Skip to main content
OpenTrials
Completed

NCT Number: NCT01379001

Assessment of Cholinergic and Cognitive Function Using Pharmacologic ASL-Perfusion MRI

This research study will look at how medications affect the pattern of blood flow in the brain. This study will use a special type of MRI (magnetic resonance imaging) scan called perfusion MRI to make measurements of cerebral (brain) blood flow. The medications we will use in this study are scopolamine (commonly used to treat motion sickness), mecamylamine (used to treat high blood pressure), and donepezil (used to treat memory loss). Cognitive testing will also be obtained, and correlated with the blood flow patterns in the brain.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cholinergic Function

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Project Summary: This research project will investigate the value of combined pharmacologic manipulation and arterial spin-labeled perfusion MRI (pharmacologic ASL-pMRI) as an in vivo probe of cholinergic function. Methods to investigate cholinergic function in vivo are needed to better understand the role of acetylcholine in the physiology of the cerebral cortex, and in cognitive processes in health and in disease states. In this study, pharmacologic ASL-pMRI will be used to characterize the normal cerebral perfusion response to cholinergic manipulation in young healthy subjects. Cognitive measures will also be obtained and correlated with cerebral perfusion changes. Pharmacologic ASL-pMRI and cognitive testing will then be used to study how the cholinergic response is altered with normal aging and in delirium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • healthy volunteers

Exclusion criteria

  • Any neurological condition, such as brain tumor, history of stroke, seizure disorder, attention deficit disorder, normal pressure hydrocephalus, dementia, traumatic brain injury
  • Any major medical conditions, such a cancer, diabetes, glaucoma, prostate disease, uncontrolled hypertension
  • antihistamine use
  • tricyclic antidepressant use
  • presence of metal in body, including pacemaker, defibrillator, neurostimulator, metal implants, or foreign metal objects such as bullets or shrapnel.
  • anxiety or panic disorder
  • history of claustrophobia
  • pregnancy

Treatment and study plan

Scopolamine

Drug

Scopolamine 0.4mg IM x 1 dose; adjustment in older group for weight (0.4mg/70kg)

Placebo

Drug

IM or PO placebo

Donepezil

Drug

donepezil 5mg PO x 1

Other names: Aricept

Primary outcomes

  1. Cerebral blood flow

    Time frame: 3 hours

    cerebral blood flow will be measured 3 hours after drug administration using Arterial spin-labeled perfusion MRI

Secondary outcomes

  1. cognitive performance

    Time frame: 4 hours

    participants will undergo cognitive testing following drug administration and MRI acquisition

Sponsors and collaborators

Lead sponsor

Hebrew SeniorLife

Other

Registry information

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Jun 23, 2011
Registry last updated
Jan 4, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.