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

Mild Cognitive Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03081546
• Other study ID #: 16-1954
• Status: Completed
• Start date: May 4, 2017
• Est. completion date: September 1, 2018

Study information

• Verified date: August 2021
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Dysfunction
• Healthy Controls
• Mild Cognitive Impairment

Locations

Country	Name	City	State
United States	University of Colorado Anschutz Medical Campus	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	Alzheimer's Association

Country where clinical trial is conducted

United States, 

Outcome

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