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Completed

NCT Number: NCT03081546

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).

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Key information

Age range

55 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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
  • psychosis,
  • uncontrolled major depression,
  • bipolar disorder,
  • alcohol or substance abuse;
  • blindness,
  • deafness or
  • any other disability which may prevent the participant from participating or cooperating in the protocol.
  • Prisoners
  • Any contraindication for MRI

Treatment and study plan

Primary outcomes

  1. University of California San Diego (UCSD) Performance-Based Skills Assessment (UPSA)

    Time frame: 30 minutes

    Measure independent functioning in everyday life for controls and individuals with MCI

  2. Medication Management Ability Assessment

    Time frame: 15 minutes

    Measure independent management of medications in controls and individuals with MCI

  3. Lawton iADL (instrumental activities of daily living) scale

    Time frame: 5 minutes

    Measure ability to perform instrumental activities of daily living in controls and individuals with MCI

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • Alzheimer's Association

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 16, 2017
Registry last updated
Aug 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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