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

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ClinicalTrials.gov Identifier: NCT01379001
Recruitment Status : Completed
First Posted : June 23, 2011
Last Update Posted : January 4, 2013
Sponsor:
Information provided by (Responsible Party):
Tamara Fong, Hebrew Rehabilitation Center, Boston

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cholinergic Function Drug: Scopolamine Drug: Placebo Drug: Donepezil Not Applicable

Detailed Description:
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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Official Title: Assessment of Cholinergic and Cognitive Function Using Pharmacologic ASL-Perfusion MRI
Study Start Date : July 2008
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Young
Young healthy controls, aged 21-35
 Drug: Scopolamine
Scopolamine 0.4mg IM x 1 dose; adjustment in older group for weight (0.4mg/70kg)

Drug: Placebo
IM or PO placebo
Experimental: Older
Older healthy controls, aged 65-80
 Drug: Scopolamine
Scopolamine 0.4mg IM x 1 dose; adjustment in older group for weight (0.4mg/70kg)

Drug: Placebo
IM or PO placebo

Drug: Donepezil
donepezil 5mg PO x 1
Other Name: Aricept


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  1. cognitive performance [ Time Frame: 4 hours ]
    participants will undergo cognitive testing following drug administration and MRI acquisition


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01379001


Sponsors and Collaborators
Hebrew Rehabilitation Center, Boston
Investigators
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Principal Investigator: Tamara Fong, MD Hebrew Rehabilitation Center
More Information
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Responsible Party: Tamara Fong, Assistant Scientist/Assistant Professor of Neurology, Hebrew Rehabilitation Center, Boston
ClinicalTrials.gov Identifier: NCT01379001     History of Changes
Other Study ID Numbers: K23AG031320 ( U.S. NIH Grant/Contract )
First Posted: June 23, 2011    Key Record Dates
Last Update Posted: January 4, 2013
Last Verified: January 2013

Keywords provided by Tamara Fong, Hebrew Rehabilitation Center, Boston:
cholinergic function
aging
pharmacologic MRI

Additional relevant MeSH terms:
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Donepezil
Scopolamine
Butylscopolammonium Bromide
Cholinergic Agents
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents
 Adjuvants, Anesthesia
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Mydriatics
Cholinergic Antagonists
Muscarinic Antagonists
Parasympatholytics