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Cognition in the Study of Tamoxifen and Raloxifene (Co-STAR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00687102
Recruitment Status : Completed
First Posted : May 30, 2008
Results First Posted : January 23, 2018
Last Update Posted : September 12, 2018
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Wake Forest University Health Sciences ( Wake Forest University )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions Cognition
Aging
Interventions Drug: tamoxifen
Drug: raloxifene
Enrollment 1498
Recruitment Details Co-STAR enrolled 1,498 women assigned in the STAR trial aged 65 years and older and no diagnosis of dementia. All participants were fluent in English and provided written informed consent for the Co-STAR study. Enrollment began in October 2001, 18 months after STAR enrollment started and continued until the unmasking of STAR in June 2006.
Pre-assignment Details  
Arm/Group Title Star Participants Assigned to Tamoxifen Star Participants Assigned to Raloxifene
Hide Arm/Group Description

Participants in the parent study, STAR assigned to Tamoxifen who were 65 or older at time of enrollment.

tamoxifen: oral tamoxifen plus placebo daily for 5 years

Participants in the parent study, STAR assigned to Raloxifene who were 65 or older at time of enrollment.

raloxifene: oral raloxifene plus placebo daily for 5 years

Period Title: Overall Study
Started 733 765
Completed 733 765
Not Completed 0 0
Arm/Group Title Star Participants Assigned to Tamoxifen Star Participants Assigned to Raloxifene Total
Hide Arm/Group Description

Participants in the parent study, STAR assigned to Tamoxifen who were 65 or older at time of enrollment.

tamoxifen: oral tamoxifen plus placebo daily for 5 years

Participants in the parent study, STAR assigned to Raloxifene who were 65 or older at time of enrollment.

raloxifene: oral raloxifene plus placebo daily for 5 years

Total of all reporting groups
Overall Number of Baseline Participants 733 765 1498
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 733 participants 765 participants 1498 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
733
 100.0%
765
 100.0%
1498
 100.0%
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 733 participants 765 participants 1498 participants
Female
733
 100.0%
765
 100.0%
1498
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
[1]
Measure Description: This study was designed to recruit female participants only.
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 733 participants 765 participants 1498 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
685
  93.5%
715
  93.5%
1400
  93.5%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
48
   6.5%
50
   6.5%
98
   6.5%
1.Primary Outcome
Title Mean Change From Baseline on the the Benton Visual Retention Test Scores by Treatment Group
Hide Description

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.

Time Frame Baseline and 3 Years
Hide Outcome Measure Data
Hide Analysis Population Description
Women who were randomly assigned in STAR were age 65 years and older, were not diagnosed with dementia, and were enrolled onto the Cognition in the Study of Tamoxifen and Raloxifene (Co-STAR) trial.
Arm/Group Title Star Participants Assigned to Tamoxifen Star Participants Assigned to Raloxifene
Hide Arm/Group Description:

Participants in the parent study, STAR assigned to Tamoxifen who were 65 or older at time of enrollment.

tamoxifen: oral tamoxifen plus placebo daily for 5 years

Participants in the parent study, STAR assigned to Raloxifene who were 65 or older at time of enrollment.

raloxifene: oral raloxifene plus placebo daily for 5 years

Overall Number of Participants Analyzed 83 93
Mean (Standard Error)
Unit of Measure: Number of errors
-0.73  (0.34) -1.41  (0.32)
2.Primary Outcome
Title Mean Change From Baseline on the the California Verbal Learning Test Scores by Treatment Group
Hide Description

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.

Time Frame Baseline and 3 Years
Hide Outcome Measure Data
Hide Analysis Population Description
Women who were randomly assigned in STAR were age 65 years and older, were not diagnosed with dementia, and were enrolled onto the Cognition in the Study of Tamoxifen and Raloxifene (Co-STAR) trial.
Arm/Group Title Star Participants Assigned to Tamoxifen Star Participants Assigned to Raloxifene
Hide Arm/Group Description:

Participants in the parent study, STAR assigned to Tamoxifen who were 65 or older at time of enrollment.

tamoxifen: oral tamoxifen plus placebo daily for 5 years

Participants in the parent study, STAR assigned to Raloxifene who were 65 or older at time of enrollment.

raloxifene: oral raloxifene plus placebo daily for 5 years

Overall Number of Participants Analyzed 83 93
Mean (Standard Error)
Unit of Measure: correct responses
Total List A trials -3.31  (0.50) -1.89  (0.48)
Total List B trials -1.56  (0.19) -1.74  (0.18)
Short-delay free recall -0.96  (0.25) -0.36  (0.24)
Long-delay free recall -0.23  (0.25) 0.10  (0.24)
3.Secondary Outcome
Title Mean Change From Baseline on the Letter Fluency and Semantic Fluency Scores by Treatment Group
Hide Description

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.

Time Frame Baseline and 3 Years
Hide Outcome Measure Data
Hide Analysis Population Description
Women who were randomly assigned in STAR were age 65 years and older, were not diagnosed with dementia, and were enrolled onto the Cognition in the Study of Tamoxifen and Raloxifene (Co-STAR) trial.
Arm/Group Title Star Participants Assigned to Tamoxifen Star Participants Assigned to Raloxifene
Hide Arm/Group Description:

Participants in the parent study, STAR assigned to Tamoxifen who were 65 or older at time of enrollment.

tamoxifen: oral tamoxifen plus placebo daily for 5 years

Participants in the parent study, STAR assigned to Raloxifene who were 65 or older at time of enrollment.

raloxifene: oral raloxifene plus placebo daily for 5 years

Overall Number of Participants Analyzed 83 93
Mean (Standard Error)
Unit of Measure: change in number of words
Letter Fluency 1.29  (0.75) 1.51  (0.71)
Semantic Fluency -.51  (.50) -.56  (.47)
4.Secondary Outcome
Title Mean Change From Baseline on Digit Span Test Scores by Treatment Group
Hide Description

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.

Time Frame Baseline and 3 Years
Hide Outcome Measure Data
Hide Analysis Population Description
Women who were randomly assigned in STAR were age 65 years and older, were not diagnosed with dementia, and were enrolled onto the Cognition in the Study of Tamoxifen and Raloxifene (Co-STAR) trial.
Arm/Group Title Star Participants Assigned to Tamoxifen Star Participants Assigned to Raloxifene
Hide Arm/Group Description:

Participants in the parent study, STAR assigned to Tamoxifen who were 65 or older at time of enrollment.

tamoxifen: oral tamoxifen plus placebo daily for 5 years

Participants in the parent study, STAR assigned to Raloxifene who were 65 or older at time of enrollment.

raloxifene: oral raloxifene plus placebo daily for 5 years

Overall Number of Participants Analyzed 83 93
Mean (Standard Error)
Unit of Measure: units on a scale
Digits Forward -0.02  (0.18) -0.08  (0.17)
Digits Backward -0.16  (0.17) -0.27  (0.16)
5.Secondary Outcome
Title Mean Change From Baseline on Card Rotations Test Scores by Treatment Group
Hide Description

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.

Time Frame Baseline and 3 Years
Hide Outcome Measure Data
Hide Analysis Population Description
Women who were randomly assigned in STAR were age 65 years and older, were not diagnosed with dementia, and were enrolled onto the Cognition in the Study of Tamoxifen and Raloxifene (Co-STAR) trial.
Arm/Group Title Star Participants Assigned to Tamoxifen Star Participants Assigned to Raloxifene
Hide Arm/Group Description:

Participants in the parent study, STAR assigned to Tamoxifen who were 65 or older at time of enrollment.

tamoxifen: oral tamoxifen plus placebo daily for 5 years

Participants in the parent study, STAR assigned to Raloxifene who were 65 or older at time of enrollment.

raloxifene: oral raloxifene plus placebo daily for 5 years

Overall Number of Participants Analyzed 83 93
Mean (Standard Error)
Unit of Measure: correct responses
6.10  (1.97) 5.40  (1.86)
6.Secondary Outcome
Title Mean Change From Baseline on the Finger Tapping Test Scores by Treatment Group
Hide Description

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.

Time Frame Baseline and 3 Years
Hide Outcome Measure Data
Hide Analysis Population Description
Women who were randomly assigned in STAR were age 65 years and older, were not diagnosed with dementia, and were enrolled onto the Cognition in the Study of Tamoxifen and Raloxifene (Co-STAR) trial.
Arm/Group Title Star Participants Assigned to Tamoxifen Star Participants Assigned to Raloxifene
Hide Arm/Group Description:

Participants in the parent study, STAR assigned to Tamoxifen who were 65 or older at time of enrollment.

tamoxifen: oral tamoxifen plus placebo daily for 5 years

Participants in the parent study, STAR assigned to Raloxifene who were 65 or older at time of enrollment.

raloxifene: oral raloxifene plus placebo daily for 5 years

Overall Number of Participants Analyzed 83 93
Mean (Standard Error)
Unit of Measure: finger taps
Fine Tapping, Dominant 0.26  (0.65) -0.04  (0.63)
Fine Tapping, Non-Dominant -0.18  (0.50) -0.45  (0.48)
7.Secondary Outcome
Title Mean Change From Baseline on the Positive and Negative Affect Schedule Scores by Treatment Group
Hide Description

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.

Time Frame Baseline and 3 Years
Hide Outcome Measure Data
Hide Analysis Population Description
Women who were randomly assigned in STAR were age 65 years and older, were not diagnosed with dementia, and were enrolled onto the Cognition in the Study of Tamoxifen and Raloxifene (Co-STAR) trial.
Arm/Group Title Star Participants Assigned to Tamoxifen Star Participants Assigned to Raloxifene
Hide Arm/Group Description:

Participants in the parent study, STAR assigned to Tamoxifen who were 65 or older at time of enrollment.

tamoxifen: oral tamoxifen plus placebo daily for 5 years

Participants in the parent study, STAR assigned to Raloxifene who were 65 or older at time of enrollment.

raloxifene: oral raloxifene plus placebo daily for 5 years

Overall Number of Participants Analyzed 83 93
Mean (Standard Error)
Unit of Measure: units on a scale
PANAS-positive -0.10  (0.06) -0.04  (0.05)
PANAS-negative 0.00  (0.06) -0.06  (0.05)
8.Secondary Outcome
Title Mean Change From Baseline on the Geriatric Depression Scale Scores by Treatment Group
Hide Description

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).

Time Frame Baseline and 3 Years
Hide Outcome Measure Data
Hide Analysis Population Description
Women who were randomly assigned in STAR were age 65 years and older, were not diagnosed with dementia, and were enrolled onto the Cognition in the Study of Tamoxifen and Raloxifene (Co-STAR) trial.
Arm/Group Title Star Participants Assigned to Tamoxifen Star Participants Assigned to Raloxifene
Hide Arm/Group Description:

Participants in the parent study, STAR assigned to Tamoxifen who were 65 or older at time of enrollment.

tamoxifen: oral tamoxifen plus placebo daily for 5 years

Participants in the parent study, STAR assigned to Raloxifene who were 65 or older at time of enrollment.

raloxifene: oral raloxifene plus placebo daily for 5 years

Overall Number of Participants Analyzed 83 93
Mean (Standard Error)
Unit of Measure: units on a scale
0.57  (0.19) 0.13  (0.18)
Time Frame 4 years, 8 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Star Participants Assigned to Tamoxifen Star Participants Assigned to Raloxifene
Hide Arm/Group Description

Participants in the parent study, STAR assigned to Tamoxifen who were 65 or older at time of enrollment.

tamoxifen: oral tamoxifen plus placebo daily for 5 years

Participants in the parent study, STAR assigned to Raloxifene who were 65 or older at time of enrollment.

raloxifene: oral raloxifene plus placebo daily for 5 years

All-Cause Mortality
Star Participants Assigned to Tamoxifen Star Participants Assigned to Raloxifene
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Star Participants Assigned to Tamoxifen Star Participants Assigned to Raloxifene
Affected / at Risk (%) Affected / at Risk (%)
Total   0/733 (0.00%)   0/765 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Star Participants Assigned to Tamoxifen Star Participants Assigned to Raloxifene
Affected / at Risk (%) Affected / at Risk (%)
Total   0/733 (0.00%)   0/765 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Sally A. Shumaker, PhD
Organization: Wake Forest University Health Sciences
Phone: 336-71696934
EMail: sshumake@wakehealth.edu
Layout table for additonal information
Responsible Party: Wake Forest University Health Sciences ( Wake Forest University )
ClinicalTrials.gov Identifier: NCT00687102    
Obsolete Identifiers: NCT00571857
Other Study ID Numbers: IA0132
1R13AG020218-01 ( U.S. NIH Grant/Contract )
First Submitted: May 28, 2008
First Posted: May 30, 2008
Results First Submitted: August 4, 2017
Results First Posted: January 23, 2018
Last Update Posted: September 12, 2018