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

NCT ID: NCT01379001

Last Updated: 2013-01-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2013-01-31

Brief Summary

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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

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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

Conditions

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Cholinergic Function

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Young

Young healthy controls, aged 21-35

Group Type EXPERIMENTAL

Scopolamine

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

IM or PO placebo

Older

Older healthy controls, aged 65-80

Group Type EXPERIMENTAL

Scopolamine

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

IM or PO placebo

Donepezil

Intervention Type DRUG

donepezil 5mg PO x 1

Interventions

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Scopolamine

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

Intervention Type DRUG

Placebo

IM or PO placebo

Intervention Type DRUG

Donepezil

donepezil 5mg PO x 1

Intervention Type DRUG

Other Intervention Names

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Aricept

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hebrew SeniorLife

OTHER

Sponsor Role lead

Responsible Party

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Tamara Fong

Assistant Scientist/Assistant Professor of Neurology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tamara Fong, MD

Role: PRINCIPAL_INVESTIGATOR

Hebrew Rehabilitation Center

Other Identifiers

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K23AG031320

Identifier Type: NIH

Identifier Source: org_study_id

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