Early Phase 1 N=83 Randomized Single-blind Prevention

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

Mild Cognitive Impairment · Cognitive Change

Bottom Line

View on ClinicalTrials.gov: NCT01571427 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2019

Primary outcome: Primary: Changes in Global Cognitive Function Using Mini Mental State Examination Score (Post-study Test Score - Baseline Test Score) — -0.51; -0.07 score on a scale — p=0.25

Study Design & Population

Study type: Interventional
Phase: Early Phase 1
Interventions: Active social engagement group (Behavioral); Control group (Behavioral)
Age: Older Adult · 70+ yrs
Sex: All
Sponsor: Oregon Health and Science University
Primary completion: Sep 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Changes in Global Cognitive Function Using Mini Mental State Examination Score (Post-study Test Score - Baseline Test Score)	-0.51; -0.07	0.25
PRIMARY Changes in Category Fluency (Animals) Test Scores (Post-study Test Score - Baseline Test Score)	1.75; -0.38	0.02 sig
PRIMARY Changes in Verbal Fluency Letter Test Scores (Post-study Test Score - Baseline Test Score)	1.14; 1.26	0.98
PRIMARY 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; 0.53	0.68
PRIMARY 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; -0.19	0.92
PRIMARY Changes in Trail Making Test A Scores (Post-study Test Score - Baseline Test Score)	-2.80; -0.85	0.46
PRIMARY Changes in Trail Making Test B Scores (Post-study Test Score - Baseline Test Score)	-10.18; -14.65	0.72
PRIMARY Changes in the Stroop Color and Word Test (Stroop Test C) Scores (Post-study Test Scores - Baseline Test Scores)	0.34; 1.14	0.38
PRIMARY Changes in Cogstate Computerized Test: Detection Test (Post-study Test Score - Baseline Test Score)	0.016; 0.065	0.03 sig
PRIMARY Changes in Cogstate One Back Accuracy (Post-study Test Score - Baseline Test Score)	0.049; 0.062	0.65
PRIMARY Changes in Cogstate Two Back Accuracy (Post-study Test Score - Baseline Test Score)	0.020; 0.048	0.45
PRIMARY Changes in CAMCI Total Score (Post-study Test Score - Baseline Test Score)	0.098; 0.182	0.30

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.

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 4 at screening

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01571427). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.