Semantic Memory, Financial Capacity, and Brain Perfusion in Mild Cognitive Impairment (MCI) (CASL)

NCT00880555 | Completed Results

• 1 other identifier: E6553-W
• Study Type: observational
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease; Dementia

Keywords

Magnetic Resonance Imaging; Alzheimer disease; Mild cognitive impairment; Continuous arterial spin labeling; Semantic memory

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

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)

Eligibility Criteria

• Age: 50 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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

You may qualify if:

• 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)

You may not qualify if:

• Pregnancy
• Inability to tolerate MRI (due to metal in body or claustrophobia)

Sponsors & Collaborators

• VA Office of Research and Development: lead
• University of Alabama at Birmingham: collaborator

Study Sites (1)

Birmingham VA Medical Center, Birmingham, AL

Birmingham, Alabama, 35233, United States

Location

Related Publications (3)

• 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.

  PMID: 22399094 BACKGROUND

• 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.

  PMID: 24384308 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.

  PMID: 24556551 RESULT

Biospecimen

Retention: NONE RETAINED

N/A- no biospecimens

MeSH Terms

Conditions

Alzheimer Disease; Dementia; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Limitations and Caveats

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.

Results Point of Contact

• Title: Dr. David Glenn Clark
• Organization: Department of Veterans Affairs

clarkda@musc.edu

843-792-7446

Study Officials

• David G Clark, MD

  Birmingham VA Medical Center, Birmingham, AL

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2009
• First Posted: April 13, 2009
• Study Start: April 1, 2009
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: March 24, 2016
• Results First Posted: March 24, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)