Preventing Cognitive Decline in African Americans With Mild Cognitive Impairment

Mild Cognitive Impairment (MCI) Clinical Trial

Official title:

Preventing Cognitive Decline in African Americans With Mild Cognitive Impairment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01299766
• Other study ID #: 1R01AG035025
• Secondary ID: 1R01AG035025
• Status: Completed
• Phase: Phase 3
• Start date: June 21, 2011
• Est. completion date: December 13, 2016

Study information

• Verified date: November 2018
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 221
• Est. completion date: December 13, 2016
• Est. primary completion date: December 13, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment (MCI)

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (5)

Lead Sponsor	Collaborator
Thomas Jefferson University	Dartmouth College, Johns Hopkins University, National Institute on Aging (NIA), University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	24 months
Secondary	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.	24 months