Preventing Cognitive Decline in African Americans With Mild Cognitive Impairment
NCT ID: NCT01299766
Last Updated: 2018-12-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
221 participants
INTERVENTIONAL
2011-06-21
2016-12-13
Brief Summary
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Detailed Description
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The control treatment is Supportive Therapy, which is a non-directive, supportive therapy that is based on empathy, reflection, and support.
This study is specifically targeting older African Americans (AAs). Most clinical trials for MCI have tested pharmacologic treatments and have enrolled mostly Whites; their results may not apply to AAs whose life experiences and medical and genetic characteristics may exert unique effects. Those with MCI are a high-risk population for whom interventions to prevent cognitive decline are particularly important. Because AAs comprise one of the largest minority groups in the U.S., suffer disparities in health outcomes, and are unlikely to seek pharmacologic treatments or participate in clinical drug trials, there is an urgent need to enroll older AAs in non-pharmacologic intervention studies of cognition.
We will recruit 200 AA subjects aged 65 and older who have amnestic Mild Cognitive Impairment (MCI) - Multiple Domain subtype of MCI (aMCI-MD). One of the inclusion criteria is for participants to have a Knowledgeable Informant (KI) who is willing to participate in the study (with the subject's permission as documented in the informed consent form). A KI is defined as a family member or friend who is identified by the subject as someone who has regular and frequent contact with the subject (at least twice per week) in-person or by phone. The KI will be asked to provide information regarding the subject's functioning.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Behavior Activation
BA is a manual-based, behavioral treatment that helps people increase activity levels through goal setting, activity scheduling, graded task assignment, identifying avoidant behaviors, and rating one's sense of accomplishment.
Behavioral Activation (BA)
BA is a manual-based, behavioral treatment that helps people increase activity levels through goal setting, activity scheduling, graded task assignment, identifying avoidant behaviors, and rating one's sense of accomplishment.
Supportive Therapy (ST)
ST is a person-centered treatment in which interventionists create a comfortable, non-judgmental environment by demonstrating genuineness, empathy, and acceptance of subjects without imposing any judgments on their decisions.
Supportive Therapy (ST)
ST is a person-centered psychotherapy in which interventionists create a comfortable, non-judgmental environment by demonstrating genuineness, empathy, and acceptance of subjects without imposing any judgments on their decisions.
Interventions
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Behavioral Activation (BA)
BA is a manual-based, behavioral treatment that helps people increase activity levels through goal setting, activity scheduling, graded task assignment, identifying avoidant behaviors, and rating one's sense of accomplishment.
Supportive Therapy (ST)
ST is a person-centered psychotherapy in which interventionists create a comfortable, non-judgmental environment by demonstrating genuineness, empathy, and acceptance of subjects without imposing any judgments on their decisions.
Eligibility Criteria
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Inclusion Criteria
* Having a friend/relative willing to serve as a Knowledgeable Informant (KI)
* Diagnosis of aMCI-MD
* Self-identified as African American
Exclusion Criteria
* Sensory deficits that preclude neuropsychological testing
* Institutional residence
* Reduced life expectancy due to known terminal illness
65 Years
ALL
No
Sponsors
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Dartmouth College
OTHER
Johns Hopkins University
OTHER
University of Pennsylvania
OTHER
National Institute on Aging (NIA)
NIH
Thomas Jefferson University
OTHER
Responsible Party
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Principal Investigators
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Robin J Casten, PhD
Role: STUDY_DIRECTOR
Thomas Jefferson University
Locations
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Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Countries
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References
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