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AKG and Brain Health in Aging

2026년 10월 2일 업데이트: University of Oklahoma

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.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

60

단계

  • 2 단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

55년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

예

연구 대상 성별

모두

설명

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 기초 과학
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 삼루타

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Calcium AKG

1 g of calcium-bound AKG daily

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.

위약 비교기: Placebo

Visually identical placebo

identically appearing placebo capsule

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change in neurogliovascular coupling using functional near infrared spectroscopy (fNIRS)
기간: 24 weeks

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.

24 weeks
Change in neurovascular coupling using electroencephalography (EEG)
기간: 24 weeks

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.

24 weeks

2차 결과 측정

결과 측정
측정값 설명
기간
Change in Attention
기간: 24 weeks

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.

24 weeks
Change in Working Memory
기간: 24 weeks

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.

24 weeks
Change in Executive Function
기간: 24 weeks

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.

24 weeks
Change in Processing Speed
기간: 24 weeks

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.

24 weeks
Change in Episodic Memory
기간: 24 weeks

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.

24 weeks
Body composition
기간: 24 weeks

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

24 weeks
Change in Language
기간: 24 weeks

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.

24 weeks
Self-reported cognitive function
기간: 24 weeks

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.

24 weeks
Change in blood metabolic panel markers
기간: 24 weeks

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

24 weeks
Physical activity
기간: 24 weeks

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.

24 weeks
Sleep quality
기간: 24 weeks

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.

24 weeks
Global Rating of Change (GRC)
기간: at final visit

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?"

at final visit

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

협력자

수사관

  • 수석 연구원: Andriy Yabluchanskiy, MD, PhD, University of Oklahoma Harold Hamm Health Campus

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2027년 2월 1일

기본 완료 (추정된)

2029년 8월 31일

연구 완료 (추정된)

2029년 8월 31일

연구 등록 날짜

최초 제출

2026년 9월 25일

QC 기준을 충족하는 최초 제출

2026년 10월 2일

처음 게시됨 (실제)

2026년 10월 6일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 10월 6일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 10월 2일

마지막으로 확인됨

2026년 10월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • 19927
  • 1R21AG103782 (미국 NIH 보조금/계약)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

unidentified data will be shared via research repositories

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .