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| Name | Class |
|---|---|
| University of Alabama at Birmingham | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Non-Dementia Memory Disorder | Elderly patients with non-dementia memory disorder (mild cognitive impairment) | ||
| Arm 2: Control | Elderly controls without memory impairment | ||
| Arm 3: Mild Alzheimer Disease | Patients with mild Alzheimer disease (but preserved routine activities of daily living) |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Year 1, Year 2, Year 3 |
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Inclusion Criteria:
Exclusion Criteria:
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160 subjects are anticipated, with the expectation that initial cognitive evaluations will exclude about 60 subjects. We intend to maintain and follow 100 subjects, 40 with non-dementia memory impairment (meeting criteria for amnestic MCI) and 40 with no cognitive impairment, and 20 with mild Alzheimer disease
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| Name | Affiliation | Role |
|---|---|---|
| David G Clark, MD | Birmingham VA Medical Center, Birmingham, AL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham VA Medical Center, Birmingham, AL | Birmingham | Alabama | 35233 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22399094 | Background | Clark DG; Alzheimer Disease Neuroimaging Initiative. Residual vectors for Alzheimer disease diagnosis and prognostication. Brain Behav. 2011 Nov;1(2):142-52. doi: 10.1002/brb3.19. | |
| 24384308 | Result | Clark DG, Wadley VG, Kapur P, DeRamus TP, Singletary B, Nicholas AP, Blanton PD, Lokken K, Deshpande H, Marson D, Deutsch G. Lexical factors and cerebral regions influencing verbal fluency performance in MCI. Neuropsychologia. 2014 Feb;54:98-111. doi: 10.1016/j.neuropsychologia.2013.12.010. Epub 2013 Dec 30. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1: Non-Dementia Memory Disorder | Elderly patients with non-dementia memory disorder (mild cognitive impairment) |
| FG001 | Arm 2: Control | Elderly controls without memory impairment |
| FG002 | Arm 3: Mild Alzheimer Disease | Patients with mild Alzheimer disease (but preserved routine activities of daily living) |
| FG003 | CIND | Individuals with cognitive impairment who did not meet criteria for MCI or dementia |
| FG004 | Intoxicated | Individuals who appeared to be intoxicated at baseline evaluation |
| FG005 | Non-AD Dementia | Other causes of dementia |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Seventy-eight individuals underwent the baseline assessment, but four were removed from the analysis and were not asked to follow up because the consensus panel did not feel that they met criteria for any of the three arms (MCI, control, mild AD). This left 74 individuals at baseline who were eligible to continue in the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1: Non-Dementia Memory Disorder | Elderly patients with non-dementia memory disorder (mild cognitive impairment) |
| BG001 | Arm 2: Control | Elderly controls without memory impairment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Individuals completing at least one assessment following baseline | Posted | Mean | Standard Deviation | points awarded for correct items | Year 1, Year 2, Year 3 |
|
1 year
Potential adverse events were discussed at each research visit. For some patients, adverse events were detected through clinical interaction with the participants.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1: Non-Dementia Memory Disorder | Elderly patients with non-dementia memory disorder (mild cognitive impairment) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Cardiac disorders | SNOMED CT | Non-systematic Assessment | This participant died from multi-organ failure within 3 months of the baseline evaluation. |
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This trial did not involve an intervention. Technical problems limited the analysis of the MRI scans. Lack of a designated rater for the study negatively impacted participant retention.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David Glenn Clark | Department of Veterans Affairs | 843-792-7446 | clarkda@musc.edu |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D003704 | Dementia |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
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N/A- no biospecimens
| 24556551 | Result | Clark DG, Kapur P, Geldmacher DS, Brockington JC, Harrell L, DeRamus TP, Blanton PD, Lokken K, Nicholas AP, Marson DC. Latent information in fluency lists predicts functional decline in persons at risk for Alzheimer disease. Cortex. 2014 Jun;55:202-18. doi: 10.1016/j.cortex.2013.12.013. Epub 2014 Jan 16. |
| Withdrawal by Subject |
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| Lack of resources (hired rater) |
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| Death |
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| Lost to Follow-up |
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| BG002 | Arm 3: Mild Alzheimer Disease | Patients with mild Alzheimer disease (but preserved routine activities of daily living) |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Educational level | Mean | Standard Deviation | years |
|
| Verbal learning - 1st immediate list A | Participants were read a list of 16 words and asked immediately to recite back as many words as they could remember. | Mean | Standard Deviation | words recalled |
|
| Verbal learning - list B immediate recall | After all 5 learning trials with list A, participants were read a second list of 16 words and asked immediately to recite back as many words as they could recall. | Mean | Standard Deviation | words recalled |
|
| Verbal learning - total trials 1-5 | Participants were read a list of 16 words five times in a row, each time being asked immediately to recite back as many words as they could recall. The sum of words recalled on the five attempts is reported here. | Mean | Standard Deviation | words recalled |
|
| Verbal learning - long delay free recall | After 30 minutes, participants were asked to recall words from list A (not from list B) that were presented during five previous exposure trials. | Mean | Standard Deviation | words recalled |
|
| Verbal learning - long delay cued recall | After attempting to spontaneously recall words from list A (following a 30 minute delay), participants were asked to recall all words they could recall within certain categories: animals, vegetables, articles of furniture, and ways of traveling (4 words in each category). | Mean | Standard Deviation | words recalled |
|
| 10/36 spatial recall - 1st trial | Participants were shown a 6 x 6 grid with black circles on 10 of the squares. After inspecting it for 10 seconds, they were given a blank grid and asked to place black checkers where the circles had been. This score is the number of checkers that were placed in actual locations of the circles. | Mean | Standard Deviation | positions recalled |
|
| 10/36 spatial recall - total | Participants were given three chances to memorize the positions of 10 black circles on a 6 x 6 grid. This score is the total number of correct responses over the three learning trials. | Mean | Standard Deviation | positions recalled |
|
| 10/36 spatial recall - delayed recall | After three exposures to a 6 x 6 grid with 10 black circles on it, participants were given a different task for 7 minutes and then asked to reproduce the pattern of circles by placing checkers on a blank grid. This score is the total number of correctly placed checkers. | Mean | Standard Deviation | positions recalled |
|
| F-, A-, and S-words | Participants were given one minute each to generate as many words as possible that started with the letter F, the letter A, and the letter S. They were instructed not to use capitalized words, such as France, Friday, or Francheska. We report the sum of valid responses over the three tasks. | Mean | Standard Deviation | words generated |
|
| Semantic fluency (7 categories) | Participants were given one minute to generate words fitting into 7 different semantic categories. We report the sum of valid responses over the 7 tasks. The categories were: animals, water creatures, tools, vehicles, fruits and vegetables, boats, and verbs. | Mean | Standard Deviation | words generated |
|
| Trail Making Test - A | Participants were asked to draw a trial connecting labeled in circles in order. The labels consisted of the numbers from 1 to 25 and participants were told to start at 1 and finish at 25. We report the time in seconds for participants to complete the task. | Mean | Standard Deviation | seconds |
|
| Trail Making Test - B | Participants were asked to draw a trial connecting circles in order according to the labels. The labels consisted of the numbers 1-13 and the letters A-M. Participants were told to alternate between numbers and letters (i.e., 1 - A - 2 - B - 3 - C, etc.) and were given a short practice form. We report the time taken to complete the task. | Mean | Standard Deviation | seconds |
|
| Boston Naming Test - 30 item | Participants were shown line drawings of objects and asked to name them. The test starts with highly familiar, high frequency words, such as 'bed,' and 'pencil,' and progresses to more difficult items, such as 'abacus' and 'octopus.' We report the number of correctly named items out of stimuli. | Mean | Standard Deviation | pictures named |
|
| Pyramids and Palm Trees - pictures | Participants were cued with a line drawing (e.g., a pyramid) and asked to decide which one of two other line drawings was most related to the cue. For the prototypical test item, the target and foil were, respectively, a palm tree and a pine tree. We report the number of correct items out of 51. | Mean | Standard Deviation | correct matches |
|
| Pyramids and Palm Trees - words | Participants were cued with a word (e.g., "pyramid") and asked to decide which one of two other words was most related to the cue. For the prototypical test item, the target and foil were, respectively, "palm tree" and "pine tree." We report the number of correct items out of 52. | Mean | Standard Deviation | correct matches |
|
| Extended Mini-Mental State Exam | The extended mini-mental state exam (xMMSE) is a 50-item test consisting of the 30 items from the standard MMSE, plus items that a give total of 20 additional possible points. The additional items are 5 points for an executive/working memory task, 2 points for naming, 6 points for delayed recall (with and without cues), 3 additional points for the visual construction, and 4 additional points for recalling the visual construction after a delay. | Mean | Standard Deviation | points awarded for correct items |
|
| Financial Capacity Instrument - total | The Financial Capacity Instrument is a test of financial knowledge and skills. We used items from five of the domains that have been previously reported: financial concepts (range 0-34), cash transactions (range 0-32), checkbook management (range 0-30), bank statement management (range 0-49), and bill payment (range 0-46). The number of points awarded for correct items depends on the estimated difficulty of the item. We report the sum of all points awarded across the five domains at the baseline evaluation (range 0-191), with higher scores representing greater financial capacity. | Mean | Standard Deviation | points awarded for correct items |
|
Elderly controls without memory impairment
| OG002 | Arm 3: Mild Alzheimer Disease | Patients with mild Alzheimer disease (but preserved routine activities of daily living) |
|
|
| 0 |
| 23 |
| 0 |
| 23 |
| EG001 | Arm 2: Control | Elderly controls without memory impairment | 0 | 40 | 0 | 40 |
| EG002 | Arm 3: Mild Alzheimer Disease | Patients with mild Alzheimer disease (but preserved routine activities of daily living) | 0 | 11 | 0 | 11 |
| EG003 | CIND | Individuals with cognitive impairment who did not meet criteria for MCI or dementia | 0 | 2 | 0 | 2 |
| EG004 | Intoxicated | Individuals who appeared to be intoxicated at baseline evaluation | 0 | 1 | 0 | 1 |
| EG005 | Non-AD Dementia | Other causes of dementia | 1 | 1 | 0 | 1 |
|
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| D019636 |
| Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003072 | Cognition Disorders |