- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01379001
Assessment of Cholinergic and Cognitive Function Using Pharmacologic ASL-Perfusion MRI
January 3, 2013 updated by: Tamara Fong, Hebrew SeniorLife
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Young
Young healthy controls, aged 21-35
|
Scopolamine 0.4mg IM x 1 dose; adjustment in older group for weight (0.4mg/70kg)
IM or PO placebo
|
Experimental: Older
Older healthy controls, aged 65-80
|
Scopolamine 0.4mg IM x 1 dose; adjustment in older group for weight (0.4mg/70kg)
IM or PO placebo
donepezil 5mg PO x 1
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cerebral blood flow
Time Frame: 3 hours
|
cerebral blood flow will be measured 3 hours after drug administration using Arterial spin-labeled perfusion MRI
|
3 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
cognitive performance
Time Frame: 4 hours
|
participants will undergo cognitive testing following drug administration and MRI acquisition
|
4 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Tamara Fong, MD, Hebrew Rehabilitation Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2008
Primary Completion (Actual)
January 1, 2013
Study Completion (Actual)
January 1, 2013
Study Registration Dates
First Submitted
June 21, 2011
First Submitted That Met QC Criteria
June 22, 2011
First Posted (Estimate)
June 23, 2011
Study Record Updates
Last Update Posted (Estimate)
January 4, 2013
Last Update Submitted That Met QC Criteria
January 3, 2013
Last Verified
January 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Parasympatholytics
- Autonomic Agents
- Peripheral Nervous System Agents
- Muscarinic Antagonists
- Cholinergic Antagonists
- Cholinergic Agents
- Enzyme Inhibitors
- Antiemetics
- Gastrointestinal Agents
- Adjuvants, Anesthesia
- Nootropic Agents
- Cholinesterase Inhibitors
- Mydriatics
- Donepezil
- Scopolamine
- Butylscopolammonium Bromide
Other Study ID Numbers
- K23AG031320 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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