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

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.

Studieöversikt

Status

Indragen

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Fas

  • Tidig fas 1

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • New York
      • New York, New York, Förenta staterna, 10065
        • Weill Cornell Medicine

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Grundläggande vetenskap
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Clonidine Pill
0.1 mg by mouth daily at bedtime for one week
0.1 mg by mouth daily at bedtime for one week
Andra namn:
  • On-Drug

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Number of Adverse Events
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in Ventricular CSF Clearance Rates of [11C]Butanol
Tidsram: 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

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Sleep Quality: Duration
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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).

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

27 augusti 2019

Primärt slutförande (Faktisk)

24 maj 2021

Avslutad studie (Faktisk)

24 maj 2021

Studieregistreringsdatum

Först inskickad

19 juli 2019

Först inskickad som uppfyllde QC-kriterierna

22 juli 2019

Första postat (Faktisk)

25 juli 2019

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

20 juli 2021

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

14 juli 2021

Senast verifierad

1 juli 2021

Mer information

Termer relaterade till denna studie

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

Ja

IPD-planbeskrivning

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.

Tidsram för IPD-delning

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

Kriterier för IPD Sharing Access

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

IPD-delning som stöder informationstyp

  • Studieprotokoll
  • Klinisk studierapport (CSR)

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

produkt tillverkad i och exporterad från U.S.A.

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Kliniska prövningar på Friska volontärer

Kliniska prövningar på Clonidine Pill

3
Prenumerera