Alzheimer Disease, Dementia
Conditions
Keywords
Magnetic Resonance Imaging, Alzheimer disease, Mild cognitive impairment, Continuous arterial spin labeling, Semantic memory
Brief summary
Alzheimer's disease (AD) often manifests as a memory disorder before dementia develops. Dementia is considered to be present when a person can no longer handle complex activities of daily living, such as managing finances. This study will investigate the relationship between changes in the ability to manage finances and brain perfusion, which will be measured using continuous arterial spin-labeling (an experimental MRI). Subjects will also undergo neuropsychological tests focusing on several types of memory and thought process, with special emphasis on semantic memory. An important question to be addressed is whether changes in function are better predicted by the neuropsychological tests or by the brain scan.
Detailed description
Alzheimer's disease (AD) often manifests as a memory disorder before dementia develops. Dementia is considered to be present when a person can no longer handle complex activities of daily living, such as managing finances. This study will investigate the relationship between changes in the ability to manage finances and brain perfusion, which will be measured using continuous arterial spin-labeling (an experimental MRI). Subjects will also undergo neuropsychological tests focusing on several types of memory and thought process, with special emphasis on semantic memory. An important question to be addressed is whether changes in function are better predicted by the neuropsychological tests or by the brain scan. Participants will undergo a single MRI scan, baseline financial capacity instrument (FCI) and cognitive evaluation, and then will be followed approximately annually to repeat the functional and cognitive assessments. Linear mixed effects models will be used to fit a model predicting financial capacity based on baseline cognitive tests. Measures from the MRI scan will be added to the model to determine whether imaging improves the predictions.
Interventions
None listed
Sponsors
University of Alabama at Birmingham
VA Office of Research and Development
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to 89 Years
Healthy volunteers
Yes
Inclusion criteria
* Veteran or non-veteran * Age 50-89 * With normal cognition or memory impairment (MCI or mild AD) * English speaking * Right handed * Adequate vision and hearing to take part in tests * Able and willing to undergo MRI scan * Medically and psychiatrically stable * No other brain disease (such as tumor, Parkinson's disease, major stroke)
Exclusion criteria
* Pregnancy * Inability to tolerate MRI (due to metal in body or claustrophobia)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| FCI Score at Follow-up | Year 1, Year 2, Year 3 | At each research visit, participants undertook 5 portions of the Financial Capacity Instrument (Domains 2, 3, 4b, 5, and 7). We report the total FCI score across the five domains tested, which has a range of possible scores from 0-191. Higher scores reflect greater capacity for understanding financial concepts and handling financial tasks. |
Countries
United States
Participant flow
Pre-assignment details
All individuals underwent baseline MRI, cognitive, and functional assessment. Four individuals (2 cognitive impairment- non dementia (CIND), 1 intoxicated, 1 with non-AD dementia) determined not to fit into one of the study arms (MCI, mild AD, or cognitively normal) were not asked to return for follow up cognitive and functional assessment.
Participants by arm
| Arm | Count |
|---|---|
| Arm 1: Non-Dementia Memory Disorder Elderly patients with non-dementia memory disorder (mild cognitive impairment) | 23 |
| Arm 2: Control Elderly controls without memory impairment | 40 |
| Arm 3: Mild Alzheimer Disease Patients with mild Alzheimer disease (but preserved routine activities of daily living) | 11 |
| Total | 74 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Death | 0 | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Lack of resources (hired rater) | 9 | 7 | 5 | 0 | 0 | 0 |
| Overall Study | Lost to Follow-up | 0 | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Physician Decision | 0 | 8 | 0 | 2 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 1 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Arm 1: Non-Dementia Memory Disorder | Total | Arm 3: Mild Alzheimer Disease | Arm 2: Control |
|---|---|---|---|---|
| 10/36 spatial recall - 1st trial | 4.3 positions recalled STANDARD_DEVIATION 2 | 5.0 positions recalled STANDARD_DEVIATION 2 | 4.0 positions recalled STANDARD_DEVIATION 1.6 | 5.6 positions recalled STANDARD_DEVIATION 2 |
| 10/36 spatial recall - delayed recall | 5.2 positions recalled STANDARD_DEVIATION 2.2 | 6.4 positions recalled STANDARD_DEVIATION 2.4 | 5.4 positions recalled STANDARD_DEVIATION 1.7 | 7.2 positions recalled STANDARD_DEVIATION 2.4 |
| 10/36 spatial recall - total | 15.9 positions recalled STANDARD_DEVIATION 5 | 17.9 positions recalled STANDARD_DEVIATION 5.3 | 13.8 positions recalled STANDARD_DEVIATION 3 | 20.2 positions recalled STANDARD_DEVIATION 5 |
| Age, Continuous | 71.91 years STANDARD_DEVIATION 7.63 | 68.55 years STANDARD_DEVIATION 9.26 | 74.18 years STANDARD_DEVIATION 6.29 | 65.08 years STANDARD_DEVIATION 9.46 |
| Boston Naming Test - 30 item | 25.6 pictures named STANDARD_DEVIATION 4.1 | 25.8 pictures named STANDARD_DEVIATION 4 | 21.6 pictures named STANDARD_DEVIATION 5.7 | 27.2 pictures named STANDARD_DEVIATION 2.2 |
| Educational level | 14.9 years STANDARD_DEVIATION 2.94 | 15.4 years STANDARD_DEVIATION 2.6 | 14.8 years STANDARD_DEVIATION 2.36 | 16.0 years STANDARD_DEVIATION 2.39 |
| Extended Mini-Mental State Exam | 44.2 points awarded for correct items STANDARD_DEVIATION 4.9 | 44.7 points awarded for correct items STANDARD_DEVIATION 5.2 | 36.5 points awarded for correct items STANDARD_DEVIATION 4.4 | 47.6 points awarded for correct items STANDARD_DEVIATION 2.5 |
| F-, A-, and S-words | 29.1 words generated STANDARD_DEVIATION 14.5 | 32.5 words generated STANDARD_DEVIATION 13.2 | 27.5 words generated STANDARD_DEVIATION 14 | 36.4 words generated STANDARD_DEVIATION 11.4 |
| Financial Capacity Instrument - total | 151.8 points awarded for correct items STANDARD_DEVIATION 17.3 | 152.4 points awarded for correct items STANDARD_DEVIATION 19 | 127.1 points awarded for correct items STANDARD_DEVIATION 27.9 | 160.2 points awarded for correct items STANDARD_DEVIATION 8.3 |
| Pyramids and Palm Trees - pictures | 49.4 correct matches STANDARD_DEVIATION 1.5 | 48.9 correct matches STANDARD_DEVIATION 2.6 | 46.4 correct matches STANDARD_DEVIATION 5.1 | 49.6 correct matches STANDARD_DEVIATION 1.4 |
| Pyramids and Palm Trees - words | 50.0 correct matches STANDARD_DEVIATION 1.8 | 49.9 correct matches STANDARD_DEVIATION 2.5 | 48.4 correct matches STANDARD_DEVIATION 4.9 | 50.4 correct matches STANDARD_DEVIATION 1.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 9 Participants | 1 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 21 Participants | 65 Participants | 10 Participants | 34 Participants |
| Semantic fluency (7 categories) | 74.6 words generated STANDARD_DEVIATION 25.7 | 86.2 words generated STANDARD_DEVIATION 28.5 | 61.5 words generated STANDARD_DEVIATION 25.9 | 101.1 words generated STANDARD_DEVIATION 23.3 |
| Sex: Female, Male Female | 4 Participants | 30 Participants | 3 Participants | 23 Participants |
| Sex: Female, Male Male | 19 Participants | 44 Participants | 8 Participants | 17 Participants |
| Trail Making Test - A | 45.4 seconds STANDARD_DEVIATION 13.8 | 44.0 seconds STANDARD_DEVIATION 30.1 | 77.0 seconds STANDARD_DEVIATION 67.7 | 34.7 seconds STANDARD_DEVIATION 11.4 |
| Trail Making Test - B | 132.2 seconds STANDARD_DEVIATION 64.4 | 110.8 seconds STANDARD_DEVIATION 63.6 | 178.7 seconds STANDARD_DEVIATION 79.2 | 78.8 seconds STANDARD_DEVIATION 25.5 |
| Verbal learning - 1st immediate list A | 5.0 words recalled STANDARD_DEVIATION 1.7 | 5.4 words recalled STANDARD_DEVIATION 2.2 | 3.3 words recalled STANDARD_DEVIATION 1.4 | 6.4 words recalled STANDARD_DEVIATION 2.2 |
| Verbal learning - list B immediate recall | 4.5 words recalled STANDARD_DEVIATION 1.4 | 4.7 words recalled STANDARD_DEVIATION 2 | 2.7 words recalled STANDARD_DEVIATION 1.3 | 5.5 words recalled STANDARD_DEVIATION 2.2 |
| Verbal learning - long delay cued recall | 7.3 words recalled STANDARD_DEVIATION 3.7 | 8.7 words recalled STANDARD_DEVIATION 4.3 | 3.3 words recalled STANDARD_DEVIATION 2.4 | 11.2 words recalled STANDARD_DEVIATION 3.2 |
| Verbal learning - long delay free recall | 5.8 words recalled STANDARD_DEVIATION 3.9 | 7.5 words recalled STANDARD_DEVIATION 4.6 | 1.6 words recalled STANDARD_DEVIATION 2 | 10.3 words recalled STANDARD_DEVIATION 3.5 |
| Verbal learning - total trials 1-5 | 35.9 words recalled STANDARD_DEVIATION 9.6 | 40.5 words recalled STANDARD_DEVIATION 13.2 | 23.0 words recalled STANDARD_DEVIATION 8.2 | 48.7 words recalled STANDARD_DEVIATION 10 |
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 / 23 | 0 / 40 | 0 / 11 | 0 / 2 | 0 / 1 | 0 / 1 |
| serious Total, serious adverse events | 0 / 23 | 0 / 40 | 0 / 11 | 0 / 2 | 0 / 1 | 1 / 1 |
Outcome results
Primary
FCI Score at Follow-up
At each research visit, participants undertook 5 portions of the Financial Capacity Instrument (Domains 2, 3, 4b, 5, and 7). We report the total FCI score across the five domains tested, which has a range of possible scores from 0-191. Higher scores reflect greater capacity for understanding financial concepts and handling financial tasks.
Time frame: Year 1, Year 2, Year 3
Population: Individuals completing at least one assessment following baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: Non-Dementia Memory Disorder | FCI Score at Follow-up | Year 2 | 150.8 points awarded for correct items | Standard Deviation 9 |
| Arm 1: Non-Dementia Memory Disorder | FCI Score at Follow-up | Year 1 | 147.3 points awarded for correct items | Standard Deviation 19.7 |
| Arm 1: Non-Dementia Memory Disorder | FCI Score at Follow-up | Year 3 | 93 points awarded for correct items | Standard Deviation 0 |
| Arm 2: Control | FCI Score at Follow-up | Year 2 | 179.0 points awarded for correct items | Standard Deviation 6.2 |
| Arm 2: Control | FCI Score at Follow-up | Year 1 | 164.0 points awarded for correct items | Standard Deviation 13.3 |
| Arm 2: Control | FCI Score at Follow-up | Year 3 | 163 points awarded for correct items | Standard Deviation 0 |
| Arm 3: Mild Alzheimer Disease | FCI Score at Follow-up | Year 1 | 123.3 points awarded for correct items | Standard Deviation 43.1 |
| Arm 3: Mild Alzheimer Disease | FCI Score at Follow-up | Year 3 | 0 points awarded for correct items | Standard Deviation 0 |
| Arm 3: Mild Alzheimer Disease | FCI Score at Follow-up | Year 2 | 0 points awarded for correct items | Standard Deviation 0 |