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AKG and Brain Health in Aging

ConditionsBrain AgingCerebrovascular Function
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age55+
SponsorUniversity of Oklahoma

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Calcium AKG

    Dietary 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 capsules

    Dietary supplement

    identically appearing placebo capsule

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Calcium AKGExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame
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.

Time frame
24 weeks

Secondary outcomes

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.

Time frame
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.

Time frame
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.

Time frame
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.

Time frame
24 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Oklahoma

Lead sponsor

National Institute on Aging (NIA)

Collaborator

Ponce De Leon Health, Inc.

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: