Cognitive FunctionNCT03109561
Apolipoprotein E (ApoE) and Metabolism
An observational study of Cognitive Function and Healthy, run by Lance Johnson at 1 site in United States.
Trial summary
Impaired metabolism and the gene apolipoprotein E (ApoE) are independent risk factors for cognitive impairment and dementia. In humans, there are three major versions of apoE (E): E2, E3, and E4. Some studies suggest that the different versions of apoE have varying effects on whole body and brain metabolism. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cognitive Function, Healthy
- What is being tested?
- Resting State Indirect Calorimetry, ApoE and Metabolism
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Apr 2018to 30 Jan 2020
- 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 18 to 65 years
- All sexes
- Adult, Older adult
Study population: Cognitively normal and are in good overall health.
Who may be able to join
- all races/ethnicities
- ages 18-65
- cognitively normal
- good health
Who cannot join
- pregnant or breastfeeding.
- have a bleeding disorder,
- have a history of stroke, seizures, Parkinson's disease, history of head injury with loss of consciousness, or other dementing disorder.
- have a history of alcoholism or drug abuse
- have a history of schizophrenia or currently suffer from bipolar disorder or major depression.
- have vision or hearing loss severe enough to interfere with cognitive testing
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kentucky Medical Center
Lexington, Kentucky, 40536
About this study
Official title: APOE, Metabolism and Cognitive Function: An Assessment Via Indirect Calorimetry
Impaired metabolism and the gene apolipoprotein E (ApoE) are independent risk factors for cognitive impairment and dementia. In humans, there are three major versions of apoE (E): E2, E3, and E4. Some studies suggest that the different versions of apoE have varying effects on whole body and brain metabolism. The goal of this project is to better understand the relationship between apoE and metabolism. This will help investigators identify new targets for the prevention and treatment of cognitive decline and dementia.
Read the detailed description
The investigator hopes determine whether a participant's version of ApoE affects their metabolic rate at rest and during a cognitive challenge. To determine this, the investigator will measure basal (resting) metabolic rates using a technique called indirect calorimetry (IC). This is accomplished by wearing a loose-fitting face mask that measures oxygen intake and carbon dioxide output.
To more accurately measure the amount of carbohydrates, fats and proteins that the body is metabolizing, participants will be asked to provide two urine samples (one at the beginning, and one at the end, of the study).
To determine what version of ApoE the participant inherited, the investigator will conduct a genetic test on DNA isolated from the participant's blood.
- Conditions
- Cognitive Function, Healthy
- Being tested
- Resting State Indirect Calorimetry, ApoE, Metabolism, Cognitive Challenge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resting State Indirect CalorimetryOther
The investigator will measure the amount of oxygen participants breathe in and the amount of carbon dioxide they breathe out using a portable unit. Participants will be asked wearing a loose-fitting face mask that measures oxygen intake and carbon dioxide output.
ApoEGenetic
The investigator will conduct a genetic test on DNA isolated from from the participants blood. Participants will be asked to provide about 2 tablespoons.
MetabolismDiagnostic test
To more accurately measure the amount of carbohydrates, fats and proteins that the participants bodies metabolize, participants will be asked to provide two urine samples (one at the beginning, and one at the end, of the study). The total amount of urine to be collected is approximately 4 teaspoons.
Cognitive ChallengeOther
Participants will be asked to follow simple instructions that are displayed on computer screen.
What is being measured
The primary outcome is the main question the study is designed to answer.
Indirect Calorimetry
Measure resting state respiratory quotient in cognitively normal participants with various ApoE genotypes
Measured: 4 hours
Secondary outcomes (1)
Respiratory Quotient (RQ)
Measure RQ during a cognitive challenge in cognitively normal individuals with various ApoE genotypes
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2017
- Study start24 Apr 2018
- Primary completion30 Jan 2020
- Study completion30 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive FunctionStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lance Johnson
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lance Johnson, University of Kentucky
- Investigators
- Lance Johnson1, PhD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03109561
- Sponsor's protocol ID
- 17-0202-F1G
- Status last verified
- Jul 2020
- First submitted
- 6 Apr 2017
- Last updated
- 23 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- APOE, Metabolism and Cognitive Function: An Assessment Via Indirect Calorimetry
- ClinicalTrials.gov ID
- NCT03109561
- Acronym / sponsor ID
- 17-0202-F1G
- Conditions
- Cognitive Function, Healthy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Lance JohnsonUniversity, hospital or other
- Study start
- 24 Apr 2018 (actual)
- Primary completion
- 30 Jan 2020 (actual)
- Study completion
- 30 Jan 2020 (actual)
- First posted
- 12 Apr 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.
Impaired metabolism and the gene apolipoprotein E (ApoE) are independent risk factors for cognitive impairment and dementia. In humans, there are three major versions of apoE (E): E2, E3, and E4. Some studies suggest that the different versions of apoE have varying effects on whole body and brain metabolism. The goal of this project is to better understand the relationship between apoE and metabolism. This will help investigators identify new targets for the prevention and treatment of cognitive decline and dementia.
Detailed description
The investigator hopes determine whether a participant's version of ApoE affects their metabolic rate at rest and during a cognitive challenge. To determine this, the investigator will measure basal (resting) metabolic rates using a technique called indirect calorimetry (IC). This is accomplished by wearing a loose-fitting face mask that measures oxygen intake and carbon dioxide output.
To more accurately measure the amount of carbohydrates, fats and proteins that the body is metabolizing, participants will be asked to provide two urine samples (one at the beginning, and one at the end, of the study).
To determine what version of ApoE the participant inherited, the investigator will conduct a genetic test on DNA isolated from the participant's blood.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Cognitively normal and are in good overall health.
Key inclusion criteria (4 listed)
- all races/ethnicities
- ages 18-65
- cognitively normal
- good health
Key exclusion criteria (6 listed)
- pregnant or breastfeeding.
- have a bleeding disorder,
- have a history of stroke, seizures, Parkinson's disease, history of head injury with loss of consciousness, or other dementing disorder.
- have a history of alcoholism or drug abuse
- have a history of schizophrenia or currently suffer from bipolar disorder or major depression.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resting State Indirect CalorimetryThe investigator will measure the amount of oxygen participants breathe in and the amount of carbon dioxide they breathe out using a portable unit. Participants will be asked wearing a loose-fitting face mask that measures oxygen intake and carbon dioxide output. | Other | – |
| ApoEThe investigator will conduct a genetic test on DNA isolated from from the participants blood. Participants will be asked to provide about 2 tablespoons. | Genetic | – |
| MetabolismTo more accurately measure the amount of carbohydrates, fats and proteins that the participants bodies metabolize, participants will be asked to provide two urine samples (one at the beginning, and one at the end, of the study). The total amount of urine to be collected is approximately 4 teaspoons. | Diagnostic test | – |
| Cognitive ChallengeParticipants will be asked to follow simple instructions that are displayed on computer screen. | Other | – |
Primary outcome
Indirect Calorimetry
Time frame: 4 hours
Measure resting state respiratory quotient in cognitively normal participants with various ApoE genotypes
1 secondary outcome
Respiratory Quotient (RQ)
Time frame: 4 hours
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 23 Jul 2020.
- Individual participant dataSharing planned: No
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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.
Lance Johnson1, PhD principal investigator
University of Kentucky
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 Cognitive Function and Healthy, run by Lance Johnson 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 4 inclusion and 6 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 23 Jul 2020. 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?
Indirect Calorimetry (time frame: 4 hours). 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 23 Jul 2020.