Preventing Cognitive Decline in African Americans With Mild Cognitive Impairment

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Thomas Jefferson University
Sponsor:
Collaborators:
Dartmouth-Hitchcock Medical Center
Johns Hopkins University
University of Pennsylvania
Information provided by (Responsible Party):
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT01299766
First received: February 16, 2011
Last updated: August 5, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Mild Cognitive Impairment (MCI)
Behavioral: Behavioral Activation (BA)
Behavioral: Supportive Therapy (ST)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Preventing Cognitive Decline in African Americans With Mild Cognitive Impairment

Resource links provided by NLM:


Further study details as provided by Thomas Jefferson University:

Primary Outcome Measures:
  • Episodic Memory [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Change from baseline to 24 months on the Hopkins Verbal Learning Test-Revised (HVLT-R)


Secondary Outcome Measures:
  • Uniform Data Set (UDS) Neuropsychological Battery, Alzheimer's Disease Cooperative Study (ADSC) Measures [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: September 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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: 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.
Placebo Comparator: 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.
Behavioral: 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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01299766

Contacts
Contact: Robin J Casten, PhD 215-503-1250 Robin.Casten@jefferson.edu
Contact: Barry W Rovner, MD 215-503-1254 Barry.Rovner@jefferson.edu

Locations
United States, Pennsylvania
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Robin J Casten, PhD    215-503-1250    Robin.Casten@jefferson.edu   
Contact: Barry W Rovner, MD    215-503-1254    Barry.Rovner@jefferson.edu   
Sponsors and Collaborators
Thomas Jefferson University
Dartmouth-Hitchcock Medical Center
Johns Hopkins University
University of Pennsylvania
Investigators
Study Director: Robin J Casten, PhD Thomas Jefferson University
  More Information

No publications provided by Thomas Jefferson University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT01299766     History of Changes
Other Study ID Numbers: 1R01AG035025, 1R01AG035025
Study First Received: February 16, 2011
Last Updated: August 5, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Thomas Jefferson University:
Mild Cognitive Impairment
Memory

Additional relevant MeSH terms:
Cognition Disorders
Mild Cognitive Impairment
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 21, 2014