Trial Outcomes & Findings for Preventing Cognitive Decline in African Americans With Mild Cognitive Impairment (NCT NCT01299766)
NCT ID: NCT01299766
Last Updated: 2018-12-12
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
221 participants
Primary outcome timeframe
24 months
Results posted on
2018-12-12
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
111
|
110
|
|
Overall Study
COMPLETED
|
77
|
87
|
|
Overall Study
NOT COMPLETED
|
34
|
23
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Death
|
5
|
4
|
|
Overall Study
Withdrawal by Subject
|
29
|
19
|
Baseline Characteristics
Preventing Cognitive Decline in African Americans With Mild Cognitive Impairment
Baseline characteristics by cohort
| Measure |
Behavior Activation
n=111 Participants
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.
|
Supportive Therapy (ST)
n=110 Participants
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.
|
Total
n=221 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
75.5 years
STANDARD_DEVIATION 7.1 • n=93 Participants
|
76.2 years
STANDARD_DEVIATION 6.9 • n=4 Participants
|
75.8 years
STANDARD_DEVIATION 7.0 • n=27 Participants
|
|
Sex: Female, Male
Female
|
86 Participants
n=93 Participants
|
89 Participants
n=4 Participants
|
175 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=93 Participants
|
21 Participants
n=4 Participants
|
46 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
110 Participants
n=93 Participants
|
110 Participants
n=4 Participants
|
220 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
111 Participants
n=93 Participants
|
110 Participants
n=4 Participants
|
221 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
111 participants
n=93 Participants
|
110 participants
n=4 Participants
|
221 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 24 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Behavior Activation
n=91 Participants
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.
|
Supportive Therapy (ST)
n=99 Participants
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.
|
|---|---|---|
|
Number of Participants With a Decline of 6 Points on the Hopkins Verbal Learning Test-Revised (HVLT-R)
|
1 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Behavior Activation
n=91 Participants
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.
|
Supportive Therapy (ST)
n=99 Participants
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.
|
|---|---|---|
|
Change in University of California Performance-based Skills Assessment (UPSA) Score Per Year
|
-.13 units per year
Interval -2.05 to 1.79
|
-2.60 units per year
Interval -4.36 to -0.83
|
Adverse Events
Behavior Activation
Serious events: 40 serious events
Other events: 0 other events
Deaths: 5 deaths
Supportive Therapy (ST)
Serious events: 35 serious events
Other events: 0 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Behavior Activation
n=111 participants at risk
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.
|
Supportive Therapy (ST)
n=110 participants at risk
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.
|
|---|---|---|
|
Infections and infestations
Death
|
0.00%
0/111 • 2 years
We reported hospitalizations
|
0.91%
1/110 • Number of events 1 • 2 years
We reported hospitalizations
|
|
Investigations
Death NOS
|
4.5%
5/111 • Number of events 5 • 2 years
We reported hospitalizations
|
3.6%
4/110 • Number of events 4 • 2 years
We reported hospitalizations
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
0.90%
1/111 • Number of events 1 • 2 years
We reported hospitalizations
|
0.00%
0/110 • 2 years
We reported hospitalizations
|
|
Musculoskeletal and connective tissue disorders
Broken shoulder
|
0.90%
1/111 • Number of events 1 • 2 years
We reported hospitalizations
|
0.00%
0/110 • 2 years
We reported hospitalizations
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/111 • 2 years
We reported hospitalizations
|
0.91%
1/110 • Number of events 1 • 2 years
We reported hospitalizations
|
|
Gastrointestinal disorders
Chrohn's Disease
|
0.00%
0/111 • 2 years
We reported hospitalizations
|
0.91%
1/110 • Number of events 1 • 2 years
We reported hospitalizations
|
|
Musculoskeletal and connective tissue disorders
Hernia repair
|
0.90%
1/111 • Number of events 1 • 2 years
We reported hospitalizations
|
0.00%
0/110 • 2 years
We reported hospitalizations
|
|
Cardiac disorders
Valve replacement
|
0.90%
1/111 • Number of events 1 • 2 years
We reported hospitalizations
|
0.91%
1/110 • Number of events 1 • 2 years
We reported hospitalizations
|
|
Cardiac disorders
Pacemaker implanted
|
1.8%
2/111 • Number of events 2 • 2 years
We reported hospitalizations
|
0.91%
1/110 • Number of events 1 • 2 years
We reported hospitalizations
|
|
Nervous system disorders
Seziure
|
0.90%
1/111 • Number of events 1 • 2 years
We reported hospitalizations
|
0.00%
0/110 • 2 years
We reported hospitalizations
|
|
Infections and infestations
UTI
|
0.00%
0/111 • 2 years
We reported hospitalizations
|
2.7%
3/110 • Number of events 3 • 2 years
We reported hospitalizations
|
|
Respiratory, thoracic and mediastinal disorders
Asthma Attack
|
0.90%
1/111 • Number of events 1 • 2 years
We reported hospitalizations
|
0.00%
0/110 • 2 years
We reported hospitalizations
|
|
Cardiac disorders
Heart attack
|
1.8%
2/111 • Number of events 2 • 2 years
We reported hospitalizations
|
0.91%
1/110 • Number of events 1 • 2 years
We reported hospitalizations
|
|
Vascular disorders
Stroke
|
3.6%
4/111 • Number of events 4 • 2 years
We reported hospitalizations
|
3.6%
4/110 • Number of events 5 • 2 years
We reported hospitalizations
|
|
Respiratory, thoracic and mediastinal disorders
bronchitis
|
0.00%
0/111 • 2 years
We reported hospitalizations
|
0.91%
1/110 • Number of events 1 • 2 years
We reported hospitalizations
|
|
Renal and urinary disorders
Dehydration
|
0.00%
0/111 • 2 years
We reported hospitalizations
|
1.8%
2/110 • Number of events 2 • 2 years
We reported hospitalizations
|
|
Cardiac disorders
bypass surgery
|
1.8%
2/111 • Number of events 2 • 2 years
We reported hospitalizations
|
0.00%
0/110 • 2 years
We reported hospitalizations
|
|
Endocrine disorders
hypoglycemia
|
0.90%
1/111 • Number of events 1 • 2 years
We reported hospitalizations
|
0.00%
0/110 • 2 years
We reported hospitalizations
|
|
Respiratory, thoracic and mediastinal disorders
COPD
|
1.8%
2/111 • Number of events 2 • 2 years
We reported hospitalizations
|
0.00%
0/110 • 2 years
We reported hospitalizations
|
|
Cardiac disorders
Chest pain
|
0.00%
0/111 • 2 years
We reported hospitalizations
|
0.91%
1/110 • Number of events 1 • 2 years
We reported hospitalizations
|
|
Cardiac disorders
Edema
|
0.90%
1/111 • Number of events 1 • 2 years
We reported hospitalizations
|
0.00%
0/110 • 2 years
We reported hospitalizations
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.90%
1/111 • Number of events 1 • 2 years
We reported hospitalizations
|
0.00%
0/110 • 2 years
We reported hospitalizations
|
|
Gastrointestinal disorders
GI bleed
|
0.00%
0/111 • 2 years
We reported hospitalizations
|
0.91%
1/110 • Number of events 1 • 2 years
We reported hospitalizations
|
|
Gastrointestinal disorders
Acid reflux
|
0.00%
0/111 • 2 years
We reported hospitalizations
|
0.91%
1/110 • Number of events 1 • 2 years
We reported hospitalizations
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.90%
1/111 • Number of events 1 • 2 years
We reported hospitalizations
|
1.8%
2/110 • Number of events 2 • 2 years
We reported hospitalizations
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
colon cancer
|
0.90%
1/111 • Number of events 1 • 2 years
We reported hospitalizations
|
0.00%
0/110 • 2 years
We reported hospitalizations
|
|
Blood and lymphatic system disorders
Blood clot
|
0.90%
1/111 • Number of events 1 • 2 years
We reported hospitalizations
|
3.6%
4/110 • Number of events 4 • 2 years
We reported hospitalizations
|
|
Cardiac disorders
CHF
|
0.90%
1/111 • Number of events 1 • 2 years
We reported hospitalizations
|
0.00%
0/110 • 2 years
We reported hospitalizations
|
|
Gastrointestinal disorders
GI symptoms
|
1.8%
2/111 • Number of events 2 • 2 years
We reported hospitalizations
|
0.00%
0/110 • 2 years
We reported hospitalizations
|
|
Respiratory, thoracic and mediastinal disorders
pneumonia
|
0.90%
1/111 • Number of events 1 • 2 years
We reported hospitalizations
|
0.91%
1/110 • Number of events 1 • 2 years
We reported hospitalizations
|
|
Nervous system disorders
Headache
|
0.00%
0/111 • 2 years
We reported hospitalizations
|
0.91%
1/110 • Number of events 1 • 2 years
We reported hospitalizations
|
|
Vascular disorders
aneurysm
|
0.90%
1/111 • Number of events 1 • 2 years
We reported hospitalizations
|
0.00%
0/110 • 2 years
We reported hospitalizations
|
|
Musculoskeletal and connective tissue disorders
Knee replacement
|
3.6%
4/111 • Number of events 4 • 2 years
We reported hospitalizations
|
1.8%
2/110 • Number of events 2 • 2 years
We reported hospitalizations
|
|
Eye disorders
internal bleeding
|
0.00%
0/111 • 2 years
We reported hospitalizations
|
1.8%
2/110 • Number of events 2 • 2 years
We reported hospitalizations
|
|
Psychiatric disorders
Depression
|
0.90%
1/111 • Number of events 1 • 2 years
We reported hospitalizations
|
0.91%
1/110 • Number of events 1 • 2 years
We reported hospitalizations
|
|
Infections and infestations
infection
|
0.90%
1/111 • Number of events 1 • 2 years
We reported hospitalizations
|
0.00%
0/110 • 2 years
We reported hospitalizations
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place