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

NCT03081546 | Completed

• 1 other identifier: 16-1954
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 1

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).

Conditions

Mild Cognitive Impairment; Healthy Controls

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

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).

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with Mild Cognitive Impairment and healthy aging adults

You may qualify if:

• 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

You may not qualify if:

• 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;
• 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
• psychosis,
• uncontrolled major depression,
• bipolar disorder,

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Alzheimer's Association: collaborator

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Louis Medina, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2017
• First Posted: March 16, 2017
• Study Start: May 4, 2017
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: August 9, 2021

Record last verified: 2021-08

Locations

US (1)