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

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).

Study Overview

• Status: Completed
• Conditions: Mild Cognitive Impairment; Healthy Controls

• Study Type: Observational
• Enrollment (Actual): 41

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Anschutz Medical Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants with Mild Cognitive Impairment and healthy aging adults

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Mild Cognitive Impairment (MCI); Persons with age-related Mild Cognitive Impairment (MCI) according to clinical diagnosis, consistent with Alzheimer's Association (AA) and the National Institute on Aging (NIA) diagnostic criteria. Must be concurrently enrolled in the Rocky Mountain Alzheimer's Disease Center Bio-AD study (clinicaltrials.gov identifier: NCT02612376).
Healthy Controls; Community dwelling controls older than 55 years of age that are concurrently enrolled in the Rocky Mountain Alzheimer's Disease Center Bio-AD study (clinicaltrials.gov identifier: NCT02612376).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Medication Management Ability Assessment	Measure independent management of medications in controls and individuals with MCI	15 minutes
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

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: Alzheimer's Association
• Investigators: Principal Investigator: Louis Medina, PhD, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): May 4, 2017
• Primary Completion (Actual): September 1, 2018
• Study Completion (Actual): September 1, 2018

Study Registration Dates

• First Submitted: March 7, 2017
• First Submitted That Met QC Criteria: March 10, 2017
• First Posted (Actual): March 16, 2017

Study Record Updates

• Last Update Posted (Actual): August 9, 2021
• Last Update Submitted That Met QC Criteria: August 5, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Cognition Disorders; Alzheimer Disease; Cognitive Dysfunction
• Other Study ID Numbers: 16-1954

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No