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Preventing Cognitive Decline in African Americans With Mild Cognitive Impairment

Preventing Cognitive Decline in African Americans With Mild Cognitive Impairment

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01299766
Enrollment
221
Registered
2011-02-18
Start date
2011-06-21
Completion date
2016-12-13
Last updated
2018-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild Cognitive Impairment (MCI)

Keywords

Mild Cognitive Impairment, Memory

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.

Interventions

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 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.

Sponsors

Dartmouth College
CollaboratorOTHER
Johns Hopkins University
CollaboratorOTHER
University of Pennsylvania
CollaboratorOTHER
National Institute on Aging (NIA)
CollaboratorNIH
Thomas Jefferson University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants With a Decline of 6 Points on the Hopkins Verbal Learning Test-Revised (HVLT-R)24 monthsA 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

MeasureTime frameDescription
Change in University of California Performance-based Skills Assessment (UPSA) Score Per Year24 monthsThe 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.

Countries

United States

Participant flow

Recruitment details

Enrollment from June 21, 2011 to October 3, 2014; follow-up ended December 13, 2016. Potential participants were recruited when they sought memory screening at senior centers, senior housing sites, churches, and primary care clinics in Philadelphia, PA.

Pre-assignment details

Prior to randomization, participants were administered neuropsychological tests to determine whether they met criteria for MCI. Participants with normal cognition and those with suspected dementia were excluded.

Participants by arm

ArmCount
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 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.
111
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. 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.
110
Total221

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDeath54
Overall StudyWithdrawal by Subject2919

Baseline characteristics

CharacteristicBehavior ActivationTotalSupportive Therapy (ST)
Age, Continuous75.5 years
STANDARD_DEVIATION 7.1
75.8 years
STANDARD_DEVIATION 7
76.2 years
STANDARD_DEVIATION 6.9
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants1 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
110 Participants220 Participants110 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
111 Participants221 Participants110 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
0 Participants0 Participants0 Participants
Region of Enrollment
United States
111 participants221 participants110 participants
Sex: Female, Male
Female
86 Participants175 Participants89 Participants
Sex: Female, Male
Male
25 Participants46 Participants21 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
5 / 1114 / 110
other
Total, other adverse events
0 / 1110 / 110
serious
Total, serious adverse events
40 / 11135 / 110

Outcome results

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.

Time frame: 24 months

Population: The primary analysis was performed on the modified intent to treat population including all available data from all participants with at least one follow-up visit.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Behavior ActivationNumber of Participants With a Decline of 6 Points on the Hopkins Verbal Learning Test-Revised (HVLT-R)1 Participants
Supportive Therapy (ST)Number of Participants With a Decline of 6 Points on the Hopkins Verbal Learning Test-Revised (HVLT-R)9 Participants
Comparison: Poisson regression with robust standard errors (GEE) was used to jointly model decline in HVLT-R Total Recall score ≥ 6 words at 6, 12, 18, and 24 months by treatment group. The model included time, treatment, time-by-treatment interaction terms, and baseline HVLT-R Total Recall score.p-value: 0.0295% CI: [0.02, 0.74]Poisson regression with robust SE (GEE)
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.

Time frame: 24 months

Population: The analysis was performed on the modified intent to treat population including all available data from all participants with at least one follow-up visit.

ArmMeasureValue (MEAN)
Behavior ActivationChange in University of California Performance-based Skills Assessment (UPSA) Score Per Year-.13 units per year
Supportive Therapy (ST)Change in University of California Performance-based Skills Assessment (UPSA) Score Per Year-2.60 units per year
Comparison: Mixed effects linear regression was used to model the trajectory. Fixed effects for time (as a continuous variable), treatment group, time-by-treatment group interaction, and age at baseline were included. Random intercepts and slopes were included to account for within-subject correlation.p-value: 0.06495% CI: [-0.14, 5.07]Mixed Models Analysis

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026