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

Tracking Information

First Received Date ^ICMJE

June 21, 2011

Last Updated Date

January 3, 2013

Start Date ^ICMJE

July 2008

Primary Completion Date

January 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01379001 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

cognitive performance [ Time Frame: 4 hours ] [ Designated as safety issue: No ]

participants will undergo cognitive testing following drug administration and MRI acquisition

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

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 Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)

Condition ^ICMJE

Cholinergic Function

Intervention ^ICMJE

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

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

January 2013

Primary Completion Date

January 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

21 Years to 80 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT01379001

Other Study ID Numbers ^ICMJE

K23AG031320

Has Data Monitoring Committee

Responsible Party

Tamara Fong, Hebrew Rehabilitation Center, Boston

Study Sponsor ^ICMJE

Hebrew Rehabilitation Center, Boston

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Tamara Fong, MD

Hebrew Rehabilitation Center

Information Provided By

Hebrew Rehabilitation Center, Boston

Verification Date

January 2013

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

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