Mild Cognitive ImpairmentNCT03081546
Cross-Cultural Use of Performance-Based Functional Assessment in Alzheimer's Disease
An observational study of Mild Cognitive Impairment and Healthy Controls, run by University of Colorado, Denver at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 55 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment, Healthy Controls
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 4 May 2017to 1 Sep 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants with Mild Cognitive Impairment and healthy aging adults
Who may be able to join
- 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
Who cannot join
- 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;
Show all 22Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
About this study
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
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
University of California San Diego (UCSD) Performance-Based Skills Assessment (UPSA)
Measure independent functioning in everyday life for controls and individuals with MCI
Measured: 30 minutes
Medication Management Ability Assessment
Measure independent management of medications in controls and individuals with MCI
Measured: 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
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2017
- Study start4 May 2017
- Primary completion1 Sep 2018
- Study completion1 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Alzheimer's Association
- Responsible party
- Sponsor
- Investigators
- Louis Medina, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03081546
- Sponsor's protocol ID
- 16-1954
- Status last verified
- Aug 2021
- First submitted
- 7 Mar 2017
- Last updated
- 9 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-Cultural Use of Performance-Based Functional Assessment in Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT03081546
- Acronym / sponsor ID
- 16-1954
- Conditions
- Mild Cognitive Impairment, Healthy Controls
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Alzheimer's Association
- Study start
- 4 May 2017 (actual)
- Primary completion
- 1 Sep 2018 (actual)
- Study completion
- 1 Sep 2018 (actual)
- First posted
- 16 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with Mild Cognitive Impairment and healthy aging adults
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (22 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Medication Management Ability Assessment
Time frame: 15 minutes
Measure independent management of medications in controls and individuals with MCI
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Louis Medina, PhD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mild Cognitive Impairment and Healthy Controls, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
University of California San Diego (UCSD) Performance-Based Skills Assessment (UPSA) (time frame: 30 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2021.