Mild Cognitive Impairment
Conditions
Brief summary
The current study will test the effectiveness of a computerized cognitive training program on auditory memory and attention in patients with mild cognitive impairment. Practice effects will also be examined as a moderator of treatment response.
Detailed description
The current study will test the effectiveness of a computerized cognitive (thinking) training program on improving thinking and memory in patients with mild cognitive impairment. The investigators will also examine how short term changes in thinking abilities (i.e., practice effects) can be related to improvement in thinking abilities after the cognitive training program.
Interventions
BEHAVIORALcomputerized cognitive exercises
Each group will perform computerized cognitive exercises, 1 hour per day, 3 - 5 days per week, for 13 weeks. The experimental group will use exercises shown to improve cognition, whereas the comparator group will use exercises without clear beneficial findings.
Sponsors
National Institute on Aging (NIA)
University of Utah
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Mild Cognitive Impairment, amnestic subtype * 65 years of age or older * Availability of a knowledgeable informant * Access to internet 3 hours per week * Adequate vision, hearing, and motor responding to participate in training
Exclusion criteria
* History of major stroke, head injury with loss of consciousness of \>30 minutes, or other neurological disorder or systemic illness that are thought to be affecting cognition (e.g., seizure disorder, demyelinating disorder, etc.) * Current or past major psychiatric illness (e.g., schizophrenia, bipolar affective disorder) * History of substance abuse * Current use of antipsychotics or anticonvulsant medications * Currently residing in a nursing home or other skilled nursing facility
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Auditory Memory Attention Index | 13 weeks | This is a composite of six subtests of the Repeatable Battery for the Assessment of Neuropsychological Status. It is a standard score (mean=100, standard deviation=15), with a range of approximately 45 - 145, with higher scores indicating better outcome. |
Countries
United States
Participant flow
Pre-assignment details
51 individuals were enrolled in the study but were withdrawn by the research team because they did not meet criteria for amnestic Mild Cognitive Impairment on objective testing.
Participants by arm
| Arm | Count |
|---|---|
| Experimental Cognitive Training Participants will use experimental computerized cognitive training exercises, 1 hour per day, 3 - 5 days per week, for 13 weeks.
computerized cognitive exercises: Each group will perform computerized cognitive exercises, 1 hour per day, 3 - 5 days per week, for 13 weeks. The experimental group will use exercises shown to improve cognition, whereas the comparator group will use exercises without clear beneficial findings. | 55 |
| Control Cognitive Exercises Participants will use control computerized cognitive activities, 1 hour per day, 3 - 5 days per week, for 13 weeks.
computerized cognitive exercises: Each group will perform computerized cognitive exercises, 1 hour per day, 3 - 5 days per week, for 13 weeks. The experimental group will use exercises shown to improve cognition, whereas the comparator group will use exercises without clear beneficial findings. | 58 |
| Total | 113 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Long Term Effectiveness (~1 Year) | Death | 2 | 0 |
| Long Term Effectiveness (~1 Year) | Lost to Follow-up | 3 | 3 |
| Long Term Effectiveness (~1 Year) | moved away | 1 | 2 |
| Long Term Effectiveness (~1 Year) | Withdrawal by Subject | 6 | 2 |
| Short-term Effectiveness (~13 Weeks) | non-compliant | 10 | 7 |
| Short-term Effectiveness (~13 Weeks) | screen fail | 1 | 0 |
| Short-term Effectiveness (~13 Weeks) | Withdrawal by Subject | 7 | 8 |
Baseline characteristics
| Characteristic | Experimental Cognitive Training | Control Cognitive Exercises | Total |
|---|---|---|---|
| Age, Continuous | 74.9 years STANDARD_DEVIATION 6.3 | 75.0 years STANDARD_DEVIATION 5.8 | 75.0 years STANDARD_DEVIATION 6.1 |
| one week practice effects | -0.4 z-score units STANDARD_DEVIATION 0.7 | -0.4 z-score units STANDARD_DEVIATION 0.7 | -0.4 z-score units STANDARD_DEVIATION 0.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 54 Participants | 57 Participants | 111 Participants |
| Region of Enrollment United States | 55 participants | 58 participants | 113 participants |
| Sex: Female, Male Female | 26 Participants | 25 Participants | 51 Participants |
| Sex: Female, Male Male | 29 Participants | 33 Participants | 62 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 73 | 0 / 73 |
| other Total, other adverse events | 0 / 73 | 0 / 73 |
| serious Total, serious adverse events | 0 / 73 | 0 / 73 |
Outcome results
Primary
Auditory Memory Attention Index
This is a composite of six subtests of the Repeatable Battery for the Assessment of Neuropsychological Status. It is a standard score (mean=100, standard deviation=15), with a range of approximately 45 - 145, with higher scores indicating better outcome.
Time frame: 13 weeks
Population: Mixed effects model
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental Cognitive Training | Auditory Memory Attention Index | 89.0 standard score units | Standard Deviation 13.1 |
| Control Cognitive Exercises | Auditory Memory Attention Index | 94.3 standard score units | Standard Deviation 12.1 |
p-value: <0.01Mixed Models Analysis