Mild Cognitive ImpairmentEarly Phase 1conversationNCT01571427

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

A Early Phase 1 study testing Active social engagement group in people with Mild Cognitive Impairment and Cognitive Change, run by Oregon Health and Science University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 70 years and olderHealthy volunteers can take part
Conditions the study is for: Mild Cognitive Impairment, Cognitive Change
What is being tested?: Active social engagement group
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 83 participants
Where: 1 siteUnited States
Study dates: Feb 2012to Sep 2013
Phase: Early Phase 1
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 70 years and older
All sexes
Healthy volunteers accepted
Older adult

Who may be able to join

Non-demented participants
Willing to participate in daily conversation using internet/webcam with interviewers for 6 weeks
Willing to monitor daily conversational amount using a digital recording device
Willing informant who has frequent contact with the participant

Who cannot join

have major illness or disabilities which interfere with interacting using the audio/video technology
diagnosed as dementia
MMSE < 24 at screening
Geriatric Depression Scale (15 items) >4 at screening

Trial locations and contacts

1 site in 1 country.

United States1 site

Oregon Health & Science University
Portland, Oregon, 97239

Other trials in United States

About this study

Official title: Conversational Engagement as a Means to Delay Alzheimer's Disease Onset

Past epidemiological studies have demonstrated that larger social networks, or more frequent social interactions, could have potential protective effects on the incidence of Alzheimer's Disease (AD). However, in those studies, indicators of social interactions were often broad, and included distinct elements that affected cognition and overall health. This project will examine whether conversation-based cognitive stimulation has positive effects on domain-specific cognitive functions among the elderly. Face-to-face communication will be conducted through the use of personal computers, webcams, and user-friendly simple interactive Internet programs to allow participants to have social engagement while staying at their home and also for the cost effective execution of the study.

Read the detailed description

Participants are randomized into the control group (weekly 10 minutes phone check-in only) or experimental group (30 minutes daily video chat with standardized/trained conversational staff). User-friendly equipment and internet are provided.

Conditions: Mild Cognitive Impairment, Cognitive Change
Being tested: Active social engagement group, Control group
Keywords: Behavioral intervention, Social engagement, Conversational engagement, Social network, Cognitive Reserve, Alzheimer's disease
Medical subject headings: Cognitive Dysfunction, Alzheimer Disease

What participants receive

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

Active social engagement groupBehavioural
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 groupBehavioural
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. Participants will be reassessed at the 3rd and 6th month after completion of the intervention.

Study groups in NCT01571427
Study group	Role	What they receive
Control group	Placebo comparator	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. Receives: Behavioral: Control group
Active social engagement group	Active comparator	Engage in 30 minutes video chat daily (5 times per week, except weekend) with interviewers for 6 weeks. Weekly web-based heath form must be submitted using internet/PC. If not, subjects receive prompts from study personnel. Receives: Behavioral: Active social engagement group

What is being measured

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

Changes in Global Cognitive Function Using Mini Mental State Examination Score (Post-study Test Score - Baseline Test Score)
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.
Measured: 6 weeks (primary endpoint) from baseline
Changes in Category Fluency (Animals) Test Scores (Post-study Test Score - Baseline Test Score)
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.
Measured: 6 weeks (primary endpoint) from baseline
Changes in Verbal Fluency Letter Test Scores (Post-study Test Score - Baseline Test Score)
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.
Measured: 6 weeks (primary endpoint) from baseline
Changes in the Consortium to Establish a Registry for Alzheimer's Disease Word List Immediate Recall (Post-study Test Score - Baseline Test Score)
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)
Measured: 6 weeks (primary endpoint) from baseline
Changes in the Consortium to Establish a Registry for Alzheimer's Disease Word List Delayed Recall (Post-study Test Score - Baseline Test Score)
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)
Measured: 6 weeks (primary endpoint) from baseline
Changes in Trail Making Test A Scores (Post-study Test Score - Baseline Test Score)
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.
Measured: 6 weeks (primary endpoint) from baseline
Changes in Trail Making Test B Scores (Post-study Test Score - Baseline Test Score)
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.
Measured: 6 weeks (primary endpoint) from baseline
Changes in the Stroop Color and Word Test (Stroop Test C) Scores (Post-study Test Scores - Baseline Test Scores)
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.
Measured: 6 weeks (primary endpoint) from baseline
Changes in Cogstate Computerized Test: Detection Test (Post-study Test Score - Baseline Test Score)
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.
Measured: 6 weeks (primary endpoint) from baseline
Changes in Cogstate One Back Accuracy (Post-study Test Score - Baseline Test Score)
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.
Measured: 6 weeks (primary endpoint) from baseline
Changes in Cogstate Two Back Accuracy (Post-study Test Score - Baseline Test Score)
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)
Measured: 6 weeks (primary endpoint) from baseline
Changes in CAMCI Total Score (Post-study Test Score - Baseline Test Score)
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.
Measured: 6 weeks (primary endpoint) from baseline

Timeline

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

Feb 2012Sep 2013

First posted5 Apr 2012 (estimated)
Study startFeb 2012
Primary completionSep 2013
Study completionSep 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

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

Study design

Study type: Interventional
Phase: Early Phase 1
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: Experimental and control groups. The experimental group will have 30 minutes daily (5 times per week) video chat with standardized conversational staff for 6 weeks, while the control group will have phone check-in once per week for 10 minutes for increasing retention. Both groups will complete weekly web-based heath form using PC and internet.
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 83 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01571427
Sponsor's protocol ID: socialengagementR01
Other IDs: R01AG033581
Acronym: conversation
Status last verified: Jan 2020
First submitted: 29 Mar 2012
Last updated: 5 Feb 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided: completely de-identified data are available upon requests

Publications

Dodge HH, Katsumata Y, Zhu J, Mattek N, Bowman M, Gregor M, Wild K, Kaye JA. Characteristics associated with willingness to participate in a randomized controlled behavioral clinical trial using home-based personal computers and a webcam. Trials. 2014 Dec 23;15:508. doi: 10.1186/1745-6215-15-508.
PubMed 25539637
Asgari M, Kaye J, Dodge H. Predicting mild cognitive impairment from spontaneous spoken utterances. Alzheimers Dement (N Y). 2017 Feb 27;3(2):219-228. doi: 10.1016/j.trci.2017.01.006. eCollection 2017 Jun.
PubMed 29067328
Dodge HH, Mattek N, Gregor M, Bowman M, Seelye A, Ybarra O, Asgari M, Kaye JA. Social Markers of Mild Cognitive Impairment: Proportion of Word Counts in Free Conversational Speech. Curr Alzheimer Res. 2015;12(6):513-9. doi: 10.2174/1567205012666150530201917.
PubMed 26027814
Dodge HH, Zhu J, Mattek N, Bowman M, Ybarra O, Wild K, Loewenstein DA, Kaye JA. Web-enabled Conversational Interactions as a Means to Improve Cognitive Functions: Results of a 6-Week Randomized Controlled Trial. Alzheimers Dement (N Y). 2015 May;1(1):1-12. doi: 10.1016/j.trci.2015.01.001.
PubMed 26203461
Cerino ES, Hooker K, Goodrich E, Dodge HH. Personality Moderates Intervention Effects on Cognitive Function: A 6-Week Conversation-Based Intervention. Gerontologist. 2020 Jul 15;60(5):958-967. doi: 10.1093/geront/gnz063.
PubMed 31112605

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Conversational Engagement as a Means to Delay Alzheimer's Disease Onset
ClinicalTrials.gov ID: NCT01571427
Acronym / sponsor ID: conversation / socialengagementR01
Conditions: Mild Cognitive Impairment, Cognitive Change
Keywords: Behavioral intervention, Social engagement, Conversational engagement, Social network, Cognitive Reserve, Alzheimer's disease
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 83 participants (actual)
Lead sponsor: Oregon Health and Science UniversityUniversity, hospital or other
Collaborators: National Institute on Aging (NIA)
Study start: Feb 2012
Primary completion: Sep 2013 (actual)
Study completion: Sep 2013 (actual)
First posted: 5 Apr 2012 (estimated)
Results: Posted 24 Apr 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2
Model description: Experimental and control groups. The experimental group will have 30 minutes daily (5 times per week) video chat with standardized conversational staff for 6 weeks, while the control group will have phone check-in once per week for 10 minutes for increasing retention. Both groups will complete weekly web-based heath form using PC and internet.

Arm	Type	Receives
Control group	Placebo comparator	Behavioral: Control groupNo 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.
Active social engagement group	Active comparator	Behavioral: Active social engagement groupEngage in 30 minutes video chat daily (5 times per week, except weekend) with interviewers for 6 weeks. Weekly web-based heath form must be submitted using internet/PC. If not, subjects receive prompts from study personnel.

Who may qualify

Ages: 70 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Older adult

Key inclusion criteria (4 listed)

Non-demented participants
Willing to participate in daily conversation using internet/webcam with interviewers for 6 weeks
Willing to monitor daily conversational amount using a digital recording device
Willing informant who has frequent contact with the participant

Key exclusion criteria (4 listed)

have major illness or disabilities which interfere with interacting using the audio/video technology
diagnosed as dementia
MMSE < 24 at screening
Geriatric Depression Scale (15 items) >4 at screening

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Active social engagement groupEngage 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	Behavioural	Active social engagement group
Control groupNo 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. Participants will be reassessed at the 3rd and 6th month after completion of the intervention.	Behavioural	Control group

Primary outcome

Changes in Global Cognitive Function Using Mini Mental State Examination Score (Post-study Test Score - Baseline Test Score)
Time frame: 6 weeks (primary endpoint) from baseline
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.
Changes in Category Fluency (Animals) Test Scores (Post-study Test Score - Baseline Test Score)
Time frame: 6 weeks (primary endpoint) from baseline
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.
Changes in Verbal Fluency Letter Test Scores (Post-study Test Score - Baseline Test Score)
Time frame: 6 weeks (primary endpoint) from baseline
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.
Changes in the Consortium to Establish a Registry for Alzheimer's Disease Word List Immediate Recall (Post-study Test Score - Baseline Test Score)
Time frame: 6 weeks (primary endpoint) from baseline
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)
Changes in the Consortium to Establish a Registry for Alzheimer's Disease Word List Delayed Recall (Post-study Test Score - Baseline Test Score)
Time frame: 6 weeks (primary endpoint) from baseline
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)
Changes in Trail Making Test A Scores (Post-study Test Score - Baseline Test Score)
Time frame: 6 weeks (primary endpoint) from baseline
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.
Changes in Trail Making Test B Scores (Post-study Test Score - Baseline Test Score)
Time frame: 6 weeks (primary endpoint) from baseline
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.
Changes in the Stroop Color and Word Test (Stroop Test C) Scores (Post-study Test Scores - Baseline Test Scores)
Time frame: 6 weeks (primary endpoint) from baseline
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.
Changes in Cogstate Computerized Test: Detection Test (Post-study Test Score - Baseline Test Score)
Time frame: 6 weeks (primary endpoint) from baseline
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.
Changes in Cogstate One Back Accuracy (Post-study Test Score - Baseline Test Score)
Time frame: 6 weeks (primary endpoint) from baseline
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.
Changes in Cogstate Two Back Accuracy (Post-study Test Score - Baseline Test Score)
Time frame: 6 weeks (primary endpoint) from baseline
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)
Changes in CAMCI Total Score (Post-study Test Score - Baseline Test Score)
Time frame: 6 weeks (primary endpoint) from baseline
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.

Results and safety

Results posted to the registry on 24 Apr 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Active Social Engagement Group	41	41
Control Group	42	42

Primary outcome: Changes in Global Cognitive Function Using Mini Mental State Examination Score (Post-study Test Score - Baseline Test Score)

Time frame: 6 weeks (primary endpoint) from baseline. Mean (Standard Deviation). Unit: score on a scale

Measure	Active Social Engagement Group n = 41	Control Group n = 42
Value	-0.51 (1.51)	-0.07 (1.65)

Active Social Engagement Group vs Control Group: Mean Difference (Final Values): -0.41, p = 0.25, Regression, Linear
Active Social Engagement Group vs Control Group: Median Difference (Final Values): -0.49, p = 0.25, Regression, Linear
Active Social Engagement Group vs Control Group: Median Difference (Final Values): -0.11, p = 0.85, Regression, Linear

Population analysed: 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.

Primary outcome: Changes in Category Fluency (Animals) Test Scores (Post-study Test Score - Baseline Test Score)

Time frame: 6 weeks (primary endpoint) from baseline. Mean (Standard Deviation). Unit: Number of words

Measure	Active Social Engagement Group n = 41	Control Group n = 42
Value	1.75 (4.21)	-0.38 (4.08)

Active Social Engagement Group vs Control Group: Mean Difference (Final Values): 2.20, p = 0.02, Regression, Linear
Active Social Engagement Group vs Control Group: Mean Difference (Final Values): 4.00, p = 0.003, Regression, Linear
Active Social Engagement Group vs Control Group: Mean Difference (Final Values): 0.52, p = 0.65, Regression, Linear

Primary outcome: Changes in Verbal Fluency Letter Test Scores (Post-study Test Score - Baseline Test Score)

Time frame: 6 weeks (primary endpoint) from baseline. Mean (Standard Deviation). Unit: Number of words

Measure	Active Social Engagement Group n = 41	Control Group n = 42
Value	1.14 (6.45)	1.26 (5.59)

Active Social Engagement Group vs Control Group: Mean Difference (Final Values): 0.03, p = 0.98, Regression, Linear
Active Social Engagement Group vs Control Group: Mean Difference (Final Values): -0.09, p = 0.96, Regression, Linear
Active Social Engagement Group vs Control Group: Mean Difference (Final Values): 0.51, p = 0.83, Regression, Linear

Primary outcome: Changes in the Consortium to Establish a Registry for Alzheimer's Disease Word List Immediate Recall (Post-study Test Score - Baseline Test Score)

Time frame: 6 weeks (primary endpoint) from baseline. Mean (Standard Deviation). Unit: Number of words

Measure	Active Social Engagement Group n = 41	Control Group n = 42
Value	0.30 (2.69)	0.53 (3.03)

Active Social Engagement Group vs Control Group: Mean Difference (Final Values): -0.27, p = 0.68, Regression, Linear
Active Social Engagement Group vs Control Group: Mean Difference (Final Values): -0.34, p = 0.69, Regression, Linear
Active Social Engagement Group vs Control Group: Mean Difference (Final Values): -0.18, p = 0.86, Regression, Linear

Adverse events

Time frame: Approximately eighteen weeks.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Control Group	0 of 42 (0%)	0 of 42 (0%)	0 of 42
Active Soocial Engagement Group	0 of 41 (0%)	0 of 41 (0%)	0 of 41

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 25539637Dodge HH, Katsumata Y, Zhu J, Mattek N, Bowman M, Gregor M, Wild K, Kaye JA. Characteristics associated with willingness to participate in a randomized controlled behavioral clinical trial using home-based personal computers and a webcam. Trials. 2014 Dec 23;15:508. doi: 10.1186/1745-6215-15-508.
Background: PubMed 29067328Asgari M, Kaye J, Dodge H. Predicting mild cognitive impairment from spontaneous spoken utterances. Alzheimers Dement (N Y). 2017 Feb 27;3(2):219-228. doi: 10.1016/j.trci.2017.01.006. eCollection 2017 Jun.
Background: PubMed 26027814Dodge HH, Mattek N, Gregor M, Bowman M, Seelye A, Ybarra O, Asgari M, Kaye JA. Social Markers of Mild Cognitive Impairment: Proportion of Word Counts in Free Conversational Speech. Curr Alzheimer Res. 2015;12(6):513-9. doi: 10.2174/1567205012666150530201917.
Results publication: PubMed 26203461Dodge HH, Zhu J, Mattek N, Bowman M, Ybarra O, Wild K, Loewenstein DA, Kaye JA. Web-enabled Conversational Interactions as a Means to Improve Cognitive Functions: Results of a 6-Week Randomized Controlled Trial. Alzheimers Dement (N Y). 2015 May;1(1):1-12. doi: 10.1016/j.trci.2015.01.001.
Results publication: PubMed 31112605Cerino ES, Hooker K, Goodrich E, Dodge HH. Personality Moderates Intervention Effects on Cognitive Function: A 6-Week Conversation-Based Intervention. Gerontologist. 2020 Jul 15;60(5):958-967. doi: 10.1093/geront/gnz063.
Web-enabled conversational interactions as a means to improve cognitive functions: Results of a 6-week randomized controlled trialLink provided by the sponsor.
Characteristics associated with willingness to participate in a randomized controlled behavioral clinical trial using home-based personal computers and a webcamLink provided by the sponsor.
Predicting mild cognitive impairment from spontaneous spoken utterancesLink provided by the sponsor.
Social markers of mild cognitive impairment: Proportion of word counts in free conversational speechLink provided by the sponsor.
Individual participant dataSharing planned: Undecided. completely de-identified data are available upon requests

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Active social engagement group in people with Mild Cognitive Impairment and Cognitive Change, run by Oregon Health and Science University at 1 site in United States.

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 4 inclusion and 4 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 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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. Some participants in this study may receive a placebo. 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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 24 Apr 2019). 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?

Changes in Global Cognitive Function Using Mini Mental State Examination Score (Post-study Test Score - Baseline Test Score) (time frame: 6 weeks (primary endpoint) from baseline). The study lists 12 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 NCT01571427, which also lists 5 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 5 Feb 2020.