Alzheimer's Disease, Mild Cognitive Impairment, Traumatic Brain Injury
Conditions
Keywords
cognitive rehabilitation, explicit memory training, mild cognitive impairment, Alzheimer's disease, traumatic brain injury, veterans
Brief summary
Memory deficits are common after traumatic brain injuries (TBI) and are characteristic of various forms of dementia, such as Alzheimer's disease and its common precursor mild cognitive impairment (MCI). This project intends to assess the efficacy of cognitive rehabilitation in these patient populations. We will also use neuroimaging (functional magnetic resonance imaging - fMRI) to assess changes in brain activity that occur following cognitive rehabilitation.
Interventions
BEHAVIORALMnemonic strategy training (MST)
BEHAVIORALRepeated exposure (XP)
BEHAVIORALSubtracting Cues training
Sponsors
Emory University
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 88 Years
Healthy volunteers
Yes
Inclusion criteria
General inclusion criteria (all patients): * A minimum of 12 years of education or attainment of a Graduation Equivalency Diploma; * All medications stable for approximately 3 months; * No history of severe mental illness; * No current untreated alcohol or substance abuse/dependence; * English as native and preferred language; * MRI-compatible if taking part in fMRI studies 7) Able to give informed consent. MCI Inclusion Criteria: * Diagnosis of amnestic MCI based on criteria set forth by Petersen (2004). Additionally, other potential causes of cognitive deficit ruled out by the referring physician; * 55 years of age or older. TBI Inclusion criteria: * History of a mild to moderate TBI; * No history of other neurological disease or injury; * A minimum of 6 months and maximum of 5 years post-onset of TBI; * 18 - 45 years old.
Exclusion criteria
* History of neurological disease or injury (other than TBI) * History of severe mental illness * Current untreated alcohol or substance abuse * Other conditions may exclude; please discuss with contact
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Memory Test Accuracy on Trained Stimuli | Pre-training, post-training, 1 month | Accuracy (Percent correct) for trained stimuli. Stage 1: Object location association test Stage 2: Face name association test |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| MST Healthy Older Adults: Stage 1 Mnemonic strategy training for object location associations for healthy older adults | 11 |
| MST MCI: Stage 1 Mnemonic strategy training for object location associations in patients with MCI | 14 |
| XP Healthy Older Adults: Stage 1 Repeated exposure for object location associations in healthy older adults | 10 |
| XP MCI: Stage 1 Repeated exposure for object location associations in patients with MCI | 14 |
| MST Healthy Older Adults: Stage 2 Mnemonic strategy training for face name associations in healthy older adults | 15 |
| SCT Healthy Older Adults: Stage 2 Subtracting cues training for face name associations in healthy older adults | 15 |
| Total | 79 |
Baseline characteristics
| Characteristic | MST Healthy Older Adults: Stage 1 | MST MCI: Stage 1 | XP Healthy Older Adults: Stage 1 | XP MCI: Stage 1 | MST Healthy Older Adults: Stage 2 | SCT Healthy Older Adults: Stage 2 | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 73.2 years STANDARD_DEVIATION 7.7 | 73.5 years STANDARD_DEVIATION 10.1 | 72.5 years STANDARD_DEVIATION 6.8 | 70.5 years STANDARD_DEVIATION 5.8 | 67.1 years STANDARD_DEVIATION 7.9 | 72.0 years STANDARD_DEVIATION 7.6 | 71.3 years STANDARD_DEVIATION 7.9 |
| Gender Female | 7 Participants | 4 Participants | 6 Participants | 8 Participants | 13 Participants | 13 Participants | 51 Participants |
| Gender Male | 4 Participants | 10 Participants | 4 Participants | 6 Participants | 2 Participants | 2 Participants | 28 Participants |
| Region of Enrollment United States | 11 participants | 14 participants | 10 participants | 14 participants | 15 participants | 15 participants | 79 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 12 | 0 / 15 | 0 / 11 | 0 / 14 | 0 / 15 | 0 / 15 |
| serious Total, serious adverse events | 0 / 12 | 0 / 15 | 0 / 11 | 0 / 14 | 0 / 15 | 0 / 15 |
Outcome results
Primary
Memory Test Accuracy on Trained Stimuli
Accuracy (Percent correct) for trained stimuli. Stage 1: Object location association test Stage 2: Face name association test
Time frame: Pre-training, post-training, 1 month
Population: MST older adults Stage 1: 1 participant excluded due to undisclosed ongoing chemotherapy treatment XP older adults Stage 1: 1 participant decided not to participate after randomization MST MCI Stage 1: 1 participant diagnosed with Alzheimer's dementia within 1 month of completing study
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MST Healthy Older Adults: Stage 1 | Memory Test Accuracy on Trained Stimuli | Post-Training | 97.0 Percent correct | Standard Deviation 4 |
| MST Healthy Older Adults: Stage 1 | Memory Test Accuracy on Trained Stimuli | Pre-training | 53.9 Percent correct | Standard Deviation 10.2 |
| MST Healthy Older Adults: Stage 1 | Memory Test Accuracy on Trained Stimuli | 1-month | 85.3 Percent correct | Standard Deviation 1.01 |
| MST MCI: Stage 1 | Memory Test Accuracy on Trained Stimuli | Post-Training | 82.5 Percent correct | Standard Deviation 14.7 |
| MST MCI: Stage 1 | Memory Test Accuracy on Trained Stimuli | Pre-training | 37.6 Percent correct | Standard Deviation 15 |
| MST MCI: Stage 1 | Memory Test Accuracy on Trained Stimuli | 1-month | 65.1 Percent correct | Standard Deviation 17.8 |
| XP Healthy Older Adults: Stage 1 | Memory Test Accuracy on Trained Stimuli | Post-Training | 92.0 Percent correct | Standard Deviation 6.9 |
| XP Healthy Older Adults: Stage 1 | Memory Test Accuracy on Trained Stimuli | Pre-training | 48.9 Percent correct | Standard Deviation 14.5 |
| XP Healthy Older Adults: Stage 1 | Memory Test Accuracy on Trained Stimuli | 1-month | 63.3 Percent correct | Standard Deviation 13.7 |
| XP MCI: Stage 1 | Memory Test Accuracy on Trained Stimuli | Post-Training | 71.4 Percent correct | Standard Deviation 13.2 |
| XP MCI: Stage 1 | Memory Test Accuracy on Trained Stimuli | Pre-training | 37.3 Percent correct | Standard Deviation 8.7 |
| XP MCI: Stage 1 | Memory Test Accuracy on Trained Stimuli | 1-month | 45.8 Percent correct | Standard Deviation 8.3 |
| MST Healthy Older Adults: Stage 2 | Memory Test Accuracy on Trained Stimuli | Post-Training | 94.9 Percent correct | Standard Deviation 4.8 |
| MST Healthy Older Adults: Stage 2 | Memory Test Accuracy on Trained Stimuli | Pre-training | 59.8 Percent correct | Standard Deviation 14 |
| MST Healthy Older Adults: Stage 2 | Memory Test Accuracy on Trained Stimuli | 1-month | 86.2 Percent correct | Standard Deviation 7.4 |
| SCT Healthy Older Adults: Stage 2 | Memory Test Accuracy on Trained Stimuli | Pre-training | 57.6 Percent correct | Standard Deviation 15.3 |
| SCT Healthy Older Adults: Stage 2 | Memory Test Accuracy on Trained Stimuli | 1-month | 69.7 Percent correct | Standard Deviation 18.1 |
| SCT Healthy Older Adults: Stage 2 | Memory Test Accuracy on Trained Stimuli | Post-Training | 83.7 Percent correct | Standard Deviation 13.7 |