An observational study in Alzheimer Disease and Dementia, sponsored by VA Office of Research and Development. Completed at 1 site in United States. Open to participants aged 50 Years to 89 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-03-24.
Sponsored by VA Office of Research and Development · Observational
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.
3,675 studies on the registry are indexed under Alzheimer Disease; 869 are open to participants now.
This study's enrollment of 78 is below the median of 200 across 751 observational studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →VA Office of Research and Development is the lead sponsor of 1,733 studies on the registry; 396 are open to participants now.
Of its 206 completed or terminated interventional studies of FDA-regulated products, 180 (87%) have results posted.
Counted across the registry records on this site, refreshed daily.
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
Exclusion Criteria:
Elderly patients with non-dementia memory disorder (mild cognitive impairment)
Elderly controls without memory impairment
Patients with mild Alzheimer disease (but preserved routine activities of daily living)
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
| Milestone | Arm 1: Non-Dementia Memory Disorder | Arm 2: Control | Arm 3: Mild Alzheimer Disease | CIND | Intoxicated | Non-AD Dementia |
|---|---|---|---|---|---|---|
| Started | 23 | 40 | 11 | 2 | 1 | 1 |
| Completed | 13 | 23 | 6 | 0 | 0 | 0 |
| Not completed | 10 | 17 | 5 | 2 | 1 | 1 |
| Withdrew: Physician decision | 0 | 8 | 0 | 2 | 1 | 0 |
| Withdrew: Withdrawal by subject | 1 | 1 | 0 | 0 | 0 | 0 |
| Withdrew: Lack of resources (hired rater) | 9 | 7 | 5 | 0 | 0 | 0 |
| Withdrew: Death | 0 | 0 | 0 | 0 | 0 | 1 |
| Withdrew: Lost to follow-up | 0 | 1 | 0 | 0 | 0 | 0 |
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.
| points awarded for correct items | Arm 1: Non-Dementia Memory Disorder | Arm 2: Control | Arm 3: Mild Alzheimer Disease |
|---|---|---|---|
| Year 1 | 147.3 ± 19.7 | 164.0 ± 13.3 | 123.3 ± 43.1 |
| Year 2 | 150.8 ± 9.0 | 179.0 ± 6.2 | 0 ± 0 |
| Year 3 | 93 ± 0 | 163 ± 0 | 0 ± 0 |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm 1: Non-Dementia Memory Disorder | — | 0/23 (0%) | 0/23 (0%) |
| Arm 2: Control | — | 0/40 (0%) | 0/40 (0%) |
| Arm 3: Mild Alzheimer Disease | — | 0/11 (0%) | 0/11 (0%) |
| CIND | — | 0/2 (0%) | 0/2 (0%) |
| Intoxicated | — | 0/1 (0%) | 0/1 (0%) |
| Non-AD Dementia | — | 1/1 (100%) | 0/1 (0%) |
| Event | Arm 1: Non-Dementia Memory Disorder | Arm 2: Control | Arm 3: Mild Alzheimer Disease | CIND | Intoxicated | Non-AD Dementia |
|---|---|---|---|---|---|---|
| DeathCardiac disorders | 0/23 | 0/40 | 0/11 | 0/2 | 0/1 | 1/1 |
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.
| Age, Continuous(years) | Arm 1: Non-Dementia Memory Disorder | Arm 2: Control | Arm 3: Mild Alzheimer Disease | Total |
|---|---|---|---|---|
| Mean | 71.91 ± 7.63 | 65.08 ± 9.46 | 74.18 ± 6.29 | 68.55 ± 9.26 |
| Sex: Female, Male(Participants) | Arm 1: Non-Dementia Memory Disorder | Arm 2: Control | Arm 3: Mild Alzheimer Disease | Total |
|---|---|---|---|---|
| Female | 4 | 23 | 3 | 30 |
| Male | 19 | 17 | 8 | 44 |
| Race (NIH/OMB)(Participants) | Arm 1: Non-Dementia Memory Disorder | Arm 2: Control | Arm 3: Mild Alzheimer Disease | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 2 | 6 | 1 | 9 |
| White | 21 | 34 | 10 | 65 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Educational level(years) | Arm 1: Non-Dementia Memory Disorder | Arm 2: Control | Arm 3: Mild Alzheimer Disease | Total |
|---|---|---|---|---|
| Mean | 14.9 ± 2.94 | 16.0 ± 2.39 | 14.8 ± 2.36 | 15.4 ± 2.6 |
| Verbal learning - 1st immediate list A(words recalled) | Arm 1: Non-Dementia Memory Disorder | Arm 2: Control | Arm 3: Mild Alzheimer Disease | Total |
|---|---|---|---|---|
| Mean | 5.0 ± 1.7 | 6.4 ± 2.2 | 3.3 ± 1.4 | 5.4 ± 2.2 |
| Verbal learning - list B immediate recall(words recalled) | Arm 1: Non-Dementia Memory Disorder | Arm 2: Control | Arm 3: Mild Alzheimer Disease | Total |
|---|---|---|---|---|
| Mean | 4.5 ± 1.4 | 5.5 ± 2.2 | 2.7 ± 1.3 | 4.7 ± 2.0 |
| Verbal learning - total trials 1-5(words recalled) | Arm 1: Non-Dementia Memory Disorder | Arm 2: Control | Arm 3: Mild Alzheimer Disease | Total |
|---|---|---|---|---|
| Mean | 35.9 ± 9.6 | 48.7 ± 10.0 | 23.0 ± 8.2 | 40.5 ± 13.2 |
| Verbal learning - long delay free recall(words recalled) | Arm 1: Non-Dementia Memory Disorder | Arm 2: Control | Arm 3: Mild Alzheimer Disease | Total |
|---|---|---|---|---|
| Mean | 5.8 ± 3.9 | 10.3 ± 3.5 | 1.6 ± 2.0 | 7.5 ± 4.6 |
13 further baseline measures are reported on the registry.
Plan to share: No
This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
VA Office of Research and Development