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Trial Outcomes & Findings for ASPIRE Cognitive Enhancement Study (NCT NCT02657954)

NCT ID: NCT02657954

Last Updated: 2024-01-09

Results Overview

Global Deficit Score (composite score) from MATRICS Consensus Cognitive Battery plus Delis-Kaplan Executive Function System (D-KEFS) subtests (Verbal Fluency, Color-Word Interference), Trail Making Test, Part B Global deficit score range = 0-5, lower scores are better, higher scores are worse. For change in global deficit score, higher is better.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

79 participants

Primary outcome timeframe

baseline to 15 weeks

Results posted on

2024-01-09

Participant Flow

79 participants were enrolled and randomized to a condition and were included in intent to treat analyses, but 10 dropped out before starting their assigned intervention (5 in each arm).

Participant milestones

Participant milestones
Measure
Compensatory Cognitive Training (CCT)
Compensatory Cognitive Training CCT: 10-week Compensatory Cognitive Training
Holistic Cognitive Education (HCE)
Holistic Cognitive Education HCE: 10-week Holistic Cognitive Education
Overall Study
STARTED
39
40
Overall Study
Received at Least One Session
34
35
Overall Study
COMPLETED
20
26
Overall Study
NOT COMPLETED
19
14

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

ASPIRE Cognitive Enhancement Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Compensatory Cognitive Training (CCT)
n=39 Participants
Compensatory Cognitive Training CCT: 10-week Compensatory Cognitive Training
Holistic Cognitive Education (HCE)
n=40 Participants
Holistic Cognitive Education HCE: 10-week Holistic Cognitive Education
Total
n=79 Participants
Total of all reporting groups
Age, Continuous
37.6 years
STANDARD_DEVIATION 7.7 • n=5 Participants
37.0 years
STANDARD_DEVIATION 6.9 • n=7 Participants
37.3 years
STANDARD_DEVIATION 7.3 • n=5 Participants
Sex: Female, Male
Female
0 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
Sex: Female, Male
Male
39 Participants
n=5 Participants
39 Participants
n=7 Participants
78 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
9 Participants
n=5 Participants
12 Participants
n=7 Participants
21 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
30 Participants
n=5 Participants
28 Participants
n=7 Participants
58 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
2 Participants
n=5 Participants
3 Participants
n=7 Participants
5 Participants
n=5 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
2 Participants
n=7 Participants
2 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
4 Participants
n=5 Participants
5 Participants
n=7 Participants
9 Participants
n=5 Participants
Race (NIH/OMB)
White
29 Participants
n=5 Participants
25 Participants
n=7 Participants
54 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
3 Participants
n=5 Participants
5 Participants
n=7 Participants
8 Participants
n=5 Participants

PRIMARY outcome

Timeframe: baseline to 15 weeks

Population: All participants who completed a baseline assessment (i.e., intent to treat sample)

Global Deficit Score (composite score) from MATRICS Consensus Cognitive Battery plus Delis-Kaplan Executive Function System (D-KEFS) subtests (Verbal Fluency, Color-Word Interference), Trail Making Test, Part B Global deficit score range = 0-5, lower scores are better, higher scores are worse. For change in global deficit score, higher is better.

Outcome measures

Outcome measures
Measure
Compensatory Cognitive Training (CCT)
n=39 Participants
Compensatory Cognitive Training CCT: 10-week Compensatory Cognitive Training
Holistic Cognitive Education (HCE)
n=40 Participants
Holistic Cognitive Education HCE: 10-week Holistic Cognitive Education
Change in Global Deficit Score From Expanded MATRICS Consensus Cognitive Battery (MCCB)
0.26 score on a scale
Standard Deviation 0.47
.14 score on a scale
Standard Deviation .12

PRIMARY outcome

Timeframe: baseline to 15 weeks

Population: All participants with baseline data included (i.e., intent to treat sample)

Performance-based functional capacity in finance and communication UPSA scores range from 0-100, higher scores are better. For change in UPSA scores, higher is also better.

Outcome measures

Outcome measures
Measure
Compensatory Cognitive Training (CCT)
n=39 Participants
Compensatory Cognitive Training CCT: 10-week Compensatory Cognitive Training
Holistic Cognitive Education (HCE)
n=40 Participants
Holistic Cognitive Education HCE: 10-week Holistic Cognitive Education
Change in UCSD Performance-Based Skills Assessment-Brief (UPSA-B)
8.3 score on a scale
Standard Deviation 8.9
8.3 score on a scale
Standard Deviation 8.6

SECONDARY outcome

Timeframe: baseline to 15 weeks

Population: All participants with baseline data (i.e., intent to treat sample)

Measure of level of disability WHODAS scores range from 0-100, higher scores are worse. For change in WHODAS scores, higher scores are also worse.

Outcome measures

Outcome measures
Measure
Compensatory Cognitive Training (CCT)
n=39 Participants
Compensatory Cognitive Training CCT: 10-week Compensatory Cognitive Training
Holistic Cognitive Education (HCE)
n=40 Participants
Holistic Cognitive Education HCE: 10-week Holistic Cognitive Education
Change in World Health Organization Disability Assessment Schedule (WHODAS) 2.0
-5.6 score on a scale
Standard Deviation 13.2
-4.5 score on a scale
Standard Deviation 8.4

Adverse Events

Compensatory Cognitive Training (CCT)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Holistic Cognitive Education (HCE)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Elizabeth Twamley

VA San Diego Healthcare System

Phone: 858-642-3848

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place