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Brain AgingPhase 2NCT07861867

AKG and Brain Health in Aging

A Phase 2 study testing Calcium AKG in people with Brain Aging and Cerebrovascular Function, run by University of Oklahoma.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This proposal will test the hypothesis that AKG supplementation will improve NGVC responses and cognitive performance in older adults. We will also test the hypothesis that these effects are mediated by a decrease in age-related oxidative stress within NGVU cells. Read more about this study

Who is it for?
Ages 55 years and olderHealthy volunteers can take part
Conditions the study is for
Brain Aging, Cerebrovascular Function
What is being tested?
Calcium AKG
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
No sites listed yet
Study dates
1 Feb 2027to 31 Aug 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age ≥55 years
  • Adequate hearing and visual acuity to participate in the examinations (with or without aids)
  • Ability to read and write in English
  • Competence to provide informed consent
  • Montreal Cognitive Assessment score ≥26
  • Stable medications for ≥3 months

Who cannot join

  • Vision or hearing impairment that would impair the ability to complete study assessments
  • Active CNS disease including multiple sclerosis, uncontrolled seizures, active brain cancer
  • Cerebrovascular accident other than TIA within 60 days prior to Visit 0
  • Major psychiatric disease, including major depression not currently controlled and alcohol or drug abuse
  • Abnormal kidney function (creatinine >2mg/dL or EGFR <30mL/min) by most recent labs within 6 months prior to Visit 0
  • Elevated liver enzymes (AST and/or ALT above x2 upper limit of normal) by most recent labs within 6 months prior to Visit 0
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  • Elevated blood calcium level (above 10.3 mg/dL) by most recent labs within 6 months prior to Visit 0
  • History of kidney stones
  • Any other medical condition which, in the opinion of investigator, would render the patient inappropriate or too unstable to complete the study protocol
  • Current use of AKG or NAD+ supplements

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Andriy Yabluchanskiy, MD, PhD contact

405-271-8000 ext. 47097

andriy-yabluchanskiy@ou.edu

About this study

Official title: Alpha-Ketoglutarate: A Novel Therapeutic Strategy to Improve Neurogliovascular Coupling and Cognitive Aging in Older Adults

This proposal will test the hypothesis that AKG supplementation will improve NGVC responses and cognitive performance in older adults. We will also test the hypothesis that these effects are mediated by a decrease in age-related oxidative stress within NGVU cells.

Read the detailed description

These hypotheses will be tested in a randomized, double-blind, placebo-controlled clinical trial with 24 weeks of AKG supplementation in community dwelling older adults. Our team has the relevant expertise in clinical trials with older adults, NGVC assessments, and EVs analysis, providing a high degree of confidence for the successful completion of this project within the award time frame.

Being tested
Calcium AKG, Oral placebo capsules
Keywords
Aging, cerebrovascular health, brain health, AKG, alphaketoglutarate

What participants receive

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

  • Calcium AKGDietary supplement

    Participants will be randomized to receive either oral Calcium AKG at a total daily dose of 1 g or an identically appearing placebo for 24 weeks.

  • Oral placebo capsulesDietary supplement

    identically appearing placebo capsule

Study groups in NCT07861867
Study groupRoleWhat they receive
Calcium AKGExperimental1 g of calcium-bound AKG daily
Receives: Dietary Supplement: Calcium AKG
PlaceboPlacebo comparatorVisually identical placebo
Receives: Dietary Supplement: Oral placebo capsules

What is being measured

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

  1. Change in neurogliovascular coupling using functional near infrared spectroscopy (fNIRS)

    Functional near infrared spectroscopy (fNIRS) will be performed during the cognitive n-back task. fNIRS approach generates data that represent a relative change in oxygenated and deoxygenated hemoglobin measured over the cortical brain tissues. Neurogliovascular coupling will be evaluated as a change in oxy- and deoxy-hemoglobin between before and after treatment. Units of measure - beta. Reported as a %change from baseline, before and after treatment.

    Measured: 24 weeks

  2. Change in neurovascular coupling using electroencephalography (EEG)

    EEG signal will be collected to generate spectral data. These data will be used for comparison of EEG activity between before and after treatment. Units of measure - power spectral density. Reported as a %change from baseline, before and after treatment.

    Measured: 24 weeks

Secondary outcomes (12)
  1. Change in Attention

    The allocation of one's limited capacities to deal with an abundance of environmental stimulation will be measured in a combined "Flanker Inhibitory Control and Attention Test".Units of measure - score (from 0 to 10, bigger number is better). Reported as a %change from baseline.

    Measured: 24 weeks

  2. Change in Working Memory

    The ability to store information until the amount of information to be stored exceeds one's capacity to hold that information will be measured using the "List Sorting Working Memory Test". Unit of measure - overall score (bigger number is better). Reported as a %change from baseline.

    Measured: 24 weeks

  3. Change in Executive Function

    The capacity to plan, organize and monitor the executive of behaviors that are strategically directed in a goal-oriented manner will be measured using the "Dimensional Change Card Sort Test". Units of measure - score (from 0 to 10, bigger number is better). Reported as a %change from baseline.

    Measured: 24 weeks

  4. Change in Processing Speed

    Pattern Comparison Processing Speed Test assesses the amount of information that can be processed within a certain unit of time. Items are simple so as to purely measure processing speed. Units of measure - score (from 0 to 130, bigger number is better). Reported as a %change from baseline.

    Measured: 24 weeks

  5. Change in Episodic Memory

    Cognitive processes involved in the acquisition, storage and retrieval of new information, will be measured using the "Picture Sequence Memory Test". Unit of measure - overall score (bigger number is better). Reported as a %change from baseline.

    Measured: 24 weeks

  6. Body composition

    Weight and body composition using a bioimpedance scale and/or DXA scan. Reported as a %change from baseline, before and after completion of study

    Measured: 24 weeks

  7. Change in Language

    Picture Vocabulary Test measures receptive vocabulary administered in a computer-adaptive test (CAT) format. Respondents select the picture that most closely matches the meaning of the word, before and after treatment. Unit of measure - overall score (bigger number is better). Reported as a %change from baseline.

    Measured: 24 weeks

  8. Self-reported cognitive function

    Self-reported cognitive function will be assessed using the PROMIS Short Form v2.0 Cognitive Function 4a, which measures participants' perceived cognitive abilities and difficulties in daily life.

    Measured: 24 weeks

  9. Change in blood metabolic panel markers

    Complete metabolic panel (General Chemistry 13 Panel and Lipid Panel from Piccolo Xpress). Reported as a %change from baseline, before and after completion of study

    Measured: 24 weeks

  10. Physical activity

    We will assess physical activity and classify it as sedentary, lightly active, active, or very active using the self-administered CHAMPS (Community Health Activities Model Program for Seniors) activities questionnaire. Outcome scores will be assessed using the weekly frequency of physical activity and calculated based on the standardized 6-point categorical duration scale, where scores range from a minimum of 0 hours per week (indicating complete inactivity) to an open-ended maximum number of hours. Higher scores indicate a better outcome, representing very active.

    Measured: 24 weeks

  11. Sleep quality

    Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), which evaluates variables including "duration of sleep", "sleep disturbance", "sleep latency", "daytime dysfunction due to sleepiness", "sleep efficiency", "overall sleep quality", and "need meds to sleep". All variables will be scored from a minimum score of 0 (better) to a maximum score of 3 (worse) based on the answers in the questionnaire, to obtain a total score ranging from 0 to 21, with the total score ≤ 5 associated with good sleep quality, and > 5 associated with poor sleep quality.

    Measured: 24 weeks

  12. Global Rating of Change (GRC)

    After 24 weeks of the intervention, participants will complete the Global Rating of Change (GRC) to report whether they perceive any overall change following the study supplement or placebo. The GRC scale quantifies a patient's change in health status over time. We will utilize an 11-point Likert scale from -5 (very much worse) to +5 (very much improved), including 0 (unchanged), as the rating scale. Participants will be asked to rate their change based on one question: (1) "With respect to your cognition (thinking, attention, concentration, memory), how would you describe yourself now compared to the baseline that is starting treatment 24 weeks ago?"

    Measured: at final visit

Timeline

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

  1. First posted6 Oct 2026
  2. Study start1 Feb 2027 (estimated)
  3. Primary completion31 Aug 2029 (estimated)
  4. Study completion31 Aug 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized, double-blinded, placebo-controlled, parallel study design
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07861867
Sponsor's protocol ID
19927
Other IDs
1R21AG103782
Status last verified
Oct 2026
First submitted
25 Sep 2026
Last updated
6 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: unidentified data will be shared via research repositories

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Calcium AKG in people with Brain Aging and Cerebrovascular Function, run by University of Oklahoma.

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 6 inclusion and 10 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: opening soon, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Andriy Yabluchanskiy, MD, PhD (405-271-8000 ext. 47097, andriy-yabluchanskiy@ou.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in neurogliovascular coupling using functional near infrared spectroscopy (fNIRS) (time frame: 24 weeks). 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?
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 6 Oct 2026.

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