AgingNCT05652140

Cardiorespiratory Fitness, Apolipoprotein E Genotype, and Cognitive Functions: A Prospective Study

An observational study of Aging and Cognitive Change, run by National Taiwan Normal University at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The current research project aims to investigate the interaction of cardiorespiratory fitness (CRF) and the ApoE genotype with neurocognitive functions. Read more about this study

Who is it for?: Ages 50 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Aging, Cognitive Change
What is being tested?: Data collections
How many people: 159 participants
Where: 1 siteTaiwan
Study dates: 1 Jul 2018to 1 May 2021
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 50 to 70 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Study population: Cognitively healthy late-middle-aged older adults recruited from the northern part of Taiwan.

Who may be able to join

right handed
no history of cardiorespiratory disease
normal or corrected-to-normal vision based on the 20/20 standard
no risk of performing physical activities, as measured by the Physical Activity Readiness Questionnaire

Who cannot join

the scores of Mini-Mental Status Examination (MMSE) < 25 and cognitively intact upon study entry
history of psychiatric or neurological diseases
color-blindness

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

Department of Physical Education and Sport Sciences, National Taiwan Normal University
Taipei, 106308

Other trials in Taiwan

About this study

Official title: Cardiorespiratory Fitness and the Apolipoprotein E (ApoE) Genotype and Its Interaction With Cognitive Functions and Cognitive Decline in Late-Middle-Aged Older Adults: A Prospective Study

The current research project aims to investigate the interaction of cardiorespiratory fitness (CRF) and the ApoE genotype with neurocognitive functions.

Read the detailed description

The current research project aims to investigate the interaction of cardiorespiratory fitness (CRF) and the ApoE genotype with neurocognitive functions. The three main purposes of the current research project seek to achieve:

An exploration of the associations of, as well as the interactions between, CRF assessed at the Baseline Stage, and the ApoE genotype, along with cognitive functions in cognitively healthy late-middle-aged older adults.
The employing of an event-related potential (ERP) to investigate the associations between the baseline CRF, the ApoE genotype, and cognitive functions in cognitively healthy late-middle-aged older adults, as well as the potential underlying neuroelectrical mechanisms.
An investigation of the interactions between the changes of CRFs assessed at the Baseline and the Follow-Up Stages and the ApoE genotype in relation to neurocognitive function, as well as the underlying neuroelectrical mechanisms, in cognitively healthy late-middle-aged older adults.

Conditions: Aging, Cognitive Change
Being tested: Data collections
Keywords: physical fitness, Apolipoprotein E, event-related potential

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Data collectionsOther
Data collections of cognitive function, neuroelectrical activities, ApoE genotype, and physical fitness.

Study groups in NCT05652140
Study group	Role	What they receive
High-Risk with increased CRF		ApoE e4 carriers with increased CRF from Baseline to the Follow-Up Stages. Receives: Other: Data collections
High-Risk with decreased CRF		ApoE e4 carriers with decreased CRF from Baseline to the Follow-Up Stages. Receives: Other: Data collections
Low-Risk with increased CRF		Non-ApoE e4 carriers with increased CRF from Baseline to the Follow-Up Stages. Receives: Other: Data collections
Low-Risk with decreased CRF		Non-ApoE e4 carriers with decreased CRF from Baseline to the Follow-Up Stages. Receives: Other: Data collections

What is being measured

The primary outcome is the main question the study is designed to answer.

Changes in Inhibitory Performance: Stroop Task
Inhibitory performance was assessed using the computerized Stroop task at the Baseline and at the Follow-Up assessments. The difference in response time (RT) between the Baseline and the Follow-Up Stages was calculated as the index of the inhibitory performance.
Measured: 30 minutes each at the Baseline and the Follow-Up visit at Month 18
Changes in Neuroelectrical Activities
The neuroelectrical activities (P3 component) during the Stroop task were recorded and analyzed using the Neuroscan system. The difference in P3 amplitudes of incongruent trials between the Baseline and the Follow-Up Stages was calculated as the index of the neuroelectrical index.
Measured: 30 minutes each at the Baseline and the Follow-Up visit at Month 18

Secondary outcomes (2)

Number of Participants for Whom ApoE Genotype Was Determined
Participants' ApoE genotype was determined based on the genetic biomarkers (rs429358 and rs7412)
Measured: 5 minutes at the Baseline Stage.
Physical Fitness Measurements: Changes in Aerobic Fitness
Participants' aerobic fitness was estimated using the submaximal cycle ergometer test at the baseline and at the follow-up assessments. The difference in maximum oxygen consumption (VO2 max) between the Baseline and the Follow-Up Stages was calculated as the index of aerobic fitness.
Measured: 30 minutes each at the Baseline and the Follow-Up visit at Month 18

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jul 20181 May 2021

First posted15 Dec 2022
Study start1 Jul 2018
Primary completion1 Apr 2021
Study completion1 May 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for AgingStudies 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: 159 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05652140
Sponsor's protocol ID: PACNL_APOE_PROSPECTIVE
Status last verified: Nov 2024
First submitted: 7 Dec 2022
Last updated: 15 Nov 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Aging trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Cardiorespiratory Fitness and the Apolipoprotein E (ApoE) Genotype and Its Interaction With Cognitive Functions and Cognitive Decline in Late-Middle-Aged Older Adults: A Prospective Study
ClinicalTrials.gov ID: NCT05652140
Acronym / sponsor ID: PACNL_APOE_PROSPECTIVE
Conditions: Aging, Cognitive Change
Keywords: physical fitness, Apolipoprotein E, event-related potential
Study type: Observational
Recruitment status: Completed
Enrolment: 159 participants (actual)
Lead sponsor: National Taiwan Normal UniversityUniversity, hospital or other
Study start: 1 Jul 2018 (actual)
Primary completion: 1 Apr 2021 (actual)
Study completion: 1 May 2021 (actual)
First posted: 15 Dec 2022 (actual)
Results: Posted 19 Aug 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The current research project aims to investigate the interaction of cardiorespiratory fitness (CRF) and the ApoE genotype with neurocognitive functions.

Detailed description

An exploration of the associations of, as well as the interactions between, CRF assessed at the Baseline Stage, and the ApoE genotype, along with cognitive functions in cognitively healthy late-middle-aged older adults.
The employing of an event-related potential (ERP) to investigate the associations between the baseline CRF, the ApoE genotype, and cognitive functions in cognitively healthy late-middle-aged older adults, as well as the potential underlying neuroelectrical mechanisms.
An investigation of the interactions between the changes of CRFs assessed at the Baseline and the Follow-Up Stages and the ApoE genotype in relation to neurocognitive function, as well as the underlying neuroelectrical mechanisms, in cognitively healthy late-middle-aged older adults.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 4

Arm	Type	Receives
High-Risk with increased CRF	–	Other: Data collectionsApoE e4 carriers with increased CRF from Baseline to the Follow-Up Stages.
High-Risk with decreased CRF	–	Other: Data collectionsApoE e4 carriers with decreased CRF from Baseline to the Follow-Up Stages.
Low-Risk with increased CRF	–	Other: Data collectionsNon-ApoE e4 carriers with increased CRF from Baseline to the Follow-Up Stages.
Low-Risk with decreased CRF	–	Other: Data collectionsNon-ApoE e4 carriers with decreased CRF from Baseline to the Follow-Up Stages.

Who may qualify

Ages: 50 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: Cognitively healthy late-middle-aged older adults recruited from the northern part of Taiwan.

Key inclusion criteria (4 listed)

right handed
no history of cardiorespiratory disease
normal or corrected-to-normal vision based on the 20/20 standard
no risk of performing physical activities, as measured by the Physical Activity Readiness Questionnaire

Key exclusion criteria (3 listed)

the scores of Mini-Mental Status Examination (MMSE) < 25 and cognitively intact upon study entry
history of psychiatric or neurological diseases
color-blindness

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
Data collectionsData collections of cognitive function, neuroelectrical activities, ApoE genotype, and physical fitness.	Other	High-Risk with decreased CRF, High-Risk with increased CRF, Low-Risk with decreased CRF, Low-Risk with increased CRF

Primary outcome

Changes in Inhibitory Performance: Stroop Task
Time frame: 30 minutes each at the Baseline and the Follow-Up visit at Month 18
Inhibitory performance was assessed using the computerized Stroop task at the Baseline and at the Follow-Up assessments. The difference in response time (RT) between the Baseline and the Follow-Up Stages was calculated as the index of the inhibitory performance.
Changes in Neuroelectrical Activities
Time frame: 30 minutes each at the Baseline and the Follow-Up visit at Month 18
The neuroelectrical activities (P3 component) during the Stroop task were recorded and analyzed using the Neuroscan system. The difference in P3 amplitudes of incongruent trials between the Baseline and the Follow-Up Stages was calculated as the index of the neuroelectrical index.

2 secondary outcomes

Number of Participants for Whom ApoE Genotype Was Determined
Time frame: 5 minutes at the Baseline Stage.
Physical Fitness Measurements: Changes in Aerobic Fitness
Time frame: 30 minutes each at the Baseline and the Follow-Up visit at Month 18

Results and safety

Results posted to the registry on 19 Aug 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
High-Risk With Decreased CRF	22	15
High-Risk With Increased CRF	21	5
Low-Risk With Decreased CRF	57	35
Low-Risk With Increased CRF	59	28

Primary outcome: Changes in Inhibitory Performance: Stroop Task

Time frame: 30 minutes each at the Baseline and the Follow-Up visit at Month 18. Mean (Standard Error). Unit: ms

Measure	High-Risk With Decreased CRF n = 15	High-Risk With Increased CRF n = 5	Low-Risk With Decreased CRF n = 35	Low-Risk With Increased CRF n = 28
Value	1.66 (13.30)	-29.85 (3.21)	21.49 (8.75)	-20.13 (9.78)

Primary outcome: Changes in Neuroelectrical Activities

Time frame: 30 minutes each at the Baseline and the Follow-Up visit at Month 18. Mean (Standard Error). Unit: microvolt

Measure	High-Risk With Decreased CRF n = 15	High-Risk With Increased CRF n = 5	Low-Risk With Decreased CRF n = 35	Low-Risk With Increased CRF n = 28
Value	-1.80 (0.90)	2.81 (1.76)	-1.20 (0.61)	0.57 (0.67)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 2.5 years.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
High-Risk With Increased CRF	0 of 22 (0%)	0 of 22 (0%)	0 of 22
High-Risk With Decreased CRF	0 of 21 (0%)	0 of 21 (0%)	0 of 21
Low-Risk With Increased CRF	0 of 57 (0%)	0 of 57 (0%)	0 of 57
Low-Risk With Decreased CRF	0 of 59 (0%)	0 of 59 (0%)	0 of 59

Limitations and caveats (from the sponsor): Due to the substantial overlapping of the study period with the COVID-19 pandemic, a larger-than-expected number of participants withdrew following the completion of the baseline stage.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Yu-Kai Chang, Ph.D. study director

Department of Physical Education and Sport Sciences, National Taiwan Normal University

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 Aging and Cognitive Change, run by National Taiwan Normal University at 1 site in Taiwan.

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 3 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 15 Nov 2024. 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 Taiwan. 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?

Yes. Results are posted in the registry (first posted 19 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Changes in Inhibitory Performance: Stroop Task (time frame: 30 minutes each at the Baseline and the Follow-Up visit at Month 18). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05652140.

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 15 Nov 2024.