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

June 21, 2011
January 3, 2013
July 2008
January 2013   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01379001 on ClinicalTrials.gov Archive Site
cognitive performance [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
participants will undergo cognitive testing following drug administration and MRI acquisition
Same as current
Not Provided
Not Provided
 
Assessment of Cholinergic and Cognitive Function Using Pharmacologic ASL-Perfusion MRI
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.

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

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Cholinergic Function
  • 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
  • Experimental: Young
    Young healthy controls, aged 21-35
    Interventions:
    • Drug: Scopolamine
    • Drug: Placebo
  • Experimental: Older
    Older healthy controls, aged 65-80
    Interventions:
    • Drug: Scopolamine
    • Drug: Placebo
    • Drug: Donepezil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
January 2013
January 2013   (final data collection date for primary outcome measure)

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
Both
21 Years to 80 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01379001
K23AG031320
No
Tamara Fong, Hebrew Rehabilitation Center, Boston
Hebrew Rehabilitation Center, Boston
Not Provided
Principal Investigator: Tamara Fong, MD Hebrew Rehabilitation Center
Hebrew Rehabilitation Center, Boston
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP