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.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
詳細な説明
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.
研究の種類
研究の種類
入学 (推定)
入学
段階
段階
- フェーズ2
連絡先と場所
研究連絡先
研究連絡先
- 名前:Andriy Yabluchanskiy, MD, PhD
- 電話番号:47097 405-271-8000
- メール:andriy-yabluchanskiy@ou.edu
研究連絡先のバックアップ
- 名前:Juvaria Anjum, MS
- 電話番号:47097 405-271-8000
- メール:Juvaria-Anjum@ou.edu
参加基準
適格基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:基礎科学
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:トリプル
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
実験的: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. |
|
プラセボコンパレーター:Placebo
Visually identical placebo |
identically appearing placebo capsule |
この研究は何を測定していますか?
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in neurogliovascular coupling using functional near infrared spectroscopy (fNIRS)
時間枠: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)
時間枠: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
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Attention
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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)
時間枠: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
|
協力者と研究者
協力者
協力者
捜査官
捜査官
- 主任研究者:Andriy Yabluchanskiy, MD, PhD、University of Oklahoma Harold Hamm Health Campus
研究記録日
主要日程の研究
研究開始 (推定)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
最終確認日
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
その他の研究ID番号
- 19927
- 1R21AG103782 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
unidentified data will be shared via research repositories
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。