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

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ClinicalTrials.gov Identifier: NCT01571427
Recruitment Status : Completed
First Posted : April 5, 2012
Last Update Posted : August 10, 2016
Information provided by (Responsible Party):

Study Description
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. the investigators will examine whether conversation-based cognitive stimulations have positive effects on general, and 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.

Condition or disease Intervention/treatment Phase
Cognitive Impairment Behavioral: Active social engagement group Behavioral: Control group Early Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Conversational Engagement as a Means to Delay Alzheimer's Disease Onset
Study Start Date : February 2012
Primary Completion Date : September 2013
Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: 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.
Behavioral: 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
Active Comparator: Active soocial engagement group
Active Social Engagement: Engage in 30 minutes conversation daily with interviewers using internet/webcam for 6 weeks
Behavioral: 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

Outcome Measures

Primary Outcome Measures :
  1. Cognitive functions measured by neuropsychological tests [ Time Frame: up to 12 months ]
    Pre-post trial changes in neuropsychological test results among the experimental group will be compared with pre-post changes among the control group

Secondary Outcome Measures :
  1. Psychological well-being [ Time Frame: up to 12 months ]
    Pre-post changes in psychological measures (loneliness scale, isolation score, self-rated health), self-rated cognitive functions at post trial assessment.

  2. Levels of social engagement [ Time Frame: up to 12 months ]
    Pre-post changes in levels of social engagement

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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 >4 at screening
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01571427

United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
National Institute on Aging (NIA)
More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hiroko H. Dodge, Associate Professor of Neurology, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT01571427     History of Changes
Other Study ID Numbers: socialengagementR01
R01AG033581 ( U.S. NIH Grant/Contract )
First Posted: April 5, 2012    Key Record Dates
Last Update Posted: August 10, 2016
Last Verified: August 2016

Keywords provided by Hiroko H. Dodge, Oregon Health and Science University:
Behavioral intervention
Social engagement
Conversational engagement
Social network
Cognitive Reserve
Alzheimer's disease

Additional relevant MeSH terms:
Alzheimer Disease
Cognitive Dysfunction
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders