- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07861867
AKG and Brain Health in Aging
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- Phase 2
Contacts et emplacements
Coordonnées de l'étude
- Nom: Andriy Yabluchanskiy, MD, PhD
- Numéro de téléphone: 47097 405-271-8000
- E-mail: andriy-yabluchanskiy@ou.edu
Sauvegarde des contacts de l'étude
- Nom: Juvaria Anjum, MS
- Numéro de téléphone: 47097 405-271-8000
- E-mail: Juvaria-Anjum@ou.edu
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Science basique
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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. |
|
Comparateur placebo: Placebo
Visually identical placebo |
identically appearing placebo capsule |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in neurogliovascular coupling using functional near infrared spectroscopy (fNIRS)
Délai: 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)
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Attention
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Andriy Yabluchanskiy, MD, PhD, University of Oklahoma Harold Hamm Health Campus
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- 19927
- 1R21AG103782 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
unidentified data will be shared via research repositories
Informations sur les médicaments et les dispositifs, documents d'étude
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