Conversations as a Means to Delay the Onset of Alzheimer's Disease
NCT01571427, Early phase 1, Completed, Oregon Health and Science University; results first posted 2019-04-24
Trial 11
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Conversations as a Means to Delay the Onset of Alzheimer's Disease | ClinicalTrials.gov |
| NCT number | NCT01571427 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Early phase 1 | ClinicalTrials.gov |
| Enrollment | 83 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Oregon Health and Science University | ClinicalTrials.gov |
| Conditions | Mild Cognitive Impairment, Cognitive Change | ClinicalTrials.gov |
| Interventions | Active social engagement group, Control group | ClinicalTrials.gov |
| First posted | 2012-04-05 | ClinicalTrials.gov |
| Last updated | 2020-02-05 | ClinicalTrials.gov |
| Results first posted | 2019-04-24 | ClinicalTrials.gov |
Registered outcomes 12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Changes in Global Cognitive Function Using Mini Mental State Examination Score (Post-study Test Score - Baseline Test Score) | 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. | ClinicalTrials.gov |
| Primary | Changes in Category Fluency (Animals) Test Scores (Post-study Test Score - Baseline Test Score) | 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. | ClinicalTrials.gov |
| Primary | Changes in Verbal Fluency Letter Test Scores (Post-study Test Score - Baseline Test Score) | 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. | ClinicalTrials.gov |
| Primary | Changes in the Consortium to Establish a Registry for Alzheimer's Disease Word List Immediate Recall (Post-study Test Score - Baseline Test Score) | 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) | ClinicalTrials.gov |
| Primary | Changes in the Consortium to Establish a Registry for Alzheimer's Disease Word List Delayed Recall (Post-study Test Score - Baseline Test Score) | 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) | ClinicalTrials.gov |
| Primary | Changes in Trail Making Test A Scores (Post-study Test Score - Baseline Test Score) | 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. | ClinicalTrials.gov |
| Primary | Changes in Trail Making Test B Scores (Post-study Test Score - Baseline Test Score) | 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. | ClinicalTrials.gov |
| Primary | Changes in the Stroop Color and Word Test (Stroop Test C) Scores (Post-study Test Scores - Baseline Test Scores) | 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. | ClinicalTrials.gov |
| Primary | Changes in Cogstate Computerized Test: Detection Test (Post-study Test Score - Baseline Test Score) | 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. | ClinicalTrials.gov |
| Primary | Changes in Cogstate One Back Accuracy (Post-study Test Score - Baseline Test Score) | 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. | ClinicalTrials.gov |
| Primary | Changes in Cogstate Two Back Accuracy (Post-study Test Score - Baseline Test Score) | 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) | ClinicalTrials.gov |
| Primary | Changes in CAMCI Total Score (Post-study Test Score - Baseline Test Score) | 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. | ClinicalTrials.gov |
Outcomes 12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|---|---|---|---|---|---|
| PRIMARY | Changes in Global Cognitive Function Using Mini Mental State Examination Score (Post-study Test Score - Baseline Test Score) | 6 weeks (primary endpoint) from baseline | 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. | score on a scale | MEAN | ClinicalTrials.gov |
| PRIMARY | Changes in Category Fluency (Animals) Test Scores (Post-study Test Score - Baseline Test Score) | 6 weeks (primary endpoint) from baseline | 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. | Number of words | MEAN | ClinicalTrials.gov |
| PRIMARY | Changes in Verbal Fluency Letter Test Scores (Post-study Test Score - Baseline Test Score) | 6 weeks (primary endpoint) from baseline | 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. | Number of words | MEAN | ClinicalTrials.gov |
| PRIMARY | Changes in the Consortium to Establish a Registry for Alzheimer's Disease Word List Immediate Recall (Post-study Test Score - Baseline Test Score) | 6 weeks (primary endpoint) from baseline | 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. | Number of words | MEAN | ClinicalTrials.gov |
| PRIMARY | Changes in the Consortium to Establish a Registry for Alzheimer's Disease Word List Delayed Recall (Post-study Test Score - Baseline Test Score) | 6 weeks (primary endpoint) from baseline | 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. | Number of words | MEAN | ClinicalTrials.gov |
| PRIMARY | Changes in Trail Making Test A Scores (Post-study Test Score - Baseline Test Score) | 6 weeks (primary endpoint) from baseline | 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. | Seconds | MEAN | ClinicalTrials.gov |
| PRIMARY | Changes in Trail Making Test B Scores (Post-study Test Score - Baseline Test Score) | 6 weeks (primary endpoint) from baseline | 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. | Seconds | MEAN | ClinicalTrials.gov |
| PRIMARY | Changes in the Stroop Color and Word Test (Stroop Test C) Scores (Post-study Test Scores - Baseline Test Scores) | 6 weeks (primary endpoint) from baseline | 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. | Number of words correctly named | MEAN | ClinicalTrials.gov |
| PRIMARY | Changes in Cogstate Computerized Test: Detection Test (Post-study Test Score - Baseline Test Score) | 6 weeks (primary endpoint) from baseline | 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. | log 10 milliseconds | MEAN | ClinicalTrials.gov |
| PRIMARY | Changes in Cogstate One Back Accuracy (Post-study Test Score - Baseline Test Score) | 6 weeks (primary endpoint) from baseline | 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. | arcsine transformed values (see above) | MEAN | ClinicalTrials.gov |
| PRIMARY | Changes in Cogstate Two Back Accuracy (Post-study Test Score - Baseline Test Score) | 6 weeks (primary endpoint) from baseline | 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. | arcsine transformed values (see above) | MEAN | ClinicalTrials.gov |
| PRIMARY | Changes in CAMCI Total Score (Post-study Test Score - Baseline Test Score) | 6 weeks (primary endpoint) from baseline | 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. | z-score (standardized score) | MEAN | ClinicalTrials.gov |
Results by group 24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|---|---|---|---|---|---|
| Changes in Global Cognitive Function Using Mini Mental State Examination Score (Post-study Test Score - Baseline Test Score) | Active Social Engagement Group | -0.51 | Standard Deviation 1.51 | score on a scale | ClinicalTrials.gov | |
| Changes in Global Cognitive Function Using Mini Mental State Examination Score (Post-study Test Score - Baseline Test Score) | Control Group | -0.07 | Standard Deviation 1.65 | score on a scale | ClinicalTrials.gov | |
| Changes in Category Fluency (Animals) Test Scores (Post-study Test Score - Baseline Test Score) | Active Social Engagement Group | 1.75 | Standard Deviation 4.21 | Number of words | ClinicalTrials.gov | |
| Changes in Category Fluency (Animals) Test Scores (Post-study Test Score - Baseline Test Score) | Control Group | -0.38 | Standard Deviation 4.08 | Number of words | ClinicalTrials.gov | |
| Changes in Verbal Fluency Letter Test Scores (Post-study Test Score - Baseline Test Score) | Active Social Engagement Group | 1.14 | Standard Deviation 6.45 | Number of words | ClinicalTrials.gov | |
| Changes in Verbal Fluency Letter Test Scores (Post-study Test Score - Baseline Test Score) | Control Group | 1.26 | Standard Deviation 5.59 | Number of words | ClinicalTrials.gov | |
| Changes in the Consortium to Establish a Registry for Alzheimer's Disease Word List Immediate Recall (Post-study Test Score - Baseline Test Score) | Active Social Engagement Group | 0.30 | Standard Deviation 2.69 | Number of words | ClinicalTrials.gov | |
| Changes in the Consortium to Establish a Registry for Alzheimer's Disease Word List Immediate Recall (Post-study Test Score - Baseline Test Score) | Control Group | 0.53 | Standard Deviation 3.03 | Number of words | ClinicalTrials.gov | |
| Changes in the Consortium to Establish a Registry for Alzheimer's Disease Word List Delayed Recall (Post-study Test Score - Baseline Test Score) | Active Social Engagement Group | -0.20 | Standard Deviation 1.72 | Number of words | ClinicalTrials.gov | |
| Changes in the Consortium to Establish a Registry for Alzheimer's Disease Word List Delayed Recall (Post-study Test Score - Baseline Test Score) | Control Group | -0.19 | Standard Deviation 2.12 | Number of words | ClinicalTrials.gov | |
| Changes in Trail Making Test A Scores (Post-study Test Score - Baseline Test Score) | Active Social Engagement Group | -2.80 | Standard Deviation 15.25 | Seconds | ClinicalTrials.gov | |
| Changes in Trail Making Test A Scores (Post-study Test Score - Baseline Test Score) | Control Group | -0.85 | Standard Deviation 9.51 | Seconds | ClinicalTrials.gov | |
| Changes in Trail Making Test B Scores (Post-study Test Score - Baseline Test Score) | Active Social Engagement Group | -10.18 | Standard Deviation 29.32 | Seconds | ClinicalTrials.gov | |
| Changes in Trail Making Test B Scores (Post-study Test Score - Baseline Test Score) | Control Group | -14.65 | Standard Deviation 46.85 | Seconds | ClinicalTrials.gov | |
| Changes in the Stroop Color and Word Test (Stroop Test C) Scores (Post-study Test Scores - Baseline Test Scores) | Active Social Engagement Group | 0.34 | Standard Deviation 3.88 | Number of words correctly named | ClinicalTrials.gov | |
| Changes in the Stroop Color and Word Test (Stroop Test C) Scores (Post-study Test Scores - Baseline Test Scores) | Control Group | 1.14 | Standard Deviation 4.29 | Number of words correctly named | ClinicalTrials.gov | |
| Changes in Cogstate Computerized Test: Detection Test (Post-study Test Score - Baseline Test Score) | Active Social Engagement Group | 0.016 | Standard Error 0.091 | log 10 milliseconds | ClinicalTrials.gov | |
| Changes in Cogstate Computerized Test: Detection Test (Post-study Test Score - Baseline Test Score) | Control Group | 0.065 | Standard Error 0.113 | log 10 milliseconds | ClinicalTrials.gov | |
| Changes in Cogstate One Back Accuracy (Post-study Test Score - Baseline Test Score) | Active Social Engagement Group | 0.049 | Standard Error 0.246 | arcsine transformed values (see above) | ClinicalTrials.gov | |
| Changes in Cogstate One Back Accuracy (Post-study Test Score - Baseline Test Score) | Control Group | 0.062 | Standard Error 0.168 | arcsine transformed values (see above) | ClinicalTrials.gov |
Participant flow 6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|---|---|---|---|---|
| Overall Study | STARTED | Active Social Engagement Group | 41 | ClinicalTrials.gov | |
| Overall Study | STARTED | Control Group | 42 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Active Social Engagement Group | 41 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Control Group | 42 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Active Social Engagement Group | 0 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Control Group | 0 | ClinicalTrials.gov |
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 6
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|---|---|---|---|
| Total, all-cause mortality | Control Group | 0 | 42 | ClinicalTrials.gov |
| Total, all-cause mortality | Active Soocial Engagement Group | 0 | 41 | ClinicalTrials.gov |
| Total, other adverse events | Control Group | 0 | 42 | ClinicalTrials.gov |
| Total, other adverse events | Active Soocial Engagement Group | 0 | 41 | ClinicalTrials.gov |
| Total, serious adverse events | Control Group | 0 | 42 | ClinicalTrials.gov |
| Total, serious adverse events | Active Soocial Engagement Group | 0 | 41 | ClinicalTrials.gov |
Papers 5
The papers the trial lists on ClinicalTrials.gov.
Grants 1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| R01AG033581 | Conversational Engagement as a Means to Delay Alzheimer's Disease Onset | DODGE, HIROKO HAYAMA | OREGON HEALTH & SCIENCE UNIVERSITY | NATIONAL INSTITUTE ON AGING | 2010 to 2012 | NIH RePORTER |
Trial comparisons 2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Active Soocial Engagement Group vs Control Group: deaths from any cause | Trial comparisons |
| Active Soocial Engagement Group vs Control Group: serious adverse events | Trial comparisons |
Tests 8
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| 1-Back Task | Primary outcome | ConductCognition |
| 2-Back Task | Primary outcome | ConductCognition |
| Category Fluency | Primary outcome | ConductCognition |
| Stroop Color-Word Test | Primary outcome | ConductCognition |
| Trail Making Test A | Primary outcome | ConductCognition |
| Trail Making Test B | Primary outcome | ConductCognition |
| Verbal Fluency | Primary outcome | ConductCognition |
| Verbal Learning | Primary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)