Clinical trial NCT03081546: Cross-Cultural Use of Performance-Based Functional Assessment in Alzheimer's Disease
Official title: Cross-Cultural Use of Performance-Based Functional Assessment in Alzheimer's Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mild Cognitive Impairment
Healthy Controls
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Alzheimer's Association
First posted: 2017-03-16
Enrollment: 41
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with Mild Cognitive Impairment and healthy aging adults

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).


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

Primary outcomes:
measure: University of California San Diego (UCSD) Performance-Based Skills Assessment (UPSA)
timeFrame: 30 minutes
measure: Medication Management Ability Assessment
timeFrame: 15 minutes
measure: Lawton iADL (instrumental activities of daily living) scale
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Louis Medina, PhD
role: PRINCIPAL_INVESTIGATOR
References: