Healthy AgingLEANNCT05207397
Lactate for Energy and Neurocognition
An observational study of Healthy Aging and Alzheimer Disease, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
Improved cardiorespiratory fitness following an aerobic exercise program elicits cognitive benefit in elderly subjects and memory improvement in Alzheimer's disease (AD). The physiological mechanism may be related to exercise-mediated change in circulating factors that permeate the brain. Read more about this study
- Who is it for?
- Ages 60 to 95 years
- Conditions the study is for
- Healthy Aging, Alzheimer Disease
- What is being tested?
- Lactate infusion
- Type of treatment
- Injection or infusion
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Apr 2023to 29 Mar 2024
- 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 60 to 95 years
- All sexes
- Adult, Older adult
Study population: The investigator will leverage the KU ADC Outreach and Recruitment (OR) Core, which reaches more than 2000 individuals annually. The OR Core supports and maintains Eligibility Database, which contains demogrpahic and health information for all individuals who contact the ADC or are referred from clinic (n>7000, ~5000 without cognitive complaints). Recruitment will also leverage the ADC Clinical Cohort, which is comprised of 400 individuals who are characterized annually with clinical and cognitive testing.
Who may be able to join
- Age 60 and older
- Stable medication doses (>1month)
- Post-menopausal
- Diagnosis of either Nondemented (CDR 0) or Probable AD (CDR 0.5 or 1 only)
Who cannot join
- Inability to provide consent
- Diagnosis of insulin-dependent (Type 1) Diabetes Mellitus
- Anti-platelet medication (Plavix), Warfarin, and other anticoagulants (Eliquis, Pradaxa, and Xarelto)
- Recent ischemic heart disease (<2 years)
- Diagnosis of a clinically significant chronic disease including CVD, other metabolic diseases (e.g., thyroid), cancer, HIV, or acquired immunodeficiency syndrome
- Any Neurological disorders that have the potential to impair cognition or brain metabolism (e.g., Parkinson's disease, stroke defined as a clinical episode with neuroimaging evidence in an appropriate area to explain the symptoms).
- Clinically significant depressive symptoms that may impair cognition, abnormalities in B12, RPR, or thyroid function that may impair cognition, use of psychoactive and investigational medications, and significant visual or auditory impairment
Trial locations and contacts
1 site in 1 country.
United States1 site
Univeristy of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Improved cardiorespiratory fitness following an aerobic exercise program elicits cognitive benefit in elderly subjects and memory improvement in Alzheimer's disease (AD). The physiological mechanism may be related to exercise-mediated change in circulating factors that permeate the brain. The response to each individual bout of exercise (i.e. the acute exercise response) may differ between subjects and be key to driving brain benefit. In young populations, the acute response to exercise can last hours and affect brain glucose metabolism. However, the field knows little about this acute exercise response in AD. Most exercise intervention trials designed to prevent and slow AD assess biomarkers at two fasting time points: pre- and post-intervention. The acute exercise response in the brain and periphery likely varies between subjects and diagnoses and provide key information regarding mechanisms of benefit. Our primary goals are to characterize the acute exercise response to exercise in the brain (glucose metabolism) and periphery (biomarker response) in aging and AD. We will identify relationships between exercise-related factors (i.e. heart rate, biomarkers) and change in brain metabolism and cognition. Understanding these mechanistic relationships will provide specific targets that can be used in future trials to develop individualized exercise prescriptions and maximize benefit.
Read the detailed description
Alzheimer's disease (AD) is the most common neurodegenerative disease, affecting over 5 million Americans, with this number expected to balloon to nearly 14 million by 2050. Annual health care costs associated with AD exceed 200 billion dollars which has led to the formation National Alzheimer's Project Act (NAPA). Goals of NAPA include the creation of a national plan to overcome AD, development of treatments to prevent, halt, or reverse AD, and improvements in early diagnosis and care of AD patients.
We have shown that an exercise program improves cognitive (primarily executive) function in cognitively healthy subjects in an exercise dose-dependent manner as well as a positive relationship between cardiorespiratory fitness change and memory change in individuals with AD who participate in 6 months of aerobic exercise. However, not all individuals benefit from exercise, and the precise mechanisms by which exercise elicits a beneficial effect are unclear. Most clinical trials, including our own, have been designed to assess metabolic outcomes at two fasting timepoints, before and after the intervention. However, the effects of each acute exercise bout on brain metabolism, and potential mechanisms by which cognition and memory may be affected, remain unclear. Longitudinal observational studies show a relationship between self-reported exercise and cognitive decline, and higher physical activity in midlife and late life is associated with a reduced risk of developing late-onset AD. Furthermore, intervention studies have shown cognitive improvement following exercise in ND and MCI subjects. Cardiorespiratory fitness decline tracks with brain atrophy and progression of dementia severity in AD and hippocampal volume has improved with a physical activity intervention in some studies of older adults. The fact that cardiorespiratory fitness change is important in achieving memory effects in AD is consistent with work that shows a positive relationship between exercise-related cardiorespiratory fitness change and markers of cortical thickness and brain volume in ND, MCI, and AD subjects. It is also consistent with work that shows physical activity and fitness levels are associated with larger brain volume. Cardiorespiratory fitness change is likely driven by the repeated, acute effects of each single, acute exercise bout that is additive over time. These acute effects include changes in peripheral biomarkers that readily cross the blood brain barrier but return to normal within a few hours. However, the effects of acute exercise on the brain are not well understood, especially in aged and AD populations, and at the intensities that are often used in exercise intervention programs. This presents a knowledge gap in the study of the beneficial effects of exercise in aging and dementia populations. One possible mediator of benefit with acute exercise is lactate. Production of lactate from pyruvate generates NAD+, a necessary intermediate for glycolysis. Peripheral lactate is transported to the liver for regeneration of pyruvate via the Cori cycle; however, lactate is transported throughout the entire body, and during physical exercise, lactate provides a key source of energy for muscle and brain. Lactate is used efficiently by the brain even at rest, the investigator hypothesize that lactate is a critical energy source for the brain, and that generation of lactate during acute exercise directly impacts glucose metabolism in the brain. This study will explore the effects of acute exercise on brain glucose metabolism as well as the dynamics of acute exercise biomarkers, including lactate and related substances that may affect brain metabolism.
- Conditions
- Healthy Aging, Alzheimer Disease
- Being tested
- Lactate infusion
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactate infusionOther
The unlabeled lactate infusion cocktail (30% L(+)-lactic acid solution (Sigma) with 2N NaOH, pH4.8) and stable isotope infusions were made by a pharmacy and tested to be sterile and pyrogen free. Upon arriving to the KU Clinical and Translational Science Unit, a catheter will be placed in the subject's hand, which will be placed into a heated hand box for collection of arterialized blood. A second catheter will be placed in the opposing forearm vein for the infusion of lactate isotope solution and unlabeled lactate infusion cocktail. After insertion of the catheters, and prior to isotope infusion, a background blood and breath sample (ParvoMedics TrueOne 2400) will be obtained. We will then administer priming doses of 57.5 mg [13C3]lactate, 250 mg D2-glucose and 136 mg H13CO3- followed by continuous infusions of [13C3]lactate at 10 mg/min and D2-glucose at 2 mg/min [53]. Along with the continuous isotope infusion we will begin infusion of the Na-lact
| Study group | Role | What they receive |
|---|---|---|
| Healthy Control | Lactate clamp: After insertion of the catheters, and prior to isotope infusion, a background blood and breath sample (ParvoMedics TrueOne 2400) will be obtained. The investigator will then administer priming doses of 57.5 mg [13C3]lactate, 250 mg D2-glucose and 136 mg H13CO3- followed by continuous infusions of [13C3]lactate at 10 mg/min and D2-glucose at 2 mg/min. Along with the continuous isotope infusion the investigator will begin infusion of the Na-lactate at approximately 2.6mg/kg·min. Based upon readings from blood samples during the infusion, this rate will be adjusted as needed to maintain the target lactate concentration of approximately 4-5 mM. Blood samples will be drawn at 10, 20, 30, 45, 60, 75, 90 and 120 minutes, while breath samples will be collected at 60, 75, 90 and 120 minutes. Receives: Other: Lactate infusion | |
| Mild Cognitive Impairment | Lactate clamp: After insertion of the catheters, and prior to isotope infusion, a background blood and breath sample (ParvoMedics TrueOne 2400) will be obtained. The investigator will then administer priming doses of 57.5 mg [13C3] lactate, 250 mg D2-glucose and 136 mg H13CO3- followed by continuous infusions of [13C3] lactate at 10 mg/min and D2-glucose at 2 mg/min. Along with the continuous isotope infusion the investigator will begin infusion of the Na-lactate at approximately 2.6mg/kg·min. Based upon readings from blood samples during the infusion, this rate will be adjusted as needed to maintain the target lactate concentration of approximately 4-5 mM. Blood samples will be drawn at 10, 20, 30, 45, 60, 75, 90 and 120 minutes, while breath samples will be collected at 60, 75, 90 and 120 minutes. Receives: Other: Lactate infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic Clearance Rate (MCR)
units of lactate cleared per minute (mg/kg×min)
Measured: 2 hours
Secondary outcomes (1)
Cognitive Performace
Calculate change in global cognition composite score between fasting and lactate-infused states
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study start12 Apr 2023
- Primary completion29 Mar 2024
- Study completion29 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Healthy AgingStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Jill Morris, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05207397
- Sponsor's protocol ID
- STUDY00144303
- Other IDs
- 1R01AG062548
- Acronym
- LEAN
- Status last verified
- May 2025
- First submitted
- 9 Aug 2021
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kemna RE, Kueck PJ, Blankenship AE, John CS, Johnson CN, Green ZD, Chamberlain T, Thyfault JP, Mahnken JD, Miller BF, Morris JK. Methods to characterize lactate turnover in aging and Alzheimer's disease; The LEAN study. Contemp Clin Trials. 2024 Nov;146:107682. doi: 10.1016/j.cct.2024.107682. Epub 2024 Sep 3.
PubMed 39236780Kemna RE, Kueck PJ, Blankenship A, John CS, Johnson CN, Green ZD, Mayfield H, Yoksh L, Johnson L, Thyfault JP, Mahnken JD, Miller BF, Morris JK. Acute effects of lactate infusion on metabolism, AD biomarkers, and cognition: The LEAN study. Alzheimers Dement. 2025 Dec;21(12):e70984. doi: 10.1002/alz.70984.
PubMed 41376120
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lactate for Energy and Neurocognition
- ClinicalTrials.gov ID
- NCT05207397
- Acronym / sponsor ID
- LEAN / STUDY00144303
- Conditions
- Healthy Aging, Alzheimer Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 12 Apr 2023 (actual)
- Primary completion
- 29 Mar 2024 (actual)
- Study completion
- 29 Mar 2024 (actual)
- First posted
- 26 Jan 2022 (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.
Improved cardiorespiratory fitness following an aerobic exercise program elicits cognitive benefit in elderly subjects and memory improvement in Alzheimer's disease (AD). The physiological mechanism may be related to exercise-mediated change in circulating factors that permeate the brain. The response to each individual bout of exercise (i.e. the acute exercise response) may differ between subjects and be key to driving brain benefit. In young populations, the acute response to exercise can last hours and affect brain glucose metabolism. However, the field knows little about this acute exercise response in AD. Most exercise intervention trials designed to prevent and slow AD assess biomarkers at two fasting time points: pre- and post-intervention. The acute exercise response in the brain and periphery likely varies between subjects and diagnoses and provide key information regarding mechanisms of benefit. Our primary goals are to characterize the acute exercise response to exercise in the brain (glucose metabolism) and periphery (biomarker response) in aging and AD. We will identify relationships between exercise-related factors (i.e. heart rate, biomarkers) and change in brain metabolism and cognition. Understanding these mechanistic relationships will provide specific targets that can be used in future trials to develop individualized exercise prescriptions and maximize benefit.
Detailed description
Alzheimer's disease (AD) is the most common neurodegenerative disease, affecting over 5 million Americans, with this number expected to balloon to nearly 14 million by 2050. Annual health care costs associated with AD exceed 200 billion dollars which has led to the formation National Alzheimer's Project Act (NAPA). Goals of NAPA include the creation of a national plan to overcome AD, development of treatments to prevent, halt, or reverse AD, and improvements in early diagnosis and care of AD patients.
We have shown that an exercise program improves cognitive (primarily executive) function in cognitively healthy subjects in an exercise dose-dependent manner as well as a positive relationship between cardiorespiratory fitness change and memory change in individuals with AD who participate in 6 months of aerobic exercise. However, not all individuals benefit from exercise, and the precise mechanisms by which exercise elicits a beneficial effect are unclear. Most clinical trials, including our own, have been designed to assess metabolic outcomes at two fasting timepoints, before and after the intervention. However, the effects of each acute exercise bout on brain metabolism, and potential mechanisms by which cognition and memory may be affected, remain unclear. Longitudinal observational studies show a relationship between self-reported exercise and cognitive decline, and higher physical activity in midlife and late life is associated with a reduced risk of developing late-onset AD. Furthermore, intervention studies have shown cognitive improvement following exercise in ND and MCI subjects. Cardiorespiratory fitness decline tracks with brain atrophy and progression of dementia severity in AD and hippocampal volume has improved with a physical activity intervention in some studies of older adults. The fact that cardiorespiratory fitness change is important in achieving memory effects in AD is consistent with work that shows a positive relationship between exercise-related cardiorespiratory fitness change and markers of cortical thickness and brain volume in ND, MCI, and AD subjects. It is also consistent with work that shows physical activity and fitness levels are associated with larger brain volume. Cardiorespiratory fitness change is likely driven by the repeated, acute effects of each single, acute exercise bout that is additive over time. These acute effects include changes in peripheral biomarkers that readily cross the blood brain barrier but return to normal within a few hours. However, the effects of acute exercise on the brain are not well understood, especially in aged and AD populations, and at the intensities that are often used in exercise intervention programs. This presents a knowledge gap in the study of the beneficial effects of exercise in aging and dementia populations. One possible mediator of benefit with acute exercise is lactate. Production of lactate from pyruvate generates NAD+, a necessary intermediate for glycolysis. Peripheral lactate is transported to the liver for regeneration of pyruvate via the Cori cycle; however, lactate is transported throughout the entire body, and during physical exercise, lactate provides a key source of energy for muscle and brain. Lactate is used efficiently by the brain even at rest, the investigator hypothesize that lactate is a critical energy source for the brain, and that generation of lactate during acute exercise directly impacts glucose metabolism in the brain. This study will explore the effects of acute exercise on brain glucose metabolism as well as the dynamics of acute exercise biomarkers, including lactate and related substances that may affect brain metabolism.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Control | – | Other: Lactate infusionLactate clamp: After insertion of the catheters, and prior to isotope infusion, a background blood and breath sample (ParvoMedics TrueOne 2400) will be obtained. The investigator will then administer priming doses of 57.5 mg [13C3]lactate, 250 mg D2-glucose and 136 mg H13CO3- followed by continuous infusions of [13C3]lactate at 10 mg/min and D2-glucose at 2 mg/min. Along with the continuous isotope infusion the investigator will begin infusion of the Na-lactate at approximately 2.6mg/kg·min. Based upon readings from blood samples during the infusion, this rate will be adjusted as needed to maintain the target lactate concentration of approximately 4-5 mM. Blood samples will be drawn at 10, 20, 30, 45, 60, 75, 90 and 120 minutes, while breath samples will be collected at 60, 75, 90 and 120 minutes. |
| Mild Cognitive Impairment | – | Other: Lactate infusionLactate clamp: After insertion of the catheters, and prior to isotope infusion, a background blood and breath sample (ParvoMedics TrueOne 2400) will be obtained. The investigator will then administer priming doses of 57.5 mg [13C3] lactate, 250 mg D2-glucose and 136 mg H13CO3- followed by continuous infusions of [13C3] lactate at 10 mg/min and D2-glucose at 2 mg/min. Along with the continuous isotope infusion the investigator will begin infusion of the Na-lactate at approximately 2.6mg/kg·min. Based upon readings from blood samples during the infusion, this rate will be adjusted as needed to maintain the target lactate concentration of approximately 4-5 mM. Blood samples will be drawn at 10, 20, 30, 45, 60, 75, 90 and 120 minutes, while breath samples will be collected at 60, 75, 90 and 120 minutes. |
Who may qualify
- Ages
- 60 to 95 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The investigator will leverage the KU ADC Outreach and Recruitment (OR) Core, which reaches more than 2000 individuals annually. The OR Core supports and maintains Eligibility Database, which contains demogrpahic and health information for all individuals who contact the ADC or are referred from clinic (n>7000, ~5000 without cognitive complaints). Recruitment will also leverage the ADC Clinical Cohort, which is comprised of 400 individuals who are characterized annually with clinical and cognitive testing.
Key inclusion criteria (4 listed)
- Age 60 and older
- Stable medication doses (>1month)
- Post-menopausal
- Diagnosis of either Nondemented (CDR 0) or Probable AD (CDR 0.5 or 1 only)
Key exclusion criteria (7 listed)
- Inability to provide consent
- Diagnosis of insulin-dependent (Type 1) Diabetes Mellitus
- Anti-platelet medication (Plavix), Warfarin, and other anticoagulants (Eliquis, Pradaxa, and Xarelto)
- Recent ischemic heart disease (<2 years)
- Diagnosis of a clinically significant chronic disease including CVD, other metabolic diseases (e.g., thyroid), cancer, HIV, or acquired immunodeficiency syndrome
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 |
|---|---|---|
| Lactate infusionThe unlabeled lactate infusion cocktail (30% L(+)-lactic acid solution (Sigma) with 2N NaOH, pH4.8) and stable isotope infusions were made by a pharmacy and tested to be sterile and pyrogen free. Upon arriving to the KU Clinical and Translational Science Unit, a catheter will be placed in the subject's hand, which will be placed into a heated hand box for collection of arterialized blood. A second catheter will be placed in the opposing forearm vein for the infusion of lactate isotope solution and unlabeled lactate infusion cocktail. After insertion of the catheters, and prior to isotope infusion, a background blood and breath sample (ParvoMedics TrueOne 2400) will be obtained. We will then administer priming doses of 57.5 mg [13C3]lactate, 250 mg D2-glucose and 136 mg H13CO3- followed by continuous infusions of [13C3]lactate at 10 mg/min and D2-glucose at 2 mg/min [53]. Along with the continuous isotope infusion we will begin infusion of the Na-lact | Other | Healthy Control, Mild Cognitive Impairment |
Primary outcome
Metabolic Clearance Rate (MCR)
Time frame: 2 hours
units of lactate cleared per minute (mg/kg×min)
1 secondary outcome
Cognitive Performace
Time frame: 2 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 14 May 2025.
- Background: PubMed 39236780Kemna RE, Kueck PJ, Blankenship AE, John CS, Johnson CN, Green ZD, Chamberlain T, Thyfault JP, Mahnken JD, Miller BF, Morris JK. Methods to characterize lactate turnover in aging and Alzheimer's disease; The LEAN study. Contemp Clin Trials. 2024 Nov;146:107682. doi: 10.1016/j.cct.2024.107682. Epub 2024 Sep 3.
- Derived from this study: PubMed 41376120Kemna RE, Kueck PJ, Blankenship A, John CS, Johnson CN, Green ZD, Mayfield H, Yoksh L, Johnson L, Thyfault JP, Mahnken JD, Miller BF, Morris JK. Acute effects of lactate infusion on metabolism, AD biomarkers, and cognition: The LEAN study. Alzheimers Dement. 2025 Dec;21(12):e70984. doi: 10.1002/alz.70984.
- 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.
Jill Morris principal investigator
University of Kansas Medical Center
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 Healthy Aging and Alzheimer Disease, run by University of Kansas Medical Center 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 7 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 14 May 2025. 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?
Metabolic Clearance Rate (MCR) (time frame: 2 hours). 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 NCT05207397, which also lists 2 linked publications.
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 14 May 2025.