Preventing Cognitive Decline in African Americans With Mild Cognitive Impairment
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01299766 |
Recruitment Status :
Completed
First Posted : February 18, 2011
Results First Posted : November 20, 2018
Last Update Posted : December 12, 2018
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Mild Cognitive Impairment (MCI) | Behavioral: Behavioral Activation (BA) Behavioral: Supportive Therapy (ST) | Phase 3 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 221 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | Preventing Cognitive Decline in African Americans With Mild Cognitive Impairment |
Actual Study Start Date : | June 21, 2011 |
Actual Primary Completion Date : | December 13, 2016 |
Actual Study Completion Date : | December 13, 2016 |

Arm | Intervention/treatment |
---|---|
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. |
- Number of Participants With a Decline of 6 Points on the Hopkins Verbal Learning Test-Revised (HVLT-R) [ Time Frame: 24 months ]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.
- Change in University of California Performance-based Skills Assessment (UPSA) Score Per Year [ Time Frame: 24 months ]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.

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, Learn About Clinical Studies.
Ages Eligible for Study: | 65 Years and older (Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01299766
United States, Pennsylvania | |
Thomas Jefferson University | |
Philadelphia, Pennsylvania, United States, 19107 |
Study Director: | Robin J Casten, PhD | Thomas Jefferson University |
Responsible Party: | Thomas Jefferson University |
ClinicalTrials.gov Identifier: | NCT01299766 |
Other Study ID Numbers: |
1R01AG035025 ( U.S. NIH Grant/Contract ) 1R01AG035025 ( U.S. NIH Grant/Contract ) |
First Posted: | February 18, 2011 Key Record Dates |
Results First Posted: | November 20, 2018 |
Last Update Posted: | December 12, 2018 |
Last Verified: | November 2018 |
Mild Cognitive Impairment Memory |
Cognitive Dysfunction Cognition Disorders Neurocognitive Disorders Mental Disorders |