Cross-Cultural Use of Performance-Based Functional Assessment in Alzheimer's Disease

Completed

• Conditions: Healthy Controls; Mild Cognitive Impairment

• Registration Number: NCT03081546
• Lead Sponsor: University of Colorado, Denver

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-03-07
• Study First Submitted QC: 2017-03-10
• Study First Posted: 2017-03-16
• Study Start: 2017-05-04
• Primary Completion: 2018-09-01
• Study Completion: 2018-09-01
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-05
• Last Update Posted: 2021-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
University of California San Diego (UCSD) Performance-Based Skills Assessment (UPSA)	30 minutes	Measure independent functioning in everyday life for controls and individuals with MCI
Medication Management Ability Assessment	15 minutes	Measure independent management of medications in controls and individuals with MCI
Lawton iADL (instrumental activities of daily living) scale	5 minutes	Measure ability to perform instrumental activities of daily living in controls and individuals with MCI

Trial Locations

Locations (1)

University of Colorado Anschutz Medical Campus; 🇺🇸 Aurora, Colorado, United States