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CognitionPhase 3Co-STARNCT00687102

Cognition in the Study of Tamoxifen and Raloxifene

A Phase 3 study testing tamoxifen and raloxifene in people with Cognition and Aging, run by Wake Forest University at 134 sites in 2 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 purpose of this study is to assess the effects of tamoxifen and raloxifene on cognitive aging in selected cognitively-healthy women. Read more about this study

Who is it for?
Ages 65 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Cognition, Aging
What is being tested?
tamoxifen and raloxifene
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,498 participants
Where
134 sitesin 2 countries
Study dates
Oct 2001to Mar 2008
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 65 years and older
  • Women only
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • 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

Who cannot join

  • Not enrolled in the STAR Trial
  • Younger than 65 years of age
  • Diagnosed with dementia

Trial locations and contacts

134 sites in 2 countries.

134 sites in 2 countries

United States127 sites

  • Don and Sybil Harrington Cancer Center

    Amarillo, Texas, 79106

  • Genesys Hurley Cancer Institute

    Ann Arbor, Michigan, 48106

  • Genesys Regional Medical Center

    Ann Arbor, Michigan, 48106

  • Oakwood Healthcare System

    Ann Arbor, Michigan, 48106

  • Saint Joseph Mercy Hospital

    Ann Arbor, Michigan, 48106

  • St. John Hospital and Medical Center

    Ann Arbor, Michigan, 48106

  • The Harry and Jeanette Weinberg Cancer Institute at Franklin Square

    Baltimore, Maryland, 21237

  • Battle Creek Health Systems

    Battle Creek, Michigan, 49016

  • Kaiser Permanente Ohio

    Bedford, Ohio, 44146

  • Montana Cancer Consortium

    Billings, Montana, 59101

  • Boston Medical Center

    Boston, Massachusetts, 02118

  • Olympic Hematology and Oncology Associates

    Bremerton, Washington, 98310

  • Roswell Park/Western New York STAR Consortium

    Buffalo, New York, 14263

  • Naval Hospital Camp Pendleton

    Camp Pendleton, California, 92055

  • Roper Hospital

    Charleston, South Carolina, 29401

  • Presbyterian Hospital

    Charlotte, North Carolina, 28204

  • Blumenthal Cancer Center

    Charlotte, North Carolina, 28231

  • Rush-Presbyterian-St. Luke's Medical Center

    Chicago, Illinois, 60612

  • Ireland Cancer Center at Case Western Reserve University

    Cleveland, Ohio, 44106

  • Penrose Cancer Center

    Colorado Springs, Colorado, 80907

  • Ellis Fischel Cancer Center

    Columbia, Missouri, 65203

  • Palmetto Richland Memorial Hospital

    Columbia, South Carolina, 29203

  • CCOP Columbus

    Columbus, Ohio, 43215

  • Bassett Healthcare

    Cooperstown, New York, 13326

  • Methodist Hospitals of Dallas

    Dallas, Texas, 75203

  • Presbyterian Hospital of Dallas

    Dallas, Texas, 75231

  • Baylor-Sammons Cancer Center

    Dallas, Texas, 75246

  • UT Southwestern Center for Breast Care

    Dallas, Texas, 75390

  • Danville Hematology & Oncology, Inc.

    Danville, Virginia, 24541

  • Genesis Medical Center

    Davenport, Iowa, 52803

  • Colorado Cancer Research Program

    Denver, Colorado, 80224

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • City of Hope National Medical Center

    Duarte, California, 91010

  • Hematology Oncology Consultants

    Duarte, California, 91010

  • Southern Nevada Cancer Research Foundation

    Duarte, California, 91010

  • Finely Hospital, Wendt Regional Cancer Center

    Dubuque, Iowa, 52001

  • St. Luke's Hospital

    Duluth, Minnesota, 55802

  • Duluth Clinic

    Duluth, Minnesota, 55805

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Hematology-Oncology Associates of CNY

    East Syracuse, New York, 13057

  • Cape Fear Valley Medical Center

    Fayetteville, North Carolina, 28302

  • McLaren Regional Medical Center

    Flint, Michigan, 48532

  • Virginia K. Crosson Cancer Center

    Fullerton, California, 92835

  • Baylor Medical Center at Garland

    Garland, Texas, 75042

  • Gaston Memorial Hospital

    Gastonia, North Carolina, 28054

  • Glendale Memorial Hospital Comprehensive Cancer Center

    Glendale, California, 91204

  • Southeastern Medical Oncology Center

    Goldsboro, North Carolina, 27534

  • Center for Cancer Care at Goshen Health Systems

    Goshen, Indiana, 46526

  • Grand Rapids Clinical Oncology Program

    Grand Rapids, Michigan, 49503

  • Great Falls Clinic, LLP

    Great Falls, Montana, 59405

  • East Carolina University

    Greenville, North Carolina, 27834

  • Cancer Centers of the Carolinas

    Greenville, South Carolina, 29605

  • Hartford Hospital

    Hartford, Connecticut, 06102

  • Margaret R Pardee Memorial Hospital

    Hendersonville, North Carolina, 28791

  • University of Hawaii, Honolulu

    Honolulu, Hawaii, 96813

  • Breast Care Center at Baylor College of Medicine/Methodist Hospital

    Houston, Texas, 77030

  • University of Texas M. D. Anderson Cancer Center

    Houston, Texas, 77030

  • St John's Regional Medical Center Cancer Center

    Joplin, Missouri, 64804

  • Kalamazoo

    Kalamazoo, Michigan, 49007

  • Good Samaritan Health Systems

    Kearney, Nebraska, 68848

  • Thompson Cancer Survival Center

    Knoxville, Tennessee, 37916

  • Wilford Hall Medical Center

    Lackland Air Force Base, Texas, 78236

  • Lakeland Regional Cancer Center

    Lakeland, Florida, 33805

  • Valley Tumor Medical Group

    Lancaster, California, 93534

  • Michigan State University

    Lansing, Michigan, 48910

  • Lima Memorial Hospital

    Lima, Ohio, 45807

  • Cancer Resource Center

    Lincoln, Nebraska, 68510

  • Joe Arrington Cancer Research and Treatment Center

    Lubbock, Texas, 79401

  • Southwest Cancer Center

    Lubbock, Texas, 79415

  • Marquette General Hospital

    Marquette, Michigan, 49855

  • Marshfield Clinic

    Marshfield, Wisconsin, 54449

  • Hennepin Consortium

    Minneapolis, Minnesota, 55415

  • Mercy Memorial Hospital Cancer Center

    Monroe, Michigan, 48162

  • Community Hospital

    Munster, Indiana, 46321

  • The Hospital of Central Connecticut

    New Britain, Connecticut, 06050

  • Lawrence & Memorial Hospital

    New London, Connecticut, 06320

  • Ochsner Cancer Institute

    New Orleans, Louisiana, 70121

  • Christiana Care Health Services

    Newark, Delaware, 19718

  • Kaiser Permanente Division of Research

    Oakland, California, 94612

  • Missouri Valley Cancer Consortium

    Omaha, Nebraska, 68106

  • Methodist Cancer Center, Omaha

    Omaha, Nebraska, 68114

  • Ventura County Hematology-Oncology Specialists

    Oxnard, California, 93030

  • CCOP Western Regional

    Phoenix, Arizona, 85006

  • UPMC/UPCI/Magee Women's Hospital

    Pittsburgh, Pennsylvania, 15213

  • Berkshire Hematology Oncology, P.C.

    Pittsfield, Massachusetts, 01201

  • Baylor Regional Medical Center

    Plano, Texas, 75093

  • Columbia River Oncology Program

    Portland, Oregon, 97225

  • Kaiser Permanente Center for Health Research (Oncology Research)

    Portland, Oregon, 97227

  • Vassar Brothers Hospital

    Poughkeepsie, New York, 12601

  • St. Mary-Corwin Medical Center

    Pueblo, Colorado, 81004

  • Riverview Medical Center

    Red Bank, New Jersey, 07701

  • North Valley Breast Clinic

    Redding, California, 96001

  • University of Rochester Cancer Center

    Rochester, New York, 14642

  • SwedishAmerican Hospital Regional Cancer Ctr

    Rockford, Illinois, 61104

  • William Beaumont Hospital

    Royal Oak, Michigan, 48073

  • Metro-Minnesota

    Saint Louis Park, Minnesota, 55416

  • Huntsman Cancer Institute at the University of Utah

    Salt Lake City, Utah, 84112

  • Kaiser Permanente Oncology Research

    San Diego, California, 92120

  • Naval Medical Center San Diego

    San Diego, California, 92134

  • Cancer Foundation of Santa Barbara

    Santa Barbara, California, 93105

  • Memorial Medical Center

    Savannah, Georgia, 31403

  • Mercy Cancer Center, Scranton

    Scranton, Pennsylvania, 18501

  • Benaroya Research Institute at Virginia Mason

    Seattle, Washington, 98101

  • Swedish Medical Center

    Seattle, Washington, 98104

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109

  • Sioux Valley Clinic Oncology

    Sioux Falls, South Dakota, 57104

  • CCOP,Northern Indiana Research Consortium

    South Bend, Indiana, 46601

  • Spartanburg Regional Medical Center

    Spartanburg, South Carolina, 29303

  • Cancer Research for the Ozarks

    Springfield, Missouri, 65804

  • St John's Health System

    Springfield, Missouri, 65804

  • Alvin J Siteman Cancer Center at Barnes-Jewish Hosp & Washington U Sch of Med

    St Louis, Missouri, 63110

  • Missouri Baptist Medical Center

    St Louis, Missouri, 63131

  • University Healthcare System

    Syracuse, New York, 13202

  • H. Lee Moffitt Cancer Center and Research Center

    Tampa, Florida, 33612

  • Scott and White Hospital

    Temple, Texas, 76508

  • Fulton County Health Center

    Toledo, Ohio, 43623

  • Toledo Community Hospital Oncology Program

    Toledo, Ohio, 43623

  • Arizona Cancer Center

    Tucson, Arizona, 85719

  • Hematology & Oncology Associates Ltd

    Tupelo, Mississippi, 38801

  • Carle Cancer Center

    Urbana, Illinois, 61801

  • Washington Cancer Institute

    Washington D.C., District of Columbia, 20010

  • Via Christi Regional Medical Center

    Wichita, Kansas, 67214

  • Forsyth Regional Cancer Center

    Winston-Salem, North Carolina, 27103

  • Wake Forest University School of Medicine

    Winston-Salem, North Carolina, 27157

  • Kaiser Permanente, Woodland Hills

    Woodland Hills, California, 91367

  • Yakima Valley Memorial Hospital/North Star Lodge Cancer Center

    Yakima, Washington, 98902

  • York Cancer Center

    York, Pennsylvania, 17403

Other trials in United States

Canada7 sites

  • Tom Baker Cancer Centre

    Calgary, Alberta, T2N4N2

  • Women's Breast Health Centre

    Ottawa, Ontario, K1Y4K7

  • Thunder Bay Regional Health Sciences Centre, Regional Cancer Care Clinical Trials

    Thunder Bay, Ontario, P7B6V4

  • North York General Hospital

    Toronto, Ontario, M5S1B6

  • Women's College Hospital

    Toronto, Ontario, M5S1B6

  • UBC-Vancouver Hospital & Health Science Center

    Vancouver, British Columbia, V6K2B5

  • CancerCare Manitoba

    Winnepeg, Manitoba, R3EOV9

Other trials in Canada

About this study

Official title: Effects of Selective Estrogen Receptor Modulators on Cognitive Aging: Cognition in the Study of Tamoxifen and Raloxifene

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

Read the detailed 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.

Conditions
Cognition, Aging
Being tested
tamoxifen, raloxifene
Keywords
breast cancer, Tamoxifen, Raloxifene, hormone therapy
Medical subject headings
Breast Neoplasms

What participants receive

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

  • tamoxifenDrug

    Also called Nolvadex

    oral tamoxifen plus placebo daily for 5 years

  • raloxifeneDrug

    Also called Evista, Keoxifene

    oral raloxifene plus placebo daily for 5 years

Study groups in NCT00687102
Study groupRoleWhat they receive
Star participants assigned to TamoxifenExperimentalParticipants in the parent study, STAR assigned to Tamoxifen who were 65 or older at time of enrollment.
Receives: Drug: tamoxifen
Star participants assigned to RaloxifeneExperimentalParticipants in the parent study, STAR assigned to Raloxifene who were 65 or older at time of enrollment.
Receives: Drug: raloxifene

What is being measured

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

  1. 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.

    Measured: Baseline and 3 Years

  2. 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.

    Measured: Baseline and 3 Years

Secondary outcomes (6)

  1. 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.

    Measured: Baseline and 3 Years

  2. 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.

    Measured: Baseline and 3 Years

  3. 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.

    Measured: Baseline and 3 Years

  4. 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.

    Measured: Baseline and 3 Years

  5. 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.

    Measured: Baseline and 3 Years

  6. 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).

    Measured: Baseline and 3 Years

Timeline

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

  1. First posted30 May 2008 (estimated)
  2. Study startOct 2001
  3. Primary completionMar 2008
  4. Study completionMar 2008

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
1,498 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00687102
Sponsor's protocol ID
IA0132
Other IDs
1R13AG020218-01
Acronym
Co-STAR
Status last verified
Aug 2018
First submitted
28 May 2008
Last updated
12 Sep 2018
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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. doi: 10.1176/appi.ajp.158.2.227.

    PubMed 11156805

  • 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. doi: 10.1212/wnl.49.6.1491.

    PubMed 9409335

  • 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. doi: 10.1006/hbeh.1998.1476.

    PubMed 9799627

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing tamoxifen and raloxifene in people with Cognition and Aging, run by Wake Forest University at 134 sites in 2 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 6 inclusion and 3 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 12 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 134 sites in United States, 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Mean Change From Baseline on the the Benton Visual Retention Test Scores by Treatment Group (time frame: Baseline and 3 Years). The study lists 2 primary outcomes in all. 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 NCT00687102, which also lists 3 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 12 Sep 2018.

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