Trial Outcomes & Findings for Cognitive Rehabilitation Therapy for Mild Cognitive Impairment (NCT NCT03225482)

Results Overview

Change in composite z score on the following tests: Hopkins Verbal Learning Test-Revised (HVLT-R) Brief Visuospatial Memory Test-Revised (BVMT-R) Wechsler Adult Intelligence Scale, Fourth Edition (WAIS-IV) Digit Span WAIS-IV Coding Delis-Kaplan Executive Function System (D-KEFS) Trails, Number and Letter Sequencing D-KEFS Trails, Number-Letter Switching D-KEFS Color-Word Interference Test, Inhibition and Inhibition-Switching A Z score of 0 represents the sample mean. Higher composite Z scores reflect better performance.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

193 participants

Primary outcome timeframe

assessed at baseline, 8 weeks, 21 weeks; change from baseline to 21 weeks reported.

Results posted on

2025-08-11

Participant Flow

Participants were considered enrolled when they signed the informed consent form. Participants then underwent baseline assessment. Once six participants completed baseline assessments, they were randomized as a group to a condition, revealed to them on the first day of treatment. Some participants exited prior to baseline assessment or after baseline assessment but before randomization or the first day of treatment. Thus, the number initiating treatment differs from the number enrolled.

Participant milestones

Participant milestones
Measure	ME-CCT Group 8-week Motivationally Enhanced Compensatory Cognitive Training group	Supportive Contact Control Group 8-week Goal-focused Supportive Contact group
Overall Study STARTED	79	66
Overall Study COMPLETED	76	61
Overall Study NOT COMPLETED	3	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Cognitive Rehabilitation Therapy for Mild Cognitive Impairment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ME-CCT n=84 Participants 8-week Motivationally Enhanced Compensatory Cognitive Training group	Supportive Contact Control Group n=72 Participants 8-week Goal-focused Supportive Contact group	Total n=156 Participants Total of all reporting groups
Age, Continuous	71.2 year STANDARD_DEVIATION 8.2 • n=5 Participants	71.8 year STANDARD_DEVIATION 7.0 • n=7 Participants	71.5 year STANDARD_DEVIATION 7.6 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	7 Participants n=7 Participants	19 Participants n=5 Participants
Sex: Female, Male Male	72 Participants n=5 Participants	65 Participants n=7 Participants	137 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	66 Participants n=5 Participants	57 Participants n=7 Participants	123 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	13 Participants n=5 Participants	9 Participants n=7 Participants	22 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants	1 Participants n=7 Participants	5 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	10 Participants n=5 Participants	4 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) White	60 Participants n=5 Participants	60 Participants n=7 Participants	120 Participants n=5 Participants
Race (NIH/OMB) More than one race	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: assessed at baseline, 8 weeks, 21 weeks; change from baseline to 21 weeks reported.

Population: 114 participants had useable data at baseline and 21 weeks.

Change in composite z score on the following tests: Hopkins Verbal Learning Test-Revised (HVLT-R) Brief Visuospatial Memory Test-Revised (BVMT-R) Wechsler Adult Intelligence Scale, Fourth Edition (WAIS-IV) Digit Span WAIS-IV Coding Delis-Kaplan Executive Function System (D-KEFS) Trails, Number and Letter Sequencing D-KEFS Trails, Number-Letter Switching D-KEFS Color-Word Interference Test, Inhibition and Inhibition-Switching A Z score of 0 represents the sample mean. Higher composite Z scores reflect better performance.

Outcome measures

Outcome measures
Measure	ME-CCT n=66 Participants 8-week Motivationally Enhanced Compensatory Cognitive Training group	Supportive Contact Control Group n=48 Participants 8-week Goal-focused Supportive Contact group
Change in Objective Cognitive Performance Composite z Score	.24 Z score Standard Deviation .39	.14 Z score Standard Deviation .35

PRIMARY outcome

Timeframe: assessed at baseline, 8 weeks, 21 weeks; change from baseline to 21 weeks reported.

Population: 111 participants had useable data at baseline and 21 weeks.

Change in composite z score on the following measures: UCSD Performance-Based Skills Assessment-Brief (UPSA-B) Medication Management Ability Assessment (MMAA) Neuropsychological Assessment Battery Daily Living Memory Neuropsychological Assessment Battery Judgment Neuropsychological Assessment Battery Driving Scenes A Z score of 0 represents the sample mean. Higher Z scores reflect better performance.