Mild Cognitive Impairment Clinical Trial
Official title:
Cross-Cultural Use of Performance-Based Functional Assessment in Alzheimer's Disease
NCT number | NCT03081546 |
Other study ID # | 16-1954 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 4, 2017 |
Est. completion date | September 1, 2018 |
Verified date | August 2021 |
Source | University of Colorado, Denver |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This study plans to assess the effectiveness of performance-based functional assessments (PBFAs) and cognitive assessments in diagnosing Alzheimer's disease in Hispanic/Latino populations. The information from this study will be analyzed with data from the Rocky Mountain Alzheimer's Disease Center Bio-AD study (NCT02612376).
Status | Completed |
Enrollment | 41 |
Est. completion date | September 1, 2018 |
Est. primary completion date | September 1, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 55 Years to 85 Years |
Eligibility | Inclusion Criteria: - Persons with age-related MCI or AD according to clinical diagnosis, consistent with National Institute on Aging-Alzheimer's Association (NIA-AA) diagnostic criteria - Community-dwelling controls - Age > 55 years - Have been enrolled and completed at least one visit in the Bio-AD study and consent to access their data (the Rocky Mountain Alzheimer's Disease Center Bio-AD study (clinicaltrials.gov identifier: NCT02612376)) - Have capacity to provide consent; capacity will be assessed at the time of consent - Ability to complete baseline assessments - Has informant (study partner) available to complete functional interviews/survey measures Exclusion Criteria: - Presence of concomitant medical, neurological, or psychiatric illness or condition that in the opinion of the investigators would confound interpretation of study results. These include: - Korsakoff encephalopathy; - active substance abuse; - hepatitis C; - opportunistic brain infection; - brain tumor; - active neoplastic disease (skin tumors other than melanoma are not exclusionary; participants with stable prostate cancer may be included at the discretion of the project director); - multiple sclerosis; - history of clinically significant stroke; - current evidence or history in the past 2 years of - focal brain lesion, - head injury with loss of consciousness in the past year, or - DSM-5 criteria for any major psychiatric disorder, including 1. psychosis, 2. uncontrolled major depression, 3. bipolar disorder, 4. alcohol or substance abuse; 5. blindness, 6. deafness or 7. any other disability which may prevent the participant from participating or cooperating in the protocol. - Prisoners - Any contraindication for MRI |
Country | Name | City | State |
---|---|---|---|
United States | University of Colorado Anschutz Medical Campus | Aurora | Colorado |
Lead Sponsor | Collaborator |
---|---|
University of Colorado, Denver | Alzheimer's Association |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | University of California San Diego (UCSD) Performance-Based Skills Assessment (UPSA) | Measure independent functioning in everyday life for controls and individuals with MCI | 30 minutes | |
Primary | Medication Management Ability Assessment | Measure independent management of medications in controls and individuals with MCI | 15 minutes | |
Primary | Lawton iADL (instrumental activities of daily living) scale | Measure ability to perform instrumental activities of daily living in controls and individuals with MCI | 5 minutes |
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