Text Size

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tamara Fong, Hebrew Rehabilitation Center, Boston
ClinicalTrials.gov Identifier:
NCT01379001
First received: June 21, 2011
Last updated: January 3, 2013
Last verified: January 2013
History of Changes
  Purpose

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 Intervention
Cholinergic Function
 Drug: Scopolamine
Drug: Placebo
Drug: Donepezil

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: Assessment of Cholinergic and Cognitive Function Using Pharmacologic ASL-Perfusion MRI

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hebrew Rehabilitation Center, Boston:

Primary Outcome Measures:
  • Cerebral blood flow [ Time Frame: 3 hours ] [ Designated as safety issue: No ]
    cerebral blood flow will be measured 3 hours after drug administration using Arterial spin-labeled perfusion MRI


Secondary Outcome Measures:
  • cognitive performance [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
    participants will undergo cognitive testing following drug administration and MRI acquisition


Enrollment: 60
Study Start Date: July 2008
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   21 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01379001

Sponsors and Collaborators
Hebrew Rehabilitation Center, Boston
Investigators
Principal Investigator: Tamara Fong, MD Hebrew Rehabilitation Center
  More Information

No publications provided

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
Study First Received: June 21, 2011
Last Updated: January 3, 2013
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 19, 2013