Trial Outcomes & Findings for Cognition in the Study of Tamoxifen and Raloxifene (NCT NCT00687102)

NCT ID: NCT00687102

Last Updated: 2018-09-12

Results Overview

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 Each of 10 designs was presented one at a time for 10 seconds, and immediately after the design was withdrawn, the participant was instructed to draw it from memory on a blank sheet of paper.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.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 1498 participants
• Primary outcome timeframe: Baseline and 3 Years
• Results posted on: 2018-09-12

Participant Flow

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.

Participant milestones

Measure	Star Participants Assigned to Tamoxifen 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	Star Participants Assigned to Raloxifene 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 Study STARTED	733	765
Overall Study COMPLETED	733	765
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Cognition in the Study of Tamoxifen and Raloxifene

Baseline characteristics by cohort

Measure	Star Participants Assigned to Tamoxifen n=733 Participants 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	Star Participants Assigned to Raloxifene n=765 Participants 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 n=1498 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	733 Participants n=5 Participants	765 Participants n=7 Participants	1498 Participants n=5 Participants
Sex: Female, Male Female	733 Participants n=5 Participants	765 Participants n=7 Participants	1498 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	685 Participants n=5 Participants	715 Participants n=7 Participants	1400 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	48 Participants n=5 Participants	50 Participants n=7 Participants	98 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 3 Years

Population: 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.

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.

Outcome measures

Measure	Star Participants Assigned to Tamoxifen n=83 Participants 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	Star Participants Assigned to Raloxifene n=93 Participants 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
Mean Change From Baseline on the the Benton Visual Retention Test Scores by Treatment Group	-0.73 Number of errors Standard Error 0.34	-1.41 Number of errors Standard Error 0.32

PRIMARY outcome

Timeframe: Baseline and 3 Years

Population: 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.

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.

Outcome measures

Measure	Star Participants Assigned to Tamoxifen n=83 Participants 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	Star Participants Assigned to Raloxifene n=93 Participants 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
Mean Change From Baseline on the the California Verbal Learning Test Scores by Treatment Group Total List A trials	-3.31 correct responses Standard Error 0.50	-1.89 correct responses Standard Error 0.48
Mean Change From Baseline on the the California Verbal Learning Test Scores by Treatment Group Total List B trials	-1.56 correct responses Standard Error 0.19	-1.74 correct responses Standard Error 0.18
Mean Change From Baseline on the the California Verbal Learning Test Scores by Treatment Group Short-delay free recall	-0.96 correct responses Standard Error 0.25	-0.36 correct responses Standard Error 0.24
Mean Change From Baseline on the the California Verbal Learning Test Scores by Treatment Group Long-delay free recall	-0.23 correct responses Standard Error 0.25	0.10 correct responses Standard Error 0.24

SECONDARY outcome

Timeframe: Baseline and 3 Years

Population: 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.

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.

Outcome measures

Measure	Star Participants Assigned to Tamoxifen n=83 Participants 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	Star Participants Assigned to Raloxifene n=93 Participants 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
Mean Change From Baseline on the Letter Fluency and Semantic Fluency Scores by Treatment Group Letter Fluency	1.29 change in number of words Standard Error 0.75	1.51 change in number of words Standard Error 0.71
Mean Change From Baseline on the Letter Fluency and Semantic Fluency Scores by Treatment Group Semantic Fluency	-.51 change in number of words Standard Error .50	-.56 change in number of words Standard Error .47

SECONDARY outcome

Timeframe: Baseline and 3 Years

Population: 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.

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.

Outcome measures

Measure	Star Participants Assigned to Tamoxifen n=83 Participants 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	Star Participants Assigned to Raloxifene n=93 Participants 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
Mean Change From Baseline on Digit Span Test Scores by Treatment Group Digits Forward	-0.02 units on a scale Standard Error 0.18	-0.08 units on a scale Standard Error 0.17
Mean Change From Baseline on Digit Span Test Scores by Treatment Group Digits Backward	-0.16 units on a scale Standard Error 0.17	-0.27 units on a scale Standard Error 0.16

SECONDARY outcome

Timeframe: Baseline and 3 Years

Population: 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.

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.

Outcome measures

Measure	Star Participants Assigned to Tamoxifen n=83 Participants 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	Star Participants Assigned to Raloxifene n=93 Participants 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
Mean Change From Baseline on Card Rotations Test Scores by Treatment Group	6.10 correct responses Standard Error 1.97	5.40 correct responses Standard Error 1.86

SECONDARY outcome

Timeframe: Baseline and 3 Years

Population: 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.

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.

Outcome measures

Measure	Star Participants Assigned to Tamoxifen n=83 Participants 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	Star Participants Assigned to Raloxifene n=93 Participants 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
Mean Change From Baseline on the Finger Tapping Test Scores by Treatment Group Fine Tapping, Dominant	0.26 finger taps Standard Error 0.65	-0.04 finger taps Standard Error 0.63
Mean Change From Baseline on the Finger Tapping Test Scores by Treatment Group Fine Tapping, Non-Dominant	-0.18 finger taps Standard Error 0.50	-0.45 finger taps Standard Error 0.48

SECONDARY outcome

Timeframe: Baseline and 3 Years

Population: 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.

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.

Outcome measures

Measure	Star Participants Assigned to Tamoxifen n=83 Participants 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	Star Participants Assigned to Raloxifene n=93 Participants 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
Mean Change From Baseline on the Positive and Negative Affect Schedule Scores by Treatment Group PANAS-positive	-0.10 units on a scale Standard Error 0.06	-0.04 units on a scale Standard Error 0.05
Mean Change From Baseline on the Positive and Negative Affect Schedule Scores by Treatment Group PANAS-negative	0.00 units on a scale Standard Error 0.06	-0.06 units on a scale Standard Error 0.05

SECONDARY outcome

Timeframe: Baseline and 3 Years

Population: 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.

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).

Outcome measures

Measure	Star Participants Assigned to Tamoxifen n=83 Participants 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	Star Participants Assigned to Raloxifene n=93 Participants 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
Mean Change From Baseline on the Geriatric Depression Scale Scores by Treatment Group	0.57 units on a scale Standard Error 0.19	0.13 units on a scale Standard Error 0.18

Adverse Events

Star Participants Assigned to Tamoxifen

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Star Participants Assigned to Raloxifene

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Sally A. Shumaker, PhD

Wake Forest University Health Sciences

Phone: 336-71696934

Email: sshumake@wakehealth.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place