Trial Outcomes & Findings for Conversations as a Means to Delay the Onset of Alzheimer's Disease (NCT NCT01571427)

NCT ID: NCT01571427

Last Updated: 2020-02-05

Results Overview

Mini Mental State Examination assess global cognitive function. Possible score ranges from 0 to 30. In this study, score ranges from 24 to 30 (those with MMSE \<24 at baseline were excluded according to the study exclusion criteria). Changes in test results among the experimental group are compared with changes among the control group using linear regression models. (no drop out reported and therefore no need to use mixed effects models or MMRM) Higher values (post-pre) indicate that decline was less or test score improved more.

• Recruitment status: COMPLETED
• Study phase: EARLY_PHASE1
• Target enrollment: 83 participants
• Primary outcome timeframe: 6 weeks (primary endpoint) from baseline
• Results posted on: 2020-02-05

Participant Flow

From November 2011 to August 2012, we distributed 2000 surveys targeting those living in retirement communities and senior centers located in the Portland, metropolitan area, within an approximately 1-hour commute from Oregon Health & Science University (Portland, OR).

Participant milestones

Measure	Active Social Engagement Group Active Social Engagement: Engage in 30 minutes conversation daily with interviewers using internet/webcam for 6 weeks Active social engagement group: Engage in 30 minutes conversation daily using internet/webcam, 5 days per week for 6 weeks, tracking of daily conversational amount outside of the trial by using a digital recording device, lasting effects will be assessed at the 3rd and 6th month after completion of the intervention	Control Group No daily conversational sessions with interviewers using webcam/internet. Weekly web-based heath form must be submitted using internet/PC. If not, subjects receive prompts from study personnel. Control group: No active intervention, weekly phone calls by interviewer to complete health/social engagement monitoring survey, tracking of daily conversational amount by using a digital recording device
Overall Study STARTED	41	42
Overall Study COMPLETED	41	42
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Conversations as a Means to Delay the Onset of Alzheimer's Disease

Baseline characteristics by cohort

Measure	Active Soocial Engagement Group n=41 Participants Active Social Engagement: Engage in 30 minutes conversation daily with interviewers using internet/webcam for 6 weeks Active social engagement group: Engage in 30 minutes conversation daily using internet/webcam, 5 days per week for 6 weeks, tracking of daily conversational amount outside of the trial by using a digital recording device, lasting effects will be assessed at the 3rd and 6th month after completion of the intervention	Control Group n=42 Participants No daily conversational sessions with interviewers using webcam/internet. Weekly web-based heath form must be submitted using internet/PC. If not, subjects receive prompts from study personnel. Control group: No active intervention, weekly phone calls by interviewer to complete health/social engagement monitoring survey, tracking of daily conversational amount by using a digital recording device	Total n=83 Participants Total of all reporting groups
Age, Continuous	80.9 years STANDARD_DEVIATION 7.2 • n=5 Participants	80.2 years STANDARD_DEVIATION 6.6 • n=7 Participants	80.5 years STANDARD_DEVIATION 6.8 • n=5 Participants
Sex: Female, Male Female	32 Participants n=5 Participants	31 Participants n=7 Participants	63 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	11 Participants n=7 Participants	20 Participants n=5 Participants
Region of Enrollment United States	41 participants n=5 Participants	42 participants n=7 Participants	83 participants n=5 Participants
Education: High school completed or greater	40 Participants n=5 Participants	40 Participants n=7 Participants	80 Participants n=5 Participants
Cognitive Status: Clinical Dementia Rating (CDR) Scale score of 0.5 (%)	17 Participants n=5 Participants	17 Participants n=7 Participants	34 Participants n=5 Participants
Global cognitive Status: Mini-Mental State Examination score	28.2 units on a scale STANDARD_DEVIATION 1.7 • n=5 Participants	28.3 units on a scale STANDARD_DEVIATION 1.8 • n=7 Participants	28.3 units on a scale STANDARD_DEVIATION 1.8 • n=5 Participants
Marital Status: Married (%)	18 Participants n=5 Participants	20 Participants n=7 Participants	38 Participants n=5 Participants
Levels of Education: The Wide Range Achievement Test--Revised (WRAT-R)	72.0 units on a scale STANDARD_DEVIATION 12.9 • n=5 Participants	72.0 units on a scale STANDARD_DEVIATION 11.5 • n=7 Participants	72.0 units on a scale STANDARD_DEVIATION 12.1 • n=5 Participants
Experience using personal computer (PC)	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks (primary endpoint) from baseline

Population: Sampling frame consists of retirement communities and Layton Aging Alzheimer's Disease research center volunteer lists. The survey asking whether they would like to participate in the study was distributed among 2000 subjects.

Mini Mental State Examination assess global cognitive function. Possible score ranges from 0 to 30. In this study, score ranges from 24 to 30 (those with MMSE <24 at baseline were excluded according to the study exclusion criteria). Changes in test results among the experimental group are compared with changes among the control group using linear regression models. (no drop out reported and therefore no need to use mixed effects models or MMRM) Higher values (post-pre) indicate that decline was less or test score improved more.

Outcome measures

Measure	Active Social Engagement Group n=41 Participants Active Social Engagement: Engage in 30 minutes conversation daily with interviewers using internet/webcam for 6 weeks Active social engagement group: Engage in 30 minutes conversation daily using internet/webcam, 5 days per week for 6 weeks, tracking of daily conversational amount outside of the trial by using a digital recording device, lasting effects will be assessed at the 3rd and 6th month after completion of the intervention	Control Group n=42 Participants No daily conversational sessions with interviewers using webcam/internet. Weekly web-based heath form must be submitted using internet/PC. If not, subjects receive prompts from study personnel. Control group: No active intervention, weekly phone calls by interviewer to complete health/social engagement monitoring survey, tracking of daily conversational amount by using a digital recording device
Changes in Global Cognitive Function Using Mini Mental State Examination Score (Post-study Test Score - Baseline Test Score)	-0.51 score on a scale Standard Deviation 1.51	-0.07 score on a scale Standard Deviation 1.65

PRIMARY outcome

Timeframe: 6 weeks (primary endpoint) from baseline

Population: Sampling frame consists of retirement communities and Layton Aging Alzheimer's Disease research center volunteer lists. The survey asking whether they would like to participate in the study was distributed among 2000 subjects.

Verbal fluency Animals test is a neuropsychological test. In the test, participants have to produce as many words as possible from a category of animals within 60 seconds. Total score ranges from 0 to 70. Changes in test results among the experimental group are compared with changes among the control group using linear regression models. (no drop out reported and therefore no need to use mixed effects models or MMRM). Higher values mean decline is less or score improve at post-study assessment.

Outcome measures

Measure	Active Social Engagement Group n=41 Participants Active Social Engagement: Engage in 30 minutes conversation daily with interviewers using internet/webcam for 6 weeks Active social engagement group: Engage in 30 minutes conversation daily using internet/webcam, 5 days per week for 6 weeks, tracking of daily conversational amount outside of the trial by using a digital recording device, lasting effects will be assessed at the 3rd and 6th month after completion of the intervention	Control Group n=42 Participants No daily conversational sessions with interviewers using webcam/internet. Weekly web-based heath form must be submitted using internet/PC. If not, subjects receive prompts from study personnel. Control group: No active intervention, weekly phone calls by interviewer to complete health/social engagement monitoring survey, tracking of daily conversational amount by using a digital recording device
Changes in Category Fluency (Animals) Test Scores (Post-study Test Score - Baseline Test Score)	1.75 Number of words Standard Deviation 4.21	-0.38 Number of words Standard Deviation 4.08

PRIMARY outcome

Timeframe: 6 weeks (primary endpoint) from baseline

Population: Sampling frame consists of retirement communities and Layton Aging Alzheimer's Disease research center volunteer lists. The survey asking whether they would like to participate in the study was distributed among 2000 subjects.

Verbal fluency letter test is a neuropsychological test. In the test, participants have to produce as many words as possible which start with a letter F, A and S (3 separate test for each letter) within 60 seconds. Each test score ranges from 0 to 40. Total of 3 tests scores (F, A and S) ranges from 0 to 120. Changes in test results among the experimental group are compared with changes among the control group using linear regression models. (no drop out reported and therefore no need to use mixed effects models or MMRM) Higher values mean decline is less or test scores improved at post-study assessment.

Outcome measures

Measure	Active Social Engagement Group n=41 Participants Active Social Engagement: Engage in 30 minutes conversation daily with interviewers using internet/webcam for 6 weeks Active social engagement group: Engage in 30 minutes conversation daily using internet/webcam, 5 days per week for 6 weeks, tracking of daily conversational amount outside of the trial by using a digital recording device, lasting effects will be assessed at the 3rd and 6th month after completion of the intervention	Control Group n=42 Participants No daily conversational sessions with interviewers using webcam/internet. Weekly web-based heath form must be submitted using internet/PC. If not, subjects receive prompts from study personnel. Control group: No active intervention, weekly phone calls by interviewer to complete health/social engagement monitoring survey, tracking of daily conversational amount by using a digital recording device
Changes in Verbal Fluency Letter Test Scores (Post-study Test Score - Baseline Test Score)	1.14 Number of words Standard Deviation 6.45	1.26 Number of words Standard Deviation 5.59

PRIMARY outcome

Timeframe: 6 weeks (primary endpoint) from baseline

Population: Sampling frame consists of retirement communities and Layton Aging Alzheimer's Disease research center volunteer lists. The survey asking whether they would like to participate in the study was distributed among 2000 subjects.

Consortium to Establish a Registry for Alzheimer's Disease Word List Immediate Recall (CERAD Word List Immediate Recall) total score counts number of words correctly recalled over 3 trials (with each trial having 10 words), and ranges from 0 to 30. Pre-post changes in test results among the experimental group were compared with pre-post changes among the control group using linear regression models. (no drop out reported and therefore no need to use mixed effects models or MMRM)

Outcome measures

Measure	Active Social Engagement Group n=41 Participants Active Social Engagement: Engage in 30 minutes conversation daily with interviewers using internet/webcam for 6 weeks Active social engagement group: Engage in 30 minutes conversation daily using internet/webcam, 5 days per week for 6 weeks, tracking of daily conversational amount outside of the trial by using a digital recording device, lasting effects will be assessed at the 3rd and 6th month after completion of the intervention	Control Group n=42 Participants No daily conversational sessions with interviewers using webcam/internet. Weekly web-based heath form must be submitted using internet/PC. If not, subjects receive prompts from study personnel. Control group: No active intervention, weekly phone calls by interviewer to complete health/social engagement monitoring survey, tracking of daily conversational amount by using a digital recording device
Changes in the Consortium to Establish a Registry for Alzheimer's Disease Word List Immediate Recall (Post-study Test Score - Baseline Test Score)	0.30 Number of words Standard Deviation 2.69	0.53 Number of words Standard Deviation 3.03

PRIMARY outcome

Timeframe: 6 weeks (primary endpoint) from baseline

Population: Sampling frame consists of retirement communities and Layton Aging Alzheimer's Disease research center volunteer lists. The survey asking whether they would like to participate in the study was distributed among 2000 subjects.

Consortium to Establish a Registry for Alzheimer's Disease Word List Delayed Recall (CERAD Word List Delayed Recall) total score counts number of words correctly recalled in one trial (10 words) and it ranges from 0 to 10. Pre-post trial changes in test results among the experimental group was compared with pre-post changes among the control group using linear regression models. (no drop out reported and therefore no need to use mixed effects models or MMRM)

Outcome measures

Measure	Active Social Engagement Group n=41 Participants Active Social Engagement: Engage in 30 minutes conversation daily with interviewers using internet/webcam for 6 weeks Active social engagement group: Engage in 30 minutes conversation daily using internet/webcam, 5 days per week for 6 weeks, tracking of daily conversational amount outside of the trial by using a digital recording device, lasting effects will be assessed at the 3rd and 6th month after completion of the intervention	Control Group n=42 Participants No daily conversational sessions with interviewers using webcam/internet. Weekly web-based heath form must be submitted using internet/PC. If not, subjects receive prompts from study personnel. Control group: No active intervention, weekly phone calls by interviewer to complete health/social engagement monitoring survey, tracking of daily conversational amount by using a digital recording device
Changes in the Consortium to Establish a Registry for Alzheimer's Disease Word List Delayed Recall (Post-study Test Score - Baseline Test Score)	-0.20 Number of words Standard Deviation 1.72	-0.19 Number of words Standard Deviation 2.12

PRIMARY outcome

Timeframe: 6 weeks (primary endpoint) from baseline

Population: Sampling frame consists of retirement communities and Layton Aging Alzheimer's Disease research center volunteer lists. The survey asking whether they would like to participate in the study was distributed among 2000 subjects.

In Trail Making test A, the subject is instructed to connect a set of 25 dots as quickly as possible while still maintaining accuracy within 150 seconds. Time to complete is used here. Pre-post trial changes in test results among the experimental group are compared with pre-post changes among the control group using linear regression models. (no drop out reported and therefore no need to use mixed effects models or MMRM). Larger changes mean subjects got slower to complete the test at the post-trial assessment. Negative changes indicates subjects completed the test faster at the post-trial assessment.

Outcome measures

Measure	Active Social Engagement Group n=41 Participants Active Social Engagement: Engage in 30 minutes conversation daily with interviewers using internet/webcam for 6 weeks Active social engagement group: Engage in 30 minutes conversation daily using internet/webcam, 5 days per week for 6 weeks, tracking of daily conversational amount outside of the trial by using a digital recording device, lasting effects will be assessed at the 3rd and 6th month after completion of the intervention	Control Group n=42 Participants No daily conversational sessions with interviewers using webcam/internet. Weekly web-based heath form must be submitted using internet/PC. If not, subjects receive prompts from study personnel. Control group: No active intervention, weekly phone calls by interviewer to complete health/social engagement monitoring survey, tracking of daily conversational amount by using a digital recording device
Changes in Trail Making Test A Scores (Post-study Test Score - Baseline Test Score)	-2.80 Seconds Standard Deviation 15.25	-0.85 Seconds Standard Deviation 9.51

PRIMARY outcome

Timeframe: 6 weeks (primary endpoint) from baseline

Population: Sampling frame consists of retirement communities and Layton Aging Alzheimer's Disease research center volunteer lists. The survey asking whether they would like to participate in the study was distributed among 2000 subjects.

In Trail Making test B, the subject is instructed to connect a set of 25 dots as quickly as possible while still maintaining accuracy within 300 seconds. In Test B, the circles include both numbers (1 - 13) and letters (A - L). Time to complete is used here. Pre-post trial changes in test results among the experimental group are compared with pre-post changes among the control group using linear regression models. (no drop out reported and therefore no need to use mixed effects models or MMRM). Larger changes mean subjects got slower to complete the test at the post-trial assessment. Negative changes indicates subjects completed the test faster at the post-trial assessment.

Outcome measures

Measure	Active Social Engagement Group n=41 Participants Active Social Engagement: Engage in 30 minutes conversation daily with interviewers using internet/webcam for 6 weeks Active social engagement group: Engage in 30 minutes conversation daily using internet/webcam, 5 days per week for 6 weeks, tracking of daily conversational amount outside of the trial by using a digital recording device, lasting effects will be assessed at the 3rd and 6th month after completion of the intervention	Control Group n=42 Participants No daily conversational sessions with interviewers using webcam/internet. Weekly web-based heath form must be submitted using internet/PC. If not, subjects receive prompts from study personnel. Control group: No active intervention, weekly phone calls by interviewer to complete health/social engagement monitoring survey, tracking of daily conversational amount by using a digital recording device
Changes in Trail Making Test B Scores (Post-study Test Score - Baseline Test Score)	-10.18 Seconds Standard Deviation 29.32	-14.65 Seconds Standard Deviation 46.85

PRIMARY outcome

Timeframe: 6 weeks (primary endpoint) from baseline

Population: Sampling frame consists of retirement communities and Layton Aging Alzheimer's Disease research center volunteer lists. The survey asking whether they would like to participate in the study was distributed among 2000 subjects.

In the Stroop test, subjects are required to read three different pages of stimuli in a designated time as quickly as possible. First, the individual is asked to name a series of colored squares (Color Naming task, Stroop Test A). Second, the individual is asked to read color words (Word Reading task, Stroop Test B). The final task is the Color-Word Naming task (Stroop Test C) on which the individual is shown the names of colors printed in conflicting ink colors (e.g., the word "red" in blue ink) and is asked to name the color of the ink rather than the word. Each test (A, B, C) is administered for 45 seconds. The number of words correctly named for the Stroop Test C was used here. The maximum score of this test is 100 (range: 0 - 100). The higher score indicates better functions. The changes (post-study - baseline test scores) among the experimental group are compared with those among the control group. The higher change scores mean improved function.

Outcome measures

Measure	Active Social Engagement Group n=41 Participants Active Social Engagement: Engage in 30 minutes conversation daily with interviewers using internet/webcam for 6 weeks Active social engagement group: Engage in 30 minutes conversation daily using internet/webcam, 5 days per week for 6 weeks, tracking of daily conversational amount outside of the trial by using a digital recording device, lasting effects will be assessed at the 3rd and 6th month after completion of the intervention	Control Group n=42 Participants No daily conversational sessions with interviewers using webcam/internet. Weekly web-based heath form must be submitted using internet/PC. If not, subjects receive prompts from study personnel. Control group: No active intervention, weekly phone calls by interviewer to complete health/social engagement monitoring survey, tracking of daily conversational amount by using a digital recording device
Changes in the Stroop Color and Word Test (Stroop Test C) Scores (Post-study Test Scores - Baseline Test Scores)	0.34 Number of words correctly named Standard Deviation 3.88	1.14 Number of words correctly named Standard Deviation 4.29

PRIMARY outcome

Timeframe: 6 weeks (primary endpoint) from baseline

Population: Sampling frame consists of retirement communities and Layton Aging Alzheimer's Disease research center volunteer lists. The survey asking whether they would like to participate in the study was distributed among 2000 subjects.

In detection test, the on-screen instructions ask: "Has the card turned over?". A playing card is presented face down in the center of the screen. The card flips over so it is face up. As soon as the card flips over the participant must press "Yes". The participant is encouraged to work as quickly as they can and be as accurate as possible.Speed of performance (mean of the log10 transformed reaction times for correct responses) is used here. Pre-post trial changes in test results among the experimental group were compared with pre-post changes among the control group using linear regression models. (no drop out reported and therefore no need to use mixed effects models or MMRM). Larger changes mean subjects got slower in reaction at the post-trial assessment. Negative changes indicates subjects got faster in reaction at the post-trial assessment.

Outcome measures

Measure	Active Social Engagement Group n=41 Participants Active Social Engagement: Engage in 30 minutes conversation daily with interviewers using internet/webcam for 6 weeks Active social engagement group: Engage in 30 minutes conversation daily using internet/webcam, 5 days per week for 6 weeks, tracking of daily conversational amount outside of the trial by using a digital recording device, lasting effects will be assessed at the 3rd and 6th month after completion of the intervention	Control Group n=42 Participants No daily conversational sessions with interviewers using webcam/internet. Weekly web-based heath form must be submitted using internet/PC. If not, subjects receive prompts from study personnel. Control group: No active intervention, weekly phone calls by interviewer to complete health/social engagement monitoring survey, tracking of daily conversational amount by using a digital recording device
Changes in Cogstate Computerized Test: Detection Test (Post-study Test Score - Baseline Test Score)	0.016 log 10 milliseconds Standard Error 0.091	0.065 log 10 milliseconds Standard Error 0.113

PRIMARY outcome

Timeframe: 6 weeks (primary endpoint) from baseline

Population: Sampling frame consists of retirement communities and Layton Aging Alzheimer's Disease research center volunteer lists. The survey asking whether they would like to participate in the study was distributed among 2000 subjects.

In this test, the on-screen instructions ask: "Is the previous card the same?". A playing card is presented face up in the center of the screen. The participant must decide whether the card is the same as the previous card. If the card is the same the participant should press "Yes", and if it is not the same the participant should press "No". The participant is encouraged to work as quickly as they can and be as accurate as possible. Accuracy of performance (arcsine transformation of the square root of the proportion of correct responses) is reported here. Pre-post trial changes in test results among the experimental group will be compared with pre-post changes among the control group using linear regression models. (no drop out reported and therefore no need to use mixed effects models or MMRM). Larger changes mean the score improved at the post trial assessment.

Outcome measures

Measure	Active Social Engagement Group n=41 Participants Active Social Engagement: Engage in 30 minutes conversation daily with interviewers using internet/webcam for 6 weeks Active social engagement group: Engage in 30 minutes conversation daily using internet/webcam, 5 days per week for 6 weeks, tracking of daily conversational amount outside of the trial by using a digital recording device, lasting effects will be assessed at the 3rd and 6th month after completion of the intervention	Control Group n=42 Participants No daily conversational sessions with interviewers using webcam/internet. Weekly web-based heath form must be submitted using internet/PC. If not, subjects receive prompts from study personnel. Control group: No active intervention, weekly phone calls by interviewer to complete health/social engagement monitoring survey, tracking of daily conversational amount by using a digital recording device
Changes in Cogstate One Back Accuracy (Post-study Test Score - Baseline Test Score)	0.049 arcsine transformed values (see above) Standard Error 0.246	0.062 arcsine transformed values (see above) Standard Error 0.168

PRIMARY outcome

Timeframe: 6 weeks (primary endpoint) from baseline

Population: Sampling frame consists of retirement communities and Layton Aging Alzheimer's Disease research center volunteer lists. The survey asking whether they would like to participate in the study was distributed among 2000 subjects.

In this test, the on-screen instructions ask: "Is the card the same as that shown two cards ago?". A playing card is presented face up in the center of the screen. The participant must decide whether the card is the same as the card shown two cards previously. If the card is the same the participant should press "Yes", and if it is not the same the participant should press "No". The participant is encouraged to work as quickly as they can and be as accurate as possible. Accuracy of performance (arcsine transformation of the square root of the proportion of correct responses) is reported here. Pre-post trial changes in test results among the experimental group will be compared with pre-post changes among the control group using linear regression models. (no drop out reported and therefore no need to use mixed effects models or MMRM)

Outcome measures

Measure	Active Social Engagement Group n=41 Participants Active Social Engagement: Engage in 30 minutes conversation daily with interviewers using internet/webcam for 6 weeks Active social engagement group: Engage in 30 minutes conversation daily using internet/webcam, 5 days per week for 6 weeks, tracking of daily conversational amount outside of the trial by using a digital recording device, lasting effects will be assessed at the 3rd and 6th month after completion of the intervention	Control Group n=42 Participants No daily conversational sessions with interviewers using webcam/internet. Weekly web-based heath form must be submitted using internet/PC. If not, subjects receive prompts from study personnel. Control group: No active intervention, weekly phone calls by interviewer to complete health/social engagement monitoring survey, tracking of daily conversational amount by using a digital recording device
Changes in Cogstate Two Back Accuracy (Post-study Test Score - Baseline Test Score)	0.020 arcsine transformed values (see above) Standard Error 0.151	0.048 arcsine transformed values (see above) Standard Error 0.209

PRIMARY outcome

Timeframe: 6 weeks (primary endpoint) from baseline

Population: Sampling frame consists of retirement communities and Layton Aging Alzheimer's Disease research center volunteer lists. The survey asking whether they would like to participate in the study was distributed among 2000 subjects.

Computer Assessment of Mild Cognitive Assessment (CAMCI) is a battery of computerized tasks to assess cognitive performance, developed by the Psychology Software Tools. The software provides standardized score (z-score) based on subject's age, sex and education.* The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean. Higher Z-score means better cognitive function. A positive change in Z-scores here indicates a favorable outcome. Total score (global cognitive function measure) is used here. Pre-post trial changes in test results among the experimental group are compared with pre-post changes among the control group using linear regression models. (no drop out reported and therefore no need to use mixed effects models or MMRM)

*: Saxton J, Morrow L, Eschman A, Archer G, Luther J, Zuccolotto A. Computer assessment of mild cognitive impairment. Postgrad Med. 2009;121(2):177-85.

Outcome measures

Measure	Active Social Engagement Group n=41 Participants Active Social Engagement: Engage in 30 minutes conversation daily with interviewers using internet/webcam for 6 weeks Active social engagement group: Engage in 30 minutes conversation daily using internet/webcam, 5 days per week for 6 weeks, tracking of daily conversational amount outside of the trial by using a digital recording device, lasting effects will be assessed at the 3rd and 6th month after completion of the intervention	Control Group n=42 Participants No daily conversational sessions with interviewers using webcam/internet. Weekly web-based heath form must be submitted using internet/PC. If not, subjects receive prompts from study personnel. Control group: No active intervention, weekly phone calls by interviewer to complete health/social engagement monitoring survey, tracking of daily conversational amount by using a digital recording device
Changes in CAMCI Total Score (Post-study Test Score - Baseline Test Score)	0.098 z-score (standardized score) Standard Error 0.394	0.182 z-score (standardized score) Standard Error 0.360

Adverse Events

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Active Soocial Engagement Group

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

Dr. Hiroko Dodge

Oregon Health & Science University

Phone: (503) 494-6695

Email: dodgeh@ohsu.edu

Results disclosure agreements

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