bassett Healthcare Cooperstown New York
United States Baylor-Sammons Cancer Center Dallas Texas
United States Methodist Hospitals of Dallas Dallas Texas
United States Presbyterian Hospital of Dallas Dallas Texas
United States UT Southwestern Center for Breast Care Dallas Texas
United States Danville Hematology & Oncology, Inc. Danville Virginia
United States Genesis Medical Center Davenport Iowa
United States Colorado Cancer Research Program Denver Colorado
United States Henry Ford Health System Detroit Michigan
United States City of Hope National Medical Center Duarte California
United States Hematology Oncology Consultants Duarte California
United States Southern Nevada Cancer Research Foundation Duarte California
United States Finely Hospital, Wendt Regional Cancer Center Dubuque Iowa
United States Duluth Clinic Duluth Minnesota
United States St. Luke's Hospital Duluth Minnesota
United States Duke University Medical Center Durham North Carolina
United States Hematology-Oncology Associates of CNY East Syracuse New York
United States Cape Fear Valley Medical Center Fayetteville North Carolina
United States McLaren Regional Medical Center Flint Michigan
United States Virginia K. Crosson Cancer Center Fullerton California
United States Baylor Medical Center at Garland Garland Texas
United States Gaston Memorial Hospital Gastonia North Carolina
United States Glendale Memorial Hospital Comprehensive Cancer Center Glendale California
United States Southeastern Medical Oncology Center Goldsboro North Carolina
United States Center for Cancer Care at Goshen Health Systems Goshen Indiana
United States Grand Rapids Clinical Oncology Program Grand Rapids Michigan
United States Great Falls Clinic, LLP Great Falls Montana
United States Cancer Centers of the Carolinas Greenville South Carolina
United States East Carolina University Greenville North Carolina
United States Hartford Hospital Hartford Connecticut
United States Margaret R Pardee Memorial Hospital Hendersonville North Carolina
United States University of Hawaii, Honolulu Honolulu Hawaii
United States Breast Care Center at Baylor College of Medicine/Methodist Hospital Houston Texas
United States University of Texas M. D. Anderson Cancer Center Houston Texas
United States St John's Regional Medical Center Cancer Center Joplin Missouri
United States Kalamazoo Kalamazoo Michigan
United States Good Samaritan Health Systems Kearney Nebraska
United States Thompson Cancer Survival Center Knoxville Tennessee
United States Wilford Hall Medical Center Lackland Air Force Base Texas
United States Lakeland Regional Cancer Center Lakeland Florida
United States Valley Tumor Medical Group Lancaster California
United States Michigan State University Lansing Michigan
United States Lima Memorial Hospital Lima Ohio
United States Cancer Resource Center Lincoln Nebraska
United States Joe Arrington Cancer Research and Treatment Center Lubbock Texas
United States Southwest Cancer Center Lubbock Texas
United States Marquette General Hospital Marquette Michigan
United States Marshfield Clinic Marshfield Wisconsin
United States Hennepin Consortium Minneapolis Minnesota
United States Mercy Memorial Hospital Cancer Center Monroe Michigan
United States Community Hospital Munster Indiana
United States The Hospital of Central Connecticut New Britain Connecticut
United States Lawrence & Memorial Hospital New London Connecticut
United States Ochsner Cancer Institute New Orleans Louisiana
United States Christiana Care Health Services Newark Delaware
United States Kaiser Permanente Division of Research Oakland California
United States Methodist Cancer Center, Omaha Omaha Nebraska
United States Missouri Valley Cancer Consortium Omaha Nebraska
United States Ventura County Hematology-Oncology Specialists Oxnard California
United States CCOP Western Regional Phoenix Arizona
United States UPMC/UPCI/Magee Women's Hospital Pittsburgh Pennsylvania
United States Berkshire Hematology Oncology, P.C. Pittsfield Massachusetts
United States Baylor Regional Medical Center Plano Texas
United States Columbia River Oncology Program Portland Oregon
United States Kaiser Permanente Center for Health Research (Oncology Research) Portland Oregon
United States Vassar Brothers Hospital Poughkeepsie New York
United States St. Mary-Corwin Medical Center Pueblo Colorado
United States Riverview Medical Center Red Bank New Jersey
United States North Valley Breast Clinic Redding California
United States University of Rochester Cancer Center Rochester New York
United States SwedishAmerican Hospital Regional Cancer Ctr Rockford Illinois
United States William Beaumont Hospital Royal Oak Michigan
United States Alvin J Siteman Cancer Center at Barnes-Jewish Hosp & Washington U Sch of Med Saint Louis Missouri
United States Missouri Baptist Medical Center Saint Louis Missouri
United States Metro-Minnesota Saint Louis Park Minnesota
United States Huntsman Cancer Institute at the University of Utah Salt Lake City Utah
United States Kaiser Permanente Oncology Research San Diego California
United States Naval Medical Center San Diego San Diego California
United States Cancer Foundation of Santa Barbara Santa Barbara California
United States Memorial Medical Center Savannah Georgia
United States Mercy Cancer Center, Scranton Scranton Pennsylvania
United States Benaroya Research Institute at Virginia Mason Seattle Washington
United States Fred Hutchinson Cancer Research Center Seattle Washington
United States Swedish Medical Center Seattle Washington
United States Sioux Valley Clinic Oncology Sioux Falls South Dakota
United States CCOP,Northern Indiana Research Consortium South Bend Indiana
United States Spartanburg Regional Medical Center Spartanburg South Carolina
United States Cancer Research for the Ozarks Springfield Missouri
United States St John's Health System Springfield Missouri
United States University Healthcare System Syracuse New York
United States H. Lee Moffitt Cancer Center and Research Center Tampa Florida
United States Scott and White Hospital Temple Texas
United States Fulton County Health Center Toledo Ohio
United States Toledo Community Hospital Oncology Program Toledo Ohio
United States Arizona Cancer Center Tucson Arizona
United States Hematology & Oncology Associates Ltd Tupelo Mississippi
United States Carle Cancer Center Urbana Illinois
United States Washington Cancer Institute Washington District of Columbia
United States Via Christi Regional Medical Center Wichita Kansas
United States Forsyth Regional Cancer Center Winston-Salem North Carolina
United States Wake Forest University School of Medicine Winston-Salem North Carolina
United States Kaiser Permanente, Woodland Hills Woodland Hills California
United States Yakima Valley Memorial Hospital/North Star Lodge Cancer Center Yakima Washington
United States York Cancer Center York Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
Wake Forest University National Institute on Aging (NIA)

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (3)

Maki PM, Zonderman AB, Resnick SM. Enhanced verbal memory in nondemented elderly women receiving hormone-replacement therapy. Am J Psychiatry. 2001 Feb;158(2):227-33. — View Citation

Resnick SM, Maki PM, Golski S, Kraut MA, Zonderman AB. Effects of estrogen replacement therapy on PET cerebral blood flow and neuropsychological performance. Horm Behav. 1998 Oct;34(2):171-82. — View Citation

Resnick SM, Metter EJ, Zonderman AB. Estrogen replacement therapy and longitudinal decline in visual memory. A possible protective effect? Neurology. 1997 Dec;49(6):1491-7. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Mean Change From Baseline on the the Benton Visual Retention Test Scores by Treatment Group Mean Change From Baseline on the Benton Visual Retention (BVRT) Test scores. Adjusted for age, ethnicity, education, and baseline measure, for participants with true baseline measures.
The BVRT measures short term visual memory and visuo-constructional abilities. Each of 10 designs was presented one at a time for 10 seconds, and immediately after the design was withdrawn, the participant was instructed to draw it from memory on a blank sheet of paper. The score on the BVRT is the total number of errors, 0-26 represents the total number of theoretically possible errors. Lower score denotes better outcomes.
Baseline and 3 Years
Primary Mean Change From Baseline on the the California Verbal Learning Test Scores by Treatment Group Adjusted for age, ethnicity, education, and baseline measure, for participants with true baseline measures.
The experimenter reads a list of 16 nouns aloud, at one-second intervals, in fixed order, over 3 learning trials (list A) . After each trial, the subject is asked to recall as many words as they can in any order (i.e., free recall) given a score 0-16 each. Total range as the sum of the 3 learning trials: 0 - 48. Participants were asked to recall a second interference list (List B) with a score range of 0-16. Free recall of list A are tested immediately after list B (short-delay) Total range 0- 16 , and again after 20 minutes (long-delay) 0-16. Each part of the scale is reported separately as Total List A trials, Total List B trials, Short-delay free recall, and Long-delay free recall.
Baseline and 3 Years
Secondary Mean Change From Baseline on the Letter Fluency and Semantic Fluency Scores by Treatment Group Mean Change From Baseline on the Letter Fluency Test scores. Adjusted for age, ethnicity, education, and baseline measure, for participants with true baseline measures.
Measures cognitive function. In this test, the participant names as many words as possible in 1 minute, beginning with each letter for letter fluency (F, A, and S) and category for semantic fluency (fruits and vegetables). To score the administrator, counts up the total number letters or words that the individual is able to produce. The score minimum would be 0 and the maximum would be the total of correct items named within 1 minute. Higher scores represent better outcomes.
Baseline and 3 Years
Secondary Mean Change From Baseline on Digit Span Test Scores by Treatment Group Mean Change From Baseline on the Digit Span Test - Digits Forward and Digits backward Test scores. Adjusted for age, ethnicity, education, and baseline measure, for participants with true baseline measures.
Measures reasoning, verbal ability, and memory. The participant is asked to provide immediate recall of a series of digits in forward and backward sequences. The individual's score is the total number of items correctly repeated forwards or backwards. Total range 0 - 14, higher results denotes a better outcome.
Baseline and 3 Years
Secondary Mean Change From Baseline on Card Rotations Test Scores by Treatment Group Mean Change From Baseline on the Card Rotations Test scores. Adjusted for age, ethnicity, education, and baseline measure, for participants with true baseline measures.
Measures the ability to mentally manipulate figures in two and three-dimensions. On each of 28 trials, participants view sample line drawings of a geometric figure and 8 alterations representing 2 or 3-dimensional rotations of the drawing. Participants are asked to identify alternatives that show the sample in 2-D but not in 3-D. Total range 0 - 160 and the number of incorrect/correct responses is measure. Higher number of correct answers is a better outcome.
Baseline and 3 Years
Secondary Mean Change From Baseline on the Finger Tapping Test Scores by Treatment Group Mean Change From Baseline on the the Finger Tapping Test scores. Adjusted for age, ethnicity, education, and baseline measure, for participants with true baseline measures.
Measures motor speed, coordination, attention, alertness, slowing of responses, and motor control. In this test of motor speed and dexterity participants are asked to depress a lever as many times as possible in each of 7, 10-second trials, first with the right hand and next with the left hand. The highest and lowest scores are dropped; the score is the average of the remaining five trials for each hand.Higher scores represent better outcomes.
Baseline and 3 Years
Secondary Mean Change From Baseline on the Positive and Negative Affect Schedule Scores by Treatment Group Mean Change From Baseline on the Positive and Negative Affect Schedule (PANAS). Adjusted for age, ethnicity, education, and baseline measure, for participants with true baseline measures.
Measures positive and negative affect. Mood is assessed with the PANAS, a list of ten pleasant mood states (e.g., interested, proud, inspired) and ten unpleasant mood states (e.g., irritable, guilty, jittery). Respondents are asked to rate on a 5-point scale (1 being "very slightly or not at all" and 5 being "extremely") the extent to which they have experienced each mood during a specific time frame. Ratings for each item can range from 0 to 4 with total scores for positive affect and negative affect subscales ranging from 0 to 40. For positive affect, higher scores denote higher levels of positive affect and for negative affect, lower scores denote lower levels of negative affect.
Baseline and 3 Years
Secondary Mean Change From Baseline on the Geriatric Depression Scale Scores by Treatment Group Mean Change From Baseline on the Geriatric Depression Scale. Adjusted for age, ethnicity, education, and baseline measure, for participants with true baseline measures.
Measures depression in older adults. Mood is also assessed with the 15-item short form of the GDS which measures non-somatic features of depressed mood. Participants indicate the presence or absence of each symptom. The GDS-SF score is the total number of positive depressive items. Score range is 0-15, with 0-4 denoting better outcomes and a score of 5 and above denoting worse outcomes (depression).
Baseline and 3 Years
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