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

NCT ID: NCT03081546

Last Updated: 2021-08-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 41 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-05-04
• Study Completion Date: 2018-09-01

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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).

No interventions assigned to this group

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).

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Alzheimer's Association

OTHER

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Louis Medina, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Countries

United States

Other Identifiers

16-1954

Identifier Type: -

Identifier Source: org_study_id