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Preventing Cognitive Decline in African Americans With Mild Cognitive Impairment

Primary Purpose

Mild Cognitive Impairment (MCI)

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Behavioral Activation (BA)
Supportive Therapy (ST)
Sponsored by
Thomas Jefferson University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Mild Cognitive Impairment (MCI) focused on measuring Mild Cognitive Impairment, Memory

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Thomas Jefferson University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Behavior Activation

Supportive Therapy (ST)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Number of Participants With a Decline of 6 Points on the Hopkins Verbal Learning Test-Revised (HVLT-R)
A decline of 6 points from baseline to 24 months on the Hopkins Verbal Learning Test-Revised (HVLT-R). Possible scores range from 0 to 12, with higher scores indicating better memory.

Secondary Outcome Measures

Change in University of California Performance-based Skills Assessment (UPSA) Score Per Year
The University of California Performance-based Skills Assessment (UPSA) was used as an objective test of accuracy with writing checks, making change, using a telephone, and scheduling a physician appointment (higher scores indicate better function). Possible scores range from 0 to 100.

Full Information

First Posted
February 16, 2011
Last Updated
November 20, 2018
Sponsor
Thomas Jefferson University
Collaborators
Dartmouth College, Johns Hopkins University, University of Pennsylvania, National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT01299766
Brief Title
Preventing Cognitive Decline in African Americans With Mild Cognitive Impairment
Official Title
Preventing Cognitive Decline in African Americans With Mild Cognitive Impairment
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
June 21, 2011 (Actual)
Primary Completion Date
December 13, 2016 (Actual)
Study Completion Date
December 13, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Thomas Jefferson University
Collaborators
Dartmouth College, Johns Hopkins University, University of Pennsylvania, National Institute on Aging (NIA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment (MCI)
Keywords
Mild Cognitive Impairment, Memory

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
221 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Behavior Activation
Arm Type
Experimental
Arm Description
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.
Arm Title
Supportive Therapy (ST)
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Activation (BA)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Supportive Therapy (ST)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants With a Decline of 6 Points on the Hopkins Verbal Learning Test-Revised (HVLT-R)
Description
A decline of 6 points from baseline to 24 months on the Hopkins Verbal Learning Test-Revised (HVLT-R). Possible scores range from 0 to 12, with higher scores indicating better memory.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Change in University of California Performance-based Skills Assessment (UPSA) Score Per Year
Description
The University of California Performance-based Skills Assessment (UPSA) was used as an objective test of accuracy with writing checks, making change, using a telephone, and scheduling a physician appointment (higher scores indicate better function). Possible scores range from 0 to 100.
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robin J Casten, PhD
Organizational Affiliation
Thomas Jefferson University
Official's Role
Study Director
Facility Information:
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31087388
Citation
Rovner BW, Casten RJ, Leiby B. Memory improvement in African Americans with amnestic mild cognitive impairment. Int J Geriatr Psychiatry. 2019 Oct;34(10):1447-1454. doi: 10.1002/gps.5141. Epub 2019 Jun 18.
Results Reference
derived
PubMed Identifier
30208380
Citation
Rovner BW, Casten RJ, Hegel MT, Leiby B. Preventing Cognitive Decline in Black Individuals With Mild Cognitive Impairment: A Randomized Clinical Trial. JAMA Neurol. 2018 Dec 1;75(12):1487-1493. doi: 10.1001/jamaneurol.2018.2513.
Results Reference
derived
PubMed Identifier
27000348
Citation
Rovner BW, Casten RJ. Preserving Cognition in Older African Americans with Mild Cognitive Impairment. J Am Geriatr Soc. 2016 Mar;64(3):659-61. doi: 10.1111/jgs.14012. No abstract available.
Results Reference
derived
PubMed Identifier
25811797
Citation
Rovner BW, Casten RJ, Leiby BE. Determinants of Activity Levels in African Americans With Mild Cognitive Impairment. Alzheimer Dis Assoc Disord. 2016 Jan-Mar;30(1):41-6. doi: 10.1097/WAD.0000000000000096.
Results Reference
derived
PubMed Identifier
22406101
Citation
Rovner BW, Casten RJ, Hegel MT, Leiby BE. Preventing cognitive decline in older African Americans with mild cognitive impairment: design and methods of a randomized clinical trial. Contemp Clin Trials. 2012 Jul;33(4):712-20. doi: 10.1016/j.cct.2012.02.016. Epub 2012 Mar 2.
Results Reference
derived

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Preventing Cognitive Decline in African Americans With Mild Cognitive Impairment

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