Clinical trial NCT01571427: Conversations as a Means to Delay the Onset of Alzheimer's Disease
Official title: Conversational Engagement as a Means to Delay Alzheimer's Disease Onset
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Mild Cognitive Impairment
Cognitive Change
Keywords: Behavioral intervention
Social engagement
Conversational engagement
Social network
Cognitive Reserve
Alzheimer's disease
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2012-04-05
Enrollment: 83
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

Brief summary: 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Changes in Global Cognitive Function Using Mini Mental State Examination Score (Post-study Test Score - Baseline Test Score)
timeFrame: 6 weeks (primary endpoint) from baseline
measure: Changes in Category Fluency (Animals) Test Scores (Post-study Test Score - Baseline Test Score)
timeFrame: 6 weeks (primary endpoint) from baseline
measure: Changes in Verbal Fluency Letter Test Scores (Post-study Test Score - Baseline Test Score)
timeFrame: 6 weeks (primary endpoint) from baseline
measure: Changes in the Consortium to Establish a Registry for Alzheimer's Disease Word List Immediate Recall (Post-study Test Score - Baseline Test Score)
timeFrame: 6 weeks (primary endpoint) from baseline
measure: Changes in the Consortium to Establish a Registry for Alzheimer's Disease Word List Delayed Recall (Post-study Test Score - Baseline Test Score)
timeFrame: 6 weeks (primary endpoint) from baseline
measure: Changes in Trail Making Test A Scores (Post-study Test Score - Baseline Test Score)
timeFrame: 6 weeks (primary endpoint) from baseline
measure: Changes in Trail Making Test B Scores (Post-study Test Score - Baseline Test Score)
timeFrame: 6 weeks (primary endpoint) from baseline
measure: Changes in the Stroop Color and Word Test (Stroop Test C) Scores (Post-study Test Scores - Baseline Test Scores)
timeFrame: 6 weeks (primary endpoint) from baseline
measure: Changes in Cogstate Computerized Test: Detection Test (Post-study Test Score - Baseline Test Score)
timeFrame: 6 weeks (primary endpoint) from baseline
measure: Changes in Cogstate One Back Accuracy (Post-study Test Score - Baseline Test Score)
timeFrame: 6 weeks (primary endpoint) from baseline
measure: Changes in Cogstate Two Back Accuracy (Post-study Test Score - Baseline Test Score)
timeFrame: 6 weeks (primary endpoint) from baseline
measure: Changes in CAMCI Total Score (Post-study Test Score - Baseline Test Score)
timeFrame: 6 weeks (primary endpoint) from baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.