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PET Study of a2a Agonist Effects on the Ventricular CSF Clearance of [11C]Butanol

2021年7月14日 更新者:Weill Medical College of Cornell University

The Effects of Alpha-2 Adrenergic Receptor Modulation on Rates of Carbon-11 Butanol Clearance From Ventricular Cerebrospinal Fluid

This investigator initiated, pilot study will assess the feasibility of characterizing the effects of an orally administered alpha-2 adrenergic (a2a) agonist, clonidine, on the clearance rates of Carbon-11 butanol from the ventricular cerebrospinal fluid (vCSF) with positron emission tomography (PET) in healthy volunteers.

調査の概要

状態

引きこもった

介入・治療

詳細な説明

This will be an open label pilot study of feasibility in healthy volunteers with no therapeutic intent. Vital signs, electrocardiogram (ECG) parameters, and sleep quality will be measured repeatedly during a one week lead-in period. Then, the ventricular cerebrospinal fluid (vCSF) clearance rates of [11C]butanol will be measured with PET before and after one week of treatment with clonidine, 0.1 mg by mouth daily at bedtime. Safety surveillance will be augmented with home health monitoring devices that are wifi and blue tooth enabled. Surveillance for adverse events related to drug discontinuation will be monitored for one week during a washout period.

Primary Objective: To assess the logistical feasibility and safety of treating normotensive adults with clonidine and monitoring its effects with home health devices. The primary outcome measure will be the number of adverse events (AEs) or serious adverse events (SAEs). Other measures will include changes in sleep quality, vital signs and ECG parameters, such as the PR and corrected QT intervals.

Secondary Objectives: To estimate drug-induced changes in vCSF clearance rates of butanol with PET scans acquired before and after treatment as a function of steady-state plasma levels of clonidine.

研究の種類

介入

段階

  • 初期フェーズ 1

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • New York
      • New York、New York、アメリカ、10065
        • Weill Cornell Medicine

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

Inclusion Criteria:

  • Able to give informed consent. No vulnerable populations.
  • Age 18-to-89 years old
  • Mini-Mental Status Examination of ≥ 28
  • Confirmed by the screening procedures to still be reasonably healthy and, in the opinion of the investigators, likely to tolerate the imaging procedures. For example, patients with chronic low back pain might not be able to lie still for very long.
  • Confirmed by the screening procedures to have normal hemodynamic function. Systolic blood pressure and pulse must be higher than 120 mmHg and 60 beats per minute (bpm) while sitting. At the discretion of the investigators, athletic people who engage in vigorous exercise of one hour or more at least four times per week may be enrolled if their systolic blood pressure and pulse are higher than 100 mmHg and 50 beats per minute while sitting.
  • Unremarkable electrocardiograms with PR intervals of less than 200 mSec and QT interval corrected with Frederica's method (QTcF) of less than 440 mSec.
  • Willing and able to refrain from abusing any recreational drugs, including marijuana because of its sleep effects, and drink less than one unit of alcoholic beverages per day starting one week prior to the lead-in period, and avoided for the next three weeks while on study (the one week lead-in period, one week on drug period, and one week washout period).
  • Willing to refrain from donating blood during the month of study (because of its potential effect of quickening pulse).
  • Willing to refrain from participating in any other research study that requires taking medication during the month of study.
  • Willing to refrain from being vaccinated during the month of study.
  • Have not participated in research with exposure to ionizing radiation that would result in approaching the exposure limits for healthy volunteers described in the Code of Federal Regulations, Title 21 Part 361.1 (21CFR361.1)

Exclusion Criteria:

  • History of allergy to clonidine.
  • History of multiple hypersensitivity reactions, as indicated by allergies to multiple medications, foods, and seasonal pollens.
  • History or physical examination suggestive of a condition, disorder, or disease that could represent a contra-indication to taking an antihypertensive. The relative contraindications to clonidine listed in the package insert under the section on precautions will be exclusionary in this study. They include subjects with coronary artery insufficiency syndromes, histories of myocardial infarction, cardiac conduction abnormalities, cerebrovascular disease, and chronic renal failure.
  • Women who are pregnant or breast feeding will not be eligible to participate in the study, as clonidine is classified as a Class C risk to a fetus. (In fact, there is a safety signal in pregnant animal models that justifies exclusion, even if the signal is weak.)
  • History, physical examination or clinical laboratory test result suggestive of a condition, disorder, or disease that could affect the adsorption, distribution, metabolism or excretion of clonidine, including an alcohol abuse or dependence disorder.
  • Positive urine toxicology screen for drugs other than cannabis.
  • Subjects may not be a member of a vulnerable population.
  • May not have donated blood in the 30 days prior to the start of the lead-in period.
  • May not have participated in research administering drugs in the last 30 days.
  • May not have been vaccinated in the 30 days prior to the start of the lead-in period.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

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:なし
  • 介入モデル:単一グループの割り当て
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
実験的:Clonidine Pill
0.1 mg by mouth daily at bedtime for one week
0.1 mg by mouth daily at bedtime for one week
他の名前:
  • オンドラッグ

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Number of Adverse Events
時間枠:one week on drug
Clinically significant changes in hemodynamic function, including vital signs (VSs) and ECG parameters, will be classified as adverse events.
one week on drug

二次結果の測定

結果測定
メジャーの説明
時間枠
Change in Ventricular CSF Clearance Rates of [11C]Butanol
時間枠:after one week on drug compared to drug free baseline rates
The rate of change in the concentration of radioactivity as a function of time before drug treatment compared to after drug treatment.
after one week on drug compared to drug free baseline rates

その他の成果指標

結果測定
メジャーの説明
時間枠
Sleep Quality: Duration
時間枠:Average of one week before drug compared to one week on drug, and one week after drug.
Time interval between falling asleep and waking up as estimated with a wearable sleep tracker.
Average of one week before drug compared to one week on drug, and one week after drug.
Sleep Quality: Time in Deep Sleep
時間枠:Average of one week before drug compared to one week on drug, and one week after drug.
Sum of time intervals classified as representing deep sleep by a wearable sleep tracker.
Average of one week before drug compared to one week on drug, and one week after drug.
Sleep Quality: number of nocturnal awakenings
時間枠:Average of one week before drug compared to one week on drug, and one week after drug.
Number of times that nocturnal activity is classified as an awakening by a wearable sleep tracker.
Average of one week before drug compared to one week on drug, and one week after drug.
Sleep Quality: Subjective Self Rating of Quality
時間枠:Component and global scale scores on Day 1 (before drug) compared to score on Day 2 (after first dose of drug), Day 8 (after one week on drug) and Day 16 (after one week of washout).
Score on each component and the "global" sum of subscale scores on the Pittsburgh Sleep Quality Index (PSQI), where the range of scores on the seven components varies from 0 (good sleep) through 3 (bad sleep).
Component and global scale scores on Day 1 (before drug) compared to score on Day 2 (after first dose of drug), Day 8 (after one week on drug) and Day 16 (after one week of washout).

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

捜査官

  • 主任研究者:P. David Mozley, MD、Weill Medical College of Cornell University

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2019年8月27日

一次修了 (実際)

2021年5月24日

研究の完了 (実際)

2021年5月24日

試験登録日

最初に提出

2019年7月19日

QC基準を満たした最初の提出物

2019年7月22日

最初の投稿 (実際)

2019年7月25日

学習記録の更新

投稿された最後の更新 (実際)

2021年7月20日

QC基準を満たした最後の更新が送信されました

2021年7月14日

最終確認日

2021年7月1日

詳しくは

本研究に関する用語

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?

はい

IPD プランの説明

The safety data will be shared. Data will be from the lead-in period, the on-drug period, and the washout period. Safety data include vital signs, electrocardiogram parameters, and quality of sleep measures.

IPD 共有時間枠

Available at end of study (anticipated date = 31 Dec 2020) for up to five years.

IPD 共有アクセス基準

All investigators who provide a brief statement expressing a scientific interest.

IPD 共有サポート情報タイプ

  • 研究プロトコル
  • 臨床試験報告書(CSR)

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

はい

米国FDA規制機器製品の研究

いいえ

米国で製造され、米国から輸出された製品。

いいえ

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。

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