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

2021년 7월 14일 업데이트: 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.

연구 개요

상태

빼는

상세 설명

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.

연구 유형

중재적

단계

  • 초기 1단계

연락처 및 위치

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

연구 장소

    • New York
      • New York, New York, 미국, 10065
        • Weill Cornell Medicine

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

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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.

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: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Clonidine Pill
0.1 mg by mouth daily at bedtime for one week
0.1 mg by mouth daily at bedtime for one week
다른 이름들:
  • 온드럭

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Number of Adverse Events
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Change in Ventricular CSF Clearance Rates of [11C]Butanol
기간: 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

기타 결과 측정

결과 측정
측정값 설명
기간
Sleep Quality: Duration
기간: 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
기간: 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
기간: 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
기간: 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).

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: P. David Mozley, MD, Weill Medical College of Cornell University

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 (실제)

2019년 8월 27일

기본 완료 (실제)

2021년 5월 24일

연구 완료 (실제)

2021년 5월 24일

연구 등록 날짜

최초 제출

2019년 7월 19일

QC 기준을 충족하는 최초 제출

2019년 7월 22일

처음 게시됨 (실제)

2019년 7월 25일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2021년 7월 20일

QC 기준을 충족하는 마지막 업데이트 제출

2021년 7월 14일

마지막으로 확인됨

2021년 7월 1일

추가 정보

이 연구와 관련된 용어

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

IPD 계획 설명

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 공유 기간

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

IPD 공유 액세스 기준

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

IPD 공유 지원 정보 유형

  • 연구 프로토콜
  • 임상 연구 보고서(CSR)

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

미국 FDA 규제 기기 제품 연구

아니

미국에서 제조되어 미국에서 수출되는 제품

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. .

Clonidine Pill에 대한 임상 시험

구독하다