Alzheimer DiseaseCASLNCT00880555
Semantic Memory, Financial Capacity, and Brain Perfusion in Mild Cognitive Impairment (MCI) (CASL)
An observational study of Alzheimer Disease and Dementia, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Dementia
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to May 2014
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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
Who may be able to join
- 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
Show all 9Show fewer
- Able and willing to undergo MRI scan
- Medically and psychiatrically stable
- No other brain disease (such as tumor, Parkinson's disease, major stroke)
Who cannot join
- Pregnancy
- Inability to tolerate MRI (due to metal in body or claustrophobia)
Trial locations and contacts
1 site in 1 country.
United States1 site
Birmingham VA Medical Center, Birmingham, AL
Birmingham, Alabama, 35233
About this study
Official title: Semantic Memory, Financial Capacity and Brain Perfusion in MCI
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.
Read the 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.
- Conditions
- Alzheimer Disease, Dementia
- Keywords
- Magnetic Resonance Imaging, Alzheimer disease, Mild cognitive impairment, Continuous arterial spin labeling, Semantic memory
- Medical subject headings
- Alzheimer Disease, Dementia, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Year 1, Year 2, Year 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- University of Alabama at Birmingham
- Responsible party
- Sponsor
- Investigators
- David G Clark, MD, Principal investigator, Birmingham VA Medical Center, Birmingham, AL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00880555
- Sponsor's protocol ID
- E6553-W
- Acronym
- CASL
- Status last verified
- Feb 2016
- First submitted
- 10 Apr 2009
- Last updated
- 24 Mar 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 22399094Clark 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.
PubMed 24384308Clark 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.
PubMed 24556551
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Semantic Memory, Financial Capacity and Brain Perfusion in MCI
- ClinicalTrials.gov ID
- NCT00880555
- Acronym / sponsor ID
- CASL / E6553-W
- Conditions
- Alzheimer Disease, Dementia
- Keywords
- Magnetic Resonance Imaging, Alzheimer disease, Mild cognitive impairment, Continuous arterial spin labeling, Semantic memory
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- University of Alabama at Birmingham
- Study start
- Apr 2009
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 13 Apr 2009 (estimated)
- Results
- Posted 24 Mar 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 50 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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
Key inclusion criteria (9 listed)
- Veteran or non-veteran
- Age 50-89
- With normal cognition or memory impairment (MCI or mild AD)
- English speaking
- Right handed
Key exclusion criteria (2 listed)
- Pregnancy
- Inability to tolerate MRI (due to metal in body or claustrophobia)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
FCI Score at Follow-up
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22399094Clark 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.
- Results publication: PubMed 24384308Clark 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.
- Results publication: PubMed 24556551Clark 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David G Clark, MD principal investigator
Birmingham VA Medical Center, Birmingham, AL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease and Dementia, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FCI Score at Follow-up (time frame: Year 1, Year 2, Year 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00880555, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2016.