Preventing Cognitive Decline in African Americans With Mild Cognitive Impairment



Status:Completed
Conditions:Cognitive Studies
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:65 - Any
Updated:12/14/2018
Start Date:June 21, 2011
End Date:December 13, 2016

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The goal of this study is to determine whether increasing participation in cognitive,
physical, and/or social activities prevents cognitive decline in older African Americans
(AAs) with Mild Cognitive Impairment (MCI). Patients with MCI are at increased risk for
Alzheimer's Disease (AD); we propose that increasing participation in activities will prevent
cognitive decline and may delay the onset of Alzheimer's Disease (AD). We will test this
hypothesis by conducting a clinical trial in which older AAs with MCI (aged 65 years and
older) will be randomized to Behavior Activation (BA) (a behavioral intervention that
increases participation in daily activities) or Supportive Therapy (ST) (a person-centered
psychotherapy that involves active listening and offering support focusing on participants'
problems and concerns). We hypothesize that BA-treated subjects will have fewer declines in
cognitive and functional abilities, fewer depressive and neuropsychiatric symptoms, and
better quality of life than ST-treated subjects at 24 months.

The goal of this study is to determine whether increasing participation in activities
prevents cognitive decline in older African Americans with Mild Cognitive Impairment (MCI).
We will attempt to increase activities with Behavioral Activation (BA). BA is a manual-based,
behavioral treatment to increase activities as a way to improve function and mood. As
patients do more (through activation) and perceive the benefit (i.e., feel better), their
activity levels increase. BA promotes activities that reflect an individual's preferences and
goals by structuring, scheduling, and reinforcing daily activities. This increases
participation in activities with strong personal value, such as social engagement or
normative role function, which in turn enhances mood and motivation to remain active.

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.

Inclusion Criteria:

- Age 65 years and older

- Having a friend/relative willing to serve as a Knowledgeable Informant (KI)

- Diagnosis of aMCI-MD

- Self-identified as African American

Exclusion Criteria:

- Psychiatric diagnosis, including dementia and major depression

- Sensory deficits that preclude neuropsychological testing

- Institutional residence

- Reduced life expectancy due to known terminal illness
We found this trial at
1
site
1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
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Philadelphia, PA
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